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Ranitidine hydrochloride capsules and production method thereof

A technology of ranitidine hydrochloride and capsules, which is applied in the field of ranitidine hydrochloride capsules, can solve the problems of short storage time, different preparation processes, and weak stability of drugs, and achieve the solution of hygroscopicity, stable quality indicators, and improved The effect of stability

Active Publication Date: 2013-02-20
JIANGSU SUNAN PHARMA IND CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0002] Although there are many varieties of ranitidine hydrochloride capsules on the market, the main ingredient is ranitidine, and the auxiliary ingredients are mainly dextrin, lactogen, and magnesium trisilicate. The capsules are mainly used to relieve hyperacidity. stomachache, heartburn (heartburn), and acid reflux; however, due to different excipients and different preparation processes, there are defects such as short storage time and weak stability of the drug

Method used

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  • Ranitidine hydrochloride capsules and production method thereof
  • Ranitidine hydrochloride capsules and production method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0022] Embodiment 1: a kind of ranitidine hydrochloride capsule, every 1000 capsules comprises the following components by weight: ranitidine hydrochloride 165g, calcium hydrogen phosphate 50g.

[0023] Weigh ranitidine hydrochloride and calcium hydrogen phosphate according to the parts by weight of the components; respectively pulverize ranitidine hydrochloride and calcium hydrogen phosphate and pass through 100 mesh sieves respectively, and add 50% ethanol in the tank mixer Stir and mix for 40 minutes to make soft materials and granulate; spread the prepared granules evenly on the baking tray with a thickness of 1-1.5cm, and then place the baking tray filled with granules in a hot air circulation drying oven at a temperature below 70°C The drying moisture is controlled at 3%; after drying, the drying car is pulled out from the oven and cooled to room temperature naturally, and the drying pan is taken out from the drying car (from bottom to top), and the granules in the pan ar...

Embodiment 2

[0024] Embodiment 2: a kind of ranitidine hydrochloride capsule, every 1000 capsules comprises the following components by weight: ranitidine hydrochloride 170g, calcium hydrogen phosphate 50g.

[0025] Weigh ranitidine hydrochloride and calcium hydrogen phosphate according to the parts by weight of the components; respectively pulverize ranitidine hydrochloride and calcium hydrogen phosphate and pass through 100 mesh sieves respectively, and add 50% ethanol in the tank mixer Stir and mix for 40 minutes to make soft materials and granulate; spread the prepared granules evenly on the baking tray with a thickness of 1-1.5cm, and then place the baking tray filled with granules in a hot air circulation drying oven at a temperature below 70°C The dry moisture is controlled within 4%; after drying, the oven is pulled out from the oven and cooled to room temperature naturally, and the oven tray is taken out from the oven (from bottom to top), and the granules in the tray are packed in...

Embodiment 3

[0026] Embodiment 3: a kind of ranitidine hydrochloride capsule, every 1000 capsules comprises the following components in parts by weight: ranitidine hydrochloride 167.4g, calcium hydrogen phosphate 43.1g.

[0027] Weigh ranitidine hydrochloride and calcium hydrogen phosphate according to the parts by weight of the components; respectively pulverize ranitidine hydrochloride and calcium hydrogen phosphate and pass through 100 mesh sieves respectively, and add 50% ethanol in the tank mixer Stir and mix for 20-40 minutes to make soft materials and granulate; lay the prepared granules evenly on the baking tray with a thickness of 1-1.5cm, and then place the baking tray filled with granules in a hot air circulation drying oven at 70 The dry moisture below ℃ is controlled within 4%; after drying, pull the drying car out of the oven to cool down to room temperature naturally, take out the drying pan from the drying car (from bottom to top), and put the granules in the pan into the tu...

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Abstract

The invention discloses ranitidine hydrochloride capsules and a production method thereof. Every 1,000 capsules comprise 165 to 170 parts of ranitidine hydrochloride and 40 to 50 parts of calcium hydrophosphate. The preparation method for the capsules comprises the following steps: weighing the ranitidine hydrochloride and the calcium hydrophosphate according to the weight part; crushing the ranitidine hydrochloride and the calcium hydrophosphate respectively, adding 50 percent ethanol in a trough type mixing machine to mix for 20 to 40 minutes to prepare a soft material, and granulating; drying the prepared granules in a hot-air circulation drying oven at the temperature of lower than 70 DEG C, and controlling the moisture within 4 percent; and filling the dried granules in capsules, andpolishing to obtain the ranitidine hydrochloride capsules. The ranitidine hydrochloride capsules and the production method thereof have the advantages that: the calcium hydrophosphate is adopted as an auxiliary material, so that each quality index of the product in a valid period is ensured to be basically stable, the problem of hygroscopicity of the ranitidine hydrochloride capsules can be solved, the product stability is improved, and intake of talc powder and magnesium stearate is prevented.

Description

technical field [0001] The invention relates to a medicine for treating stomach diseases and a preparation method thereof, in particular to ranitidine hydrochloride capsules for relieving stomach pain, heartburn and acid reflux caused by hyperacidity and a production method thereof. Background technique [0002] Although there are many varieties of ranitidine hydrochloride capsules on the market, the main ingredient is ranitidine, and the auxiliary ingredients are mainly dextrin, lactogen, and magnesium trisilicate. The capsules are mainly used to relieve hyperacidity. Stomachache, heartburn (heartburn), acid reflux; but due to different excipients and different preparation processes, there are defects of short shelf life and weak stability of medicines. Contents of the invention [0003] Goal of the invention: in order to overcome the deficiencies in the prior art, the first purpose of the present invention is to provide a kind of ranitidine hydrochloride capsule with goo...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/48A61K31/341A61K47/04A61P1/04
Inventor 丁子君汤太平胡世成
Owner JIANGSU SUNAN PHARMA IND CO LTD
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