The Quality Control And Primary Stability Of The New Preparation Of Traditional Chinese Medicine Cuiqingzhuyun Liquid

Cuiqingzhuyun Liquid as a liquid compound preparation of the traditional Chinese medicine was exploited after years of clinical practices instructed by the theory of the traditional Chinese veterinary medicine(TCVM).It was used to treat the infertility caused by ovarian disease of cow.To perfect the production technology,to standardize the quality control system,to prepare application datum for the medicine and to afford standard for the authority,the quality control and stability of Cuiqingzhuyun liquid was studied in this paper from these aspects:(1) Study on preparation analysis and prescription technology of the medicine.The function of the medicine was to warm yang and promotes meridians circulation,promote blood circulation for removing blood stasis,benefit qi for promoting production of blood and nourish liver and kidney. Epimedium herb was the major drug in the prescription.The medicine used in the treatment of infertility caused by static ovarian in cows,ovarian atrophy,persistent corpus luteum,Ovarian cysts,etc.By using the content of Icariin as index,the preparation technology was optimized.Two times alcohol precipitation was the optimum technology.(2) Study on quality control of the herbs and medical materials.The herbs were identified by TLC quoted in China Pharmacopoeia(2005).All the herbs were in accordance with the requirement of the prescription.Furthermore,the identifying methods of Epimedium herb,radix salvia mitliorrhizae,flos carthami,motherwort herb,radix sinensis angelicae and radix astragali were established.The determination of the active ingredients of the Epimedium herb was established by HPLC method,the content of icariin in Epimedium herb was determined by HPLC.The prescript could be made that total content of the icariin in material should be above the level of 0.50%.(3) Study on quality control of the patent medicine.It was investigated that the identification of the essential components,as well as the assaying of the icariin in the prescription.The method of identification was straight,simple and specific.The method of assaying was accurate and repeatable. According to the experimental results,total content of the icariin in preparation should be more than 0.165mg/mL.(4) Study on primary stability of the medicine.The preparation characters,identification,clarity and pH were observed.Assaying of icariin and Microbial Limit Tests were carried out.Meanwhile, preparation were studied for three consecutive months and then test once every six months according to the Technical Requirements of the Quality of Chinese Medicine Study the Stability.The results showed that the medicine was in accordance with standards under the market conditions at room temperature, within a year.