Return To A Balanced Capsule Pharmacy And Pharmacodynamic Study

Huigui pingheng capsule is a compound preparation which can treat children sexual precocity .The main research contents on HuiGui Pingheng Capsule include technology of preparation, criteria of quality, the stability of the pharmaceuticals, the effect of medicine , the pharmacody and the toxicology.During the research of the technology of preparation the optimum prescribe, dosage and the dose of the preparation were studied by its taste, appearance, pharmacody , and stability(by comparing oral liquid with Capsules). We practiced several projects designed as the above factors and manufactured lots of samples, by which we got a great deal of data. In the same time specialist in our hospital were invited to help analysis and compare the drugs. The results showed that the effect of the oral liquid and capsule were almost no difference, but the oral liquid was so bitter that it was difficult to be accepted by children. At last we chose Capsules as the dosage .we selected total quantity of dry ointment and gentiopicrin as marker ,utilizing L9(34) orthogonal test optimize the process of water-extraction and determined as following :decocted twice ,first ten times volume 2.5hr,then eight times volume 2hr ,combing and concentrated to 1.15g/ml .We chose spray-drying method to desiccate this ointment ,air-inlet temperature at 125℃, air-outlet temperature at 90 ℃and pressure 0.7Mpa in drying tower .During the quality research preceedings , we identified Anemarrhena asphodeloides Bge and Eclipta prostrata L. by TCL(Thin Layer Chromatogragh) method, which was special and accurate .The contents of berberine and gentiopicrin were determined by HPLC (High Performance Liquid Chromatograg) after the methodology was completed . The HPLC showed that the rate of recovery was up to standard and its precision, stability and reappearance were good. For the sake of inspecting primary stability of huigui pingheng capsule, the room-temperature and accelerating test were carried into execution, from which the results showed every index marker was normal .It indicated the quality of huigui pingheng capsule was steady and controllable.We carried out main Pharmacodynamical experiment ,in which special rabbits were used .The experiment shows that the preparation can reduce the rabbit levels of hormone E2. PROG, TESTC, LH, FSH and lead them to normal levels.To find out the toxicity of the drug we carried out the research of the toxicology which included the acute and chronic toxicity experiments. The result declared that the drug had little toxic reaction and could be taken for a long time.In a word, according to the above experiments, we made an acknowledge of the technology of preparation, criterion of quality, stability, pharmacodynamic and toxicity. Moreover, we succeeded in researching the effective safe and convenient patent drug, which would be a first new patent drug for sexual precocity in China. We rest assured that the drug would no only benefit our society and human being but also would have a good effect on the value of society and economic.