To analyze the major changes and existing problems of bioassay methodrelated to specifications of biochemicalsin the Chinese Pharmacopoeia 2015 edition and to discuss the trend of the quality control of biochemical and bioassay method improved

OBJECTIVE:To establish a method for the simultaneous determination of ethambutol(EMB)and isoniazid(INH) in children’s plasma. METHODS:After precipitated with acetonitrile,plasma samples were determined by UPLC-MS/MS method. Using lamivudine as internal standard,Waters ACQUITY? UPLC HSS T3 column was adopted with mobile phase consisted of ace-tonitrile-water(containing 0.05% formic acid and 15 mmol/L ammonium formate)in gradient mode at the flow rate of 0.2 ml/min. By ESI,positive ion detection was conducted in MRM mode. The monitoring transition ion-pair was m/z 205.2→116.0 for EMB, m/z 138.1→121.1 for INH and m/z 230.2→111.9 for internal standard. RESULTS:The linear range of EMB and INH was 10-5 000 ng/ml and 50-5 000 ng/ml,respectively;the limits of quantitation were 10 and 50 ng/ml;RSDs of inter-day and intra-day were all lower than 15% and relative recoveries were 98.7%-105.5%. Plasma concentrations of EMB and INH in 4 children with tuberculo-sis were 94.5-99.7 and 55.1-80.9 ng/ml. CONCLUSIONS:The method is rapid and sensitive,which suitable for children’s plasma concentration monitoring of EMB and INH and pharmacokinetic study.

OBJECTIVE: To analyze the utilization of Chinese patent medicines in our hospital to provide scientific basis of rational use of drugs in clinic.METHODS: Data about annual consumption sum and consumption amount of Chinese patent medicines in our hospital during 2005～2009 were collected to analyze annual consumption sum,DDDs end daily cost of Chinese patent medicine statistically.RESULTS: The annual consumption sum of Chinese patent medicines showed a upward trend in our hospital during 2005～2009.The top 15 Chinese patent medicine in the list of consumption sum which took up a large proportion affected the total consumption sum.Injection was used more and more so that the ratio of its consumption sum to rank of DDDs was lower than one.CONCLUSION: Cheap and effective Chinese patent medicines play an important part in the clinic.DDDs order should be emphasized in the drug supervision and Chinese traditional medicines injection should be managed strictly.

OBJECTIVE: To facilitate separate-store management and cold-chain management for hospital drugs. METHODS: The temperature division of separate-store management of hospital drugs was analyzed. The cold-chain management of cold-storage and freeze-storage drugs was discussed. RESULTS & CONCLUSIONS: During the storage period of hospital drugs,the temperature of cold-storeroom should be kept at 2～8 ℃,that of shady and cool storeroom at 0～20 ℃,and that of the normal temperature storeroom at 0～30 ℃. In the cold-chain management,great importance should be attached to several key steps such as to standardize the transport vehicles,set up stores for the turnover of drugs,and to clarify the operational procedure and working standard. It is necessary to strengthen separate-storehouse management and cold-chain management for hospital drugs.

OBJECTIVE: To establish the preparation process and the quality control standards for Jinhuanglidan Granules (JHLD). METHODS: Rheum Officinale, Rhizoma Coptis, Radix Paeoniae Alba and Radix Scutellariae were identified by TLC. The content of berberine hydrochloride in the preparation was determined by TLCS. RESULTS: Rheum Officinale, Rhizoma Coptis, Radix Paeoniae Alba and Radix Scutellariae could be identified by TLC. Berberine hydrochloride showed a good linearity in the range of 0 .05 985ug- 0. 29 925ug, r = 0. 9 996(n = 5). The average recovery was 99. 64%, RSD = 2. 54%. CONCLUSIO- N: This method is simple, accurate and specific. It can be used for the quality control of JHLD.

Objective:To investigate the expression of c myc and cdc2 gene in iliac femoral arteries of rabbits fed with high cholesterol diet. Methods:Totally 24 New Zealand rabbits fed with high cholesterol and high lipid diet were chosen for the experiment. In treated groups,the iliac femoral arteries were dilated by balloon catheter in 2 week high lipid diet fed rabbits. After 6 8 weeks,angiography was performed to detect the stenosis in iliac femoral,and ballon dilation was carried out when stenosis beyond 50%. Expression of c myc and cdc2 mRNA (24 h following balloon dilation) and their proteins (2 weeks following balloon dilation) were measured by means of RT PCR and immunohistochemistry (GISS) methods. Results: Expressions of c myc,cdc2 mRNA and their proteins in dilated arteries were all increased 24 h and 2 weeks following balloon dilation. Immuno positive particles were mainly located at nuclei of SMC in neotima layer,and a little at cytoplasma. Conclusion: Expressions of c myc,cdc2 mRNA and their proteins are increased in arteries following angioplasty. It is indicated that c myc and cdc2 may play an important role in neointimal formation after angioplasty.

