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Metformin hydrochloride transdermal delivery preparation and preparation method thereof

A metformin hydrochloride preparation technology, which is applied in the field of metformin hydrochloride transdermal preparations and its preparation, can solve the problems of stimulating lactic acid and large oral doses

Inactive Publication Date: 2019-12-03
江苏山信药业有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Oral solid preparations mainly include immediate-release tablets, enteric-coated tablets, sustained-release tablets, and sustained-release pellet capsules. The specific disadvantages of oral metformin hydrochloride include: large oral doses, and metformin may stimulate the production of lactic acid when renal excretion decreases. Produces; up to 20% of patients taking metformin orally experience side effects such as anorexia, nausea, vomiting, abdominal discomfort and diarrhea

Method used

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  • Metformin hydrochloride transdermal delivery preparation and preparation method thereof

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0031] Embodiment 1 prepares the metformin hydrochloride liposome gel containing amphiphilic nano silicon dioxide

[0032] Metformin hydrochloride 50g, lecithin 90g, cholesterol 30g, amphiphilic nano silicon dioxide 10g, carbomer 15g, glycerin 5g, ethylparaben 2g, triethanolamine 0.25g, water for injection to 1000g, accurately weighed according to the above ratio Quantity, the preparation process is as follows:

[0033] 1) According to the ratio of lecithin: cholesterol: amphiphilic nano-silica: metformin hydrochloride = 9:3:1:5, take the above four substances and dissolve them in a small amount of ethanol; prepare an appropriate amount of phosphate buffer solution with a pH value of 6.8 , put it in a constant temperature water bath at 50°C, stir slowly, slowly inject the above mixture, stir for 2 hours, and obtain a liposome solution after the ethanol evaporates to dryness.

[0034] 2) Put the carbomer in an appropriate amount of phosphate buffer solution with an appropriate...

Embodiment 2

[0036] Embodiment 2 prepares the metformin hydrochloride liposome gel containing amphipathic hyaluronic acid

[0037] Metformin hydrochloride 50g, lecithin 90g, cholesterol 30g, hyaluronic acid 10g, carbomer 15g, glycerin 5g, ethylparaben 2g, triethanolamine 0.25g, add water for injection to 1000g, accurately weigh according to the above ratio, The preparation process is as follows:

[0038] 1) According to the ratio of lecithin: cholesterol: hyaluronic acid: metformin hydrochloride = 9:3:1:5, take the above four substances and dissolve them in a small amount of ethanol; prepare an appropriate amount of phosphate buffer solution with a pH value of 6.8, place In a constant temperature water bath at 50°C, stir slowly, slowly inject the above mixture, stir for 2 hours, and obtain a liposome solution after ethanol evaporates to dryness.

[0039] 2) Put the carbomer in an appropriate amount of phosphate buffer solution with an appropriate pH value of 6.8, let it fully swell overni...

Embodiment 3

[0041] Embodiment 3 prepares the metformin hydrochloride liposome gel containing amphipathic polyethylene glycol-polylactic acid-glycolic acid

[0042] Metformin hydrochloride 50g, lecithin 90g, cholesterol 30g, polyethylene glycol-polylactic acid-glycolic acid 10g, carbomer 15g, glycerin 5g, ethylparaben 2g, triethanolamine 0.25g, add water for injection to 1000g, press The above proportions are accurately weighed, and the preparation process is as follows:

[0043] 1) According to the ratio of lecithin: cholesterol: polyethylene glycol-polylactic acid-glycolic acid: metformin hydrochloride = 9:3:1:5, take the above four substances and dissolve them in a small amount of ethanol; configure a pH value of 6.8 Put an appropriate amount of phosphate buffer solution in a constant temperature water bath at 50°C, stir slowly, slowly inject the above mixture, stir for 2 hours, and obtain a liposome solution after the ethanol evaporates to dryness.

[0044] 2) Put the carbomer in an a...

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Abstract

The invention belongs to the field of transdermal delivery drug preparations in pharmaceutics, and provides a metformin hydrochloride transdermal delivery preparation. The metformin hydrochloride transdermal delivery preparation is prepared from metformin hydrochloride, amphipathic substances and pharmaceutically acceptable excipients. A technological means with higher transdermal delivery efficiency is introduced; compared with traditional creams and patches, the metformin hydrochloride transdermal delivery preparation has better transdermal effects; and the technological means can be appliedto more external drug forms, the external drug forms such as ointments, aerosols, sprays, liniments, gels and patches can be made, raw materials can be saved, and the cost can be reduced.

Description

technical field [0001] The invention belongs to the field of drug transdermal administration preparations in pharmacy, and in particular relates to a metformin hydrochloride transdermal administration preparation and a preparation method thereof. Background technique [0002] Type 2 diabetes mellitus (T2DM) is a polygenic hereditary disease formed by the joint action of genetic factors and environmental factors. or) Insulin secretion disorder, which is a heterogeneous disease with insulin deficiency and insulin resistance. [0003] Metformin hydrochloride is the first-line drug for controlling hyperglycemia and the basic drug in combination drugs recommended in the diabetes treatment guidelines of many countries. Good affinity can be used in combination with any other class of hypoglycemic drugs. For example, metformin sustained-release tablets can be used in combination with sulfonylureas, Baitangping, and insulin. Metformin reduces blood glucose levels in patients with ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/127A61K9/06A61K47/04A61K47/28A61K47/36A61K47/34A61K9/70A61K31/155A61P3/10
CPCA61K9/0014A61K9/06A61K9/127A61K9/7023A61K31/155A61K47/02A61K47/28A61K47/34A61K47/36A61P3/10
Inventor 林山王松杨云松朱明哲朱荣成孟文静
Owner 江苏山信药业有限公司
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