The Quality Control And Primary Stability Of The New Preparation Of Traditional Chinese Medicine Of Qinggongye 3

Qinggongye 3 as a matrix-administered oil-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 endometritis of cow. In order 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 Qinggongye 3 was studied in this paper from these aspects:⑴Study on preparation technology of the prescription. Salvia miltiorrhiza and radices lithospermi were the major drugs in the prescription. The medicine had the function of heat-clearing and detoxicating, restraining leucorrhea, promoting blood circulation to arrest pain and promoting granulation. It was used to treat endometritis which was induced by the invasion of bacteria or the factors of the damnification. By using the content of salviol IIA andβ,β'– dimethylacrylalkani as indices,the preparation technology was optimized. The optimum decoction technology was to extract salvia miltiorrhiza by the alcohol which was higher than 90% for 3 times and microwave drying, extract radices lithospermi in 140℃～150℃for 2 times and 2 hours.⑵Study on quality control of the herbs and material. The herbs were identified by TLC, and the content of salviol IIA in salvia miltiorrhiza andβ,β'– dimethylacrylalkani in lithospermi were determined by HPLC quoted in China pharmacopoeia (2005). All the herbs were in accordance with the requirement of the pharmacopoeia by TLC. The average assaying value of salviol IIA was 0.43%, which was higher than 0.20% quoted in China pharmacopoeia, and theβ,β'– dimethylacrylalkani was 0.72%, which was higher than 0.30% quoted in China pharmacopoeia.⑶Study on quality control of the patent medicine. It was investigated that the identification of the essential components, as well as the content determinination of the salviol IIA andβ,β'– dimethylacrylalkani in the prescription. The methods of identification, which were set up by crocidismus consulting literature, were straight, simple and specific. The method of content determining was accurate, repeatable and of high recovery rate.⑷Study on primary stability of the medicine. The content change of salviol IIA andβ,β'– dimethylacrylalkani were inspected through short-term and long-term room temperature laying up experiments. Every item of index did not have marked changes in natural conditions for 3 months, so it was indicateded that this medicine was of good stability in short-term; The long-term experiment was in progress.