Gel composition containing tacrolimu and its preparation method and medicinal application

A technology of tacrolimus and gel, applied in the pharmaceutical field, can solve the problems of easily polluting clothes, not easy to clean, bad smell and so on

Inactive Publication Date: 2008-10-22
杨喜鸿
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Tacrolimus ointment (trade name: Protobi) is an oily semi-solid external preparation, thick and greasy, poor spreadability, easy to stain clothes and has a bad smell of mineral oil, and is not easy to clean

Method used

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  • Gel composition containing tacrolimu and its preparation method and medicinal application
  • Gel composition containing tacrolimu and its preparation method and medicinal application
  • Gel composition containing tacrolimu and its preparation method and medicinal application

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0093] Embodiment 1. Tacrolimus gel and its preparation

[0094] Prescription: Tacrolimus 0.03g, carbomer 1g, triethanolamine 2g, propylene glycol 6g, glycerin 5g, polyethylene glycol-400 33g, purified water plus 100g.

[0095] Preparation: Take carbomer and add 35ml of purified water to make it fully swell, adjust the pH value of the solution to 6.0-7.5 with triethanolamine, stir well, and obtain a blank gel; take another tacrolimus and dissolve it in polyethylene glycol- 400, stir well, add propylene glycol and glycerin, stir to completely dissolve tacrolimus in the mixed solvent of polyethylene glycol-400, propylene glycol and glycerin, then slowly add the liquid medicine into the carbomer matrix, Stir evenly while adding, and finally add purified water to 100g to obtain tacrolimus gel with a content of 0.03%, packed in aluminum tubes, 20g each, to obtain.

Embodiment 2

[0096] Embodiment 2. Tacrolimus gel and its preparation

[0097] Prescription: Tacrolimus 0.1g, chitosan 1.2g, triethanolamine 1g, glycerin 8g, laurocapram 1g, polyethylene glycol-300 28g, distilled water to 100g.

[0098] Preparation: Sprinkle chitosan on the surface of 45ml of distilled water to make it fully swell, stir well, add laurocapram, stir well, then add triethanolamine, stir well to get a blank gel; another take tacrolimus , Glycerol was added to polyethylene glycol-300, stirred to completely dissolve tacrolimus in the mixed solvent of polyethylene glycol-300 and glycerin, stirred evenly, and the blank gel was mixed evenly with the tacrolimus solution, and added Distilled water to 100g, stirred evenly to obtain tacrolimus gel, packaged.

Embodiment 3

[0099] Embodiment 3. Tacrolimus gel and its preparation

[0100] Prescription: Tacrolimus 0.02g, Carbomer (940) 2.5g, Menthol 2g, Propylene Glycol 20g, Polyethylene Glycol-400 25g, Ethylparaben 0.2g, Triethanolamine amount, Purified water up to 100g.

[0101] Preparation: Sprinkle carbomer (940) evenly in an appropriate amount of purified water to make it fully swell, add purified water to 50ml, and stir evenly to obtain a carbomer solution. Use triethanolamine to adjust the pH value of the solution to 6.0-7.5, stir Mix well to get a blank gel; take tacrolimus, menthol, ethylparaben, add polyethylene glycol-400 and propylene glycol, stir to dissolve, slowly add the blank gel under constant stirring, stir evenly, add water to 100g, stir well to obtain tacrolimus gel, and pack it.

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Abstract

The invention relates to a gel composition containing tacrolimus, which contains the tacrolimus and ingredients of a matrix, wherein, the ingredients of the matrix contain one or more of liquid polyethylene glycol, glycerin and propylene glycol, the content of the tacrolimus in the gel is 0.01 percent to 0.5 percent, and the weight ratio of the tacrolimus to one or more of the liquid polyethylene glycol, the glycerin and the propylene glycol is 1: (50 to 3000). The invention further relates to a preparation method of the gel composition of the tacrolimus and the application of the gel composition in the preparation of drugs for the treatment of atopic dermatitis, vitiligo, psoriasis, hormone-dependent dermatitis, intractable neurodermatitis, lupus erythematosus, alopecia areata and other diseases.

Description

technical field [0001] The invention belongs to the technical field of pharmacy, and relates to a gel composition for skin external application containing tacrolimus, a preparation method thereof and its application in medicine. Background technique [0002] Tacrolimus, the chemical name is 17-allyl-1,14-dihydroxy-12-[2-(4-hydroxy-3-methoxycyclohexyl)-1-methylvinyl] -23,25-dimethoxy-13,19,21,27-tetramethyl-11,28-dioxa-4-azatricyclo[22.3.1.0 4，9 ]-Octadec-18-ene-2,3,10,16-tetraketone, monohydrate, the molecular structure is as follows: [0003] Molecular formula C 44 h 69 NO 12 ·H 2 O, molecular weight 822.05. [0004] Tacrolimus is an immunosuppressive and antimicrobial active drug with very poor water solubility that is indicated for the treatment and / or prevention of the following diseases and conditions: Rejection resulting from organ or tissue transplantation; Transplantation resulting from bone marrow transplantation Drug anti-host response; autoimmune diseases...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/00A61K31/436A61K47/34A61K47/10A61P37/06A61P31/00
Inventor 杨喜鸿
Owner 杨喜鸿
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