最新刊期
卷 32 ， 期 19 ， 2021
- 摘要：OBJECTIVE：To provide reference for i mproving the post-marketing drug risk management in China by refering to the experience of post-marketing drug risk management plan （RMP）in Japan. METHODS ：The process of post-marketing drug regulation in Japan was introduced ，and the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use （ICH）guidelines embodied in RMP in Japan were analyzed. The formulation and application of RMP in Japan during the post-marketing safety management were studied. And suggestions were offered for the improvement of post-marketing drug risk management in China. RESULTS & CONCLUSIONS ：The post-marketing regulation of drugs in Japan is characterized with dynamic regulation and social co-governance. ICH principle runs through the RMP management in Japan. Safety specification and risk minimization activities stipulated in RMP in Japan are consistent with ICH guidelines. RMP is defined in Pharmaceutical Affairs Law in Japan ，and is formulated and implemented under the guidance of the Good Vigilance Practice ；the changes are made under the guidance of the Good Post-marketing Study Practice. RMP is a necessary document for the registration and the re-review of new drugs in Japan ，its formulation is responsible by pharmaceutical enterprise ；RMP of new drug is available to the public through the subscription media system of Pharmaceuticals and Medical Devices Agency （PMDA）， which reflects the multi-governance of the government-pharmaceutical enterprises-the public. In China ，RMP supervision is not systematic and is inexperienced，and there is a lack of guidance documents and insufficient application of information and communication technology. It is suggested that China should strengthen post-marketing safety data management ，promote the connection between sentinel hospitals and pharmacovigilance systems of pharmaceutical enterprise ，increase the application of information and communication technology. Relevant normative documents and guidance documents of RMP should be issued by National Medical Products Administration. And the post-marketing supervision system for drugs should be clarified. Taking RMP publicity as an opportunity promote drug risk mamagement co-government ， realize sunshine and scientific supervision .
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发布时间：2022-06-21 - 摘要：OBJECTIVE：To prov ide effective improvement paths and policy suggestions for improving the innovation efficiency of TCM industrial enterprises. METHODS ：Based on the input and output data of innovation resources of 38 listed TCM industrial enterprises from 2014 to 2020，an evaluation index system was constructed from the perspective of all factors. First ，the deta envelopment analysis （DEA）model was used to measure the static efficiency of the sample enterprises ，and at the same time ， four patterns of innovative resource utilization were provided ；then the total factor Malmquist index method was used to analyze the decomposition of the changes in utilization efficiency of innovative resources according to different periods and micro-individuals. RESULTS & CONCLUSIONS ：The overall efficiency of innovative resource utilization of listed TCM industrial enterprises was too low，and the average overall efficiency was only 0.293. The input and output of innovation resources of 33 enterprises were unreasonable，and the reasons for the inefficiency are mostly due to insufficient pure technical efficiency. The average value of the all-factor Malmquist index was 0.818 for 38 sample enterprises ，and the overall efficiency was declining. The obstacles to technological progress were a more important reason for the decline in efficiency. It is recommended to improve TCM industrial enterprise’s ability to allocate innovation resources and adjust the proportion of R&D investment in conjunction with the return to scale；clarify the development principles with scientific and technological innovation as the core driving force ，and actively carry out basic research work ；implement the production and research platform of “TCM industrial enterprise-TCM research institution ” to promote the overall technological progress of the industry.
