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Process for producing pharmaceutical auxiliary material hydroxypropyl methylcellulose through slurry process

A technology of hypromellose and pharmaceutical excipients, which is applied in the field of hypromellose slurry production process of pharmaceutical excipients, can solve the problems of less specifications, yellowish color, and large fluctuations in product viscosity, and achieve The effect of increasing output, large single batch output, and improving product quality

Inactive Publication Date: 2014-05-14
山东光大科技发展有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the domestic products have fewer specifications, the product viscosity fluctuates greatly, the color is yellowish, and the product quality needs to be further improved.

Method used

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  • Process for producing pharmaceutical auxiliary material hydroxypropyl methylcellulose through slurry process

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0022] The production process of hypromellose slurry method for pharmaceutical excipients comprises the following steps:

[0023] (1) Ingredients: Mix toluene, isopropanol, and purified water evenly. The parts by weight of the toluene are 82 parts, the parts by weight of isopropanol are 18 parts, and the parts by weight of purified water are 2.6 parts. Distribution is made into a transparent and non-turbid mixed solvent; the parts described below are parts by weight;

[0024] Add 7000 parts of the above mixed solvent to the reaction kettle, add purified water, the total amount of purified water is 360-440 parts, put 800 parts of caustic soda into the reaction kettle, then raise the temperature to 80°C, keep it for 30min, and then immediately cool down To 26°C, add 800 parts of refined cotton to the reaction kettle; the bulk density of refined cotton is ≥160g / L, and the transmittance of 80 mesh is ≥90%;

[0025] (2) Start timing from the time of adding refined cotton, stir for...

Embodiment 2

[0032] The production process of hypromellose slurry method for pharmaceutical excipients comprises the following steps:

[0033] (1) Ingredients: Mix toluene, isopropanol, and purified water evenly. The parts by weight of the toluene are 80 parts, the parts by weight of isopropanol are 15 parts, and the parts by weight of purified water are 2.5 parts. Distribution is made into a transparent and non-turbid mixed solvent; the parts described below are parts by weight;

[0034] Add 7000 parts of the above-mentioned mixed solvent to the reaction kettle, add purified water, the total amount of purified water is 360 parts, put 780 parts of caustic soda into the reaction kettle, then raise the temperature to 75°C, keep it for 25min, and then immediately cool down to 25°C ℃, add 780 parts of refined cotton to the reactor;

[0035] (2) Reaction: Start timing from the time of adding refined cotton, stir for 15 minutes, heat up to 80°C, time for 8 minutes, then cool down to 22°C, time ...

Embodiment 3

[0041] The production process of hypromellose slurry method for pharmaceutical excipients comprises the following steps:

[0042] (1) Ingredients: Mix toluene, isopropanol, and purified water evenly. The parts by weight of the toluene are 85 parts, the parts by weight of isopropanol are 20 parts, and the parts by weight of purified water are 3.5 parts. Distribution is made into a transparent and non-turbid mixed solvent; the parts described below are parts by weight;

[0043]Add 7000 parts of the above-mentioned mixed solvent to the reaction kettle, add purified water, the total amount of purified water is 440 parts, put 820 parts of caustic soda into the reaction kettle, then raise the temperature to 85°C, keep it for 35min, and then immediately cool down to 30°C ℃, add 820 parts of refined cotton to the reactor;

[0044] (2) Reaction: Start timing from the time of adding refined cotton, stir for 30 minutes, heat up to 90°C, time for 12 minutes, then cool down to 26°C, time ...

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Abstract

The invention belongs to the technical field of pharmacy, and particularly relates to a process for producing pharmaceutical auxiliary material hydroxypropyl methylcellulose through a slurry process. The process comprises the following steps of: blending; reacting; desolventizing; washing; drying; packaging. By adopting the process, the single batch output of the hydroxypropyl methylcellulose is increased, and the single batch output is increased nearly twice from the output in a common method; because the indices of batches have certain difference, larger single batch output can better reduce the index difference of the batches. The process disclosed by the invention is larger in single batch output and reduces the processing cost of ton products.

Description

technical field [0001] The invention belongs to the technical field of pharmacy, and in particular relates to a slurry method production process of hypromellose, a medical auxiliary material. Background technique [0002] In China, HPMC, a pharmaceutical excipient, is used more and more widely, such as film coating materials, solid preparation binders or mixed binders, and is also used to increase the dissolution of pharmaceuticals. However, domestic products have fewer specifications, higher and lower product viscosity fluctuations, yellowish color, and product quality needs to be further improved. Contents of the invention [0003] In order to solve the above-mentioned technical problems, the present invention provides a production process of hypromellose slurry method for pharmaceutical excipients. [0004] A pharmaceutical excipient hypromellose slurry production process, the process comprises the following steps: [0005] (1) Ingredients: mix toluene, isopropano...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C08B11/193A61K47/38
Inventor 李培芹陈爱猛王公新李大纲王敬水
Owner 山东光大科技发展有限公司
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