Objective To establish a method for bacterial endotoxin test of flumazenil bulk drug.Methods According to the bacterial endotoxin test(BET)method in general rule 1143 in the Chinese Pharmacopoeia(2020 Edition,VolumeⅣ),flumazenil was dissolved with dimethyl sulfoxide(DMSO)and diluted with BET water.The gel-clot method and kinetic turbidimetric assay were used to carry out the interference test and endotoxin recovery test.Results Flumazenil was dissolved with DMSO to 10 mg·mL-1,and then diluted 100 times or more by BET water,which has no interference effects on the bacterial endotoxin test.Conclusion The BET method established in this study can be used to control the quality of flumazenil by performing bacterial endotoxin tests.

OBJECTIVE：To provide reference for improving the operation efficiency of drug quality sampling and inspection in China . METHODS ：Starting from the application and management situation of inspection standards/methods in provincial inspection institutions ，the problems existing in the application and management of inspection standards/methods in provincial inspection institutions were analyzed ；the inspection standards/methods database of provincial inspection institutions is attempted to build，combining with the relevant experience and practices of FDA. RESULTS & CONCLUSIONS ：The inspection methods involved in drug sampling and inspection could be divided into official standards and non-standard methods. Official standards were the main standards for drug sampling and inspection ，and were mainly used for routine inspection. Such kind of standards could be classified according to the characteristics of compiled ，single-page and later-issued supplementary ；an electronic catalogue should be established for unified management. Non-standard methods were only used for sample preliminary screening ，verification of official inspection results ，quality evaluation and inspection of unknown or suspicious samples in emergency inspection. Its tracking，collection and management mechanisms were not yet complete. It is recommended to draw on the experience of drug sampling and inspection in the United States so as to establish method database hierarchically. For the mature method established in drug supervision system ，an electronic catalog and document content database should be established and the method should be confirmed before use ；for national standards and the recommended methods published by authoritative institutions in other industries，and mature methods published in scientific and technological literature ，the retrieval channels should be listed ，the methods should be verified ，reviewed and approved before use ，and an electronic catalogue should be established and recorded in time after use. The electronic catalogue format of non-standard methods generally include controlled number ，applicable variety name，method name ，inspection items ，etc.

Objective:To observe the therapeutic effect of warm needling moxibustion for erectile dysfunction (ED).
Methods:A total of 46 eligible ED patients were randomized into a treatment group (n=24) and a control group (n=22). The treatment group was intervened by warm needling moxibustion while the control group by conventional acupuncture treatment, for a total of 4 courses. The therapeutic effect was evaluated by the international index of erectile function 5 (IIEF-5).
Results:After 4 courses of treatment, the overall effective rate was 91.3% in the treatment group (23 completed), versus 75.0% in the control group (20 completed), with a significant difference (P<0.05). After the treatment, the change of IIEF-5 score in the treatment group was significantly different from that in the control group (P<0.05).
Conclusion:Warm needling moxibustion can produce a more significant efficacy than conventional acupuncture in the treatment of ED.

Objective:To evaluate the cytotoxicity of ibuprofen and its 6 kinds of impurities.Methods:Different concentrations of ibuprofen and the impurities were used to act on mouse fibroblasts (L929) for 72 h,and the cytotoxicity was observed under a microscope.Results:In ibuprofen raw material,the cytotoxicity of impurity B was the weakest with slight toxicity,the cytotoxicity of impurity N,D,J and V was moderate,and that of impurity E was severe.Conclusion:At the same concentration,the toxicity of impurity E is the strongest,and its content in ibuprofen preparations should be strictly controlled.

Objective:To study the acute toxicity and genotoxicity of Sanqi liver-protecting capsules to evaluate the toxicological safety. Methods:The mouse acute oral toxicity test, Ames test, micronucleus test of mouse bone marrow and mouse sperm shape ab-normality test were carried out for Sanqi liver-protecting capsules. Results:The mouse acute oral maximum tolerance dose ( MTD) of Sanqi liver-protecting capsules was above 20 g·kg-1 in the mouse acute oral toxicity test, which showed a non-toxic substance. The results of Ames test, micronucleus test of mouse bone marrow and mouse sperm shape abnormality test were negative in all the groups. Conclusion:Under the above experimental conditions,the genotoxicity of Sanqi liver-protecting capsules is not found out, therefore, the capsules are classified as a non-toxic drug.

Objective:To study the acute toxicity and genotoxicity of Sanqi liver-protecting capsules to evaluate the toxicological safety. Methods:The mouse acute oral toxicity test, Ames test, micronucleus test of mouse bone marrow and mouse sperm shape ab-normality test were carried out for Sanqi liver-protecting capsules. Results:The mouse acute oral maximum tolerance dose ( MTD) of Sanqi liver-protecting capsules was above 20 g·kg-1 in the mouse acute oral toxicity test, which showed a non-toxic substance. The results of Ames test, micronucleus test of mouse bone marrow and mouse sperm shape abnormality test were negative in all the groups. Conclusion:Under the above experimental conditions,the genotoxicity of Sanqi liver-protecting capsules is not found out, therefore, the capsules are classified as a non-toxic drug.