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发布时间：2022-06-21 - 摘要：OBJECTIVE：To study the prot ective effects of crocin （CR）against triptolide （TP）-induced visceral organ injury in mice，and to provide reference for the studying TP compatibility and detoxification. METHODS ：Fifty mice were randomly divided into normal group ，TP low-dose and high-dose groups （i.e. TP-L group ，TP-H group ，with 300，600 μg/kg），TP low-dose and high dose combined with CR groups （i.e. TP-L+CR group ，TP-H+CR group ，with 300 μg/kg TP+100 mg/kg CR ，600 μg/kg TP+ 100 mg/kg CR ），with 10 mice in each group. Except for normal group ，other groups were given relevant medicine intragastrically ， once a day ，for consecutive 7 d. The body weight of mice was weighted every day ，and their death was recorded. After last administration，the mice were sacrificed ，and the heart ，liver，kidney and testis were taken ，and the organ index was calculated ； serum levels of ALT ，AST，BUN and Scr ，the activity of T-SOD and the contents of MDA were all determined. The pathological changes of heart ，liver，kidney and testis were observed ；mRNA expression of Bcl- 2，Bax and caspase- 3 in liver tissue were determined. RESULTS ：Three，five，two and three mice in TP-L group ，TP-H group ，TP-L+CR group and TP-H+CR group died respectively，and the survival rates were 70％，50％，80％ and 70％，respectively. Compared with normal group ，the body weight （7th day of experiment ），heart index ，liver index ，kidney index （except for TP-L group ），testicular index ，T-SOD activity and mRNA expression of Bcl- 2 in liver tissue ，serum levels of ALT （except for TP-L group ），AST（except for TP-L group ），BUN and Scr，MDA content and mRNA expression of Bax ，mRNA expression of caspase- 3 in liver tissue were increased significantly （P＜ 0.05 or P＜0.01）. There were obvious pathological changes in heart ，liver，kidney and testis tissue. Compared with the same dose of TP alone group ，the above indexes of TP combined with CR group were improved in varying degrees. Except for the renal index and serum ALT level of TP-L+CR group ，there was statistical significance for all indexes （P＜0.05 or P＜0.01）；the pathological injuries of heart ，liver，kidney and testis were significantly improved. CONCLUSIONS ：CR can relieve the damage of heart ， liver，kidney and testis induced by TP ，which may be related to the antioxidant stress of CR.关键词：Triptolide;Crocin;Compatibility attenuation;Organ damage;Oxidative stress;Mice
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发布时间：2022-06-21 - 摘要：OBJECTIVE：To optimize the form ulation of Zuojin pectin c apsules，and to prepare modern Zuojin pectin capsules with protective effects against gastric ulcers. METHODS ：The formulation of Zuojin pectin capsules was optimized with orthogonal test with the contents of pectin ，soluble starch and dextrin as factors ，using formability ，moisture absorption and flow ability as indicators. Zuojin pectin capsule was prepared by wet granulation filling method with Zuojin extract powder as raw material. The contents of palmatine hydrochloride ，berberine hydrochloride ，evodiamine and rutaecarpin were evaluated by HPLC. Basket method was used to investigate the release behavior of the capsule in 0.1 mol/L HCl solution. The gastric ulcer model of rats was established by intragastric administration of 75％ ethanol. Gastric ulcer index ，the inhibition rate of gastric ulcer and the pathological sections were used as indexes to investigate the protective effect of Zuojin pectin capsules （the doses were 54，108， 216 mg/kg）on gastric ulcer. RESULTS ：The optimal formulation of Zuojin pectin capsules included 45％ pectin，12％ soluble starch，27％ dextrin and 1％ xylitol. Results of in vitro drug ， release showed that palmatine hydrochloride and berberine， hydrochloride in Zuojin pectin capsules released 53.76％ and No.54.82％ respectively within 1 h，completely released at about 8 h， and conformed to the zero-order release behavior. 2492109374@qq.com Different doses of Zuojin pectin capsule could improve the ulcer injury of gastric tissue in gastric ulcer model rats to different extent ，and significantly reduced the gastric ulcer index（P＜0.01），significantly increased the inhibition rate of gastric ulcer and the percentage of positive expression area of Schiff ’s iodate staining （P＜0.01）. CONCLUSIONS ：Zuojin pectin capsule with protective effect on gastric ulcer and certain sustained- release effect is successfully prepared.关键词：Zuojin pectin capsule;Gastric ulcer;Orthogonal test;Sustained-release effect;Rat
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发布时间：2022-06-21 - 摘要：OBJECTIVE：To discuss the mechanism of synovitis of knee osteoarthritis （KOA）relieved by “Sanse powder ” volatile oil based on the activation of Nod-like receptor family 3（NLRP3）inflammasome. METHODS ：“Sanse powder ”volatile oil was extracted by distillation- condensation process and the components of it were analyzed by GC-MS. Fibroblast-like synovial cells（FLS）were extracted from the knee joint of male SD rats. The effects of 10，25，50，100，250，500，1 000 μg/mL“Sanse powder”volatile oil on the viability of FLS were examined by CCK-8 assay. KOA inflammatory cell model was induced by lipopolysaccharide for 12 h. The effects of 10，250 μg/mL“Sanse powder ”volatile oil on the protein and mRNA expression of NLRP3，caspase-1 and apoptosis-associated speck-like protein （ASC）were detected. The levels of IL- 1β and IL-18 in supernatants of FLS were determined . RESULTS ：Totally 0.51-0.61 g volatile oil with yellow clear and unique aromatic odor were extracted from“Sanse powder ”，and the extraction rate was 0.33％-0.41％（n＝9）. A total of 41 chemical components were isolated ，and 30 of them were identified and their peak area accounted for 90.073 6％ of the total peak area. The components with high relative content were gingerol flavonoids （17.573 9％），δ-junionene（15.434 5％），gingerol（11.509 5％），etc. When the concentration of volatile oil was 10-250 μg/mL，there was no significant effect on survival rate of FLS （P＞0.05）. Compared with blank group ，the relative protein and mRNA expression of NLRP 3，caspase-1 and ASC and the levels of IL- 1β and IL-18 in supernatant were significantly increased in model group （P＜0.05）. Compared with model group ，relative expression or levels of above indexes were all decreased significantly in FLS and supernatant of “Sanse powder ”volatile oil 10 and 250 μg/mL groups（P＜0.05）. CONCLUSIONS：“Sanse powder ”volatile oil can inhibit NLRP 3 inflammasome activation in FLS and reduce the downstream inflammatory cascade response ，thus exerting its efficacy in ameliorating synovial inflammation of KOA.