Alzheimer's disease (AD) is a progressive, degenerative disease of the brain, which causes learning and memory to become seriously impaired. AD not only influences the patient's quality of life, but also places a great burden on caregivers. With the increasing of aging population, the pressures can be wide-ranging, involving social, psychological, physical, and economic elements of the caregivers' life.The cause and progression of Alzheimer's disease are not well understood. Currently used treatments include pharmaceutical and psychosocial ones, each offering a small symptomatic benefit. Actually, there are still no available medicines and treatments to delay the progression of the disease. Therefore, the development of a new ideal medicine to treat AD patients becomes the first priority. In recent years, most researchers have turned to natural products, hoping to find a drug candidate to cure AD patient. Baicalein, a traditional Chinese medicine extracted from Scutellaria Baicalensis (Chinese herb), has been demonstrated holding the properties of anti-inflammatory, anti-apoptosis, anti-oxidant, and improving learning and memory of human brain. Baicalein is becoming a potential ideal medicine for treating AD patient.

OBJECTIVE:To provide reference for the improvement of Metaanalysis. METHODS:13 repots about Meta-analysis of randomized controlled trials(RCTs)on antivirus traditional Chinese medicine(TCM)injections for respiratory tract infections were collected and analyzed. Their qualities were evaluated using QUOROM statement,CONSORT statement,Jadad scale and the quality evaluation method for Metaanalysis posed by Sacks,etc. Disagreements were resolved by consensus. RESULTS:The obtained average mark of 13 studies was(64?10.13)with the highest mark of 84 and the lowest of 52. Quality evaluations of reports were conducted from 5 aspects including 25 items. 5 aspects were all considered in 13 studies. 60% of the 25 items were in- volved in 13 reports at least and 88% at most. CONCLUSION:Meta- analysis methods are improved significantly in China. It should be still standardized to make sure correctness and reliability of results of meta-analysis. Meta-analysis method should be stan-dardized to obtain correct and reliable results.

Objective To investigate the accumulation of mutations and single nucleotide polymorphisms ( SNPs) in the displacement loop ( D-loop ) of mitochondrial DNA ( mtDNA ) might be associated with cancer risk and disease outcome.Methods We obtained cancerous and noncancerous liver tissues from 49 HBV-related HCC patients at the Fourth Hospital of Hebei Medical University.mtDNA of the liver tissues was extracted with Mitochondrial DNA Extraction Kit.Mutation and polymorphism were confirmed by repeated analysis.We assessed the prediction power of D-loop SNPs in hepatocellular carcinoma ( HCC) patients.Results No mutation in these HCC patients had prediction power for post-operational survival, whereas one SNP site ( nucleotide 150 C/T ) was identified by the log-rank test for statistically significant prediction of HCC survival.In an overall multivariate analysis, allele 150 was identified as an independent predictor of HCC outcome.The length of survival of patients with allele 150C was significantly shorter than that of patients with allele 150T (relative risk, 0.246;95% CI, 0.070–0.861; P=0.028).Conclusions The analysis of genetic polymorphisms in the mitochondrial D-loop helps to identify patient subgroups at high risk of a poor disease outcome.

OBJECTIVE:To provide reference for the understanding of quality status of Insulin injection and improvement of related standards. METHODS:The statutory methods of Insulin injection were adopted to test 32 batches of samples(including ap-pearance,identification,capacity,visible foreign matter,sterility and potency determination of biological method). Consulting specification of other similar products,RP-HPLC was conducted to determine the related impurities,content and phenol in sam-ples;HPSEC was conducted to determine the high molecular weight proteins and atomic absorption spectrophotometry was conduct-ed to determine the Zn content. RESULTS:Results of all the 32 batches of samples were qualified by the test of statutory methods. According to the method of other similar products,the determination result of A21 desamido insulin was 15.6%-39.2% and general-ly greater than 5.0%, which was the highest limit of similar products;insulin was 93.2%-102.7%;protein polymer was 0.5%-0.6%;phenol was 2.34-2.51 mg/ml and Zn was 12.3-14.8 μg/100 U. CONCLUSIONS:The statutory specification of Insulin injection is short of many key specification items such as impurities and content determination;the contents of protein polymer, phenol and Zn were in good control;the contents of A21 desamido insulin are generally high,and stability of insulin main peak is relatively poor.