Quality Drugs Only

RECENTWestern media reports blaming China for the flood of counterfeit malar- ia drugs sent to Africa have once again highlighted a major health problem on the continent. Malaria remains the main cause of death for children under five in Sub-Saharan Africa. and costs the continent an estimated $12 billion in lost productivity each year. Counterfeit anti-malaria medicines are contributing to deaths across the world and also leading to drug resistance - putting billions of people at risk. According to a World Health Organization （WHO） study, an estimated one third of the drugs used worldwide to combat malaria are substand- ard. This is a critical problem, particularly serious in Africa. where Tanzania and Uganda have the highest number of malaria cases in the world.

Monitoring the quality of drugs in circulation using rapid NIR spectral comparison methods

Four rapid spectral comparison methods are introduced in mobile labs.They are conformity test method,general correlation coefficient method,reverse correlation coefficient method and correlation coefficient method using characteristic spectral ranges.The first method is used for tracking the movements of drugs in the distribution channels;the second is used for quickly identify new counterfeit drugs;the last two are used to screen drugs illegally added in Traditional Chinese Medicine （TCM）.The applicability of the four methods is evaluated with counterfeit and authentic drugs.Our results show that these methods can be quickly constructed and used to identify counterfeit drugs accurately.

Relationship between alkaloid contents and growth environment of Yimu Cao (Herba Leonuri)

Objective: To study the relationship between alkaloids contents in Chinese traditional drug Yimu Cao (the dried aerial parts of Leonurus artemisia) and its growing environment. Methods: Samples of the drug and the soil at the growing site collected from 5 selected regions. Reference materials were checked and on-the-spot observations were carried out to investigate the growth environment. RP-HPLC was performed to determine the alkaloid contents in the drug. Results: Different regions had different environmental conditions, including climate, soil, vegetation, and so on. No matter barren or fertile the soil at the growing site was, the herb of L. artemisia could grow well, but the contents of alkaloid in the drug varied greatly. The drugs produced in 2 northern regions, where the soil is alkaline, had higher content of alkaloid (about 0.4%) than that produced in southern regions (0.1l%-0.2%), where the soil is acid. Conclusion: The contents of organic matters, effective phosphorus, quick-acting potassium, and the pH value of the growing site soil were the factors correlating with alkaloid contents in the drug, among which the pH value of soil was an important positively correlating factor. The alkaline soils in North benefit the accumulation of alkaloids more than the acid soils in South. The other probable elements affecting the alkaloid contents in Yimu Cao were climate and genetic factors.

我国非国家组织药品集中采购模式比较

目的比较分析我国各省市的药品集中采购方案及相关政策,探讨各地非国家组织药品集中采购模式的特点。方法围绕采购内容、采购规则等比较分析各地的非国家组织药品集中采购模式的特点,以及采购内容、采购环境、采购规则之间的内在关系。结果我国目前的非国家组织药品集中采购模式可划分为药品集中采购组织(group purchasing organization,GPO)、非过评仿制药带量采购、专项药品带量采购、带量议价以及分类采购框架下的带量采购5种。我国非国家组织药品集中采购的特点是分品种、分批次,以政府主导为主,执行机构主要为医疗保障局。结论目前,各地的非国家组织药品集中采购仅覆盖了部分品种的药品,对非过评仿制药进行集中采购是未来的重要趋势,建立公平、科学的质量分组规则是非国家组织药品集中采购亟待解决的重要技术问题。

Development of the generic drug industry in the US after the Hatch-Waxman Act of 1984

The key events in the development of the US generic drug industry after the Hatch-Waxman Act of 1984 are systematically reviewed,including the process of approval for generic drugs,bioequivalence issues including“switchability”,bioequivalence for complicated dosage forms,patent extension,generic drug safety,generic substitution and low-cost generics.The backlog in generic review,generic drug user fees,and“quality by design”for generic drugs is also discussed.The evolution of the US generic drug industry after the Hatch-Waxman Act in 1984 has afforded several lessons of great benefit to other countries wishing to establish or re-establish a domestic generic drug industry.

