Studies On The Ganyue Capsule

Ganyue Capsule’s original prescription was orthodox praeparatum. It is composed of Astilbe chinensis (Maxim.) Franch. et Sav, Panax quinquefolium L., Schisandra chinensis (Turcz.) Baill. and so on. It has been utilized more than10years as Medicinal Broth. It has good therapeutic effect. But it has some shortcomings whill it was utilized as Medicinal Broth. In order to give the patient a more convenient and effective dosage form, we develop it to capsules. It has laid a good foundation for the research and development of new drug. Meanwhile, it can offer references for the modernization of traditional Chinese medicine.We conducted a systematic research on the preparation technology, quality standard and stability.First, for studying the major influential factors of extraction system, we adopt the orthogonal test which inspect the ethanol concentration, reflux time, and the times of reflux to achieve the best extraction technology of the bergenin of Astilbe chinensis (Maxim.) Franch. et Sav by HPLC. HPLC was used to determine the content of the bergenin. I design four technical condition for Ganyue Capsule. We got the optimum extraction process which is scientific and available by the pharmacological pretesting. This method has a certain practical value. Second, we studied on three batchs of Ganyue Capsule’s disintegration time, weight variation and the content of bergenin.According to <China Pharmacopoeia (2010Edition)>, we used traditional identification. We used TLC to identify Astilbe chinensis (Maxim.) Franch. et Sav and Panax quinquefolium L. We determined the content of bergenin in Astilbe chinensis (Maxim.) Franch. et Sav by HPLC. We separated the sample by ODS-C18(4.6mm×250mm,5μm) with the mobile phase consisting of A:methanol and B:water,(A(%):B(%)=20:80). The detective wavelength was275nm. The flow rate was1mL/min. The content was10μL. The column temperature was30℃. The precision, stability and reproducibility of the method were perfect. Referring to the results,we should controll the content of bergenin (C14H16O9) that couldn’t be lower than6.5mg in a pill.According to the regulation of <the administration way of drugs’ register>,we studied on the stability of Ganyue Capsule. We confirmed the character, the content of bergenin, microbial limit and so on by the method of accelerating and room-temperature observative. The results indicated that the quality of Ganyue Capsule is stable. So, we determined that the validity duration was24months.In pharmacological research, we made a study of the pharmacodynamics and acute-term toxicity. We made a study of the influences of the Drug-induced Disease rat Model which were established with CCl4and alcohol to observe the effect of Ganyue Capsule on the Acute Drug-induced Disease. The mice were randomly divided into6groups. Observe the decoction effects of Ganyue Capsule on the mice’s behaviour, body weight, coefficient of liver, ALT, AST, the quantity of SOD and MDA in liver. The result showed that the levels of serum ALT, AST and MDA in group of Ganyue Capsule were more signifieantly redueed than the model group. It has the excellent therapeutic effect on Drug-induced Disease.In acute-term toxicity research, we supply Ganyue Capsule which the dosage was about more four hundreds times than the adult’s clinical one-day dosage to the hungry mice three times every day for fifteen days. The results indicated that compared with the control group and the medication administration group’s body weight had no conspicuous difference, and no one was died. So, we can say that Ganyue Capsule is safe, and has no conspicuous toxicity.In a word, the Ganyue Capsule has the scientific and reasonable technology, the controllable quality, the stability and the definite pharmacodynamic action, it has no conspicuous toxicity. It is safe to take for a long time.Distinct points:1.We study a new dosage of traditional Chinese medicine to treat Drug-induced Disease.2.According to the chemical properties of the different medicine, we designed many precipitated technology condition in technical research. By using pharmacological pretesting, we choose the best technology condition which was a scientific and reasonable precipitated technology.3.After a lot of research, we changed it to capsules and solved a lot of shortcomings of Medicinal Broth. In terms of <China Pharmacopoeia (2010Edition)>, I drafted the Quality Control Specification of Ganyue Capsule. We explained scientifically its pharmacodynamic action and improved its quality control. It has laid a good foundation for the research and development of new drug.