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Aspirin enteric coated tablet with low content of free salicylic acid and preparation process thereof

A technology of dissociating salicylic acid and aspirin, which is applied to medical preparations containing active ingredients, drug delivery, blood diseases, etc. It can solve the problems of many subjective factors, inconspicuous colorimetry, and difficult to judge accurately, and the effect is obvious. , The method is simple, the effect of great application value

Active Publication Date: 2010-06-16
SHANGHAI SINE PROMOD PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Although the Pharmacopoeia stipulates the limit of salicylic acid in aspirin enteric-coated tablets, the colorimetric method is used to check, but the colorimetric method is not obvious, there are many subjective factors, and it is not easy to judge accurately, which leads to hidden dangers

Method used

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  • Aspirin enteric coated tablet with low content of free salicylic acid and preparation process thereof
  • Aspirin enteric coated tablet with low content of free salicylic acid and preparation process thereof
  • Aspirin enteric coated tablet with low content of free salicylic acid and preparation process thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0037] Formula: aspirin 2.5kg; pregelatinized starch 3.939kg; starch 0.132kg; tartaric acid 0.3kg; 15% starch slurry 1.86kg; dry starch 0.1kg.

[0038] Starch 0.132kg was sieved through 80 meshes with a disc, and starch was pre-dried at 80°C for 4 hours. 2.5kg of aspirin raw material is pulverized with a high-efficiency pulverizer with a coarse sieve; 3.939kg of pregelatinized starch is sieved with a ZS-600 vibrating sieve with 80 meshes; 1.86kg of 15% hot starch slurry is prepared according to the prescription; 3kg of tartaric acid is completely dissolved in boiling and allowed to cool 6kg of purified water; put aspirin and pregelatinized starch in the DH200II tank mixer and mix for 10 minutes, then add the prescribed amount of tartaric acid solution and stir for 15 minutes, then add 15% hot starch slurry and stir until soft For soft materials, use 16-mesh wide-type nylon sieve to make wet granules; put the wet granules in the hopper of the boiling drying granulator, boil and...

Embodiment 2

[0041] Processed according to the production process described in Example 1, the finished product numbered 0854002 was detected by ultraviolet spectrophotometry, and the concentration of free salicylic acid was 3.32 μg / ml.

Embodiment 3

[0043] Processed according to the production process described in Example 1, the finished product numbered 0854003 was detected by ultraviolet spectrophotometry, and the concentration of free salicylic acid was 1.65 μg / ml.

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Abstract

The invention provides an aspirin enteric coated tablet with low content of free salicylic acid. A given amount of tartaric acid is added in the recipe of a tablet core, and the content of the free salicylic acid is effectively lowered. The invention provides an improved process. The invention has simple, convenient and easy method and is suitable for industrialized production.

Description

Technical field: [0001] The invention relates to pharmaceutical preparations, in particular to an aspirin enteric-coated tablet with low content of free salicylic acid and a preparation process thereof. Background technique: [0002] Aspirin is an antipyretic and analgesic with a long history. It has been used for hundreds of years and has become one of the three classic drugs in the history of medicine. It is still the most widely used antipyretic, analgesic and anti-inflammatory drug in the world. Standard preparations for other drugs. [0003] Aspirin enteric-coated tablets have a variety of pharmacological effects, the main ingredient is aspirin, the chemical name is: 2-(acetoxy)benzoic acid; the molecular formula is: C 9 h 8 o 4 ; Molecular weight: 180.16. This product reduces thrombus A in platelets by inhibiting prostaglandin cyclooxygenase 2 The formation of platelets can inhibit platelet aggregation and prevent thrombus formation. It is clinically used to prev...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/30A61K31/616A61P29/00A61P7/02A61P9/10A61P9/00
Inventor 胡林森
Owner SHANGHAI SINE PROMOD PHARMA
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