| Yangxuezhuyu capsule is a prescription that composed by a famous doctor from the Sichuan Secondary TCM hospital, on the basis of TCM theory,comb ined with his years’clinical practice, has a good curative, effects on menoxenia. The prescription that consists of Radix Rehmanniae Praeparata,safflower cartha mus etc.,six kinds in all,contributes nourishing and promoting the blood, dissol ving stasis,increasing menstruation, mainly used for postmenstruation,hypomenorr hea and menostaxis caused by blood deficiency and stasis.The original formulas were mainly powder or pills, which were inconvenie nt to use, hard to preserve, easily to absorb moisture, and breed mildew and i nsects, pills would take long time to produce, also were vulnerable to microbia1pollution, which shorten the storage period and limited clinical application. S o the modern formula which satisfies common use are made in this subject. In this study, preparation process are inspected, quality standards are established, and the stability test has been doneIn the preparation process investigation, according to physical and chemica1properties of effective ingredients of prescription drugs, combine modern phar macology study and clinical medication requirements, soak period are inspected by adoption of single factor experiment, combined with the orthogonal experi ment, decoction technological parameters are also determined as:water use leve1is8times the crude drugs, extract times is2, each lasts1hour; Salvia milti orrhiza ethanol-extraction process are determined by the same method as:75%ethanol solution use level is10times the Salvia miltiorrhiza amount, immerse3hours, reflux extraction two times, each last1.5hours; PWE is purified by centrifugal separation (8000r/min), PAE is purified by the use of D-101type macroporous resin, the optimum adsorption and elution requirement are determi ned; The best types and ratio relations of auxiliary materials are determined by single factor experiment, combined with the design-effect star face optimizatio n experiment method; The experiment discussed granulating process further, ind icated by granule yield, the feeding speed, the wheel speed, roller pressure are examinated, through the multiple linear regression analysis, combining the actu al industrial production, technological parameters are determined as:feeding spe ed40r/min, roller speed10r/min, roller pressure70bar; In consideration of t he extracts of the prescription, combined with angle of response and density of powder,0th capsule is chosen, which are filled in the environment that T=25℃, humidity below75%, that is the end product.In the quality standard research, thin layer (TLC) method is used for quali tative identification of each crude drug;5-HMF and HSYA are quantitative det erminated by HPLC method, The HPLC conditions for5-HMF content determi nation is:Agilent-Eclipse XDB-C18, mobile phase, acetonitrile-0.1%phosphoric acid solution (21:79), flow rate,1.0ml/min, detected wavelength,283nm, col umn temperature,30℃, and sample size,5μl, linear relation,0.274～1.37u g, and the average recovery was99.98%(n=9), and RSD is2.08%. The HP LC conditions for HSYA content determination is:Agilent-Eclipse XDB-using C18column, mobile phase, methanol-acetonitrile-0.7%phosphoric acid solution (26:2:72). flow rate is1.0ml/min, detected wavelength is403nm, column tem perature is30℃, sample size is5μl. linear relation is good between0.286～1.43ug, the average recovery was99.65%(n=9), and RSD is2.81%. The capsules are fully inspected according to "China pharmacopoeia",2010edition, which conform to the provisions.Reserved sample observational method is used in the stability study, which shows that Yangxue Zhuyu capsule is stable within a year. |
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