Etamsylate gel patch and preparation method thereof

Abstract

The invention relates to the technical field of medicine, and discloses an etamsylate gel patch and a preparation method thereof. The etamsylate gel patch is composed of a backing layer, an adhesive layer, a gel layer and an anti-adhesive layer in sequence, wherein the gel layer comprises a gel substrate and a medicine active ingredient etamsylate. Adhesion tests, in-vitro dissolution tests and in-vitro skin penetration tests prove that the etamsylate gel patch has good adhesion performance, can be used repeatedly, can effectively release medicines through the skin, and can be stopped administrating at any time as needed to reduce systemic adverse reactions, and is safe and reliable.

Description

technical field [0001] The invention relates to the field of pharmacy, in particular to a phensulfame gel patch and a preparation method thereof. Background technique [0002] Etamsylate (English name Etamsylate), is clinically used to prevent and treat bleeding before and after various operations, and can also be used for bleeding caused by platelet dysfunction and increased vascular fragility. It was first patented by Lab.OM in the UK in 1962 And it was approved. In 1981, Wuhan Wu Pharmaceutical Co., Ltd. applied for and was approved for listing in my country. Currently, tablets, injection powder injections, injections, sodium chloride injections and glucose injections are on the market in China. [1] , to control post-operative bleeding, oral or intramuscular or intravenous injection of 250-500 mg dose, repeated every 4-6 hours if necessary, adverse reactions include nausea, headache, rash, temporary hypotension, etc., occasionally intravenous Anaphylactic shock has been r...

AI Technical Summary

Problems solved by technology

In addition, clinical studies have found that the abuse of hemostatic or coagulation drugs can sometimes cause thrombosis or aggravate bleeding on the basis of the original disease, and those with a history of thrombosis should be cautious in using phensulfame [2]

[0003] Xu Wei [3] , Yang Tao [4] etc. successively found in clinical research that the treatment of children with recurrent simple allergic purpura treated with ethanamine can effectively relieve clinical symptoms and improve the curative effect, which has a high promotion value. Oral administration, the concentration of the drug dispersed in the blood of the whole body is basically the same, and the use in patients with a history of thrombosis may cause thrombosis or aggravate bleeding, and may also be accompanied by adverse effects such as nausea, headache, rash, and temporary hypotension. Response, in the prior art of phensulfame, in addition to the listed tablet, injection powder injection, and injection, some patents also disclose external dosage forms containing phensulfame

Chinese patent CN 1320931C discloses a medical hydrogel auxiliary material added with antibacterial drugs, disinfectants, anti-inflammatory drugs, analgesics, hemostasis, blood coagulation drugs, water-soluble anticancer drugs, etc., which can be used as mild skin trauma or chronic skin The permanent auxiliary materials for diseases can also be used for immediate closure of severe skin tissue trauma or burn wounds, but based on the use of hydrogel dressings, if it is used for the treatment of recurrent Henoch-Schonlein purpura simplex, it needs to be applied after applying the auxiliary materials on the affected area. Then use gauze or bandage to cover and fix it, which is cumbersome to use and cannot be peeled off at any time, so it is convenient to stop or continue the administration

Chinese patent CN 101700408A discloses a gluconacetobacter xylinum cellulose hydrogel dressing whose active ingredient contains ethylamine, which also has the problem of being cumbersome to use and cannot be peeled off at any time

Chinese patent CN 107375994A discloses a medical gel band-aid product, which is suitable for hemostasis and sterilization of skin trauma. Although the active ingredient of this invention also includes phensulfame, no penetration enhancer is added, so it cannot be guaranteed that the skin will not be damaged. When the skin layer is intact, fensulfame can penetrate into the subcutaneous hemorrhage and continue to exert its drug effect

Chinese patent CN 104922740A discloses a medical polymer composite material with hemostatic and anti-adhesion properties containing phensulfame as an active ingredient, also without a penetration enhancer

Chinese patent CN 105616478A discloses a local anesthesia gel preparation, which contains many active ingredients, including anesthetics, hemostatics, anti-inflammatory drugs, etc. The solubility and stability of all ingredients need to be considered comprehensively when preparing, so it includes After adding pure water to the active ingredients including ethanol, choose to adjust the pH to 6-8, and the relatively stable pH of ethanol itself is around 5.5. The gel preparation of this invention cannot give priority to ensuring the stability, and contains anesthetic components, it is not suitable for the daily administration of fensulfame in the treatment of recurrent Henoch-Schonlein purpura simplex

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