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Lansoprazole enteric-coated tablet and preparation method thereof

A technology for enteric and tablet-dissolving lansoprazole, applied in the field of medicine, can solve problems such as affecting the stability of lansoprazole, and achieve the effects of good market prospect, high dissolution rate, and improved bioavailability

Active Publication Date: 2020-12-29
广州美迪高生物医药科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In addition, studies have shown that lansoprazole is easy to form a salt in the presence of NaOH to generate lansoprazole sodium, its polarity and hydrophilicity will increase, and the solubility will also be improved, but the addition of NaOH will Affect the stability of Lansoprazole

Method used

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  • Lansoprazole enteric-coated tablet and preparation method thereof
  • Lansoprazole enteric-coated tablet and preparation method thereof
  • Lansoprazole enteric-coated tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0061] 1. Preparation of drug-containing tablet core:

[0062] The prescription composition and process parameters of lansoprazole enteric-coated tablet core are as shown in table 1, and preparation method is as follows:

[0063] Weigh the binder povidone K30 and dissolve it in an appropriate amount of 95% ethanol, stir to dissolve completely, and obtain the binder solution for later use; weigh sodium hydroxide separately, dissolve them in 50ml purified water, and add 200ml 95% ethanol, stir evenly, then add 225g lansoprazole, until dissolving completely (if necessary, can be heated to 25 degrees), for subsequent use; Take by weighing mannitol, sodium bicarbonate, sodium starch glycolate, low Replace hydroxypropyl cellulose, pass through a 60-mesh sieve, and mix with the alkaline solution of lansoprazole in a one-step granulation mixer at a speed of 3r / min for 10min. Then, within 90 seconds, the above-mentioned binder solution was evenly added to the above-mentioned material,...

Embodiment 2

[0083] The dissolution rate of the lansoprazole enteric-coated tablet prepared by the present invention in pH6.8 phosphate buffer saline

[0084] Get the lansoprazole enteric-coated tablet (15mg) that embodiment 1 prepares as test group object, measure according to dissolution rate and release rate assay method (Chinese Pharmacopoeia two general rules 0931 first method method 2), with hydrochloric acid solution (9→ 1000ml) 1000ml is the dissolution medium, the speed is 100 revolutions per minute, operate according to the law, after 120 minutes, immediately lift the basket out of the liquid surface, discard the hydrochloric acid solution, and immediately add phosphoric acid with a pH of 6.0 preheated to 37°C 1000ml of salt buffer solution or phosphate buffer solution of pH 6.8, keep the rotation speed constant, and continue to operate according to the law. After 5, 10, 15, 20, 30, 45 and 60 minutes, take the solution and filter it, and accurately measure the subsequent filtrate ...

Embodiment 3

[0089] Embodiment 3 Lansoprazole enteric-coated tablet is in the stability in accelerated test (40 ± 2 ℃, RH75% ± 5%) and long-term test (25 ± 2 ℃, RH60% ± 10%)

[0090] Make the samples of prescriptions 1-4 and comparative prescriptions 1-2 into market packaging (double aluminum, sealed, carton packaging), and set the test conditions as an accelerated test of 40°C±2°C / 75%RH±5%RH, The investigation time is 6 months, and the detection includes at least 3 time points (such as 0, 3, and 6 months) of the initial and final time, and all investigation items should be included. The results are shown in Tables 5-10.

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Abstract

The invention relates to a lansoprazole enteric-coated tablet and a preparation method thereof. The lansoprazole enteric-coated tablet is composed of a medicine-containing tablet core, an isolation layer and an enteric-coated layer from inside to outside, wherein the medicine-containing tablet core is prepared from the following raw materials in parts by weight of 200 to 250 parts of lansoprazole,180 to 250 parts of a stabilizing agent, 780 to 840 parts of a disintegrating agent, 1600 to 1750 parts of a filling agent, 10 to 14 parts of an adhesive and 40 to 70 parts of an additional lubricating agent; and the stabilizer is sodium hydroxide and sodium bicarbonate. According to the lansoprazole enteric-coated tablet disclosed by the invention, the stability and the dissolution rate of the lansoprazole sodium enteric-coated tablet are improved.

Description

technical field [0001] The invention relates to the field of medicine, in particular to a lansoprazole enteric-coated tablet and a preparation method thereof. Background technique [0002] Lansoprazole is developed by Takeda Pharmaceutical Co., Ltd. of Japan. It is a drug for inhibiting gastric acid secretion. It is clinically used for gastric ulcer, duodenal ulcer, reflux esophagitis, Zollinger-Ai syndrome Ellison syndrome), the treatment of anastomotic ulcer, the treatment is remarkable, and it has inhibitory effect on Helicobacter pylori. First launched in Japan in December 1992, it is a new generation of proton pump inhibitors after omeprazole. It is now on the market in dozens of countries around the world, and it was launched in China in April 1995. At present, there are more than 50 domestic enterprises producing lansoprazole preparations, and the main dosage forms are enteric-coated tablets, enteric-coated capsules and injections (lyophilized powder for injection)....

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/28A61K47/38A61K47/36A61K47/26A61K31/4439A61P1/04
CPCA61K9/2866A61K9/2009A61K9/2059A61K9/2054A61K9/2018A61K31/4439A61P1/04
Inventor 赖锦昌
Owner 广州美迪高生物医药科技有限公司
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