Low hygroscopicity gliquinone tablet and preparation method thereof
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A technology for gliquidone and glitazone tablets, which is applied in the field of low-hygroscopicity glitazone tablets and their preparation, can solve the problems of reduced physical, chemical and biological stability and the like, and achieves reduced hygroscopicity, good stability, Tablet easy effect
Active Publication Date: 2017-08-08
BEIJING WANHUI DOUBLE CRANE PHARMA
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Problems solved by technology
After moisture absorption, the preparation is more likely to be oxidized, hydrolyzed and moldy, which reduces its physical, chemical and biological stability
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Embodiment 1
[0040] Embodiment 1 preparation of low hygroscopicity gliquinone sheet
[0041] Weigh 35 parts of lactose, 5 parts of microcrystalline cellulose, 35 parts of ethyl cellulose, 1.9 parts of pluronic, 10 parts of magnesium aluminum silicate and 2.0 parts of talcum powder as auxiliary materials, set aside. The raw material drug is gliquidone.
[0042] The preparation method is as follows:
[0043] (1) Pass the lactose, microcrystalline cellulose, ethyl cellulose and magnesium aluminum silicate in the auxiliary materials through a 150-mesh sieve respectively, and set aside.
[0044] (2) Dissolve Pluronic in 30% (v / v) aqueous ethanol to obtain a Pluronic solution for later use.
[0045](3) Weigh the raw material drug of gliquidone according to the prescription amount, first mix the gliquidone, lactose and microcrystalline cellulose with the method of equal addition, then add ethyl cellulose and magnesium aluminum silicate and mix well , Stirring, spraying and adding Pluronic solu...
[0049] The dissolution rate was determined according to the second method of Appendix XC of the 2010 edition of the Chinese Pharmacopoeia. Get the gliquidone tablet obtained in Example 1, use phosphate buffer (10 g of disodium hydrogen phosphate, add 1000 ml of water, adjust the pH value to 8.5 with phosphoric acid) 500 ml as the dissolution medium, the rotating speed is 75 rpm, and the temperature is 37 ° C ±0.5℃, operate according to law. After 45min, the solution was taken and filtered, and the filtrate was taken as the test solution.
[0050] Take about 30mg of gliquidone reference substance, accurately weigh it, put it in a 100ml measuring bottle, add 10ml of dimethylformamide to dissolve, dilute to the mark with the dissolution medium, shake well, accurately measure 10ml, put it in a 50ml measuring bottle , dilute to the mark with dissolution medium, shake well, and use it as the...
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Abstract
The invention discloses a low-moisture-absorption gliquidone tablet and a preparation method thereof. The low-moisture-absorption gliquidone tablet comprises the main material (gliquidone) and auxiliary materials, wherein the auxiliary materials comprise lactose, microcrystalline cellulose, ethylene cellulose, pluronic, magnisium aluminometasilicate and talcum powder. The preparation method comprises the following steps: weighing the raw drug of gliquidone according to the prescription; uniformly mixing gliquidone, lactose and microcrystalline cellulose by adopting the equivalent progressive increase method; then adding ethylene cellulose and magnisium aluminometasilicate, and fully mixing; atomizing to add a pluronic ethanol solution under stirring to prepare a soft material; sieving and pelletizing; drying; granulating; adding talcum powder, uniformly mixing, and tabletting. Through improvement on the auxiliary material formula, the consumption of microcrystalline cellulose is reduced while ethylene cellulose and magnisium aluminometasilicate are added, pluronic is adopted as a wetting raw material of a wetting agent to prepare the soft material, and talcum powder is added to prevent excessive adhesion and realize easy tabletting. The obtained low-moisture-absorption gliquidone tablet is effectively reduced in moisture absorption, good in stability and easy to disintegrate, and dissolution release of gliquidone is not influenced.
Description
technical field [0001] The invention relates to an improved technique of gliquidone tablets, in particular to a low-hygroscopic gliquidone tablet and a preparation method thereof. Background technique [0002] Gliquidone tablets are the second generation of sulfonylurea hypoglycemic drugs with definite effect and relatively low price. It is one of the most widely used oral hypoglycemic drugs for the treatment of type 2 diabetes. Compared with other sulfonylurea drugs, gliquidone tablets have the advantage that its main metabolites enter the intestinal system with bile and are excreted from the body, and only 5% are excreted from the urinary system through the kidneys, which are less affected by the glomerular filtration rate. Weak, drug metabolism can reduce the burden on the kidneys, and it is the drug of choice for diabetic patients with mild to moderate renal insufficiency. [0003] The main drug of gliquidone tablets is compressed into tablets by the main drug of gliqui...
Claims
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