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A damp proof composition for pharmaceutical and its preparation methods

A composition and drug technology, applied in the direction of pharmaceutical formula, medical preparations of non-active ingredients, inorganic non-effective ingredients, etc., can solve the problems of active ingredient changes, high hygroscopicity, narrow adaptability, etc., to improve stability, Good moisture-proof effect and quality assurance effect

Inactive Publication Date: 2007-04-11
BEIJING UNIV OF CHINESE MEDICINE
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0002] The problem of moisture absorption of solid preparations of traditional Chinese medicine is a relatively common problem encountered in pharmaceutical work. Due to moisture absorption, it brings difficulties to the molding operation of traditional Chinese medicine preparations. After molding, it becomes soft, agglomerated, and discolored due to moisture absorption during storage. Disintegration overtime, difficult to dissolve, changes in active ingredients, reduced curative effect, moldy deterioration
In particular, the number of capsules of traditional Chinese medicine can not be taken more, the amount of extract in the content is large, and the amount of auxiliary materials is less, at most no more than 50% of the extract. Therefore, the choice of auxiliary materials is small, and moisture absorption is more common. Capsules prepared from cream powder are more hygroscopic. Often within the validity period, they absorb moisture, agglomerate, become hard, and are difficult to disintegrate. Quality and Efficacy
Some even cannot be molded due to moisture absorption and stickiness
[0003] In recent years, pharmaceutical workers have carried out a lot of research work on the moisture absorption of traditional Chinese medicine solid preparations. However, the development of traditional Chinese medicine tablets is still affected by the moisture absorption and stickiness of traditional Chinese medicine extract powder during the preparation process.
Preparation of capsules from traditional Chinese medicine extract powder brings certain difficulties to production due to high hygroscopicity and poor fluidity
Even if it is made into capsules, the finished product will agglomerate due to moisture absorption, become hard and difficult to disintegrate, the dissolution of active ingredients will be slower, and the curative effect will be reduced
[0004] The current research on the moisture-proof problem only plays a certain moisture-proof effect on individual varieties, and the adaptability is narrow; the selection of accessories is not suitable, and some accessories themselves absorb moisture, so the moisture-proof effect is not obvious; the amount of hydrophobic lubricating accessories is not appropriate, and the moisture-proof effect is not good. Good or prolonged disintegration time

Method used

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  • A damp proof composition for pharmaceutical and its preparation methods
  • A damp proof composition for pharmaceutical and its preparation methods

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0035] Mix 5 kg of diluent auxiliary materials α-lactose and 20 kg of acrylic resin IV; mix 2 kg of lubricant auxiliary materials magnesium trisilicate and 4 kg of calcium stearate; mix the diluent auxiliary materials and lubricant auxiliary materials by 5: 1 to obtain Moisture-resistant composition.

Embodiment 2

[0037] Diluent auxiliary materials are preferably mixed with acrylic resin II 2.3kg, hydroxypropyl methylcellulose 0.4kg, low-substituted hydroxypropyl cellulose 4.5kg, and pregelatinized starch 0.6kg; lubricant auxiliary materials magnesium stearate 4kg, talc Mix 1 kg of powder; take release agent auxiliary materials and lubricant auxiliary materials at a ratio of 5:2 and mix to obtain a moisture-proof composition.

Embodiment 3

[0039] Mix diluent auxiliary materials acrylic resin IV 17kg, hydroxypropyl methylcellulose 20kg, low-substituted hydroxypropyl cellulose 30kg; lubricant auxiliary materials calcium stearate 4kg, talcum powder 3kg; release agent auxiliary materials and lubricant Agents and auxiliary materials are mixed according to the ratio of 5:3 to obtain a moisture-proof composition.

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Abstract

The invention discloses a moisture-proof compound of drugs and its preparation method. It comprises accessories of thinner kind and accessories of lubricant kind; the thinner kind accessories includes galactose, acrylic resin IV, acrylic resin II, hydroxypropyl methyl cellulose, low substituted hydroxypropyl cellulose or a kind or several kind pregelatinized starch; the lubricants kind accessories includes magnesium trisilicate, calcium stearate, magnesium stearate, one kind of talc or several. The preparation method is mixting the two kind accessories together.

Description

technical field [0001] The invention relates to a composition and a preparation method thereof, in particular to a medicinal moisture-proof composition and a preparation method thereof. Background technique [0002] The problem of moisture absorption of solid preparations of traditional Chinese medicine is a relatively common problem encountered in pharmaceutical work. Due to moisture absorption, it brings difficulties to the molding operation of traditional Chinese medicine preparations. After molding, it becomes soft, agglomerated, and discolored due to moisture absorption during storage. The disintegration is overtime, it is difficult to dissolve, the active ingredients are changed, the curative effect is reduced, moldy and deteriorated. In particular, the number of capsules of traditional Chinese medicine can not be taken more, the amount of extract in the content is large, and the amount of auxiliary materials is less, at most no more than 50% of the extract. Therefore,...

Claims

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Application Information

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IPC IPC(8): A61K47/02A61K47/26A61K47/30A61K47/12
Inventor 杜守颖
Owner BEIJING UNIV OF CHINESE MEDICINE