Insulin cream suppository and preparation method

Abstract

The invention provides an insulin cream suppository which comprises insulin cream and a cream administration device, wherein the insulin cream is prepared by mixing the following raw materials: an effective dose of insulin, soft cream matrix and an absorption promoter; the mass of the soft cream matrix is 250-420 times of that of the insulin; the mass of the absorption promoter is 1-4 percent of that of the soft cream matrix. The insulin cream is poured into the cream administration device to obtain the insulin cream suppository. The invention further provides a preparation method of the insulin cream suppository, which comprises the following steps: preparing the soft cream matrix; preparing an insulin-glycerin mixture; preparing the insulin cream; pouring the insulin cream into the cream administration device to obtain the insulin cream suppository. The insulin cream suppository provided by the invention directly administrates insulin to a rectum, is convenient and safe, protects diabetics from injection pain, especially has the same blood glucose reduction effect as the same dose of injected insulin after being administrated, and has a high application value.

Description

technical field [0001] The invention relates to the technical field of medicine, in particular to an insulin ointment suppository for rectal administration and a preparation method thereof. Background technique [0002] Insulin is a hypoglycemic drug, and it is mainly used clinically for patients with insulin-dependent (type I) and patients who are ineffective with chemical hypoglycemic drugs and need insulin injections (patients with severe type II diabetes). Since it was discovered in 1923 that insulin can effectively lower blood sugar in diabetic patients, until today, insulin is administered by injection, usually three times a day after meals, and insulin-dependent patients are injected three times a day without interruption for many years Administration is painful, and the risk of injection administration is relatively high. In order to control their blood sugar and maintain their lives, diabetic patients can only endure the pain and insist on injections. [0003] In o...

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Problems solved by technology

[0003] In order to alleviate the pain of insulin injections for diabetic patients for many years, medical workers have been trying to explore for a long time, seeking ways other than insulin injection, such as oral administration, rectal administration, nasal cavity administration, etc., but so far to no avail

In 2006, after years of research and at a cost of 2.8 billion U.S. dollars, Pfizer of the United States launched a new dosage form of insulin spray for the first time in the world, named Exubera. For other reasons, Pfizer can only announce the delisting of Exubera

[0005] There have been half a century of research on trying to replace injection administration with insulin suppositories, but there has been no significant progress so far. The reason is that the grain weight of suppositories is generally about 1.5 grams, that is, 1500mg, and the insulin added in insulin suppositories Only a few tenths of a milligram, and a few tenths of a milligram of insulin is evenly dispersed in a matrix tens of thousands of times larger than its own mass when preparing a suppository to make an insulin suppository. After the suppository enters the human rectum, the suppository melts and is wrapped in the matrix Most of the insulin in the suppositories cannot touch the rectal mucosa. Even with the best absorption enhancer, most of the insulin in the suppository cannot be absorbed by the rectum because it cannot contact the rectal mucosa. Even if a small amount is absorbed by the rectal mucosa, it can reach Less than the dose required for hypoglycemia, so it does not have a hypoglycemic effect

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