Study Of Preparation Process And Quality Standard Of Da Lianqiao Granules

ObjectiveDa Lianqiao Granule is a compound preparation which consists of fifteen Chinese herbs(Foreythiae Fructus, Dianthi herba,Talcum, Plantaginis Semen, Arctii Fructus, Paeoniae Radix Rubra, Gardeniae Fructus, Akebiae Caulis, Angelicae sinensis Radix, Saposhnikoviae Radix, Scutellariae Radix, Bupleuri Radix, Glycyrrhizae Radix Et Rhizoma, Schizonepetae Herba, Cicadae Periostracum).It has the function of expelling pathogenic factors from the Heart Sutra for clearing heat and using in upper energizer toxic heat, Pediatric Stomatitis, and Urine being red and astringent. Under the guidance of Traditional Chinese Medicine theory, applying modern pharmaceutical technology and according to correlative regulations of patent Traditional Medicine, we systematically studied the Preparation process and Quality standard.MethodsAccording to the function and property of chemical ingredients in this prescription, and using orthogonal design with multifactor evaluation comprehensively, the optimum process and quality standard of Da Lianqiao Granule were obtained.In the preparation technology research, we considered the extract method of essential oil in complex prescription at first. By using single factor test and based on the yield of essential oil, we optimizated the best steam distillation process parameter. Secondly, according to the Traditional Chinese Medicine priniciple, we used water to decocte herbs, adopting orthogonal design and optimizated the best parameter of extraction. Next, Bupleuri Radix was extracted by ethanol. Using orthogonal design method, optimizated the best parameter of extraction. Based on the active component, contrasted the different alcohol precipitation process, and then optimizated the best alcohol precipitation process. Last, optimizated the best parameter of condense, granulate, dry to offer the reasonable, normative and scientific data for industrialized production.In the research of quality specifieation, the methods and conditions of TCL of Gardeniae Fructus,Angelicae sinensis Radix, Scutellariae Radix, Bupleuri Radix, Glycyrrhizae Radix Et Rhizoma were offered. We also established the limits of the forsythin with HPLC. Besides, it was examined under the relevant contents of granule in the "China Pharmacopoeia"2010Edition. All of this is to establish a reasonable, normative and scientific quality control systerm.ResultsAngelicae sinensis Radix and Schizonepetae Herba Were steamed with10times of water for5hours, the essential oil was enveloped in brown bottles with low temperature storage. The dregs of the two drugs mentioned above and Foreythiae Fructus, Dianthi herba, Talcum, Plantaginis Semen, Arctii Fructus, Paeoniae Radix Rubra, Gardeniae Fructus,Akebiae Caulis, Angelicae sinensis Radix,Saposhnikoviae Radix, Scutellariae Radix, Glycyrrhizae Radix Et Rhizoma, Schizonepetae Herba, Cicadae Periostracum were then extracted with8times of water for two times, each time for2hours. Then the all extract was incorporated together and concentrated till the density of which reached1.05～1.15(60℃).After that, we leted it cool, and added ethanol with alcohol amounted to70%. At the same time, stiring it and standing overnight.The ethanol extract was then concentrated till the density of which reached1.15～1.20(60℃). Bupleuriwas Radix extracted by8times of80%ethanol for two times, each time for1hours. The ethanol extract was then concentrated till the density of which reached1.15～1.20(60℃) Then the extract mentioned above was incorporated together,adding a certain amount of powdered sugar and dextrin,and then made into granule.The granule were dried by desiccator15hours at80℃.At last, the essential oil mentioned above sprayed on the dry granule and sealed for24hours. Collected the granule and bagged it. Through the Physico-description investigat ion, granule’s quality specification is qualifica-tion. ConclusionsStudies show that the extraction, purification and forming processes of Da Lianqiao granules are simple, reasonable and practicable. TCL and determination method are simple, specific. The quality standards of the preparation are stable and controllable.