Targeted, control-release and thin film coating material made of denatured starch for oral medicine to treat colonic diseases, its prepn. and use
A film coating material, modified starch technology, applied in pharmaceutical formulations, medical preparations with non-active ingredients, drug delivery, etc., can solve the problem of lack of controlled release speed of active functional ingredients, incomplete release of active functional ingredients, active functional ingredients Leakage and other problems, to achieve good application prospects, good social and economic benefits, and fast release rates
Patent Information
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Publication Date
- 2007-01-31
Abstract
Description
technical field
[0001] The invention relates to a film coating material, in particular to a modified starch oral colon-targeted controlled-release film coating material and a preparation method and application thereof. Background technique
[0002] Oral colon-targeted controlled-release system is to select appropriate carrier materials and controlled-release technology to position and transport active functional ingredients to the ileocecal site of the human body, disintegrate or release active ingredient particles, and then release them at a suitable speed. The active ingredient inside has the effect of increasing the local concentration and bioavailability of the active ingredient. The colon-targeted controlled release system can protect the functional components that are easily destroyed by gastric acid or metabolized by pancreatic enzymes and lose their activity, especially to avoid the inactivation of polypeptides and protein biomacromolecules ...
Examples
Embodiment 1
[0027] Oral colon-targeted controlled-release film coating materials were prepared by using acetate starch (laboratory preparation, the preparation method was referred to "Research on the Digestibility of Acetate Starch as a Drug Controlled Release Carrier" Li Xiaoxi et al., Functional Polymers, 2003, (4)), It includes the following steps:
[0028] (1) Preparation of acetate starch oral colon-targeted controlled-release film coating liquid:
[0029] Add 0.6 g of acetate starch with a degree of substitution of 1.0, 2.02 and 2.70 to 20 ml of acetone solution respectively, to prepare an acetone solution containing 3% by mass of starch acetate, and then add in an amount of 10% by mass of starch acetate, 15% and 35% of plasticizer dibutyl sebacate to obtain acetate starch oral colon-targeted controlled-release film coating solution (ie acetate starch oral colon-targeted controlled-release film coating material).
[0030] (2) Establishment of oral colon-targeted controlled-release ...
Embodiment 2
[0036] Oral colon-targeted controlled-release film coating materials were prepared by using phosphate starch (laboratory, the preparation method refers to "Optimization of Preparation Conditions of Sweet Potato Starch Phosphate Monoester" Chen Ling et al., Journal of Zhengzhou Institute of Engineering, 2004(1)), including Follow the steps below:
[0037] (1) Preparation of ester starch oral colon-targeted controlled-release film coating liquid:
[0038] Add 0.4 g of phosphate ester starch with a degree of substitution of 1.0, 1.58 and 2.4 to 20 ml of deionized water, and heat at 80°C for 10 minutes to prepare a suspension containing 2% of phosphate ester starch by mass, and then add the dosage It is glycerol with 15% mass of phosphate starch, that is, phosphate starch oral colon-targeted controlled-release film coating solution (ie, phosphate-starch oral colon-targeted controlled-release film coating material).
[0039] (2) Establishment of phosphate starch oral colon-targete...
Embodiment 3
[0045] Utilize xanthate starch (laboratory, the preparation method refers to "modified starch" Zhang Litian, South China University of Technology Press, 1992) to prepare oral colon-targeted controlled-release film coating material, including the following steps:
[0046] (1) Preparation of xanthate starch oral colon-targeted controlled-release film coating liquid:
[0047] Add 0.6 g of xanthate starch with a degree of substitution of 1.13, 1.82 and 2.60 to 20 ml of deionized water, heat at 80°C for 10 minutes, and prepare a suspension containing 4% of xanthate starch by mass. , and then add glycerol with an amount of 15%, 18% and 20% of the xanthate starch mass respectively to prepare different xanthate starch oral colon-targeted controlled-release film coating solutions (that is, xanthate starch Oral colon-targeted controlled-release film coating).
[0048] (2) Establishment of oral colon-targeted controlled-release film coating system of xanthate starch:
[0049] Will trea...