Studies On Extracts From Huidouba And Its Preparations

Object: To study on an ideal preparation Huidouba Capsule to provide new clues for drug treatment in clinical diabetes and to develop and research new materials for treating diabetes mellitus, which is of great significance. Method: Using the total sugar content of Huidouba polysaccharides and the total solid content of extracts from Huidouba as double evaluation indices, phenol-sulfuric acid reaction and absorption spectrometry method, the best extraction condition was studied and determined by orthogonal design test after the extraction method being chosen. And the preliminary purification technic of crude extracts from Huidouba was optimized through single factor test. The basic pharmaco-properties of lyophilized crude extracts from Huidouba were studied and researched by physical chemistry methods. The capsule preparation technology of lyophilized crude extracts from Huidouba was studied according to the standard of liquidity, hydroscopicity and contents of the particulate compounds. The qualitation identification of Huidouba capsule preparations was identified by the chemical method of alkaline cupric tartrate test solution and the total sugar content of polysaccharides in Huidouba capsule preparations was determined by the chemical-evaluation pattern of phenol-sulfuric acid reaction, which was initially established quality specification of Huidouba capsule preparations. Huidouba Capsule was studied on the preliminary pharmacodynamics by intragastric administration to normal mice and alloxan-induced diabetic mice. Result: Select the traditional refluxing extraction method with boiled water as the extraction method of Huidouba. And the best extraction technology of extracts from Huidouba was optimized and determined as follows: take the right amount of the coarse powder pulverized from medicinal materials Huidouba, add the amount of distilled water 10 times(The 2 times was about water absorption ratio of medicinal materials.)of the amount of raw medicinal materials in the first time, extract 2 h by refluxing extraction with boiled water after materials being sank 1 h, then add the amount of distilled water 8 times in the second time, extract 2 h by refluxing extraction with boiled water without materials being sank. The preliminary purification technic was that the extract concentration ratio was with range from 1:10 to 1:15, the alcohol concentration was 80%, the deposition time was 12 h. The basic pharmaco-properties of the lyophilized floccus and its powder of the crude extracts from Huidouba were in the following. The color of the gray soil quality was gray yellow brown. The odor was caramel-like. The taste was little bitter. The dissolubility was soluble in water by ultrasound, insoluble in ethanol or acetone. The mean content of water was 4.91% under the condition of strictly being controlled the environment and storage when lyophilization finished, and over 9.0% if not controlling the temperature and the humidity of surrounding environment, storage and preparation prosess. The chemical compositions were identified to confirm containing polysacchaides, glycosides and saponins, possibly containing binding proteins, tannins, organic acids and alkaloids, but possibly not containing phenols and floating proteins. The flowability of its powder did not met the manufacturing demand. And the hydroscopicity was not good. The optimal preparation condition of Huidouba Capsule was that firstly squeeze lyophilized crude extract floccus into powder by hand-made way, secondly let them through 30 screen mesh sieve, thirdly prepare them to a certain hardness tablets without adding any excipient, fourthly shiver them properly and sieve the right screen mesh sieve, and lastly fill the 1# capsule with acquired granulo-powder. It had been proved that alkaline cupric tartrate test solution was good for identifying Huidouba Capsule containing the polysaccharide compositions but little or no interference of the monosacchide compositions. Meanwhile, the standard curve between the mass concentration of the total sugar content of polysaccharides and absorbance was linear in the range of (15～50)μg·mL-1 after phenol-sulfuric acid reaction and using the method of absorption spectrometry. The average recovery rate was 101.00%. The initial pharmacodynamics test indicated that the Huidouba capsule preparations could improve weight and significantly lower blood sugar value and showed obvious dose-effect relationship, which had been proved that the preparation had better effects on prevention and treatment in diabetes. Conclusion: The extraction technology of Huidouba matched the requirements of production. The preparation technology of Huidouba Capsule was reasonable. The quality specification established could initially and effectively control the content of the preparation. And the preparation had better preventive and therapeutic effects on diabetes.