Studies On The Preparation And Quality Control Of Celandine Alkaloids Capsule

Celandine was Papaveraceae Chelidonium majus L. dry complete grass,alais Rhizoma Picrorhizae,mountain Coptis,Gelsemium elegans,etc, mainly distributed in China’s northeast,northwest,north China,the general growth at the edge of the meadow,shrubs,or by the roadside a cool and humid place. Celandine taste bitter,cold,a small drug; belong to lung,stomach. With the function of analgesic and antispasmodic,relieving cough and asthma, detoxification. This product is taken orally,to cough,analgesia for long.The stomachache has a very high prevalence in the crowd,the majority of people may be more or less,or long or short experience pain in the stomach,stomach and other digestive system dysfunction symptoms in their lifetime,causing inconvenience to people’s life,work,in physiological and psychological aspects seriously affects people’s quality of life.Objective:Celandine decoction was clinical prescription,for the treatment of bile duct and gastrointestinal spasm-like discomfort (hereinafter referred to as the stomach) has a good curative effect.For the convenience of patients with medication, further improve the stability of the drug.This topic through scientific research system for preparing capsules screening of new materials in order to provide more patient choice.Method:The excipients were selected by orthogonal experimental design method,to observe with the rate of moisture absorption and formation rate,determining the best molding process of Celandine alkaloids capsule.In order to control the quality of this product,according to the China Pharmacopoeia2010Edition appendix check capsule, inspection items include the disintegration time, load difference, moisture.At the same time in order to ensure the quality of preparation and efficacy,using thin layer chromatography (TLC),high performance liquid chromatography (HPLC) and sample observation method to establish the quality control index of Celandine alkaloids capsule.Result:Selected the best molding process for the Celandine alkaloids extract and supplementary material ratio (4:5); accessories (soluble starch, dextrin3:1);Wetting agent ethanol volume fraction(75%),the drying temperature (50℃),the critical relative humidity(CRH) was80%. Made Celandine alkaloids capsules per pack0.2g;Capsules general examination results are qualified.This paper established a method for the identification of the product of chelidonine and chelerythrine,established the determination method of chelerythrine in this product,methodological study results meet the requirements;The preliminary stability test results are qualified.Conclusion:Optimization of the preparation process is reasonable, feasible, stable. Quality control index established complete, accurate, simple, reproducible, and can control the quality of Celandine alkaloids capsule.