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发布时间：2022-06-21 - 摘要：OBJECTIVE：To explore the therap eutic effects and its mech anism of Jianpi yiqi decoction on diethylnitrosamine （DEN）induced liver cancer model rats. METHODS ：Totally 80 male SD rats were divided into normal group ，model group ， Nod-like receptor family 3（NLRP3）inhibition group （MCC950，4.5 mg/kg），caspase-1 inhibitory group （VX-765，4.5 mg/kg）， Jianpi yiqi decoction low-dose ，medium-dose and high-dose groups （5.25，10.5，21 g/kg），with 10 rats in each group except for 20 rats in model group （10 of them were only used to judge whether modeling was successful ）. Rats in each group were intraperitoneally injected with DEN （70 mg/kg）to induce liver cancer model ，except for the rats in normal group which were replaced by normal saline. After modeling ，normal group and model group were given normal saline intragastrically ；inhibitor groups were given relevant medicine intraperitoneally ；Jianpi yiqi decoction groups were given relevant medicine intragastrically ， once a day ，for consecutive 4 weeks. After last administration ，histopathological morphology of liver tissue was observed. The contents of serum inflammatory factors TNF-α and IL-1β were detected. The expression of NLRP3 and programmed cell necrosis associated protein （ASC，pro-caspase-1，RIP1，RIP3 and MLKL ）in liver tissue were detected. RESULTS ：Compared with the normal group ，the hepatocytes of model group showed varying， degrees of steatosis ，enlarged nuclei ，lumpy，bleeding and necrosis，accompanied by proliferative foci and nodules. Liver 198086， tissue injury index ，serum content of TNF-α and IL-1β as well as the protein expression of NLRP 3，ASC，pro-caspase-1，RIP1，RIP3 and MLKL in liver tissue were significantly increased （P＜0.05 or P＜0.01）. Compared with model 防治。E-mail：sherwin_zhuo@126.com group，there were still a large number of inflammatory cell infiltration in the liver tissue of rats in Jianpi yiqi decoction low-dose and medium dose groups ，while the inflammatory cell infiltration of rats in high-dose group and inhibitor groups decreased significantly ；the liver tissue injury index and above indexes levels in serum and liver tissue were decreased significantly （P＜0.05 or P＜0.01）. CONCLUSIONS ：Jianpi yiqi decoction shows therapeutic effect on liver cancer model rats ，the mechanism of which may be associated with down-regulating the expression of NLRP3 inflammasome and inhibiting programmed cell necrosis.关键词：Jianpi yiqi decoction;Liver cancer;Nod-like receptor family 3 inflammasome;Programmed necrosis
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发布时间：2022-06-21 - 摘要：OBJECTIVE：To study the effects of Cu rcumin solid lipid n anoparticels （Cur-SLN） on cardiac ，renal and pulmonary functions ，the expression of autophagy related factors in cardiorenal syndrome model rats. METHODS ：The rats were divided into sham operation group ，model group ，rapamycin group （positive control ，2 mg/kg），Cur-SLN low-dose and high-dose groups（5，10 mg/kg），except for 13 rats in the model group （3 of which are used to judge whether modeling is successful ），10 rats in the other groups. Except for sham operation group ，cardiorenal syndrome of other groups were induced by abdominal aortic coarctation combined with acute renal ischemia-reperfusion injury. After successful modeling ，rats in each administration group were injected with corresponding drugs through caudal vein ，and rats in sham operation group and model group were injected with equal volume normal saline ，once a day for 4 weeks. Twenty-four hours after the last administration ，the contents of angiotensin converting enzyme （ACE），free triiodothyronine （FT3） and arginine vasopressin （AVP） in rat serum were detected. The pathological morphology of rat heart ，kidney and lung were observed. The distribution and expression of LC 3 and Beclin- 1 protein in rat heart ，kidney and lung were detected. RESULTS ：Compared with sham operation group ，the contents of ACE and FT 3 in serum，the indexes of heart and kidney ，the expression of LC 3（except in renal tissue ）and Beclin- 1 protein in heart ，kidney and lung were significantly increased （P＜0.01），and the contents of AVP and lung index were decreased significantly （P＜0.01）； myocardial cells in the non-infarcted area of the heart were obviously hypertrophic ，the arrangement of myocardial fibers was disordered ； the structure of renal tubules in the non-infarcted area of the kidney was disordered ；and