Study On CP Capsule And The Quality Control

The CP capsule, which was composed of traditional Chinese medicine CP, was studied in this paper.CP was extracted by ethanol and the acute toxicity experiment was carried out. Then make sure the best dosage of CP by means of setting up a mus model with solid tumor S₁₈₀.The hydroscopicity was improved by adding suitable bulking agent to CP extract, which was made into particle, then make sure the suitable drying temperature and time. The recipe of CP capsule was optimized by adding Gum Arabic as lubricant and sodium carboxymethyl starch as disintegrating agent. Preparation craft of CP capsule was definite by a series of procedure like granulating and so on.Fingerprint of three batches of the raw material and CP capsule were developed respectively by HPLC. In the fingerprinting chromatograms, 16 common peaks were obtained, and 9 common peaks were identified. Based on the results, similarity and contents of bufalin, cinobufagin, resibufogenin and bufotalin were chosen as the quality control indices to judge and evaluate CP capsule more effectively. Correlation research was progressed through the HPLC fingerprint chromatograms of the raw material and CP capsule. The result indicated that the technologic process of CP capsule was reproductive.