The Quality Control And Stability Of The New Preparation Of Traditional Chinese And Western Medicine Of Libao

Libao as a oral-administered liquid compound preparation of the traditional Chinese and western 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 acute and chronic diarrhea on calf.To perfect the production technic, 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 Libao was studied in this paper from these aspects:(1)Study on analysis and decoction technology of the prescription. Cortex Fraxini was the major drug in the prescription. The function of the medicine was clearing away heat and toxic materials, strengthening the spleen, drying the dampness, regulating Qi, and activating the blood. It was used to treat diarrhea which was induced by the invasion of exogenous pathogenic factors or weakness of the spleen and stomach. By using the content of aesculin and aesculetin as indices, the decoction technology was optimized by orthogonal test. The optimum decoction technology was decocting the medicine three times, for 0.5h and adding 7-fold of water each time.(2)Study on quality control of the herbs and material.The herbs were identified by TLC and the content of aesculin and aesculetin determined by HPLC quoted in China pharmacopoeia (2005). All the herbs were in accordance with the requirement of the prescription. Furthermore, the methods of identifying and content determinination of the mequindox were established. The prescript could be made that total content of the aesculin and aesculetin should be above the level of 1.10%,and that of mequindox 90.0%.(3)Study on quality control of the patent medicine. It was investigated that the identification of the Cortex Fraxini and mequindox, as well as the content determinination of the aesculin, aesculetin, and the mequindox in the prescription. The method of identification was straight, simple and specific. The method of content determining was accurate and repeatable. The prescript could be made that total content of the aesculin and aesculetin should be more than 0.55mg/ml, and that of the mequindox should be 0.85mg/ml.(4)Study on stability of the medicine, not only was investigated that the impact of the light, pH and high temperature on the content of the aesculin, aesculetin, and the mequindox, but also the expiry date of the medicine by classical constant temperature method. Results: This medicine should be prepared into acidic solution at about pH=4.45, and stored away from light and high temperature.