Highly-soluble sulbenicillin sodium colon-targeted starch capsule and preparation method thereof
A technology of sulbenicillin sodium and starch capsules, which is applied in the field of highly soluble sulbenicillin sodium colon-targeted starch capsules and its preparation, which can solve the problems of unstable release and large-scale burst release of film-layer drugs, and achieve low cost , easy to operate, simple process effect
Examples
Embodiment 1
[0023] Preparation of Sulbenicillin Sodium
[0024] Add the crude sulbenicillin sodium to 95% ethanol, add 0.5% (w / v) activated carbon, stir and dissolve at 50°C for 30 minutes, filter out the activated carbon while it is hot, cool the filtrate to 0°C, crystallize for 5 hours, filter, Dry to obtain refined sulbenicillin sodium; ultrasonicate the refined sulbenicillin sodium under ultrasonic conditions, and then put it into microwave conditions and microwave at 150°C for 40 minutes to obtain uniform, stable and highly soluble sulphonic acid Benzillin Sodium.
Embodiment 2
[0026] Prepare hard capsules according to the conventional process: fill the refined sulbenicillin sodium in the tapioca starch capsule shell, and use the sealing material (mixed solution of HPMC5%, PVA11%, ethanol 34%, water 60%) to fit the capsule shell seal at the place to make hard capsules; prepare colon enteric coating liquid, its formula is made up of hypromellose phthalate, 95% ethanol, succinate, and the weight percent of each component is: hypromellose 7.0% of phthalate, 90.0% of 95% ethanol, and 3.0% of succinate; the above-mentioned colon enteric coating solution is used to coat the starch capsule to obtain the colon enteric starch capsule of the present invention.
[0027] The in vitro dissolution test of the capsule was carried out, and the results were as follows: the dissolution rate of the capsule was less than 1% in 3 hours in 37 ℃, pH=6.8 artificial intestinal fluid; 10% in 1 hour in 37 ℃, pH=7.4 artificial intestinal fluid; 37 ℃, pH=7.8 More than 90% dissol...
Embodiment 3
[0029] Prepare hard capsules according to the conventional process: fill the refined sulbenicillin sodium in the tapioca capsule shell, and use sealing materials (HPMC5%, PVA11%, ethanol 34%, water 60%) to seal the joint of the capsule shell , prepared into starch hard capsules; preparation of colonic enteric coating liquid, its formula is made up of cellulose acetate trimellitate, 95% ethanol, octenyl succinate starch, and the weight percentage of each component is: cellulose acetate 7.0% trimellitate, 90.0% 95% ethanol, 3.0% octenyl succinate starch; coat the capsule with the above colonic enteric coating solution to obtain the colonic enteric starch capsule of the present invention.
[0030]The in vitro dissolution test of the capsule was carried out, and the results were as follows: the dissolution rate of the capsule was less than 1% in 2 hours in artificial gastric juice at 37 ℃; About 4% was dissolved in 1 hour in artificial intestinal juice; 92% was dissolved in 1 hour...
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Description
Claims
Application Information
- IPC
- A61K9/48; A61K47/36; A61K47/38; A61K47/10; A61K47/14; A61K47/32; A61K31/43; A61P31/04
- CPC
- A61K9/4816; A61K9/4891; A61K31/43; A61K47/10; A61K47/14; A61K47/32; A61K47/36; A61K47/38
- Inventors
- 帅放文; 王向峰