The Role of the European Pharmacopoeia(Ph Eur)in Quality Control of Traditional Chinese Herbal Medicine in European Member States

In order to assure the safety and efficacy of the Chinese Medicines in Europe, the quality of TCM herbals should be guaranteed so that they can be freely imported in the European Union and other Western European Countries which are signatories of the European Pharmacopoeia Convention. Consequently, new Ph Eur TCM herbal drug Monographs should be elaborated, based on preexisting Monographs in the Chinese Pharmacopoeia(Ch P) 2010.Such a program has been inaugurated in 2005 by the Ph Eur Groups of Experts 13 A and B(Phytochemistry). Since then good progress has been made, elaborating of about one third of the originally proposed 100 TCM herbals being identified as important monographs for the European Market. Taking into account the many challenges still laying ahead, the establishment of a specialized Working Party(WP) on TCM with specialists and experts from many EU Member States has been decided by the Ph Eur Commission in 2008 which is highly active ever since in the examination and elaboration of new TCM herbal drug monographs, primarily to assure the safety of the European patient and further to provide quality parameters extremely important for all registration and licensing procedures of the respective National Authorities all over Europe.This paper is a survey of results and difficulties obtained so far which has been encountered meanwhile in the elaboration process by the Ph Eur TCM WP of these monographs and will discuss these in detail. Moreover the role of Ph Eur TCM monographs in the European community is addressed.

Application of UHPLCMS/ MS method in determining the content of multiingredient in hospital preparations

In the present study, we established an ultra-high pressure liquid chromatography-tandem mass spectrometry （UHPLC-MS/MS） method to simultaneously determine 11 compounds in two hospital preparations （Shegan mixture and Gandi capsules）, including ephedrine, caffeic acid, ferulic acid, rutin, scutellarin, belamcandin, baicalin, baicalein, astragaloside IV, irisflorentin and wogonin. The chromatographic separation was conducted on ZORBAX SB-C18 （2.1 mm×50 mm, 1.8 μm）. Eleven analytes and IS were detected using ESI and MRM combined with positive and negative scanning switch. Caffeic acid, ferulic acid, scutellarin and belamcandin were detected using negative ion mode detection, whereas ephedrine, rutin, baicalin, baicalein, astragaloside IV, irisflorentin and wogonin were detected using positive ion mode detection. The quantification limits of ephedrine, caffeic acid, scutellarin, belamcandin, baicalin, baicalein, irisfiorentin and wogonin were 4.90×10^-3 ng/mL, 7.80 ng/mL, 6.8 ng/mL, 5.3×10^-2 ng/mL, 4.20×10^-3 ng/mL, 4.6×10^-2 ng/mL, 1.44×10^-4 ng/mL, 4.85 ng/mL, 0.23 ng/mL, 3.18× 10^-4 ng/mL and 2.95× 10^-4 ng/mL, respectively. The detection limits of these components were 2.90× 10^-4 ng/mL, 0.77 ng/mL, 2.0 ng/mL, 0.016 ng/mL, 1.3×10^-3 ng/mL, 3.33×10^-4 ng/mL, 4.32×10^-5 ng/mL, 1.46 ng/mL, 0.07 ng/mL, 9.5×10^-5 ng/mL and 8.84× 10^-5 ng/mL, respectively. All calibration curves showed good linearity （R^2〉0.99） within the test range. The RSD values of intra-day and inter-day precision were less than 5%, and the average recovery rates of the 11 components ranged fi＇om 80% to 120%. In conclusion, our newly developed method was simple, rapid, sensitive and accurate. It could be used to determine ephedrine, caffeic acid, ferulic acid, rutin, scutellarin, belamcandin, baicalin, baicalein, astragaloside IV, irisflorentin and wogonin in Shegan mixture and Gandi capsules, which was helpful for the quality control of drugs.