Study Of Preparation Process And Quality Standard Of Tiaojing Huoxue Granules

Tiaojing Huoxue tablet was specified in "Health of People’s Republic of China Ministry of Pharmaceutical standards the Chinese medicine Narikata preparations" The prescription consists of Angelica, Rhizoma Cyperi, Salvia, Corydalis yanhusuo, Paeonia,15kinds of chinese herbs, has the effect of Tiaojing blood circulation, relieve pain, clinical mainly for irregular menstruation, menstrual pain. The original dosage form of Tiaojinghuoxue tablets as sugar coated tablet, medicine prescription medicine with starch directly, there is a large dose, disintegration speed is slow, and this process of sugar in the actual production of the required time long, material consumption, coating weight increased too much; in the original formulation of quality standard only on the established TLC, cannot control the drug quality.Considering less dosage, rapid absorption, easy to carry, stable quality and other factors,we will change the dosage form of Tiaojinghuoxue tablets to do with the fautiness and uncontrollability of quality. According to the properties of functions and components of drug prescription, combined with the actual production under the guidance of TCM theory, made into granules, the test samples to study the quality standard and stability, verify to the feasibility of the obtained formulation and and preparation process and the controllability of quality standard.The whole work included three parts:study on preparation process, quality standard, and the stability studies. With the total content of Corydalis tetrahydropalmatine as the indexes, the optimal percolation extraction process was screened by onhogonal design. With the paste-forming rate and total content of paeoniflorin as the indexes, the optimal water-extraction condition was screened by onhogonal design. With hydroscopicity, fluidity and formability as the indexes, the appropriate ratio of the excipient and the formula were selected. The optimum preparation process for:Aucklandia,Lindera,Atractylodes, Corydalis yanhusuo, Angelica, Rhizoma Cyperi, Euodia, Locopi, eight kinds of herbs crushed into coarse powder, with70%ethanol as solvent, after24hours of immersion, percolation, collecting percolate, vacuum recovery of ethanol, concentrated to a relative density of1.05to1.10(65℃), spare; the remaining seven flavor, decocting two times, each time1.5hours, liquid filtration, combined, concentrated to a relative density of1.01to1.02(65℃), standing for12hours, filtering, adding extract ethyl alcohol continue to concentrate, to a relative density of1.15to1.20(65℃), adding lactose, sucrose powder, dextrin (6:3:1), the boiling granulator granulation, granulation, packing, to obtain the Tiaojinghuoxue Granula.According to Pharmacopoeia of the P.R. China and the relevant provisions, determine the quality standard of Tiaojinghuoxue granules. TLC method is used to indentify Salvia miltiorrhiza, Evodia rutaecarpa, Corydalis yanhusuo, Paeonia lactiflora; HPLC method was used to detemine the paeoniflorin of Paeonia, and the provisions of contents of paeoniflorin in Tiaojing Huoxue granules on each bag shall not be less than4.0mg. Tests of results showed that paeoniflorin in0.12±1.44p.g showed a good linear relationship; stability study results indicate that the samples within24hours of stable; blank test results prove that the negative samples without interference of the test; precision test results show that the precision of the instrument is good, repeat the test6times independent determination of RSD is1.07%; the recovery rate of6tests results, the average recovery was98.98%, RSD1.16%.According to the drug registration management regulations, according to the requirement of quality stability research of new drugs of traditional Chinese medicine technical requirements and Tiaojing Huoxue granules quality standard draft, three batches of samples under sold packaging (pharmaceutical packaging composite film) for6months accelerated test and long-term stability test for36months.6months accelerated test results show that:the product indexes smaller fluctuations, the product conforms to the standards of quality. Long term results of stability test for36months show that:36months of granules the content of paeoniflorin declined slightly, but still meet the quality standards.Through the above research show that:Tiaojing Huoxue granules process is reasonable, simple, practical, suitable for the actual production. TLC identification and content determination method is simple, reproducible, stable, the quality standard was controllable and the products were qualified.