The Quality Control And Stability Of Chinese Materia Medica Preparation Of Qinggongye Ⅱ

Qinggongyeâ…¡is Chinese herbal medicine product used to treat endometritis, which was researched independently by Lanzhou Institute of Animal Science & Veterinary Pharmaceutics of CAAS. In order to establish a specific method to control the quality of Qinggongyeâ…¡, some experiments were carried out to study the quality control and stability of Qinggongyeâ…¡:1 Analyse the quality of Danshen and Honghua. Danshen and Honghua raw material medica were identificated by Thin-layer chromatography(TLC), the content of Tanshinoneâ…¡_A in Danshen was determinated by high performance liquid chromatography (HPLC), results prove that Danshen and Honghua satisfy the requirements of Chinese Pharmacopoeia 2005 Edition.2 Study the quality control of Qinggongyeâ…¡prescription. Quality control of Qinggongyeâ…¡prescription was established with TLC and HPLC. Danshen and Honghua were identificated by TLC, outspread agent was benzene-ethyl-acetate(19:l) and n-butanol-methanol-water(6:5:l) respectively, Control sample and examine sample display same spot on thin-layer at same position. Negative experiments demonstrated that it was noninterference. In the experimental process of content determination,at first to study the optimum extraction conditions for Qinggongyeâ…¡prescription,the orthogonal design L₉(3⁴) was used with the sum of content of Cryptotanshinone and Tanshinoneâ…¡_A as marker and determined by HPLC. The significant effects of methanol amount and ultrasonic time on the extraction yield were discovered, the optimum extraction conditions: adding 5 times amount of methanol and the ultrasonic time is 10 min. The content of Cryptotanshinone and Tanshinoneâ…¡_A in Qinggongyeâ…¡prescription were determinated by HPLC in 5 batches of Qinggongyeâ…¡prescription, the results show that good linear relationship was achieved between Cryptotanshinone and peak area when the concentration range of which was 0. 07384⁰. 36920μg (r=0. 9995),The average recovery rate was 97. 9% (RSD=4.20) ,and establish the medicine contain Cryptotanshinone is no less than 0.12mg/ml,Good linear relationship was achieved between Tanshinoneâ…¡_A and peak area when the concentration range of which was 0. 3932μg～1.966μg(r=0.9991), the average recovery rate was 100.1% (RSD=4.82) , and establish the medicine contain Tanshinoneâ…¡_A is no less than 0. 47mg/ml.The method of identification is visualized,simple, and specific; The method of content determination is simple, accurate and good duplication, which could be used for controlling the quality of Qinggongyeâ…¡prescription.3 Study the stability of Qinggongyeâ…¡prescription and to predict its expiration date. The effects of temperature and pH on the stability of Qinggongyeâ…¡prescription was detected and predicted its expiration date. The results show that high temperature and alkali condition have some effects on stability of Qinggongyeâ…¡prescription.