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Traditional Chinese medicine gel plaster and its matrix

A technology of gel and plaster, which is used in drug delivery, pharmaceutical formulations, non-active components of polymer compounds, etc., can solve problems such as affecting drug efficacy, adverse drug quality control system, and increasing difficulty in handling sample preparation.

Active Publication Date: 2020-10-23
四川省骨科医院
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  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The drawbacks of this type of treatment method are also obvious. First, the emulsifier will affect the rate and degree of transdermal release of many components (components) of traditional Chinese medicine, thereby affecting the efficacy of the drug.
Secondly, the addition of emulsifiers significantly increases the difficulty of sample pretreatment in quality inspection, especially demulsification and removal of emulsifiers, which is not conducive to the establishment of a comprehensive quality control system for drugs
Finally, some emulsifiers have potential toxicity risks, including some substances that are considered to be basically safe and non-toxic by traditional toxicological evaluation

Method used

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  • Traditional Chinese medicine gel plaster and its matrix
  • Traditional Chinese medicine gel plaster and its matrix
  • Traditional Chinese medicine gel plaster and its matrix

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0046] Example 1 Screening without emulsifier and having "direct seal-in-bag crosslinking / curing" gel plaster base test

[0047] Preparation Process:

[0048] (1) Take Corydalis Corydalis, Notopterygium, Duhuo, Angelica, Angelica dahurica, Chuanxiong, Zanthoxylum bungeanum, Myrrh, Woody Fragrance, Clove, Kaempferia, Safflower, Dipsacus, Asarum, and Cinnamon 15 oil-containing traditional Chinese medicines, 90% ethanol extraction, Concentrate to a relative density of 1.1-1.2 (80°C) to obtain an extract for use.

[0049] (2) Dissolve tartaric acid and EDTA-2Na (if there is no EDTA-2Na in the prescription, do not add it) in water, cool to room temperature, and obtain substance 2.

[0050] (3) Povidone (K-90) was added to substance 2, stirred, pre-swollen, and left overnight to obtain substance 3.

[0051] (4) Add the extract prepared in step (1) into glycerin, stir and disperse to obtain substance 4.

[0052] (5) Add gelatin to substance 3, fully swell in a water bath environme...

Embodiment 2

[0078] Example 2 Contains no emulsifier and has "direct seal-in-bag crosslinking / curing" gel plaster matrix validation test

[0079] Prepare 3 batches of samples according to the matrix prescription (see Table 5 for specific prescription) and process screened out by the mixture design in Example 1. The test results and comprehensive scores are shown in Table 6. The results show that the “direct seal-in-bag cross-linking” gel plaster matrix preparation can be realized without adding emulsifiers, and it is relatively stable, but dialysis spots still appear in the paste .

[0080] Table 5. Validation Prescription

[0081] components Weight (g) Proportion(%) NP700 1.79 3.98 Aluminum glycylate 0.08 0.17 tartaric acid 0.05 0.11 glycerin 15.33 34.15 K-90 2.56 5.69 extract 0.82 1.82 Menthol 0.23 0.51 ice flakes 0.18 0.40 Camphor 0.18 0.40 Azone 0.26 0.57 Propylene Glycol 4.09 9.11 Potassium...

Embodiment 3

[0086] Embodiment 3 Direct sealing-in-bag crosslinking / curing control test

[0087] Sodium polyacrylate (NP-700) is a cross-linked skeleton material, by adding a cross-linking agent and a cross-linking regulator. In an acidic environment, the aluminum ions of the cross-linking agent are gradually released, resulting in a cross-linking / curing reaction, and the linear molecular chains of the polymer are bonded to each other to form a cross-linked network structure. Cross-linking modifiers control the Al 3+ The release rate and degree of release make the paste have suitable cohesion and viscosity, and at the same time, it is beneficial to stirring, coating and cutting. Based on Example 2, add EDTA-2Na to the verified prescription, and investigate the effect of adding ratios of aluminum glycolate and EDTA-2Na at 6:1, 3:1, 3:1.5 and 3:2 on the properties of the paste. The prescription is shown in Table 7 . The results show that the paste completed crosslinking / curing in 15 days,...

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Abstract

The invention relates to a traditional Chinese medicinal gel plaster and a substrate thereof, belongs to the technical field of traditional Chinese medicinal composition gel plasters, and aims at providing the traditional Chinese medicinal gel plaster substrate and eliminating dialysis spots caused by substrate crosslinking on the premise of not adopting emulsifying agents. In order to achieve thetechnical purposes, the traditional Chinese medicinal gel plaster substrate is composed of, by weight, 3-5 parts of sodium polyacrylate, 0.1-0.3 part of an aluminium-ion crosslinking agent, 0.1-0.45part of a crosslinking adjusting agent, 34-52 parts of a moisturizing agent, 5-15 parts of a tackifying agent, 1-3 parts of a penetration enhancer, 0.2-0.8 part of a preservative, and 32-42 parts of water. According to the traditional Chinese medicinal gel plaster substrate, specific components and proportions are adopted, after being spread and cut well, a raw traditional Chinese medicinal gel plaster can be directly bagged, crosslinking / aging reactions are conducted in an inner-package sealed dark environment and completed within a proper period of time, finally, no airing processes are required, the dialysis spots produced in the traditional Chinese medicinal gel plaster can be eliminated, and meanwhile, the moisturizing and adhesion properties of the traditional Chinese medicinal gel plaster are ensured.

Description

technical field [0001] The invention relates to a traditional Chinese medicine gel plaster and a matrix thereof, and belongs to the technical field of traditional Chinese medicine composition gel plasters. Background technique [0002] Black plaster, rubber plaster and gel plaster are three common dosage forms of transdermal administration of traditional Chinese medicine, and are important components of external treatment of traditional Chinese medicine. The production of black plaster is mostly manual, and the product quality is affected by factors such as region, climate and pharmaceutical experience. There are outstanding problems such as long preparation time, difficult control of the process, large environmental pollution, and high labor protection requirements. It is not suitable for industrial mass production. Traditional Chinese medicine rubber ointment is a traditional Chinese medicine transdermal drug delivery preparation developed by absorbing rubber ointment on t...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/70A61K47/32A61K47/24A61K47/12A61K47/18A61K47/10A61K47/42A61K47/22A61K47/46
CPCA61K9/0014A61K9/7023A61K47/10A61K47/12A61K47/183A61K47/22A61K47/24A61K47/32A61K47/42A61K47/46
Inventor 吴明权涂禾彭伟
Owner 四川省骨科医院
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