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A traditional Chinese medicine moisture-proof coating agent

A coating agent and coating technology, applied in the direction of pharmaceutical formula, microcapsules, capsule delivery, etc., can solve the problems of difficult storage, high price, unacceptable to patients, etc., achieve obvious moisture-proof effect, high localization rate, and easy to obtain Effect

Active Publication Date: 2021-08-06
TIANJIN TASLY PHARMA CO LTD
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  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0002] With the development of the general health business, the application of traditional Chinese medicine in the field of health is becoming more and more extensive. The various preparations processed by modern technology on the extract of traditional Chinese medicine are more and more accepted by consumers. However, there are various dosage forms. The same defect, that is: Chinese medicine extracts are easy to absorb moisture, and the various dosage forms made by it also have the disadvantages that they are easy to absorb moisture and deteriorate, and are not easy to store.
[0003] At present, although there are many kinds of moisture-proof research on traditional Chinese medicine granules, due to various limitations in the technology itself, some of the laboratory technologies are mature, but cannot be industrialized. For example, water chestnut pots are used to coat the granules. During the process, the particles are flying, the friction is broken, the yield is reduced, etc.
Some moisture-proof technologies are mature, and the industrial technology is mature, but the coating formula is poor in water solubility. After dissolving in hot water, a large amount of coating materials cannot be dissolved and suspended in the solvent. The appearance is poor, which is difficult for patients to accept.
At present, the coating premixes sold in the market are mainly used for tablet coating, and the price is relatively expensive
[0004] There are also some coatings that choose pure polyethylene glycol (1000-20000) for particle coating, but because polyethylene glycol (1000-20000) itself has strong viscosity and poor film-forming property, it will cause the coating film to be uneven. It is smooth and flat, and consumes a lot of materials, so it cannot be used for coating tablets, capsules, pills, etc.; at the same time, because the water content of the coating solution is generally above 82%, this technology is used for the coating of tablets and pills. The quality of the coating is acceptable, but if it is used for the coating of capsules, it will easily lead to deformation of the capsule shell
Therefore, it absorbs moisture and deteriorates, which is inconvenient for storage and clinical formula adjustment.
The above are still technical issues that affect the large-scale and industrialization of traditional Chinese medicine granule products in the field of general health

Method used

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  • A traditional Chinese medicine moisture-proof coating agent
  • A traditional Chinese medicine moisture-proof coating agent
  • A traditional Chinese medicine moisture-proof coating agent

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0051] Embodiment 1 Danshen Formula Granules

[0052] Salvia miltiorrhiza dry powder is mixed with appropriate amount of lactose, polyethylene glycol and silicon dioxide, dry granulated, and 700g of granules are taken for moisture-proof coating. Specific prescription:

[0053] Danshen Formula Granules 700g

[0054] Lactose 24.5g

[0055] Macrogol 6000 24.5g

[0056] Purified water 73.5g

[0057] The coated particles were exposed to a humidity environment of 75.3%, and the moisture absorption weight gain was 4.08% in 10 hours (the uncoated particles were exposed to a humidity environment of 75.3%, and the moisture absorption weight gain was 7.60% in 10 hours).

[0058] After moisture absorption, the uncoated product has hardened and does not have the flow characteristics of granules.

Embodiment 2

[0059] Embodiment 2 hawthorn formula granules

[0060] Hawthorn dry powder is mixed with appropriate amount of maltodextrin and polyethylene glycol, dry granulated, and 4kg of granules are taken for moisture-proof coating. Specific prescription:

[0061] Hawthorn Formula Granules 4kg

[0062] Lactose 140g

[0063] Macrogol 6000 140g

[0064] Purified water 420g

[0065] The coated granules were exposed to a humidity environment of 75.3%, and the moisture absorption weight gain was 6.67% in 10 hours (the uncoated granules were exposed to a 75.3% humidity environment, and the moisture absorption weight gain was 8.10% in 10 hours).

[0066] After absorbing moisture, the uncoated product has compacted and does not have the flow characteristics of granules. After the coated product is placed naked for 10 hours in an environment with a humidity of 75.3%, the appearance and fluidity of the granules do not change significantly compared with those at time 0.

Embodiment 3

[0067] Embodiment 3 red clover formula granules

[0068] Using dextrin and lactose as the base material and red clover extract as the slurry, perform fluidized granulation, take 15kg of granules for moisture-proof coating, specific prescription:

[0069] Red Clover Formula Granules 15kg

[0070] Lactose 750g

[0071] Macrogol 10000 750g

[0072] Purified water 2250g

[0073] The coated granules were exposed to a humidity environment of 75.3%, and the moisture absorption weight gain was 4.92% in 10 hours (the uncoated granules were exposed to a 75.3% humidity environment, and the moisture absorption weight gain was 5.31% in 10 hours).

[0074] After absorbing moisture, the uncoated product has hardened and does not have the flow characteristics of granules. After the coated product is placed naked for 10 hours in an environment with a humidity of 75.3%, the appearance and fluidity of the granules remain unchanged compared with those at time 0.

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Abstract

The invention discloses a moisture-proof coating agent for traditional Chinese medicine, which mainly contains 78-98% by mass of medicine, 1-11% of macromolecular skeleton auxiliary materials that are easily soluble in water and have poor hygroscopicity and other auxiliary materials, wherein the macromolecular skeleton auxiliary materials One or any combination of two or more selected from polyethylene glycol 1000-20000, solid poloxamers, and other excipients selected from one of lactose, mannitol and a small amount of low-substituted cellulose Or any two or any combination of two or more, the moisture-proof coating agent for traditional Chinese medicine has obvious moisture-proof effect, dissolves quickly, has no insoluble suspended matter, and can still maintain the powder of granules or powders under normal temperature conditions with a relative humidity below 75%. Physical characteristics, convenient for industrial application.

Description

Technical field: [0001] The invention relates to a coating material in the fields of medicine and food, in particular to the moisture-proof coating of solid preparations such as granules, tablets, pills and capsules prepared from extracts of traditional Chinese medicines. Background technique: [0002] With the development of the general health business, the application of traditional Chinese medicine in the field of health is becoming more and more extensive. The various preparations processed by modern technology on the extract of traditional Chinese medicine are more and more accepted by consumers. However, there are various dosage forms. Same defect, that is: the Chinese medicine extract is easy to absorb moisture, and the various dosage forms that it makes also exist the shortcoming that easily absorbs moisture and deteriorates, and is difficult for storage. [0003] At present, although there are many kinds of moisture-proof research on traditional Chinese medicine gra...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/50A61K47/10A61K47/26A61K47/38
CPCA61K9/5015A61K9/5031A61K9/5042
Inventor 朱永宏王苹杨建会孙艳刘朋付永艳裴岩薛宇陈京辉王超
Owner TIANJIN TASLY PHARMA CO LTD
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