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This test was prepared by a saturated aqueous solution of the legal system dihydropyridine-β-cyclodextrin inclusion complex, and their identification by optical microscopy and UV spectrophotometer. The effects of the inclusion compound solubility, dissolution, and the recovery and stability, provide a theoretical basis for the development of the dihydropyridine new dosage forms and further optimize the preparation process of the dihydropyridine-β-cyclodextrin inclusion complexes, and reference . The test β-cyclodextrin molecule as dihydro pyridine carrier, because the β-cyclodextrin molecule annular hollow cylinder type, the opening of its voids or external were hydrophilic, while the internal was hydrophobic and therefore inclusion of hydrophobic drugs commonly used in the formation of β-cyclodextrin. The solubilizer polyvinylpyrrolidone polymers to improve the ability of β-cyclodextrin inclusion dihydropyridine. The combination L9 (34) orthogonal test table test as index utilization, analysis of variance by SPSS software to determine the best preparation. Inclusion complex was identified with an optical microscope and ultraviolet spectrophotometry. The stability of clathrate inclusion complexes of characteristics and quality control requirements of the dihydropyridine main emphasis on several projects from the appearance, color, content. By the light of the long-term, high-temperature, constant temperature accelerated stability test visits dihydropyridine-β-cyclodextrin inclusion complex. UV spectrophotometer dihydropyridine-β-cyclodextrin inclusion complex in various mid-1, 2, 3, 4, 5, 6, the maximum absorption peak absorbance, substituting the standard regression equation calculated clathrate ; bulk drugs and dihydropyridine-β-cyclodextrin physical mixture of dihydropyridine comparison investigated clathrate raise the percentage of the drug content in the drug content. And further through the identification of a clathrate animal experiments and to examine the stability of the clathrate. By UV spectrophotometry dihydropyridine bulk drugs measured maximum absorption peak at 238nm at, which is consistent with other reported. The standard analysis method dihydropyridine establish, within the concentration range of 10 ~ 50μg · mL-1 for linear regression, and regression equation, after analysis of a good linear relationship (r = 0.9932). The average recovery of 98.85%, RSD 0.19%, intraday and interday precision were less than 1%. The dihydropyridine-β-cyclodextrin inclusion complexes can be drawn through the orthogonal test and analysis of variance results best preparation: β-CD: dihydropyridine molar ratio of 5:1, mixing temperature of 75 ° C. stirring time of 2h. Nine groups of drugs by calculating drug loading was 45.5 ± 1.8%, encapsulation efficiency was 86.8 ± 1.1%. Dissolution of clathrate slurry method and 2.2 times the measured solubility in water, the inclusion complexes dissolution of bulk drugs. The inclusion compound solubility 5 h to 4.8 times the bulk drugs. Drugs have a greater improvement inclusion dissolution and solubility drugs through inclusion can improve the bioavailability of the drug. Drawn through the long-term stability experiment, the inclusion complex have good stability under the conditions of light, temperature, humidity, and the physical mixture and APIs comparison significant differences within a time of six months. Light, high temperature and humidity conditions within one month APIs loss rates were the clathrate 4.6,7,4.1 times. Light, high temperature and humidity conditions, the first six months of APIs loss rates were inclusion compound 2.55,2.5,3.22 times. Experimental animal weight gain further evidence of clathrate and API, system with good results. In summary, the dihydropyridine-β-CD inclusion complex prepared in the present study can improve the solubility and bioavailability of the drug substance of the dihydropyridine. Clathrate prepared in light, heat, and humidity conditions can significantly increase the antioxidant capacity of bulk drugs, and provide some theoretical reference and a basis for the development of the dihydropyridine new dosage forms.
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