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A slow-release preparation, the technology of lansoprazole, is applied in the directions of pill delivery, medical preparations without active ingredients, and medical preparations containing active ingredients, etc., to achieve the effects of improving drug compliance, avoiding influence, and reducing technical requirements
Pending Publication Date: 2019-04-30
汉寿康运医药科技有限公司
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Problems solved by technology
There is no research on lansoprazole sustained-release tablets at present both at home and abroad, so lansoprazole sustained-release tablets have good development and application prospects and have certain clinical significance
Method used
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[0021] Tablet core prescription (mg):
[0022]
[0023] Coating layer prescription (mg):
[0024]
[0025] Preparation:
[0026] 1. Preparation of tablet core: take by weighing an appropriate amount of lansoprazole powder, add the auxiliary materials in the above table, pass through a 20 mesh sieve to make wet granules, dry at 50°C, dry the granules through a 15 mesh sieve for granulation, add 1% stearin Magnesium acid is mixed evenly, and tablet cores are obtained after tableting.
[0027] 2. Preparation of the coating layer: After mixing the auxiliary materials of the coating layer, pass through a 20-mesh sieve to make wet granules, dry at 50°C, pass the dry granules through a 20-mesh sieve for granulation, add 1% magnesium stearate, mix well, Made into coating material.
[0028] 3. Press coating: Weigh the prescribed amount of coating material and divide it into 2 parts, the ratio is 1:1. Fill a portion of the coating material into the die, place the tablet core i...
experiment example 1
[0031] Experimental Example 1 Linearity and Range
[0032] Measure 0.4ml, 0.6ml, 0.8ml, 1.0ml, 1.2ml, 1.4ml of the reference substance stock solution respectively and place them in a 50ml measuring bottle, add pH6.8 buffer solution to constant volume and shake well. The absorbance values were measured at 284nm, the results are shown in Table 1-1
[0033] The absorbance of table 1-1 different concentration lansoprazole solution
[0034]
[0035] With the absorbance A as the ordinate and the concentration C as the abscissa, linear regression is carried out to obtain the standard curve, see
[0036] figure 1 .
experiment example 2
[0037] Physical evaluation of experimental example 2 tablet core:
[0038]
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Abstract
The present invention provides a lansoprazole sustained-release preparation, which is characterized in that a sustained-release preparation prescription consists of a core prescription and a coating layer prescription. The core prescription consists of lansoprazole, lactose, hydroxypropyl methylcellulose, cross-povidone, powdered steatile, and magnesium stearate. The coating layer prescription isa mixture of two or more of ethyl cellulose, hydroxypropyl methylcellulose, polyacrylic resin, microcrystalline cellulose, and magnesium stearate. The preparation of lansoprazole sustained-release tablets by a compression coating method can better avoid the sudden release of the drug, and the prescription is simple, and separated addition of a pore forming agent and other sustained-release materials is not required. The invention provides the preparation method of lansoprazole sustained-release tablets with slow release in the intestine and high stability, is suitable for industrial production, and improves patient compliance, medication safety and bioavailability.
Description
technical field [0001] The invention belongs to the field of pharmaceutical preparations, in particular to a sustained-release preparation of lansoprazole. Background technique [0002] Peptic ulcer, mainly gastric ulcer and duodenal ulcer, is one of the most common diseases in the world. It has been clinically recorded for many years, and its pathogenesis is complex and changeable. Its pathogenesis has not yet been fully explored. At present in our country, the incidence of peptic ulcer has far exceeded 15%. The pace of life of modern people is accelerating day by day. Smoking, alcoholism, excessive stress and depression, overeating, emotional changes, excessive mental work, irregular rest, etc., may all lead to peptic ulcer. In addition, genetic factors and changes in the living environment are also factors that lead to the occurrence of the disease. For example, in Europe and the United States, the common patient is duodenal ulcer, while in Asia, the incidence of gastri...
Claims
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