| Dan huang hua yu tablet is traditional Chinese medicine compound Preparation made from Salvia miltiorrhiza Bunge and Curcuma longa L,with effect of activiating blood and dissolving stasis, promoting Qi and relieving pain, and it was useful to treat hepatic fibrosis such as to protect hepatic function,to improve blood circulation,to inhibit collagen protein synthesis,etc. The subject is guided by traditional Chinese medicine theory, applying modern science and technology and methods, studying systemly experimentally on the extraction process, preparation processes and quality of the preparation, providing a scientific basis for the development of the new drug for liver fibrosis. Study are as follows:1.Study on extraction and purification processStudy on extraction process:by using tanshioneⅡA, salvianolic acid B and curcumin as evaluating index, extraction ratio of the effective components of Salvia Miltiorrhiza Bge and Curcuma longa L with different extraction methods were compared, selecte the adaptive extraction method, and the orthogonal test was conducted with the main influence factors to obtain the optimal extraction condition.The result was:the Curcuma longa L was reflux extracted with 80%alcohol for 1h and three times, extracting with 8 times solvent of the medicine amount in the first time, and with 8 times in the second and third time. Filtrate and mix filtrate, and the filter residue was reserved. The Salvia Miltiorrhiza Bge was cold-soaked extracted with 95%alcohol as much as 8 times of the medicine amount for 3h and twice. Filtrate and mix filtrate, and the filter residue was reserved. Combine the filtrate and reflux extract with water as much as 5 times of the medicine amount for 1h and three times. Study on purification process:with the curcumin as the index, the effect of water amount on dry extraction amount was investigated in the precipitation method by water of the extract of Curcuma longa L;With the salvianolic acid B as the index, adsorption technology with macroporous resin of the extract of Curcuma longa L and Salvia Miltiorrhiza Bge filtrate was optimized by the test. The result of the precipitation method by water was:the extract was decompress concentrated to about 50mL, and precipitated by adding water as much as 8 times of the medicine amount and centrifuged(3500r/min, l0min) to obtain the centrifugal precipitation;the macroporous adsorption resin purify process was:the extract of Curcuma longa L and Salvia Miltiorrhiza Bge filtrate was absorbed by macroporous resin, and watered till to the negative glucose reaction, eluted with 60%alcohol as much as 3 times of column volume, and the eluate was collected and decompress concentrated till to thick paste.2. Study on preparation processesThe effect of different adhesive, filler, disintegrant and the amount on granulation process and tablet quality was investigated. The result was: we selected MCC and lactobiose as filler, BHA as antioxidant and 10%of dextrin as adhesive, mixed well and granulated, and then added sodium carboxy methyl starch and PVPP as disintegrant to tablet.3. Study on preparation qualityExcept for routine examination, the controllable component content of Dan huang hua yu tablet was studied. Study on determination:determine the content of Tanshione IIA, salvianolic acid B and curcumin in the Dan huang hua yu tablet by HPLC, in accordance with Chinese Parmacopoeia(2005 Edition), a methodological survey has been conducted. The result was:the calibration curves of Tanshione IIA, salvianolic acid B and curcumin were good in the ranges of 0.0392～0.3136μg (r=0.9994),0.2850～2.2800μg (r = 0.9997) and 0.025～0.200μg (r=0.9994), and the average recoveries were 99.1%,97.3%and 98.0%with RSD of 1.14%,1.80%and 1.88%, respectively.The methodological studys of HPLC show that the methods are reasonably practicable, simple, sensitive and nicely reproducible, and suitable for quality control of the preparation.
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