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Effervescent disintegrant containing sodium bicarbonate micro-capsules and preparation method thereof

A technology of effervescent disintegrant and sodium bicarbonate, which is applied in the field of effervescent disintegrant containing sodium bicarbonate microcapsules and its preparation, can solve the problems of easy deterioration of tablets, prolonged disintegration time, and fragmentation, and achieve Good adhesion and lubrication, stable product quality, and high qualified rate of finished products

Inactive Publication Date: 2009-04-29
崔学龙
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, this tablet containing an effervescent disintegrant must be strictly protected against moisture in the process of manufacture, packaging and storage to ensure its disintegration. Once the drug is in an environment with high temperature and relative humidity, it is prone to moisture absorption and discoloration , fragmentation, prolonged disintegration time and other deterioration phenomena
For this reason, the manufacturer has tried various methods, such as: mixing the acid and alkali separately after granulation, changing sugar-coated tablets into film-coated tablets, using multi-layer aluminum-plastic composite film bags for packaging, etc., but the effect is still unsatisfactory.
Especially in the case of high temperature and high humidity in summer, tablets are easy to deteriorate, and even packaging deformation occurs

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0016] (1) Prepare sodium bicarbonate and polyethylene glycol in a mass ratio of 1:1, put the polyethylene glycol in a stainless steel container, place it in a water bath and heat it to 50°C, and wait until it is completely melted;

[0017] (2) Add the sodium bicarbonate crushed to 100 meshes into the stainless steel container of step 1, stir while adding, until all the sodium bicarbonate is added and mix evenly;

[0018] (3) the stainless steel container is taken out from the water bath, the material in the stainless steel container is crushed to 80 orders, and polyethylene glycol microcapsules wrapped with sodium bicarbonate are obtained;

[0019] (4) Take tartaric acid according to the mass ratio of tartaric acid and sodium bicarbonate as 1:1, crush tartaric acid into 80 meshes and mix with polyethylene glycol microcapsules wrapped with sodium bicarbonate to obtain sodium bicarbonate-containing microcapsules effervescent disintegrant.

[0020] Finally, the effervescent dis...

Embodiment 2

[0022] (1) Sodium bicarbonate and polyethylene glycol are mixed according to the mass ratio of 1:2. The polyethylene glycol is a mixture formed by polycondensation of ethylene oxide and water, and the molecular formula is HO(CH 2 CH 2 O) n H, the molecular weight is 400, put polyethylene glycol in a stainless steel container, put it in a water bath and heat it to 60°C, and wait until it is completely melted;

[0023] (2) Add the sodium bicarbonate crushed to 120 mesh into the stainless steel container of step 1, stir while adding, and mix well until all the sodium bicarbonate is added;

[0024] (3) The stainless steel container is taken out from the water bath, and the material in the stainless steel container is pulverized to 85 orders to obtain polyethylene glycol microcapsules wrapped with sodium bicarbonate;

[0025] (4) Take tartaric acid according to the mass ratio of tartaric acid and sodium bicarbonate as 1:2, crush tartaric acid into 100 meshes and mix evenly with p...

Embodiment 3

[0028] (1) Sodium bicarbonate and polyethylene glycol are prepared according to the mass ratio of 1:1.5. The polyethylene glycol is a mixture formed by polycondensation of ethylene oxide and water, and the molecular formula is HO(CH 2 CH 2 O) n H, the molecular weight is 6000, put polyethylene glycol in a stainless steel container, put it in a water bath and heat it to 55°C, and wait until it is completely melted;

[0029] (2) Add the sodium bicarbonate crushed to 110 meshes into the stainless steel container of step 1, stir while adding, and mix well until all the sodium bicarbonate is added;

[0030] (3) The stainless steel container is taken out from the water bath, and the material in the stainless steel container is pulverized to 85 orders to obtain polyethylene glycol microcapsules wrapped with sodium bicarbonate;

[0031] (4) Take tartaric acid according to the mass ratio of tartaric acid and sodium bicarbonate as 1:1.5, pulverize tartaric acid into 90 meshes and mix ...

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PUM

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Abstract

The invention discloses an effervescent disintegrant containing sodium bicarbonate microcapsules, and a preparation method thereof. The effervescent disintegrant consists of citric acid (or tartaric acid) and polyethylene glycol microcapsules encapsulated with sodium bicarbonate, which are well mixed. Firstly, sodium bicarbonate and polyethyleneglycol are dissolved and mixed to prepare the polyethylene glycol microcapsules encapsulated with the sodium bicarbonate, and then the microcapsules containing the sodium bicarbonate are uniformly blended with the citric acid (or tartaric acid) to prepare the effervescent disintegrant containing the sodium bicarbonate microcapsules. The preparation method is simpler but more practical than the traditional micro-encapsulation techniques. The sources of acid and carbon dioxide can be effectively separated by the micro-encapsulation techniques, therefore, the obtained products are stable in quality and the effective period of medicines can be prolonged by more than one year. Since the polyethyleneglycol has excellent adhesive effect and lubrication effect, other adhesives and lubricants are unnecessary to be added when tabletting is carried out, and the produced tablets are bright and clean, with beautiful appearance and high qualification rate of finished products.

Description

technical field [0001] The pharmaceutical auxiliary material and the preparation method thereof of the present invention specifically relate to an effervescent disintegrant containing sodium bicarbonate microcapsules and a preparation method thereof. Background technique [0002] Effervescent disintegrant refers to a kind of commonly used disintegrating agent that uses citric acid (or tartaric acid) mixed with an appropriate amount of sodium bicarbonate as the disintegrating agent of the tablet. antidote. Because of its rapid drug action, high bioavailability, and convenient use, it is often used as a disintegrant in various effervescent tablets, such as: Qingkailing Effervescent Tablets, Jieeryin Effervescent Tablets, etc. In recent years, we have used effervescent disintegrants in the production of oral solid preparations containing a large amount of traditional Chinese medicine extracts, and the effect is very good. However, this tablet containing an effervescent disint...

Claims

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Application Information

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IPC IPC(8): A61K9/46A61K47/34A61K47/12A61K47/04A61K47/10
Inventor 崔学龙
Owner 崔学龙