| This test is mainly to study the the preparation process of effective fractions of total isoflavones from Puerariae lobatae and total alkaloids from Coptis chinensis,alsot its quality standards, best compatibility prescription and preparations molding process, aimed at laying the foundation for the development of post-preparation.The main contents include:1. Recognizing the effective ingredients in fractionsPreliminary test results show that the effective ingredients in fractions of total isoflavones from Puerariae lobatae were puerarin,3’-methoxy puerarin,3’-hydroxyl puerarin, daidzin and daidzein; total alkaloids from Coptis chinensis were columbamine, epiberberine, coptisine, palmatine and berberine.2.Determination of effective fractions from Herbal slices(1) Establishment of a method for the determination of effective fractions of total alkaloids from Coptis chinensis Pieces, and measured the content of the five effective ingredients of alkaloid. It was provisionally formulated that the contents of columbamine, epiberberine, coptisine, palmatine and berberine in the Coptis chinensis Pieces were in ranges of 0.40%～0.87%,0.75%～2.09%,1.66%～2.85%,1.24%～2.78%,5.0%～10.24%.(2)Establishment of a method for the determination of effective fractions of total isoflavones from Puerariae lobatae Pieces,and measured the content of the five effective ingredients of isoflavone. It was provisionally formulated that the contents of 3’-hydroxy puerarin, puerarin,3’-methoxy puerarin, daidzin and daidzein in the Puerariae lobatae slices were in ranges of 0.56%～1.58%,2.40%～9.27%,0.72%～1.85%,0.37%～ 1.30%,0.10%～0.43%.3.Study on the preparation process of effective fractions(1)The preparation process of effective fractions of total alkaloids from Coptis chinensis:Coptis chinensis was extracted with 15 times the amount of 70% ethanol, boiling three times,90mins per time, recovoering ethanol from the alcoholic extract. Type of AB-8 macroporous adsorption resin was chosed to impurity totalf alkaloids from Coptis chinensis when the process conditions were as the follows:the content in the extract was 37.5 mg per 1mL equivalent to raw material, the ratio of diameter and height was 1:10, velocity of adsorption was 1 BV·h-1, solvent of removing impurities was water, volume of removing impurities was 5 BV, velocity of removing impurities was 1 BV·h-1, solvent of reagent was 50% of ethanol, volume of elution was 6 BV, velocity of elution was 1 BV·h-1. Combined the eluent,then the extract was concentrated to the relative density of 1.06-1.10 (60℃ temperature measurement),65～75℃ vacuum drying.(2)The preparation process of effective fractions of total isoflavones from Puerariae lobatae:Puerariae lobatae was extracted with 15 times the amount of 60% ethanol, boiling three times,60mins per time, recovoering alcohol from the alcoholic extract. Type of AB-8 macroporous adsorption resin was chosed to impurity total isoflavones from Puerariae lobatae when the process conditions were as the follows:the content in the extract was 75 mg per 1mL equivalent to raw material, the ratio of diameter and height was 1:10, velocity of adsorption was 1 BV·h-1, solvent of removing impurities was water, volume of removing impurities was 5 BV, velocity of removing impurities was 1 BV·h-1, solvent of reagent was 50% of ethanol, volume of elution was 6 BV, velocity of elution was 2 BV·h-1. Combined the eluent,then the extract was concentrated to the relative density of 1.06-1.10 (60℃ temperature measurement),65～75℃ vacuum drying.4.Study on the quality specification of effective fractionsThe TLC identification method for each effective fractions was established. Also we have set up a HPLC method for the determination of effective fractions. It was provisionally formulated that the standard content of total isoflavones in effective fractions is no less than 50%,total alkaloids is no less than 70%. Besides,we have developed reasonable content limitation for heavy metal,residue,ignition,moisture of both of the the effective fractions.5. Choose of the best compatibility prescriptionThe levels of FBG of different diabetic mice model were chosen as indexes to evaluated the six compatibility prescriptions, equally th elevels of TG and TC in erum of diabetic mice mode induced by STZ were chosen as indexes to evaluated the six compatibility prescriptions. The results show that the optimum ratio is 2:8 (total isoflavones to total alkaloids)6. Process of FormingThe compound forms was selected as hard capsules.Also the reasonable prescription specifications and molding process parameters were defined. |
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