Objective To introduce the "World Health Organization Good Practices for Pharmaceutical Quality Control Laboratories"(referred to WHOGPCL) established by WHO in 2010.Methods Comprehensively introduce the scope of WHOGPCL.Results and Conclusion Understanding the guiding principles will help to international coordination of laboratory practice,and facilitating cooperation between laboratories and the mutual recognition of test results.This principle applies to all pharmaceutical quality control laboratories,including national,business and non-government laboratories,but not in the vaccines,blood products and other biological products testing laboratory.

Objective:To evaluate the quality on the devise of ipratropium bromide aerosol Method:According to WS-10001-(HD-1459)-2003,BP2009 and the appendix I L of ChP 2005 Vol Ⅱ,evaluate the leakage test,number of discharges per container,the content of active ingredient delivered by actuation of the valve and deposition of the emitted dose,compare the quality between the homemade drugs and the import drugs.Results:the quality of homemade drugs doesn't meet the requirements,such as:the average leakage rate per year at room temperature(25 ℃) for the 12 containers is more than 3.5% of the net fill weight,the inhalers contain less than the number of discharges stated on the label.the uniformity of the contents of Delivered-Dose is dissatisfactory,the quality is worse than the import drugs.Conclution:the quality of the devise of aerosol should be improved.the national standard should be revised,so that the quality of homemade drugs could be better controlled.

OBJECTIVE To establish a high performance liquid chromatography assay for the determination of vitamine B_(12)injection. METHODS C_(18) was packed in the analytical column. The mobile phase consisted of methanol-phosphate buffer solvent pH 3.5(26: 74). The detection wavelength was 361 nm. RESULTS The calibration curve was linear in the range of 20. 22 to 505.60 mg·L~(-1) (r = 0.999 97). The LOD was 3 ng. The sample solution kept in dark place was stable within 24 h. The average recoveries were 100.8%. Validation(RSD = 0.1%) and repeatability (RSD =0.1%) were good. CONCLUSION This method was simple, sensitive and could be used for the quality evaluation of vitamine B_(12) injection.

Objective:To improve the examine method of related substances for Vitamine B_(12) in ChP 2005. Method:The resolution of not less than 2. 5 was adopted to ensure the system suitability. The mobile phrase consisted of methanol -phosphate buffer solvent pH 3.5 (26: 74). The detection wavelength was 361 nm. Results and Conclusion:The new examine method as more practicable, applicable and specific, and was recommended to be adopted in the new edition of Chinese Pharmacopoeia.

Objective To lay a solid foundation for further research and development of securinine.Methods Relevant literature of securinine was searched and summarized.Results and Conclusions The studies on securinine of phytochemical properties,isolation and purification,bioactivities,and others have been reviewed,and correlative work on quality control of securinine need to be improved.

Objective:To probe into the thermal property and the change of crystal forms of artesunate and artemether.Methods:The thermal property and the change of crystal forms of artesunate and artemether were investigated by using thermogravimetric analysis(TGA) and differential scanning calorimetry(DSC) in the different temperature range and different heating rate.Results:The diagram of DSC curves of sample of artesunate almost shows no difference with the diagram of curves of reference substance;The diagram of DSC curves of reference substance of artemether shows a single peak,or presents two peaks sometimes.Conclusion:The thermal property of artesunate is quite stable,and the crystal forms of the reference substance of artemether changes frequently.

OBJECTIVE To check the result of the content determination of one certain batch of paracetamol tablets.METHODS Three methods in Pharmacopoeia,including reference substance comparison method,absorption coefficient method by UV,and content determination method by HPLC,were adopted to assay the content of the paracetamol tablets.RESULTS The content of the paracetamol tablets is 90.5% in reinspection,and the results of the three methods were equivalent.CONCLUSION The reinspection result has been proved by three individual methods each other,and the conclusion is accurate and reliable.

药物制剂采用红外鉴别有专属性强的优点.目前英美药典制剂采用红外光谱法鉴别的品种数在用该法鉴别总数中所占百分比高达30%左右[1],而相比较于英美药典,我国药典及国内药品标准中制剂采用红外鉴别的品种尚较少.