| Danhuangqianlie capsule is a clinical-researching ,recipe with the purpose of eliminating dampness and heat, using diuretic, treating stranguria ,activating blood circulation to dissipate blood stasis , invigorating the kidney and detoxicating. It is intended to frequent micurition, urgency, odynuria, urethro-calor, whitish turbid urine , nervure slide, the moisture of bursa of testes, and drop of post-urina caused by prostatitis. It is composed of Dandelion, Plantain Seed, Dianthi, Red Peony Root, Baical Skullcap Root ,Danshen root, Lalang Grass Rhizome.Traditional medicine dosage forms are mainly soup, pill, powder, ointment and small pill, and they appear coarseness, bigness, blackness. By comparison to western medicine, its bulk is bigger, coller is worse, smell is not better, and it is more difficult to carry, and it is slower to be absorbed. In order to overcome these disadvantages, many experts in pharmacy have improved the forms of traditional medicine dosage by the means of introducing many dosage forms of western medicine. In this paper, Danhuangqianlie capsule, the new dosage of traditional medicine, was developed with 70% alcohol and water as eluent. Herein, we are applying for the patent of Danhuangqianlie capsule.Firstly, the alcohol extract process of Baical Skullcap Root and Danshen root were adopted according to the optimal results of orthogonal design experiment. Secondly, the effective ingredient of other herb were extracted by water decocting method.At last, through the investigation of quality standard and stability, we found that content and quality were steady. This topic is composed of three partOne: Extraction technics1. Studying the alcohol extraction technics of Baical Skullcap Root and Danshen root in the prescription by testing the content of baicalin, an effective component of Baical Skullcap Root. The optimum alcohol concentration was studied firstly. Then selecting extraction time, extraction times and the alcohol amount as the investigating factors, the optimum preparation procedure was studied by orthogonal text. The reasonable and available process conditions were established.2. Studying the water extraction technics of other drugs and remainder of Baical Skullcap Root and Danshen root after alcohol extraction by testing extract content and the content of peoniflorin, an effective component of Red Peony Root in the prescription. Selecting the water amount, decoction time, decoction times and error as the investigating factors, the optimum preparation procedure was studied by orthogonal text. The reasonable and available process conditions were established.3. Studying the water extraction-alcohol deposition technics of drugs by testing extract content and the content of peoniflorin. Selecting relative density of the liquor and alcohol concentration as the investigating factors, the optimum preparation procedure was studied by orthogonal text. The reasonable and available process conditions were established.Two: Praeparatum form technicsBecause of the characteristics of moisture absorption of drug, the starch was used as an excipient and anti-moisture absorption agent, then the drug powder was made into particles against moisture absorption. 95% ethanol was elected as wetting agent through factors test. The 2 mesh sieve were used for pelleting, and 3 mesh sieved complete pellet, then loaded into capsules.Three: Quality standard studyIn order to control the quality of Danhuangqianlie capsule ,we have used TLC to videntify Dandelion, Plantain Seed, Dianthi, Red Peony Root, Baical Skullcap Root ,Danshen root, Lalang Grass Rhizome. Because traditional medicine has various complement ,the TLC of Dandelion can not succeed ,but the others were successful .At the same time ,we have taken baicalin and peoniflorin as index, the high performance liquid chromatography method was used to determine the content of baicalin and peoniflorin in the drug, and provided the content of baicalin and peoniflorin proprietary not less than 6.1%. and 0.78%. As a result, this method is feasible, repeated stability and the complement do not disturb the determination .It can be used to control the inside quality of the drug . |