Study On The Production Process And Quality Standard Of Chuangxiong Formula Granule

Chuanxiong (CX), as the famous-region drug in Sichuan province, is the drystenophora of umbelliferae Ligusticum chuanxiong Hort. With the drug efficacy ofpromoting blood circulation to remove blood stasis, promoting qi circulation andrelieving pain, CX is called “The drug of qi in blood” for the treatment ofcardiovascular and cerebrovascular diseases, and pain illness. CX is one of mostimportant traditional Chinese medicine (TCM), and the annual output and theapplication amount in clinic of CX stay among the largest in China. Chinese medicineformula granule is made with modern pharmaceutical technology under the guidanceof TCM theory. As the advantages of stable quality, convenience of taking andcarrying, safety, and health, the study of CX formula granule is of great significance.In terms of the require of2010edition of Chinese pharamacopoeia, the decoctionpieces of CX used was successfully validated in aspect of character, identification,examination and determination of extract and the content. The results indicated thatthe decoction pieces of CX validated could be used for the development of formulagranule.The technology of extraction, volatile oil inclusion, separation, concentration,drying and forming was optimized by orthogonal experiment, and the optimalproduction process of CX formula granule was obtained as follows: extract CX bydistillation for3times and2h,1h,1h per time with5,4,4portions water aftersoaking2h, filter immdiately and merge, then concentration under reduced pressureto extract solution with a relative density of1.12(70℃), spray drying to obtainextract powders; collect volatile oil with the process of extract, mix it with equalvolume of ethanol, grind for1.5h with6g β-cyclodextrin and18portions water perml, filter and dry under reduced pressure, smash to obtain the coated volatile oil. Addthe extract powders and appropriate amount of maltodextrin, mix well, drygranulating. The production process was reasonable and feasible after pilot test.The quality standard of CX formula granule was established based on the systematic research of character, identification, examination and determination ofextract and the content. Thin-layer chromatography (TLC) was used for identificationwith ferulic acid as control. The items of examination included particle size, moisturecontent, melting, microbial limit, heavy metals, arsenic salts and so on. Hot-dipmethod was used for the determination of extract with ethnal as solvent. Highperformance liquid chromatography (HPLC) was used for determination of ferulicacid. CX formula granule contains ferulic acid not less than1.69mg per bag. Theestablishment of quality standard provides reference for the quality control of CXformula granule.The preliminary stability test was performed for three batch of pilot productsaccording to the quality standard. After six months of long-term stability, and sixmonths of accelerated stability test, the results of three batch of pilot productsindicated that CX formula granule is stable.