The Study Of Jianer Xiaoshi Oral Liquid

Objectives: The purpose of the research is according to the prescription of Jianer Xiaoshi Oral Liquid,which is included the Department of Health drug standard.This project include four important sections:to optimize the prescriptions and prepare techniques;to establish the quality standard;to study the stability of Jianer Xiaoshi Oral Liquid,and to study pharmacodynamics. Methods: (1)The extractive technology of Jianer Xiaoshi Oral Liquid was screened by means of optimal experiment design,basing on the content of polysaccharide,baicalin and extractum.(2)Establish the quality standard of Jianer Xiaoshi Oral Liquid.Identified atractylodes macrocephalia,astragalus,baicalin and hesperidin in Jianer Xiaoshi Oral Liquid by TLC.Determined the content of baicalin and hesperidin in Jianer Xiaoshi Oral Liquid by HPLC.(3)Accelerating and long-term tests were conducted according to guidelines regarding the experiments of stability of medicine from the Chinese Pharmacopoeia(Edition 2005)(as attached XIXC) to evaluate the stability of the product.(4)We use Jianer Xiaoshi Oral Liquid which had sold in drugstore as reference preparation to study the speed of small intestine moving forward,secretory volume of gastric juice,the activity of gastric proteinase,and swimming test. Results: (1)The optimal conditions of preparation process is with an amount of 10 times of water for 3 times of extractions.Then,condense the extraction solution to 1:3 and add alcohol to make contain alcohol attain to 40%.The filtrate were placed 10 hours.(2)The quality standard of Jianer Xiaoshi Oral Liquid can practicably control the quality.(3)There was no obvious change with all indicators of the samples of the experiments monitored through the 6-month period of accelerating and 9-month period of long-term tests.(4)The result of the statistical analysis showed that test drugs and control group can promote gastrointestinal motility,increase secretory volume of gastric juice and the activity of gastric proteinase. Conclusions: (1)The preparation process is stable and suitable for Pharmacia production.(2)The quality standard of the preparation is feasible and controllable.(3)The initial stability of the preparation is sound and provides evidence for the feasibility of technological and packing materials.(4)The test group possess the same drug action as the control group.