Formulation Of Quality Standards Research Articles

Study on Quality Standards and Hepatoprotective Effect of Curcuma phaeocaulis Radix.

Curcuma phaeocaulis Radix (Lüsiyujin) is a mainstream variety of Curcumae Radix cultivated in Sichuan for more than 900 years, but its broader utility is limited by a lack of quality control and pharmacodynamic research. We used the Chinese Pharmacopoeia, 2015 edition, to guide the determination of germacrone and furanodienone content in extracts. We established an animal model of Qi stagnation and blood stasis in a clinical context. Pathological changes in liver function indexes were evaluated to investigate the hepatoprotective effect of Lüsiyujin. In 20 extraction batches of Lüsiyujin, ethanol extracts yielded 9.22%–15.01%, average 12.03%. The germacrone content was 0.003%–0.011% (average 0.0069%), and the furanodienone content was 0.090%–0.478% (average 0.201%). Compared with the control group, the model rats exhibited functional liver damage. Serum markers of liver function varied after treatment with Lüsiyujin, but significant effects were observed with alanine aminotransferase and total bile acid. This study demonstrates a simple method of quality control for Lüsiyujin. The study also demonstrated that Lüsiyujin inhibits hepatocyte damage and regulates the excretion and secretion of hepatic bile. Our findings provide a theoretical basis for the formulation of quality standards, clinical application, and resource development for the utilisation of Lüsiyujin.

Extraction technology optimization of total flavonoids in Wudang pine needle tea by orthogonal test

Objective To optimize the best extraction technology of total flavonoids in Wudang pine needle tea. Methods The contents of total flavonoids were taken as index, and orthogonal design of L9(34) was applied to process ultrasonic extraction. Results The order of factors of affecting extraction technology was solid to liquid ratio > ultrasonic power > ultrasonic time. The optimized extraction technology was as follows: adding 500 times volume of purified water, ultrasonic extracting for 15 minutes with ultrasound power 500 W at 40 ℃. The average content of total flavonoids was 39.701 mg/g. Conclusions The optimal extraction technology is simple, efficient and feasible, and can be used for extracting total flavonoids from Wudang pine needle tea, providing basis for the formulation of quality standards. Key words: Orthogonal test; Flavones; Extraction technology; Wudang pine needle tea

Pharmacognostical study on four origin plants of folk medicine Sikuaiwa

In order to develop characteristic folk medicine resources in Jiangxi, a pharmacognostical study was systematically performed for four different origin plants of Sikuaiwa, the result of study provides the microscopic features of powder and tissue of the crude drug. The research provided reference for the identification of Sikuaiwa, as well as a theoretical basis for the further development and the formulation of quality standards.

Gender‐comparative use of small business training and assistance: a literature review

Undertakes a gender‐comparative review and comparison of the Australian and international literature on the use, needs and awareness of government and independent sources of training and assistance for women in small business to identify whether women's needs differ from those of men and whether existing delivery mechanisms disadvantage them. Consolidates findings of research and sets an agenda for researchers, policy makers and assistance providers. The findings highlight: the potential for accountants, the most used source, to expand their role; the formulation of quality standards and accreditation for consultants engaged by government; electronic information technology systems to mitigate location and language barriers; and user‐friendly training content and delivery. Future research should clearly delineate between the various sources of training and assistance; their use and usefulness; the awareness, use and needs of women; and variations over business life‐cycle stages.

Substances of Plant Origin in Homeopathic Pharmacy: Methodology of Quality Standard Formulation

Put into effect, the “Standards of Drug Quality. Main Stipulations” OST 91500.05.001-00 determined the general order in the development, formulation, presentation, expertise, coordination, validation, and denotation of the standards of drug quality and gave the main rules for constructing such standards. Section XIV of this document refers to the structure and formulation of quality standards for homeopathic preparations in various medicinal forms for injection, internal and external administration, including suppositories, ointments, tablets, capsules, and granules. However, no rules are given concerning the structure and formulation of the quality standards for initial substances of plant origin (homeopathic tinctures), as well as of mineral and animal origin, used for further processing into various homeopathic products. There is a stable increase, in the pharmaceutical market, of homeopathic preparations, as manifested by the growing number of registered homeopathic drugs, the development of pharmacopoeial articles for the manufacture of homeopathic tinctures, and the formation of the corresponding database. This requires developing rules governing principles of the structure and formulation of quality standards. At the same time, such work will facilitate the generalization of experience, which is necessary for preparing the first edition of the Russian Homeopathic Pharmacopoeia. Analysis of the state of the art in this field in some foreign countries [1], where the homeopathic method was recognized much earlier than in Russia, shows that the main and the only document determining the quality of parent substances is the collection of general and partial articles (monographs) in the homeopathic pharmacopoeia. Such pharmacopoeias exist in Germany, Great Britain, India, and USA. In France, the 10th edition of the State Pharmacopoeia includes articles for substances used in homeopathy. Articles of the German homeopathic pharmacopoeia [2] include sections determining the quality of the initial raw materials used for preparing tinctures and sections describing tests and criteria for evaluating the quality of the final tinctures. Each article (monograph) is organized as follows.