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Compound omeprazole capsule and preparation method and detection method thereof

The technology of omeprazole and detection method is applied in the field of compound omeprazole capsules and preparation thereof, and can solve the problem that there is no good solution for controlling the relative humidity of medicine powder mixing uniformity and filling environment, and sodium bicarbonate has adsorption Moisture, not easy to mix evenly, etc.

Inactive Publication Date: 2013-03-06
GUIZHOU XINBANG PHARMACEUTICAL CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] Because sodium bicarbonate is a crystalline particle, and omeprazole is an amorphous powder, so in the process of drug preparation, the two are difficult to mix evenly; Direct filling, and sodium bicarbonate has hygroscopicity, so the control of the relative humidity of the filling environment is the most important parameter in the preparation process
The existing preparation technology of compound omeprazole capsules does not have a good solution to control the mixing uniformity of the drug powder and the relative humidity of the filling environment
[0005] In addition, there is currently no set of strict and reliable quality testing standards for compound omeprazole.

Method used

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  • Compound omeprazole capsule and preparation method and detection method thereof
  • Compound omeprazole capsule and preparation method and detection method thereof
  • Compound omeprazole capsule and preparation method and detection method thereof

Examples

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Effect test

Embodiment 1

[0268] Embodiment 1: Each compound omeprazole capsule is made of 20mg omeprazole, 1100mg sodium bicarbonate, 30mg magnesium stearate and 10mg talcum powder. Weigh the sodium bicarbonate of prescription, pulverize it, and screen it through a 60-mesh sieve for subsequent use; weigh the omeprazole of prescription, mix it with sodium bicarbonate by equal increment method Finally, add magnesium stearate and talcum powder, and further mix thoroughly; the above mixture is tested and packed into No. 00 ordinary capsules; during the mixing and capsule filling process, the ambient humidity is controlled below 55%.

Embodiment 2

[0269] Embodiment 2: Each compound omeprazole capsule is made of 40mg omeprazole, 1100mg sodium bicarbonate, 10mg magnesium stearate and 10mg talcum powder. Weigh the sodium bicarbonate of prescription, pulverize it, and screen it through a 60-mesh sieve for subsequent use; weigh the omeprazole of prescription, mix it with sodium bicarbonate by equal increment method Finally, add magnesium stearate and talcum powder, and further mix thoroughly; the above mixture is tested and packed into No. 00 ordinary capsules; during the mixing and capsule filling process, the ambient humidity is controlled below 55%.

Embodiment 3

[0270] Embodiment 3: the complete detection method of compound recipe omeprazole capsule of the present invention is:

[0271] (1) Properties: This preparation is white or off-white powder.

[0272] (2) Check:

[0273](1) Dissolution: The instrument adopts the ZRS-8G drug dissolution apparatus; this preparation is the preferred basket method for capsules, and the paddle method is used for comparison at the same time; take this preparation, refer to the second method of Appendix X C of the 2010 edition of the Chinese Pharmacopoeia, Take 1000mL of water as the dissolution medium, the rotating speed is 100 revolutions per minute, operate according to the law, after 45 minutes, take 10mL of the solution, filter, accurately measure the subsequent filtrate and dilute with water to make a solution containing 10 μg of omeprazole per 1mL as a test Reference substance solution; refer to "Chinese Pharmacopoeia" 2010 edition two appendix Ⅳ A ultraviolet-visible spectrophotometry, measure...

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Abstract

The invention provides a compound omeprazole capsule, a preparation method and a detection method thereof. The capsule is prepared from the following components in accordance with parts by weight: 200 parts of omeprazole, 1100 parts of sodium bicarbonate and a right amount of magnesium stearate and talcum powder or 40 parts of omeprazole, 1100 parts of sodium bicarbonate and a right amount of magnesium stearate and talcum powder. According to the compound omeprazole capsule, the preparation method and the detection method aiming at the defects of the prior art, the preparation process of the compound omeprazole capsule is optimized, so that the compound omeprazole capsule has obvious curative effects on treating diseases such as peptic ulcers, gastroesophageal reflux diseases and the like which are caused by hyperchlorhydria, and a systemic, integral and effective component identification and content determination method is established, so that the quality of the compound omeprazole capsule can be effectively controlled, thereby guaranteeing the clinic curative effects of the compound omeprazole capsule.

Description

technical field [0001] The invention relates to a compound omeprazole capsule, a preparation method and a detection method thereof, and belongs to the technical field of western medicine. Background technique [0002] Stomach acid can help digestion, but if there is too much stomach acid, it will damage the stomach, duodenum, and even "burn" the mucous membranes and muscles, causing peptic ulcers, gastroesophageal reflux disease and other digestive system diseases. Digestive system disease is a kind of frequently-occurring disease common in people's daily life. According to statistics, the incidence of gastrointestinal diseases in the world accounts for about 12% of the population, and the incidence of digestive system in China is also increasing year by year. At present, the proportion of medicines for treating peptic ulcer is as high as 59% in the whole digestive system medicine. According to the sample survey data in 2003, in the total sales of peptic ulcer treatment dr...

Claims

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Application Information

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IPC IPC(8): A61K33/00A61K9/48A61P1/04G01N21/33G01N30/02G01N31/16G01N31/02A61K31/4439
Inventor 张观福
Owner GUIZHOU XINBANG PHARMACEUTICAL CO LTD
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