there was cystic expansion and obvious inflammatory cell infiltration llittls- in the alveoli ；positive expression of LC 3 and Beclin- 1 protein nows@126.com in heart ，kidney and lung increased ，mainly distributed in the cytoplasm of cardiomyocytes ，distal renal tubular epithelial cells ，alveolar macrophages and epithelial cells. Compared with model group，the above indexes of rats in each dose group of Cur-SLN were mostly significantly reversed ；the pathological changes of heart，kidney and lung tissues were reduced ，the infiltration of inflammatory cells was reduced ；and the positive expression of LC 3 and Beclin- 1 protein were reduced ，which were mainly distributed in the cytoplasm of cardiomyocytes and proximal renal tubular epithelial cells ，and a few in distal renal tubular epithelial cells ，alveolar macrophages and epithelial cells. CONCLUSIONS ： Cur-SLN can improve the heart ，kidney and lung functions of rats with cardiorenal syndrome ，and its mechanism may be related to regulating the distribution or expression of LC 3 and Beclin- 1 protein in heart ，kidney and lung.关键词：Curcumin;Solid lipid nanoparticles;Cardiorenal syndrome;Autophagy
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发布时间：2022-06-21 - 摘要：OBJECTIVE：To establish the method for the content de termination of 17 quality markers in Dahuang zhechong pills（DHZCP）. METHODS ：HPLC method was adopted to determine the contents of 17 quality markers in 10 batches of DHZCP ， such as allantoin ，hypoxanthine，salidroside，hydroxypaeoniflorin，glycyrrhizin，isoglycyrrhizin，baicalin，p-methoxyphenylacetic acid，wogonin，cinnamic acid ，apigenin，naringin，norwogonin，aloe emodin ，rhein，chrysin，emodin. The determination was performed on Kromasil 100-5-C18（250 mm × 4.6 mm，5 μm）column with mobile phase consisted of 0.1％ phosphoric acid solution-acetonitrile （gradient elution ） at the flow rate of 1.0 mL/min. The column temperature was 30 ℃ ，the detection wavelength was 210 nm and the sample size was 20 μ L. RESULTS：The linear range of above 17 quality markers were 5.74-183.53，6.51-208.24，4.30-137.65，4.60-147.06，4.12-131.76，4.25-135.88，6.31-201.76，4.60-147.06，1.94-62.06，4.47- 142.94，0.69-22.06，2.29-73.24，2.33-74.41，1.42-45.29，6.65-212.94，1.11-35.44 and 1.47-47.06 μg/mL，respectively（all R2≥ 0.999 0）. RSDs of precision ，repeatability，stability and durability tests were all less than 2％（n＝6）；average recovery of 17 quality markers ranged from 96.31％ to 101.73％，and the RSDs were less than 3％（n＝6）. CONCLUSIONS ：The method is simple， rapid，speific，specise，reproducible，stable，accurate and durable ，and can be used for improving the quality standard of DHZCP.关键词：Dahuang zhechong pills;Quality marker;HPLC;Quality stan dard;Content determination
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发布时间：2022-06-21 - 摘要：OBJECTIVE：To establish UPLC fingerpri nt of Ligusticum sinense ，Ligusticum jeholense and Conioselinum vaginatium，and to conduct their chemometrics analysis so as to provide reference for the identification of Rhizoma Ligustici from different origins. METHODS ：UPLC method combined with Similarity Evaluation System of TCM Chromatographic Fingerprints （2012 edition） were used to establish the fingerprints of Rhizoma Ligustici from different origins. Chromatographic peak identification and similarity evaluation were carried out. Cluster analysis （CA），principal component analysis （PCA） and orthogonal partial least squares discriminant analysis （OPLS-DA）were performed to analyze Rhizoma Ligustici from different origins，and screen differential components. RESULTS ：Totally 13，11，11 characteristic peaks were identified in UPLC fingerprints of L. sinense ，L. jeholense and C. vaginatium ，respectively. Similarity evaluation showed that the similarity between C. vaginatium and L. jeholense were 0.312-0.541；that between C. vaginatium and L. sinense were 0.324-0.682；that between L. sinense and L. jeholense were 0.312-0.671，indicating there was great difference among Rhizoma Ligustici from different origins. CA，PCA and OPLS-DA showed that Rhizoma Ligustici from different origins were clustered into each category respectively ； chemical components represented by peak 10，peak 13，peak 12，peak 7 and peak 6 were differential components for Rhizoma Ligustici from 3 origins. CONCLUSIONS ：The study establishes UPLC fingerprint of Rhizoma Ligustici from different origins ， and screens 5 differential components ，which can be used to identify Rhizoma Ligustici from different origins.
