The Study Of Pharmaceutical And Preliminary Pharmacodynamics On Changershu Colon Capsule

Ulcerative colitis is an inflammatory bowel disease with unknown pathogeny,different conditions,attacking repeated,difficulte to recover and lasting for a long time.Modern medicine treats the disease mainly by the surgrry and durg therapy,but the effect is dissatisfied and mang durgs with side-effects and required long-term medication.According to the clinical application for more than ten years,Changershu capsule,which is clearing intestine and invigorating spleen,regulating vital energy and eliminating haemostasis,healing tumefactions and antidiarrheal,is definite effect,safe and reliable.Guided by Traditional Chinese Medicine theory,this projects study the preparation,quality specification and stability in accordance with the requirement of the sixth-types of new drug.Preparation:The alcohol extraction technology of phellodendri chinensis cortex and coptidis rhizoma was studied by orthogonal test with extraction rate of berberine hydrochloride and the solid rate as indexes.The optimum extraction technology was as follows:alcohol extracting for 3 times and 2 hours each time with 8 times 50%alcohol.The water extraction of paeoniae radix alba and sanguisorbae radix et al was studied by orthogonal test with extraction rate of paeoniflorin and the solid rate as indexes.The optimum extraction technology was as follows:water extracting for 3 times and 2 hours each time with 8 times water.The ethanol precipitation was studied by orthogonal test with retention rate and purity of paeoniflorin as indexes.The optimum ethanol precipitation was as follows:the decoction was concentrated to 1:2(1mL solution is equivalent to 2 g medicine.).95%ethanol was added to 70%capacity and kept for 8 hours.Both decoctions were concentrated to be the thick pastes,then dried to obtain extract powder.The optimum preparation process based on hygroscopicity and flowability was as follows:eighty percent of dextrin and twenty percent of colloidal silicon dioxide were added to powder,suitable 95%ethanol was added to the extract powder to make wet granules and then dried and screened,filled into capsules.Quality specification:The scale-up products were used in this research.The character was confirmed by observing.The quality differentiation methods of phellodendri chinensis cortex,coptidis rhizoma,paeoniae radix alba,draconis sanguis and sanguisorbae radix were established by TLC indicated with reference substances?reference medicine and negative reference sample.The characterization of properties,water content,disintegration test and microbial limit were checked according to Chinese Pharmacopoeia(2010),and the result complied with the rule.HPLC methods for the product have been established to determine the contents of berberine hydrochloride,palmatine hydrochloride and paeoniflorin.The methods were easible.The recursive equation of berberine hydrochloride was Y=4100419.1X-12038.2,r=0.9999,and the average recovery was 98.7%with RSD 1.7%.The recursive equation of palmatine hydrochloride was Y=5904786.5X-10215.7,r=0.9998,and the average recovery was 98.5%with RSD 1.3%.The recursive equation of paeoniflorin was Y=1349928.4X-3106.5,r=0.9999,and the average recovery was 98.3%with RSD 1.2%.Stability:According to the established quality specification,three batches of capsules were tested under the condition of accelerated stability test for 6 months and ordinary temperature stability test for 6 months.The results showed that the capsules were stable.Pharmacodynamic:Changershu colons capsule can significantly improve the ulcerative colitis in the rat by pharmacodynamic experiment.Conclusion:The results showed that the process of the preparation is reasonable and feasible,the quality can be controlled,the product quality is stable,and the efficacy is significant.