Studies On Preparation And Quality Control Of Mafugan Capsule

Objective:To study a traditional Chinese medicine of “Mafugan Capsule” for the treatment of after infection cough and research its preparation and quality standards.Method:Detect the water uptake rate by decoction method;The content of single ester type alkaloids,soluble composition of alcolhol and extract rate as index,by orthogonal experimental design method,optimized the water extraction technology;the type of accessories was optimized with using absorption rate as assessment index;the mount of the accessories was optimized with taking fluidity of dry cream;the appropriate size of capsule was determined on the base of bulk density,daily dose and daily frequency;TLC method was adopted to identify Glycyrrhizae Radix et Rhizoma,Ephedrae Herba,Aconiti Lateralis Praeparata Radix;Single ester type alkaloids,Ephedrine,Pseudoephedrine,Liquirtin were determined by HPLC then established the HPLC fingerprint.Result:The best preparation technology was:By detecting the rate of absorption,2 times volume was absorbed;water was used to extract medicine for 2 times,fist time,adding 8 times amount of water into medicine and reflux for 3 hours,second time, adding 6 times amount of water into medicine and reflux for 2 hours,filtered,merge the filtrate,decompression concentrate to the relative density was 1.10(60℃),reserved,mixed the dry cream and crushed into fine powder,add proper amount of Starch,blended,loaded into capsules,geted 1000 capsules.The Ephedrae Herba,Aconiti Lateralis Praeparata Radix in the chromatogram of the test,had the same color spots with reference on the corresponding position,negative without interference, Glycyrrhizae Radix et Rhizoma in the chromatogram of the test,had the same color spots with reference drug on the corresponding position,negative without interference.In the preparation determined by quantitative analysis,Single ester type alkaloids shall not be less than 0.2 mg of per capsule,Liquirtin shall not be less than 2.0 mg of per capsule,the total of Ephedrine and Pseudoephedrine shall not be less than 1.5 mg of per capsule.Established the HPLC fingerprint by using Liquirtin as reference sample,10 batches of capusle were high similarity,and developed the quality standard draft of capsule.Conclusion:The preparation of Mafugan capsule are stable and simple,the quality standared is accurate with a good reproducibility,it have an effective treatment on after infection cough.