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发布时间：2022-06-21 - 摘要：OBJECTIVE：To study the effect and potential mechanism of the total flavonoids from Marchantia convoluta on anti-hepatic fibrosis in the mice. METHODS ：Seventy-two mice were randomly divided into blank group ，model group ，positive control group （colchicine 0.2 mg/kg）and M. convoluta total flavonoids high-dose ，medium-dose and low-dose groups （300，150， 75 mg/kg），with 12 mice in eac group. Except for blank group ，other groups were subcutaneously given 25％ CCl4-peanut oil solution on the back to induce liver fibrosis model. At the same time ，blank group and model group were given water intragastrically，while other groups were given relevant medicine intragastrically 20 mL/kg，once a day ，for consecutive 10 weeks. After last administration ，the serum levels of ALT and AST were detected . Histopathological changes of liver tissue in mice was observed. The levels of COL- Ⅰ，COL-Ⅲ and TGF-β1 in liver tissue were detected . The protein expression levels of α-SMA and TGF-β1，Smad2，Smad4 and Smad 7 in liver tissue were detected . The expression levels of TGF-β1，Smad2，Smad4 and Smad 7 mRNA in liver tissue were detected . RESULTS ：Compared with blank group ，the serum levels of ALT and AST in model group，the levels of COL- Ⅰ，COL-Ⅲ and TGF-β1 in liver tissue，protein expression levels of α-SMA，TGF-β1，Smad2 and Smad 4，mRNA expression levels of TGF-β1，Smad2 and Smad4 were increased significantly （P＜0.05 or P＜0.01）.The mRNA and protein expression levels of Smad 7 in liver tis sue were decreased significantly （P＜0.05）. The degree of liver tissue injury and collagen fiber hyperplasia were serious. Compared with model group ，above indexes of mice were reversed significantly in positive control group and M. convoluta total flavonoids high-dose group （P＜0.05 or P＜0.01）. Serum level of ALT ，the levels of COL- Ⅰ，mRNA and protein expression of TGF-β1，Smad2 and Smad 4 in liver tissue were decreased significantly in M. convoluta total flavonoids medium-dose group （P＜0.05 or P＜0.01）. Protein expression of Smad 2 and Smad 4 in liver tissue were decreased significantly in M. convoluta total flavonoids low-dose group （P＜0.05）. The liver injury and fibrosis of mice were relieved in administration groups. CONCLUSIONS ：M. convoluta total flavonoids possess the effect of anti-hepatic fibrosis ，the mechanism of which is related to the regulation of mRNA and protein expression of TGF-β1，Smad2，Smad4 and Smad 7 in the signaling pathway of TGF-β/Smad.关键词：Marchantia convoluta;Total flavonoids;Hepatic fi brosis;TGF-β/Smad signaling pathway;Mice
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发布时间：2022-06-21 - 摘要：OBJECTIVE：To study the sta bility，in vivo release characteristics and tissue distribution of docetaxel （DTX）- dihydroartemisinin（DHA）conjugated prodrug self-assembled nanoparticles （DTX-S-S-DHA NPs ）. METHODS ：HPLC method was adopted to analyze DTX-S-S-DHA in vitro . The phycial and long-term stability of DTX-S-S-DHA NPs in mediums [water ， saline，phosphate buffer （PBS，pH 7.4）and RPMI 1640 medium] were investigated by using particle size ，polydispersity index （PDI）and encapsulation efficiency （EE）as evaluation indexes. The in vitro release characteristics of DTX-S-S-DHA released from DTX-S-S-DHA NPs was also investigated with small glass method ，using 30％ ethanol solution with or without 10 mmol/L dithiothreitol（DTT）as medium. The small live animal imager was adopted to investigate the tissue distribution and tumor targeting capability of DiR-labeled DTX-S-S-DHA NPs （DTX-S-S-DHA/DiR NPs ）in breast cancer bearing mice. RESULTS ：In stability test，there was no statistical difference in particle size ，PDI and EE of DTX-S-S-DHA NPs incubated in water ，normal saline ，PBS and RPMI 1640 medium for 24 h. When stored at 4 ℃，with the increase of storage time ，the particle size of DTX-S-S-DHA NPs in normal saline gradually increased ，while those in PBS gradually decreased ；EE of both gradually decreased to less than 75％， but there was no significant change in particle size ，PDI and EE of DTX-S-S-DHA NPs in water and RPMI 1640 medium. In the in vitro release experiments ，DTX-S-S-DHA in DTX-S-S-DHA NPs was not released in the release medium containing 10 mmol/L DTT；at 24 h，the cumulative release rate of DTX-S-S-DHA released from DTX-S-S-DHA NPs in release medium without DTT was about 83％，which was in line with first-order kinetic model. In tissue distribution test ，the distribution of DTX-S-S-DHA/DiR NPs in tumor sites of mice was significantly more than in other tissues （heart，liver，spleen，lung and kidney ）. CONCLUSIONS ： DTX-S-S-DHA NPs show good physical stability in different mediums ，especially have good long-term stability in water and RPMI ； 1640 medium；they can quickly release the parent drug in the reduction environment and has good tumor targeting.
