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Adhesive film agent and its preparing method

A technology of patching agent and adhesive, which is applied in the direction of pharmaceutical formula, aerosol delivery, and other medical devices, etc. It can solve the problems of restricting patients to choose to use, low blood drug concentration, and not suitable for long-term sticking, so as to achieve blood drug concentration and lasting, The effect of normal blood circulation and high blood drug concentration

Inactive Publication Date: 2004-04-28
马德林
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

But one thing in common is that these transdermal drug delivery systems are tightly adhered to the skin by pharmaceutical glue such as polyacrylates, polysiloxanes and polyisobutylene pressure-sensitive adhesives. Stimulating effect on the skin, so that the skin of patients will be allergic to varying degrees after medication
It often makes the patient's skin allergic or uncomfortable, which limits the patient's choice of use, and it is not suitable for long-term sticking
More importantly, the patch is tightly adhered to the skin during transdermal administration, causing the skin to be airtight, seriously affecting the normal metabolism of the skin and excretion of secretions, and affecting the absorption of the drug by the skin
In addition, the active ingredients of traditional Chinese medicine are dispersed in medicinal adhesives, that is, the mixture of active ingredients of traditional Chinese medicine and polymer glue, the drug loading is small, the release speed is slow, and the blood drug concentration is low, which seriously affects the effective ingredients of traditional Chinese medicine entering the blood or through the skin. The amount of lymphatic circulation can play a therapeutic role in the whole body, so it can only treat diseases on the surface of the body, and cannot meet the requirements of treating internal organs diseases
Similarly, although the film does not contain medicinal glue, the thickness of the film is usually only 0.1-0.2mm, generally not more than 1mm, which limits the drug loading of the film, and is not suitable for traditional Chinese medicine, because the traditional Chinese medicine is weak. , it is necessary to increase the dosage to truly achieve the purpose of transdermal drug delivery to the whole body so as to achieve the purpose of external treatment of internal diseases
[0003] Due to the above-mentioned defects in the current external dosage forms, it is inconvenient for patients to take medication. When the active ingredient is traditional Chinese medicine, it cannot be used to provide effective systemic treatment. Therefore, it is impossible to truly realize the transdermal administration of traditional Chinese medicine to treat visceral diseases. The effect is also very unsatisfactory, which seriously limits the application of traditional Chinese medicine transdermal administration therapy

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0043] Embodiment 1. The preparation of the Baoxinbao traditional Chinese medicine patch for preventing and treating coronary heart disease

[0044] a) Weigh the raw materials of each medicinal material in the prescription according to the following dosages:

[0045] Chuanxiong 234g Sandalwood 87g Tulip 87g Agarwood 45g Cyperus 87g

[0046] Dalbergia 87g, Frankincense 87g, Myrrh 87g, Chrysanthemum 129g, Clove 45g

[0047] Angelica 87g Angelica 87g Allium 87g Shichangpu 87g Salvia 234g

[0048] Benzoin 87g Astragalus 87g Radix Paeoniae Rubra 87g Yuanhu 87g Yejiao 87g

[0049] Cassia seed 87g, storax 234g, borneol 87g, notoginseng 234g, kudzu root 129g;

[0050] b) Boil Chuanxiong, Sandalwood, Tulip, Clove, Angelica, Shichangpu, Cyperus Cyperi, Dalbergia, Allium, Agarwood, Chrysanthemum, Angelica, Frankincense, and Myrrh in heated water for 10 to 12 hours, extract and distill The volatile oil (boiled liquid filtered) filtrate is concentrated into a thick paste, and the amoun...

Embodiment 2

[0058] Embodiment 2. The transdermal absorption test of Baoxinbao Tie membrane for prevention and treatment of coronary heart disease to rabbit normal and operation skin

[0059] "Ferulic acid", "borneol" and "cinnamon fragrance" in Baoxinbao film medicine 3 After H isotope labeling, they were added to Baoxinbao film medicines respectively, applied externally on the middle skin (intact and operated) of rabbit abdomen, and blood was collected regularly, and counted (cpm value) on a dual-channel liquid scintillation instrument by heterogeneous measurement method , the results: ① Baoxinjiao film 3 H-cinnamic acid, 3 After external application of H-borneol and ferulic acid on the skin of rabbits, both can be quickly absorbed through the skin, and there is radioactivity in the blood within 1 hour of external application, which can last for more than 24 hours. ②Particole film 3 H-cinnamic acid in vivo experiment The 24-hour absorption of intact skin accounts for more than 3.26% o...

Embodiment 3

[0060] Example 3. Thin-layer chromatography detects the main component test of the pericardial film in the rabbit transdermal liquid collection pool

[0061] The effective ingredients in the prescription of Baoxinbao film were selected from cinnamic acid, borneol and ferulic acid. 3 After H isotope labeling, add it on the film and stick it on the free skin flap with pedicle of the rabbit, put it on the liquid collection pool filled with normal saline, collect the normal saline in the pool regularly after applying the medicine, measure its cpm value, After 24 hours, its collected liquid was extracted and separated by chemical methods, and thin layer chromatography (TLC method) was used to separate and detect the transdermal situation of the above-mentioned components in the liquid collection tank. 3 The pure product marked by H) is compared with the plate, and the spot Rf value size and depth are compared after unfolding, and then the corresponding sample spots are scraped off,...

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PUM

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Abstract

The adhesive film preparation consists of back lining material, medicine layer and protecting film, and the medicine layer is fixed to the back lining material via two opposite adhesive edges or some regularly distributed points around it. The medicine layer consists of skeleton supplementary material in 20-30 wt%, effective medicine components in 60-75 wt% and plasticizer in 5-10 wt%, and is 0.13-0.5 cm in thickness. The adhesive film preparation has no influence on the blood circulation, metabolism and secretion of the skin in the applied part, no allergy, great medicine carrying amount, fast medicine release, effective transdermal absorption for great concentration of medicine in blood to reach the aim of curing internal disease via external application. The preparation process of the adhesive film preparation is also disclosed.

Description

technical field [0001] The invention relates to a patch, specifically a new dosage form between a patch and a film, not only applicable to western medicine, but also to traditional Chinese medicine, and a preparation method of the patch. technical background [0002] The transdermal drug delivery system is a treatment method in which drugs enter the body circulation through the skin through blood vessels or lymphatic vessels to produce systemic therapeutic effects. It is used to treat various medical diseases by producing systemic therapeutic effects through blood circulation. The traditional dosage forms suitable for this treatment system include ointment, plaster, ointment, gel, and cream. At present, modern transdermal drug delivery preparations are divided into three types, namely, membrane storage type, matrix controlled release type, and microstructure. There are three types of reservoir type, among which the skeleton controlled-rel...

Claims

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Application Information

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IPC IPC(8): A61K9/06A61K9/70A61K47/00A61M37/00A61P1/00A61P9/00
Inventor 马德林
Owner 马德林
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