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Stable, uniform and efficient lansoprazole enteric-coated tablets and preparation method thereof

A technology of lansoprazole enteric and enteric-coated tablets, which is applied in the direction of non-active ingredient medical preparations, active ingredient-containing medical preparations, pharmaceutical formulas, etc., can solve the problem of destroying lansoprazole, poor uniformity, Release rate is not high, to achieve the effect of improving release rate and bioavailability, improving content uniformity, and good quality controllability

Active Publication Date: 2014-04-09
湖北潜龙药业有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] Because lansoprazole is unstable to factors such as moisture and acid, it is currently coated with a resin barrier layer to prevent moisture and acid from entering. If the plain tablet coating is too thick, it will affect the release rate of lansoprazole; too thin or Factor tablet edges and corners, may lead to moisture, acid ingress, damage lansoprazole
[0008] According to the daily dosage of lansoprazole, 30mg per day, the specifications of lansoprazole on the market are 15mg and 30mg. Incremental method can be improved appropriately, but the operation is complicated and prone to errors, which will lead to poor uniformity
[0009] The raw material of lansoprazole has low solubility and cannot be well absorbed in the body. At present, the raw material is micronized, or the method of adding solubilizer, internal or external or internal and external disintegrating agent is used to improve the release rate. Although there is a certain improvement, but not optimal
Therefore the application is aimed at the problems such as poor stability, low release rate and poor uniformity of lansoprazole tablets at present, and proposes a solution

Method used

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  • Stable, uniform and efficient lansoprazole enteric-coated tablets and preparation method thereof
  • Stable, uniform and efficient lansoprazole enteric-coated tablets and preparation method thereof
  • Stable, uniform and efficient lansoprazole enteric-coated tablets and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0043] Prescription: (according to 1000 tablets)

[0044] Blank pellets (sucrose type): 200g

[0045] Main drug layer:

[0046] Lansoprazole 30g

[0047] Hypromellose 10g

[0048] Tween-80 2g

[0049] Alkaline layer:

[0050] Hypromellose 5g

[0051] Basic magnesium carbonate 5g

[0052] Isolation layer:

[0053]

[0054] Enteric layer:

[0055] Enteric coating solution 125g

[0056] Triethyl citrate 4g

[0057] Talc powder 5g

[0058] Preparation:

[0059] (1) Preparation of drug-loaded pellets: Take the prescribed amount of sodium carboxypropylmethylcellulose, add an appropriate amount of purified water and stir to dissolve, add the prescribed amount of Tween-80, stir to dissolve completely, add water to 200mL, and then add the prescription Amount of lansoprazole raw material, stirred to obtain a uniform suspension solution.

[0060] Weigh the prescribed amount of blank pellets, place them in a fluidized bed coating machine, ad...

experiment example 1

[0067] This experimental example relates to the content uniformity inspection of the lansoprazole enteric-coated tablets prepared in Example 1 of the present invention.

[0068] According to the content uniformity inspection method stipulated in the Chinese Pharmacopoeia 2010 edition, 10 lansoprazole enteric-coated tablets were extracted, and put into 100mL measuring bottles according to the quality standards of the first supplement of the Chinese Pharmacopoeia (2010 edition) Lansoprazole enteric-coated tablets , add 5mL of 0.1mol / L sodium hydroxide solution to ultrasonically disintegrate, add an appropriate amount of methanol-water (60:40) solution, ultrasonically dissolve, let cool, dilute to the mark with methanol-water (60:40) solution, Filtrate or centrifuge, take the subsequent filtrate or supernatant as the test solution, measure the content according to the high performance liquid chromatography under the content determination item, and the content uniformity limit is ±...

experiment example 2

[0073] This experimental example relates to the release test of lansoprazole enteric-coated tablets prepared in Example 1 of the present invention.

[0074] According to the Chinese Pharmacopoeia (2010 edition), the first supplement of this lansoprazole enteric-coated tablet quality standard, the release inspection method, get this product, according to the release assay (appendix X D second method), adopt the dissolution assay (appendix X C first method) device, using 1000mL of hydrochloric acid solution (9→1000) as the release medium, the rotation speed is 100 rpm, operate according to the law, after 120 minutes, immediately raise the rotating basket out of the liquid level, discard the hydrochloric acid solution, immediately Add 1000mL of phosphate buffer (pH6.8) preheated to 37°C, and continue to operate according to the law. After 45 minutes, take the solution and filter it, accurately measure 5mL of the filtrate, and accurately add 0.15mol / L sodium hydroxide solution 1mL...

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Abstract

The invention discloses stable, uniform and efficient lansoprazole enteric-coated tablets and a preparation method thereof. Each enteric-coated tablet comprises a main medicament layer, an alkaline layer, an isolation layer and an enteric coated layer from inside to outside. The enteric-coated tablets are characterized in that a pellet drug loading and pellet tabletting coating technology is adopted to perform coated pellet tabletting so as to ensure that each pellet forms an integral drug release unit. The lansoprazole enteric-coated tablets disclosed by the invention are simple in preparation process, large in production volume, good in quality controllability, stable in product quality, high in release speed, good in homogeneity and high in bioavailability, and are suitable for industrial mass production.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and in particular relates to a stable, uniform and efficient lansoprazole enteric-coated tablet and a preparation method thereof. Background technique [0002] Lansoprazole (Lansoprazole) is the second proton pump inhibitor anti-ulcer drug in the world developed by Takeda after Omeprazole (Omeprazole), which can selectively inhibit the proton pump H in gastric parietal cells + / K + -(adenosine triphosphate) ATPase, which blocks the terminal stage of gastric acid secretion and plays an acid-suppressive role, is clinically used for duodenal ulcer, gastric ulcer, reflux esophagitis, Helicobacter pylori, Zollinger- Ellison syndrome (gastrinoma). As an upgraded product of omeprazole, lansoprazole introduces fluorine into the 4-position side chain of the pyridine ring and has a trifluoroethoxy substituent, its bioavailability is increased by more than 30% compared with omeprazole, and it ca...

Claims

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Application Information

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IPC IPC(8): A61K9/30A61K31/4439A61K47/26A61K47/38A61P1/04A61P35/00A61P31/04
Inventor 姜建国贺俊峰刘志刚
Owner 湖北潜龙药业有限公司
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