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发布时间：2022-06-21 - 摘要：OBJECTIVE：To investigate the contents of 5 kinds of heavy metal as copper （Cu），arsenic（As），cadmium （Cd），mercury（Hg）and lead （Pb）in Yougui pills ，and to evaluate its safety risk. METHODS ：Using yttrium （89Y），indium （115In）and bismuth （209bi）as internal standard ，the contents of each element were determined by ICP-MS. ICP-MS condition included that atomization gas flow rate was 0.95 L/min，auxiliary gas flow rate was 1.2 L/min，plasma gas （argon）flow rate was 18 L/min，pump speed was 30 r/min. RF power of inductively coupled plasma was 1 200 W，the voltage in simulation stage was 1 750 V，the voltage in pulse stage was 1 300 V，the voltage of deflection device was －12 V，and the detector was in analog and pulse dual-mode. The determination methods of various elements were investigated ，and 45 batches of marketed Yougui pills were determined. Hazard index （HI）was used to analyze the non-carcinogenic risk of each element and calculate the maximum residual limit（MRL）of each element. RESULTS ：The linear range of Cu ，As，Cd，Hg and Pb ranged from 10-200，1-50，0.4-30，0.2-6 and 2-100 μg/L（all r＞0.999 0），respectively. The limits of quantitation were 0.67，0.23，0.20，0.07，0.27 μg/L. The limits of detection were 0.20，0.07，0.06，0.02，0.08 μg/L. RSDs of precision，stability and reproducibility tests were all lower than 3.5％ （n＝6 or n＝5）. Average recoveries were 92.96％-100.89％（RSD＝2.23％-3.62％，n＝3）. Average contents of Cu ，As，Cd，Hg and Pb in 45 batches of Yougui pills were 2.72，0.28，0.07，0.05，0.62 mg/kg，and superimposed HI of each element was less than 1. The contents of 5 kinds of heavy metals in Yougui pills were lower than the proposed MRL （MRL of Cu ，As，Cd，Hg and Pb were 20，2，1，0.2，5 mg/kg or 111.11，4.44，2.22，1.48，8.89 mg/kg respectively ）. CONCLUSIONS ：Established method can be used for the determination of content of 5 kinds of heavy metal in Yougui pills ；the heavy metal pollution rate of marketed Yougui pills is low and the safety risk is small.关键词：Yougui pills;Heavy metals;ICP-MS;Limit;Maximum residual limit;Hazard index
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发布时间：2022-06-21 - 摘要：OBJECTIVE：To optimize the formulation of Curcumin （CUR）transethosomes（CUR-TEs）. METHODS ：The contents of CUR in CUR-TEs were determined by HPLC. CUR-TEs were prepared by injection method. Using comprehensive score of encapsulation efficiency and drug loading as index ，based on signal factor test ，Box-Behnken design-response surface method was used to optimize and validate the formulation. The property of CUR-TEs prepared by the optimal formulation was investigated. RESULTS：The optimal formulation of CUR-TEs was as follows as lecithin of 4％，CUR of 0.13％，1，2-propylene glycol of 25％，tween-80 of 1％. Results of validation test of optimal formulation showed that comprehensive score of encapsulation efficiency and drug loading of CUR-TEs was 93.04±2.16，relative error of which to predicted value （91.19）was 2.03％. The encapsulation efficiency of CUR-TEs prepared by optimal formulation was （91.17±1.35）％，and its drug loading was （0.94± 0.02）％. The particle size was （190.64±15.97）nm with polydispersity index of 0.086±0.007，and Zeta potential was （－12.74± 1.60）mV. CONCLUSIONS ：The optimized formulation of CUR-TEs is stable ，feasible and repeatable ，with good stability.关键词：Curcumin;Transethosomes;HPLC;Box-Behnken design-response surface method;Formulation optimization
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发布时间：2022-06-21 - 摘要：OBJECTIVE：To study the relationship of polymorphism of clopidogrel absorption and metabolism related genes CYP2C19（* 2，* 3，* 17），ABCB1 C3435T and PON1 Q192R in patients with coronary heart disease in Xinjiang Uygur Autonomous Region ，and to explore the characteristics of population and combined diseases. METHODS ：A total of 1 126 patients with coronary heart disease who underwent clopidogrel absorption and metabolism related gene testing during hospitalization in the First Affiliated Hospital of Xinjiang Medical University from January 2016 to June 2020 were included as the study subjects. The gender，age，body mass index （BMI），nationality and the proportion of combined with hypertension and diabetes were compared among different CYP2C19 metabolic phenotypes and ABCB1 C3435T and PON1 Q192R genotypes. RESULTS ：Among 1 126 patients，1 126 had CYP2C19 * 2，* 3 and * 17 genotypes，1 109 had ABCB1 C3435T genotype and 1 123 had PON1 Q192R genotype. The distribution of each genotype was in line with Hardy-Weinberg balance （P＞0.05）. There were 66（5.86％）， com 459（40.76％），476（42.27％） and 125（11.10％）patients with CYP2C19 ultra-rapid metabolizer （UM）， extensive metabolizer（EM），intermediate metabolizer （IM）and poor metabolizer（PM），respectively. The proportion of patients with UM metabolism phenotype with BMI ＞24 was significantly higher than those of patients with IM and PM metabolism phenotypes （P＜0.05）. The proportion of Han nationality patients with UM metabolic phenotype was significantly lower than those of patients with EM ，IM and PM metabolic phenotypes （P＜0.05）；the proportion of Uygur nationality was significantly higher than that of patients with EM ，IM and PM metabolic phenotypes （P＜ 0.05）. There were 355，538 and 216 patients with ABCB1 C3435T wild-type（CC），heterozygous（CT）and mutant homozygous （TT）genotypes，respectively；the proportion of Han nationality in TT genotype patients was significantly lower than that in CC and CT genotype patients （P＜0.05），and the proportion of Uygur nationality was significantly higher than that in CC and CT genotype patients （P＜0.05）；the proportion of TT genotype patients with diabetes was significantly higher than that of patients with CT genotype （P＜0.05）. There were 365，519 and 239 patients with PON1 Q192R wild-type（GG），heterozygous（GA）and mutant homozygous （AA），respectively；the proportion of Han nationality in AA genotype patients was significantly lower than that in GG and GA genotype patients （P＜0.05），and the proportion of Uygur nationality was significantly higher than that of GG and GA genotype patients （P＜0.05）；the proportion of Han nationality and BMI ≤24 in patients with AA genotype were significantly lower than those with GA genotype （P＜0.05），and the proportion of Uygur nationality ，BMI＞24 and hypertension were significantly higher than those in GA genotype patients （P＜0.05）. CONCLUSIONS ：There are significant nationality differences among patients with different CYP2C19 metabolic phenotypes and ABCB1 C3435T and PON1 Q192R genotypes. In addition，patients with BMI ＞24 account for high proportion among CYP2C19 UM metabolism genotype ；patients with diabetes account for high proportion among ABCB1 C3435T TT genotype ；patients with BMI ＞24 and hypertension account for high proportion among PON1 Q192R AA genotype.关键词：Clopidogrel;Metabolic phenotype;Gene polymorphism;Xinjiang Uygur Autonomous Region;Coronary heart
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发布时间：2022-06-21 - 摘要：OBJECTIVE：To study the effects of virus in activation treatment of plasma specimen on plasma concentration determination of voriconzole ，linezolid，vancomycin and teicoplanin. METHODS ：The remaining plasma of 36 inpatients in our hospital after routine blood concentration examination of voriconazole ，linezolid，vancomycin and teicoplanin were collected as specimen（9 drug-contained plasma specimens for each drug ），and merged into three different concentration levels （low，medium， high）of mixed samples according the results of routine blood test. Then the mixed samples with different concentration levels were divided into inactivated group and non-inactivated group ，with 3 samples in each group. The inactivated plasma samples were heated at 56 ℃ for 30 min in metal bath with constant temperature. Non-inactivated group were not treated. After pretreating plasma sample of 2 groups，2-dimensional liquid chromatography was used to detect plasma concentration of the four drugs ；the difference of detection result between inactivated group and non-inactivated group were analyzed. RESULTS ：Plasma samples containing voriconazole，linezolid，vancomycin and teicoplanin were still stable after heating at 56 ℃ for 30 min in metal bath with constant temperature. Compared with non-inactivated group ，relative error of plasma concentration detection result of above 4 drugs were all lower than 15％ in low ，medium，high concentration mixed samples of inactivated group. CONCLUSIONS ：Plasma samples can be inactivated by heating at 56 ℃ for 30 min in metal bath with constant temperature ，when the plasma concentration of voriconazole，linezolid，vancomycin and teicoplanin are determined by 2-dimensional liquid chromatography.关键词：Voriconazole;Linezolid;Vancomycin;Teicoplanin;Plasma concentration;Plasma sample;Virus inactivation
