| Dingtongning granules is a kind of topical preparation developed by traditional Chinese medicine hospital of Kunshan. The preparation, consisting of ChuanXiong Rhizoma,Paeoniae Radix Rubra, Salvia miltiorrhiza Radixet Rhizoma, Asari Radix et Rhizoma, Safflower carthamus, Achyranthes bidentata Blume, Radix angelicae dahuricae, FructusViticis, Radix Aconiti praeparata, prepared Kusnezoff monkshood root and so on. Having a reputation for facilitating blood circulation and dispersing blood stasis, the preparation is intended to treat blood-stasis migraine with marked clinical effect. Focusing on the registration requirements of pharmaceutical preparation in a hospital, starting from a variety of active and effective ingredients of each medicine and the theoretic basis, the research combines the pharmacodynamics test to confirmed a preliminary fixed solvent technological process. It includes the application of modern extraction, inclusion and refinement and the molding process to be made into granules. This paper includes the following areas:1. Documentary ResearchGuided by the theory of traditional Chinese medicine, the paper briefly expounded Dingtongning granules's background and the basis and significance of the research. At the same time it concludes and summarize the chemical constituents of each medicinal materials contained in the prescription together with their pharmacological effects, physical and chemical identification and molding process.2. Preparation technology research2.1 The preparation processCombined with comprehensive evaluation and based on document analysis, the extraction technique of volatile oil like ChuanXiong Rhizoma and Asari Radixet Rhizoma in the Dingtongning Granules is concluded. So are the alcoholic extraction technique of Salvia miltiorrhiza Radix et Rhizoma, Radix angelicae dahuricae, Fructus Viticis, Radix Aconiti praeparata, prepared Kusnezoff monkshood root, and the water extraction route of Paeoniae Radix Rubra, Safflower carthamus, Achyranthes bidentata Blume. The method of writhing by acetic acid, hot-plate and plasma PGE2 in mice, NOS content changes is made to evaluate the process extracts analgesic and anti-inflammatory effects and security. Results show that the proposed technique is reasonable and the efficacy of the new technology is better than that of the original process.2.2 Orthogonal test to optimize the extraction process conditions? Volatile oil extraction technologyBy establishing multi index synthetical evaluation system and using orthogonal testing method, the research optimizes the original technological process. The extraction amount of volatile oil was used as an index, determining ChuanXiong Rhizoma and Asari Radix et Rhizoma mixed with 8 times of water, soaking for 1 h and vapor distillation for 6 hours. The distillation liquid(?) and herb residues (?)were in reserve; based on the index of he volatile oil utilization efficiency and inclusion yield, the research adopted the saturated water solution method. The ratio of volatile oil from ligusticum wallichii and asarum to ?-CD was 1:8; the temperature was at 50? and the stirring time was 1.5 h, and the product were in reserve.? Ethanol-extracting processSalvia miltiorrhiza Radix et Rhizoma, Radix angelicae dahuricae, FructusViticis, Radix Aconiti praeparata, prepared Kusnezoff monkshood root were added six times the amount of 80% alcoholl, with no soaking, but heating reflux 2 times, each time for 2 h., collecting the twice filtrate liquid(?) and herb residues (?) in reserve.? Water extraction and alcohol precipitation processPaeoniae Radix Rubra, Safflower carthamus, Achyranthes bidentata Blume were mixed with herb residues (?)and (?), and then 12 times of water, soaking for 0.5h, extracted 2 times and each time lasted 2 h. Filtrate the liquid, and mix it with the distillation liquid(?), and concentrate its relative density to 1.10 g/ml (25 ?); add alcohol to 70%, stirring and refrigerating for 18h; combine the liquid supernatant with filtrate liquid(?).2.3 Concentration and drying processRemove the alcohol, then enrich and dry under reduced pressure the liquid to extract powder.2.4 Pharmaceutical technologymix the powder with excipients consisting of soluble starch, mannitol and dextrin at a certain ratio (1:0.2:0.8:0.2)and was screened through mesh size of 80;then moistened with 90% alcohol to soft materials and screened through mesh size of 10 and decompressed drying to pressed granules under 60? together with the mixture of ?-CD.3. Quality standards researchThe paper conduct an research on the Thin Layer Chromatography(TLC) identification and content determination. It mainly use the TLC identification on the herbs like ChuanXiong Rhizoma,Paeoniae Radix Rubra, Salvia miltiorrhiza Radix et Rhizoma, Safflower carthamus and received good results. Establish the method of measuring the contents of ferulic acid, poaeoniflorin and tanshinone IIA according to the High Performance Liquid Chromatography (HPLC) method, and make a systematic study on methodology on the Analysis Method.The results show that optimized preparation technology is reasonable and reliable and the quality standards are accurate and reproducible. It can be used for the quality control and evalutaion of the constant pain grain quality control and evaluation of Dingtongning granules. |
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