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Traditional Chinese medicine soft capsule auxiliary material with universality and method for preparing traditional Chinese medicine soft capsules

A soft capsule and universal technology, applied in the field of medicine, can solve problems such as prolonged disintegration time limit, poor drug stability, and large amount of excipients, and achieve the effects of good drug stability, expanded application range, and increased specific gravity

Inactive Publication Date: 2015-03-04
山西黄河中医药研究所(有限公司)
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, there are no breakthrough research results in the four core technologies that restrict the formation of traditional Chinese medicine soft capsules, such as content preparation and emulsification, capsule material preparation and melting, compression molding and drying, such as low content of medicinal substances, large amount of excipients, and poor drug stability. Quality and technical problems such as delamination, oil leakage, deformation, migration, excessive loading difference, and extended disintegration time limit have not been completely resolved

Method used

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  • Traditional Chinese medicine soft capsule auxiliary material with universality and method for preparing traditional Chinese medicine soft capsules

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0040] Molding process of Lingyang Ganmao soft capsule preparation

[0041] 1. Preparation formula

[0042] Main ingredients: dry extract powder (water extract of forsythia and nepeta paniculae after extraction of volatile oil, water extract of honeysuckle, platycodon, light bamboo leaf, licorice, alcohol extract of burdock seed and light tempeh) 220g, Antelope horn powder 6.0g, menthol 1.5g, peppermint oil 0.75ml, forsythia and nepeta volatile oil 3.0ml.

[0043] Excipients: Emulsifier I 218.75g.

[0044] Specifications: 0.45g per capsule, made into 1000 capsules.

[0045] 2. Preparation of emulsifier Ⅰ

[0046] Formula: Soybean Oil 80%, Soy Lecithin 8%, Hydrogenated Soybean Oil 6%, Beeswax 6%.

[0047] Preparation method: Weigh 1 / 4 of soybean oil in proportion, add beeswax, soybean lecithin, and hydrogenated soybean oil, heat to 60°C to melt completely, mix well, then add the remaining soybean oil, mix well, pass Colloid mill, made into emulsion, that is.

[0048] 3. C...

Embodiment 2

[0078] Preparation process of Yimaikang soft capsule

[0079] 1. Preparation formula

[0080] Main ingredients: 160g of dry extract powder (ethanol extract of breviscapine).

[0081] Excipients: Emulsifier I 290g.

[0082] Specifications: 0.45g per capsule, made into 1000 capsules.

[0083] 2. Preparation of emulsifier Ⅰ

[0084] Formula: Soybean Oil 82%, Soy Lecithin 6%, Hydrogenated Soybean Oil 6%, Beeswax 6%.

[0085] Preparation method: Weigh 1 / 4 of soybean oil in proportion, add beeswax, soybean lecithin, and hydrogenated soybean oil, heat to 62°C to melt completely, mix well, then add remaining soybean oil, mix well, pass Colloid mill, made into emulsion, that is.

[0086] 3. Content preparation

[0087] Take emulsifier Ⅰ, heat to 48°C, add breviscapine dry extract powder, mix evenly, first pass through a colloid mill, and then use a high-pressure homogenizer to form a microemulsion.

[0088] 4. Preparation of capsule material (glue)

[0089] Formula: 100 parts o...

Embodiment 3

[0116] Forming process of Yixindone soft capsule preparation

[0117] 1. Preparation formula

[0118] Main ingredients: Hawthorn leaf extract 35g.

[0119] Excipients: Emulsifier I 145g.

[0120] Specifications: 0.18g per capsule, made into 1000 capsules.

[0121] 2. Preparation of emulsifier Ⅰ

[0122] Formula: Soybean Oil 88%, Soy Lecithin 4%, Hydrogenated Soybean Oil 4%, Beeswax 4%.

[0123] Preparation method: Weigh 1 / 4 of soybean oil in proportion, add beeswax, soybean lecithin, and hydrogenated soybean oil, heat to 65°C to melt completely, mix well, then add the remaining soybean oil, mix well, pass Colloid mill, made into emulsion, that is.

[0124] 3. Content preparation

[0125] Take emulsifier Ⅰ, heat to 46°C, add hawthorn leaf extract, mix evenly, first pass through colloid mill, and then use high-pressure homogenizer to make microemulsion.

[0126] 4. Preparation of capsule material (glue)

[0127] Formula: 100 parts of gelatin (hide glue), 4 parts of gelat...

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Abstract

The invention relates to a traditional Chinese medicine soft capsule forming core technology with universality and a traditional Chinese medicine soft capsule forming core process with universality. The process consists of the following technologies: preparing the content and emulsifying, preparing a capsule wall material and melting, pressing and forming, and drying. The process comprises the following three aspects: 1, a mixed emulsifier used for the traditional Chinese medicine soft capsules and a preparation method thereof; 2, a capsule wall material formula used for the traditional Chinese medicine soft capsules and a preparation method thereof; and 3, technical parameters for pre-drying and final drying in the method for preparing the traditional Chinese medicine soft capsules. The application research proves that the application range of the traditional Chinese medicine soft capsules is widened; the specific gravity of the drug effect material is improved, and the amount of auxiliary materials is reduced; the drug stability is high, and phenomena of layering, leakage, deformation and transfer are avoided; the difference control level of the device is improved; and the disintegration time limit prolonging is effectively controlled.

Description

technical field [0001] The invention relates to the technical field of medicine, and specifically provides a general Chinese medicine soft capsule molding technology supported by technologies such as content preparation and emulsification, capsule material preparation and melting, compression molding and drying of the molding of traditional Chinese medicine soft capsules. Technology and craftsmanship. Background technique [0002] Traditional Chinese medicine soft capsules refer to soft capsules in which extracts, liquid drugs and appropriate amount of auxiliary materials are mixed and sealed in soft capsules by dripping or pressing. It is a new dosage form developed on the basis of hard capsules. In the past 20 years, with the development and finalization of new equipment such as domestic fully automatic soft capsule pill making machine, rotary cage type predrying machine, and special glue machine, the development of traditional Chinese medicine soft capsules has been promo...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K47/44A61K47/24A61K9/48
Inventor 吴守恭杨兆寅张博扬杨履中
Owner 山西黄河中医药研究所(有限公司)
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