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发布时间：2022-06-21 - 摘要：OBJECTIVE：To evaluate the efficacy and safety of atomization inhalation of polymyxin combined in the adjunctive treatment for ventilator-associated pneumonia ，and to provide evidence-based reference for clinical treatment. METHODS ： Retrieved from Cochrane Library ，Embase，PubMed，Web of Science ，CNKI，CBM，VIP and Wanfang database （from their inception to March 2021），randomized controlled trials （RCTs）about efficacy and safety of atomization inhalation of polymyxin combined with conventional treatment （trial group ） versus conventional treatment （control group ） for ventilator- associated pneumonia were collected. After data extraction and quality evaluation of included literatures met inclusion and exclusion criteria ， Meta-analysis was performed by using Rev Man 5.4 software. RESULTS ：A total of 13 clinical studies were included ，involving 2 RCTs and 11 cohort studies with a total of 1 066 patients. The results of Meta-analysis showed that clinical response rate [OR ＝ 1.53，95％CI（1.17，2.00），P＝0.002]，microbial clearance rate [OR ＝1.46，95％CI（1.11，1.91），P＝0.007] of trial group were significantly higher than those of control group ，with statistical significance. There was no statistical significance in the mortality rate [OR ＝0.88，95％CI（0.68，1.14），P＝0.32] and the incidence of renal impairment [OR ＝1.04，95％CI（0.72，1.49），P＝0.85] between 2 groups. CONCLUSIONS ：Based on current evidence ，atomization inhalation of polymyxin combined with conventional treatment can significantly improve clinical response rate and microbial clearance rate of patients with ventilator- associated pneumonia. However ， more strictly-designed ， long-term follow-up and large-scale RCTs are needed.
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发布时间：2022-06-21 - 摘要：OBJECTIVE：To provide reference for the development and application of pharmacy popular-science video courseware. METHODS ：Combined with the problems existing in the medication of patients with chronic diseases at the present stage and the key points of medication management ，the theme ，content and form of this popular-science were determined ；the video shooting and production were completed ，and publicity and promotion were carried out. Questionnaire survey was conducted ， and the reception of pharmacy outpatient service in our hospital was counted ；the broadcasting effects of popular-science video were analyzed. RESULTS ：The theme of popular-science video courseware was determined to be self-medication management of patients with chronic diseases at home assisted by pharmacists. Combined with the “five moments ”of medication safety proposed by WHO ， the content included six units as knowing pharmacists ，understanding drugs ，taking drugs ，adding drugs ，checking drugs ，and discontinuing drugs. PPT video was used to explain the contents of each unit ，with an average duration of about 25 min. After the first unit was launched ，a total of 39 327 hits were received within two months. A total of 100 questionnaires were sent out ，97 questionnaires were collected （recovery rate of 97.0％）. Among them ，80（82.5％）thought it helpful to watch the video. Within two months after the broadcast of unit 1 video，the reception volume of pharmacy outpatient department of our hospital （1 160 person times ）increased by 104.2％ compared with the two months in the same period last year （568 person times ），and increased by 18.7％ compared with the two months before the broadcast （977 person times ）；99 patients came to the pharmacy outpatient department to consult because of watching the video ，and 55.6％ of the registered patients consulted the demonstration of video courseware and repeatedly mentioned related problems. CONCLUSIONS ：It is a beneficial exploration for pharmacists to develop popular-science video courseware with the theme of safe and rational drug use. It is the direction for future work to increase the scope of disease types ，target different groups of people or focus on different types of drugs and promot them in various forms.
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发布时间：2022-06-21
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