Study On Prepration Process And Quality Standards Of Pu Lizhikang Capsules

Objective:Hyperlipidemia refers to increased levels of lipids in the blood which is causedby abnormal lipid metabolism and can induce a series of serious damage to human health diseases, such as fatty liver, coronary heart disease, hypertension, stroke, myocardial infarction. The preparation process, quality standards and preliminary stability of Pu Lizhikang Capsules which can regulate blood lipids were studied in this dissertation. These reserach provide the evidence for the development and utilization of Pu Lizhikang capsules.Methods:(1) Prescription screening and preparation process of Pu Lizhikang capsules: the capsule disintegration time, fluidity of materials, the rate of divergence were used as indexes to investigate the best formulation and preparation process of Pu Lizhikang Capsules.(2) Study on Quality Standards of Pu Lizhikang Capsules: Establish methods of characters, TLC identification, moisture, disintegration time, content uniformity and gas chromatography determination for Pu Lizhikang Capsules.(3) Preliminary Stability of Pu Lizhikang Capsules: We examine influencing factor stability for 6 months, accelerated stability for 6 months and long term stability for 12 months of Pu Lizhikang Capsules in the aspects of character, moisture, disintegration time and content. Results:(1) The optimal composition of preparation and the preparation process of Pu Lizhikang capsules were determined.(2) we have established methods of character, identification, inspection, determination for Pu Lizhikang Capsules and developed a draft quality standard.(3) The characters, moisture, disintegration time and content were examined for the tests of influence factor experiment for 6months, the accelerated testing(40 ℃,75%RH) for 6 months and long-term testing(25 ℃,60%RH) for 12 months.These results suggest that Pu Lizhikang capsules is stable, and should pay attention to moisture during storage. Conclusion:Pu Lizhikang capsule preparation process is simple and feasible, Quality standard is reasonable, preparation quality is stable and controllable.