Objective: To summarize and critically assess the evidence from randomized controlled trials (RCTs) of acupuncture in treating dry eye syndrome (DES) according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement and the Cochrane Collaboration recommendations. Methods: A search of PubMed, the Cochrane Central Register of Controlled Trials, ClinicalTrials.gov and Embase was made from their inception to August 2016, as well as Chinese, Japanese, and Korean databases. Two reviewers independently selected RCTs and assessed the methodological quality. Meta-analysis and the level of evidence were processed by RevMan 5.3 and the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach. Results: After selection, 8 trials were subjected to our systematic review. The methodological quality was low generally. The 3-10 weeks follow-up showed that acupuncture improved the tear film break-up time (BUT) (MD=1.33, 95%CI=1.01-1.66, 619 participants). The mean difference of Schirmer's test was 1.73 mm (95%CI=1.28-2.18, 618 participants) between the acupuncture group and the control group. The subjective variables exhibited no significant differences. Conclusion: The low methodological quality of the trials does not suggest drawing firm conclusions on the value of acupuncture therapy for DES. Acupuncture treatment may have some effects on the tear film BUT and Schirmer's test, but not on the subjective symptoms. Well-planned large-scale high-quality RCTs are needed to make it clear whether acupuncture is effective in treating DES.

Objective To investigate whether inhibiting the expression of typeⅠ collagen gene is one of the mechanisms of action of electroacupuncture in improving knee osteoarthritis.Methods Forty male adult SD rats were randomized into normal, model, medication and electroacupuncture group, 10 rats each. A rat model of MIA-induced knee osteoarthritis was made by injecting monomer sodium iodoacetate (MIA) and driving rat movement. After model making, the medication group received an oral gavage of celecoxib dissolved in 10% DMSO and the electroacupuncture group, electroacupuncture at points Zusanli and Yanglingquan. Pain thresholds and the levels of cartilage expression of typeⅠ collagen mRNA were compared between various groups of rats before and after treatment.Results There was a statistically significant difference in pain threshold between the model, medication or electroacupuncture group of rats and the normal group after model making (P<0.01) and between the medication or electroacupuncture group of rats and the model group before sacrifice (P<0.01). There was no statistically significant difference in pain threshold between the medication and andelectroacupuncture groups of rats before sacrifice (P>0.05). There was a statistically significant difference in the expression of typeⅠ collagen mRNA between the model, medication or electroacupuncture group of rats and the normal group (P<0.01) and between the medication or electroacupuncture group of rats and the model group before sacrifice (P<0.01). There was no statistically significant difference in the expression of typeⅠ collagen mRNA between the electroacupuncture and medication groups of rats before sacrifice (P>0.05).Conclusion The mechanisms of actions of electroacupuncture and medication in treating knee osteoarthritis may be related to inhibiting the expression of typeⅠ collagen mRNA.

Objective:To observe the clinical efficacy of warm needling moxibustion plus functional exercises in treating knee osteoarthritis (KOA).Methods:Totally 108 eligible KOA patients were intervened by warm needling moxibustionplus functional exercises. The warm needling moxibustion was given 3 times a week, successively for 4 weeks. The visual analogue scale (VAS) was adopted to evaluate the pain intensity of the knee joint. After 4-week treatment, the change of VAS score, range of motion (ROM) of knee, and Lysholm score were observed, and the clinical efficacy was also estimated. Results:After treatment, the VAS score dropped obviously, and the ROM and Lysholm score increased markedly; the total effective rate was 83.3%. Conclusion:Warm needling moxibustionplus functional exercises is effective in treating KOA, as it can relieve the knee joint pain and improve the joint motion.

OBJECTIVE To investigate whether quinolinic acid(QA)induces autophagy in PC12 cells and its relationship with glycogen synthase kinase-3β(GSK-3β)/β-catenin related signaling path?ways. METHODS PC12 cells were treated with QA 2.5,5.0 and 10.0 mmol·L-1 for 24 h. The cell viability was determined by MTT assay. Autophagy fluorescent spots labelled form of microtubule-associated protein 1 light chain 3(LC3)was examined by LC3 immunostaining. The expressions of GSK-3β,β-catenin,LC3 and Beclin 1 were determined by Western blotting. RESULTS QA inhibited PC12 cell survival in a concentration-dependent manner,and IC50 was 8.7 mmol · L- 1. Compared with normal control group,QA 2.5,5.0 and 10.0 mmol · L-1 increased autophagic intracellular LC3 fluorescence spots,elevated the expression ratio of LC3-Ⅱ/LC3-Ⅰ and expression of Beclin 1 in PC12 cells(P<0.05). In addition,QA enhanced GSK-3βexpression and decreasedβ-catenin expression(P<0.05,P<0.01). CONCLUSION QA induces autophagy in PC12 cells. This mechanism may be associated with the activation of GSK-3β/β-catenin related signaling pathways.