Pharmaceutical Research Of Baihuang Xiere Zhili Tablets

Baihuang Xiere Zhili Tablets whose prescription was from clinical experience prescription were comprised of 4 herbs. With cleaning heat and drying humidity, cooling the blood and removing the toxic materials, and arresting diarrhea and dysentery effect, it's mainly used for the treatment of diarrhea associated with heat, urine red astringent and under the heavy heat dysentery, and could achieve better clinical curative effect. Guided by the theory of TCM, this research aims to develop the TCM formula into a secure and active, stable and controllable, easy to take tablet by modern pharmaceutical technology.Based on the clinical curative effect and combined with preliminary pharmacodynamic contrast test, this research determined with water as the extraction solvent. With the extraction capacity of anemoside B4, berberine hydrochloride, aesculin, aesculetin, scopoletin in each herb ingredients, and ratio of extraction as comprehensive evaluation indexes, the weighting coefficient in six synthetic evaluation indexes was determined by mixed weighted AHP-CRITIC. Then compound water extraction process parameters were optimized by orthogonal test. Taking the transfer rate of index components, the yield of dry extract as the evaluation index.to optimize the separation and purification of aqueous extractives. In order to extract powder, yield and moisture content as evaluation index, optimization of technological parameters of spray drying. Ultimately determine the extract of powder preparation process as follows:Prescription medicines added 9 times the amount of water for 1 h, extracting 1 h, then added 8,8 times the amount of boiling water 2 times,1 h each time. With the filtrate and concentrated to 1.10 (70?) clear paste,50% alcohol sedimentation 24 hours, filtering, recovering ethanol, concentrated to relative density is 1.10-1.15 (65?), spray drying.In the study of preparation for molding process, investigation results of powder properties showed that extract powder had strong moisture absorption under normal temperature. In order to select suitable filler, this research had a single factor exploration of different fillers on the tablet forming starting from the excipients which could reduce hygroscopicity of extract powder. Consequences of microcrystalline cellulose and lactose in combination, the soft material viscosity was moderate, the pressure of the granules was good, the disintegration time of the tablets was short and the moisture absorption is improved. In addition, types and dosage of wetting agents and adhesive, disintegrator, lubricant and adding methods of disintegrator were investigated. Finally determine the tablet preparation process as:Taking extract powder of spray drying, added microcrystalline cellulose and lactose each 72.5g, mixed with 95% ethanol solution prepared soft material, granulating, drying, sieving, added sodium carboxymethyl starch 15g and talc 5g, tabletting, and film coat, that is, too.In the quality specification study, TLC identification methods of Pulsatilla chinensis, Coptis chinensis, Cortex fraxini, Artemisia annua.L and the rules of preparation for tablet had been checked. In addition, content determination methods of anemoside B4 and berberine hydrochloride were established, achieving a multi index HPLC method content determination.In the preparation stability study, because of the content of of anemoside B4 and berberine hydrochloride decreased slightly under high humidity test, the PTP aluminum foil is used to carry out the packaging in order to ensure the tablet quality and reduce the moisture absorption of the tablet. The preliminary stability result indicated that three batches of test samples were good within six months according to the following formulation, a positive reaction by TLC, a qualified determination results and routine examination of tablet to meet the requirements.In this study, the extraction process was determined by preliminary pharmacodynamic comparison test, on the basic of which the extraction, purification, concentration and drying, preparation technology of preparation were studied. Therefore, the clinical efficacy of the preparation was guaranteed. This study established the control method of preparation was stable and controllable in quality, and the results included in the quality standard of the text. The research provided a preparation of TCM for clinical in the treatment of yin and damp heat diarrhea, which was safe and effective, stable and controllable, easy to take and store.