Study On CP Injection (Lyophilized Powder) And The Quality Control

The CP injection (lyphilized powder), which is composed of traditional Chinese medicine CP, is an effective new formulation. The chemical constituent, effect of pharmacology, clinical application of CP and quality control of the relative TCM bufonis venenum were summarized.According to literatures and experiments, in this paper, HPLC methods for serotonin and cinobufagin were used to determine their contents in the preparation respectively. Using the contents of major effective components serotonin, cinobufagin and the weight of extract as indices, the extraction process of the raw material was studied with orthogonal experiment, reviewing the alcohol amount, the extraction time, the extraction times and the concentration of alcohol. The refined technology was studied by a series of single factor experiments.In present study, the investigation on formulation’s composition was emphasized. To increase the solubility and to ensure the resolubility and transparence after freezing-dried fitted for correlative requirements, ExcipientA was formulated and optimized by screening.The recipe of CP injection was optimized by comparing different kind of support agents, dosages of support agent and freeze time, which have different effects on appearance, color, resolubility and transparence of CP injection (lyophilized powder). The influences of the factor to the stability of the injection, the pH value, were also studied.Fingerprint chromatographs of ten batches of the raw material, CP injection and intermediate were developed respectively by HPLC. In the fingerprint chromatograms, 20 common peaks were obtained, and 15 common peaks were identified. Based on the results, similarity and contents of serotonin, bufalin, cinobufagin and resibufogenin were chosen as the quality control indices to judge and evaluate CP injection more effectively. Correlation research was studied through the HPLC fingerprint chromatograms of the raw material, CP injection and intermediate. The result indicated that the technologic process of CP iniection was repeatable.