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Injection of Shuxuening pharmacodynamic evaluation and biological activity assay for quality control

Author: GuoYuDong
Tutor: WangZhiBin
School: Beijing University of Traditional Chinese Medicine
Course: Pharmacology
Keywords: Shuxuening injection Re-evaluation of efficacy Platelet aggregation Bioassay method Quality Control
CLC: R285
Type: Master's thesis
Year: 2011
Downloads: 188
Quote: 0
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Abstract

The injection of Shuxuening Ginkgo biloba extract preparation, the research and development of Ginkgo biloba use in nearly half a century has swept the world. Through long-term research, Ginkgo biloba extract Efficacyt pharmacological mechanisms and clinical applications have been widely recognized, comprehensive understanding and in-depth study. Beijing Drug testing where the 2009 State of TCM injections evaluative testing, found that the different manufacturers, there are differences the injection of Shuxuening production process, resulting in some production factors that may affect the clinical safety and effective; foundation for further enriching pharmacodynamic information to ensure its safe and effective, so its pharmacodynamic re-evaluation and re-evaluation of the pharmacodynamic experiments including the four main areas of myocardial ischemia, cerebral ischemia, thrombosis, microcirculation. The complex Chinese medicines, single control of a small number of index components is difficult to control the safety and efficacy of the drug, which forced us to make improvements to the existing method of Chinese medicine quality control. Bioassay in recent years, maturing, and the bioassay have occupied a dominant position in some western medicine quality control, so take advantage of the bioassay for medicine quality control is an inevitable trend. A Chinese Pharmacopoeia 2010, an increase of the bioassay studies guiding principles of traditional Chinese medicine, traditional Chinese medicine quality control methods, in order to further improve the updating bioassay items in traditional Chinese medicine, especially traditional Chinese medicine injection quality standards, has a direction. If you can take the lead to develop the bioassay items, in traditional Chinese medicine quality standards will largely improve the accuracy of the traditional Chinese medicine quality control, to speed up the process of modernization of Chinese medicine. So this topic in-depth study of the pharmacological effects of the injection of Shuxuening finished several scientific design dose experimental indicators for the guarantee Shuxuening injection is safe and effective in clinical use, provide basic information. The pharmacodynamic study found Shu Xue Ning injection in vivo and in vitro platelet aggregation inhibition have good and clear dose-effect relationship, based on the biological effects of biological statistics as a tool, the use of a particular experimental design to quantify the biological activity of the drug, the establishment of the injection of Shuxuening vitro platelet aggregation biological activity test method to learn, quality control supplement. The experiment mainly include the re-evaluation of pharmacodynamic and platelet aggregation in vitro bioassay method two parts, the following discourse respectively. The first part Shuxuening injection pharmacodynamic evaluation the injection of Shuxuening of myocardial ischemia: sublingual intravenous pituitrin caused by acute myocardial ischemia model, investigated before and after modeling after administration of ST segment and heart rate changes, changes in myocardial infarct size in the serum of LDH, CK, MDA, SOD and biochemical changes. The results show that injection of Shuxuening inhibition of myocardial ischemia in rats ST segment elevated ST segment reduce confrontation caused by the posterior pituitary hormone rat heart rate slows down. Same time be able to reduce the incidence of positive rate of myocardial ischemia and arrhythmia, reduce myocardial ischemia rat myocardial infarct size and infarct rate. To reduce serum LDH, CK, MDA content, increase SOD activity in serum. Anti-ischemic mechanism the Shuxuening injection may reduce harmful enzymes in myocardial cells release to improve metabolic disorders of the radicals, the antioxidant effect. Second, the injection of Shuxuening brain ischemia: experimental cerebral ischemia model of mice ligation of bilateral carotid artery ligation in mice of both common carotid artery and vagus nerve after administration, investigated mice survival infarction area cerebral index measured biochemical markers of brain MDA, SOD, LDH. Results table Ming Shu Xue Ning injection can prolong the survival time of acute incomplete cerebral ischemia in mice, cerebral edema, reduce the infarct area, lower infarction rate. At the same time be able to improve the content of SOD in brain tissue, decreased MDA content, reduce free radical damage, reduce LDH release within the brain tissue against oxidative damage of brain tissue, strengthen the protective effect on the brain, so Shuxuening injection improves cerebral infarction mechanism may be related to its antioxidant effects. Three antithrombotic effect Shuxuening injection: subcutaneous injection of epinephrine hydrochloride combined with an ice bath, causing acute blood stasis model rats, 1h administered after successful modeling once before surgery 15min and then administered once electrical stimulation neck artery thrombosis, recording thrombosis and thrombosis length, measured in plasma prothrombin time (PT), activated partial thromboplastin time (APTT) and platelet aggregation, measuring the viscosity of the whole blood and plasma. Shu Xue Ning injection can prolong blood stasis model rats bolt time shorten the bolt length, significantly extend the 50% of the time into a suppository better inhibition of the initial formation of blood clots. It can also reduce the rate of platelet aggregation in the plasma of blood stasis model rats, prolong prothrombin (PT) and activated partial thromboplastin clotting time (APTT), to reduce the viscosity of whole blood and plasma viscosity, the injection of Shuxuening anti thrombosis mechanism may prolong clotting time and reduce the rate of platelet aggregation, and reduce blood viscosity. IV injection of Shuxuening improving effect on the microcirculation: visits mouse ear micro-arterial administration of normal and blood stasis model, venules, the number of capillary cross open by the results can be seen the Shuxuening injection normal mouse ear micro arteries and venules diameter, capable of expansion to increase the number of capillaries crossover open; expansion of blood stasis model mice narrowing of arterioles and venules diameter, to increase the number of capillaries crossover open and improve blood stasis model mice blood flow pattern, so that most of the mitochondria from tablets slow rheological flow with the role of microcirculation, thus Table the Ming Shu blood Ning injection, and has a good dose-dependent manner. ADP and PAF Two inducers the second part Shuxuening injection in vitro inhibition of platelet aggregation bioassay method to establish of the Shuxuening injection Ginaton injection in vitro inhibition of platelet aggregation experiments, the results show that The injection of Shuxuening better inhibition of in vitro platelet aggregation induced by ADP, PAF. And visit, I found that by the time a good linear relationship between the number of maximum platelet aggregation rate conversion dose linear relationship. Ginaton injection as standard, the amount of bioassay reaction parallel three three methods for potency determination and, at the same time to test the reliability and repeatability visits. The reliability test qualified obtained show that the method measured titer reliable repeatability study showed that the establishment of two inducers induced platelet aggregation in vitro bioassay method determined Shuxuening Injection biological potency reliable good reproducibility, the feasibility of having a certain, can be more in-depth study, accelerate the biological activity assay process for the quality control of TCM.

Injection of Shuxuening pharmacodynamic evaluation and biological activity assay for quality control

Abstract

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