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Rhubarb is commonly used in traditional Chinese herbal medicine in China, the long history of medicinal only contained in the \Its unique efficacy, with diarrhea heat bowels, cooling blood detoxification, stasis pass through the efficacy of commonly used in clinical excess heat, constipation, abdominal pain Indigestion unhappy dysentery, jaundice, the hot spit blood nosebleed treatment. Health, wine fried, Steamed or fried carbon. Rhubarb in the garden clinical widely used, has an important position, in great demand. Traditional decoction dose, unstable quality, boiling, taking not convenient to carry, it will be the preparation for the safe and effective, stable and controllable quality, accurate dosage, easy to take, easy to carry rhubarb recipes particles is of great significance . The focus of this study is the pharmaceutical part of the study, including rhubarb recipe particle preparation process, quality standards (fingerprint) and stability studies. According to its composition, physical and chemical properties as well as modern pharmacological studies, using orthogonal test method, the composite score of the multi-index filter out the optimum extraction conditions: rhubarb Pieces, add boiling water three times, each time plus 8 times the amount of water, boiling 1h, combined decoction. Single factor impurity concentration and drying process: filtrate 12000r/min high-speed centrifugation for 15 min, concentrated under reduced pressure (0.08 to 0.1 Mpa, 85 ° C) to the relative density of 1.02 to 1.10 (60 ° C) extract, the following conditions for the spray-dried to obtain the extract powder: extract the relative density of 1.02 to 1.10 (60 ° C); liquid feed speed: 50 ~ 60ml/min; inlet air temperature: 160 ° C ~ 165 ° C; outlet air temperature: 85 ~ 90 ° C. The molding process: collection of spray-dried powder, add appropriate amount of dextrin, mix dry pressed tablets (main pressure 3.0 ~ 3.5Mpa, 0.3Mpa side pressure of 0.25), that is, too. Developed the rhubarb recipes particles quality standards, including: character, identification (TLC was used as a control the Rhein reference, rhubarb reference drug), check (water, melting, particle size, the amount of installed difference, heavy metals, arsenic salt and microbial limit), determination (This product limit: bag containing the rhubarb, aloe-emodin, rhein, emodin, chrysophanol, physcion content of the total amount shall not be less than 20.0 mg); reference to the \0,1,2,3-month stability). The fingerprint study to determine the methanol-0.1% phosphoric acid gradient elution chromatography conditions for the the rhubarb recipes particles fingerprint feature common peaks in the chromatogram, method validation show that its integrity, characteristics, stability in line with the requirements . On the basis of experimental studies to develop a more objective quality standards, this is one of the points of this innovation. The pharmacodynamic equivalence experimental study, the results showed that the the rhubarb recipes particles Pieces role was no significant difference; acute toxicity study results show that, compared with the rhubarb Pieces, rhubarb recipes particle toxicity no difference. From the a pharmacodynamic comparison and safety evaluation of results, rhubarb instead of the traditional decoction medication is feasible. This method of evaluation of the rhubarb traditional sliced ??and dispensing granule effectiveness and safety is new, this is the second of Innovation in this article. The test results show that: the preparation process is reasonably practicable, controllable quality standards, the quality of the finished product is basically stable. This study investigated the for rhubarb recipes particles quality standards standardization pilot study laid the foundation, but also provide a scientific basis for the national authorities to develop quality standards of the particles of the formulation.
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