Stable compound dimeticone hydrotalcite suspension

Abstract

The invention discloses a pharmaceutical suspension compounded of dimeticone and hydrotalcite, in particular to a stable compound dimeticone hydrotalcite suspension. Auxiliary materials in the prescription of the suspension related by the invention mainly comprise sodium cellulose glycolate and polyoxyethylene (40) hydrogenated castor oil, the prices of the auxiliary materials are lower than those of Span 80, Span 65 and glycerin monostearate which are adopted in the prescription of a foreign product, and the dosage of the auxiliary materials is reduced. Therefore, the suspension produced by adopting the suspension prescription of the invention can save more production cost, and the thermal stability of the suspension is improved.

Description

technical field [0001] The invention relates to a stable compound dimethicone aluminum magnesium carbonate composition and a preparation method thereof, in particular to a compound dimethicone aluminum magnesium carbonate suspension and a preparation method thereof. Background technique [0002] Dimethicone (Dimethicone), the chemical name is dimethyl siloxane polymer. [0003] Simethicone is a colorless and clear oily liquid; odorless or almost odorless, tasteless, simethicone can be arbitrarily mixed in chloroform, ether, benzene, toluene or xylene, and insoluble in water or ethanol. [0004] Aluminum magnesium carbonate is used as an antacid in medicine for gastric and duodenal ulcers, chronic gastritis, reflux esophagitis, etc. [0005] The suspension combined with simethicone and aluminum magnesium carbonate was first developed and marketed by Peckforton Pharmaceuticals Ltd in the United Kingdom. Its trade name is: Altacite Plus. It is a drug commonly used in clinical...

AI Technical Summary

Problems solved by technology

[0005] The suspension combined with simethicone and aluminum magnesium carbonate was first developed and marketed by Peckforton Pharmaceuticals Ltd in the United Kingdom. Its trade name is: Altacite Plus. It relieves burning symptoms and is a commonly used drug in clinical practice, but there is no such product on the market in China, and there is no manufacturer's declaration so far on the website of the Food and Drug Administration.

But simethicone belongs to oily substance, is insoluble in water, aluminum magnesium carbonate is solid, also insoluble in water, because the above-mentioned character of two kinds of active ingredients brings very big to the solution agent that prepares simethicone and aluminum magnesium carbonate combination Difficult, and with two active ingredients, it also poses a great challenge to solution preservation

[0007] Products listed abroad: The excipients in the instruction manual of Altacite Plus are composed of sodium carboxymethylcellulose, Tween 80, Span 80, Span 65, glyceryl monostearate, micropowder silica gel, methylcellulose 2500, microcrystalline Cellulose, bronopol (bronopol), spearmint flavor, sodium saccharin, chloroform, purified water, etc. There are many types of auxiliary materials, and the formula and process are complicated; among them, methyl cellulose, microcrystalline cellulose, and Span 80. The market price of Span 65 is relatively high, resulting in an increase in production costs; and chloroform, one of the preservatives in the prescription, belongs to the third class of solvents, which is highly toxic and pollutes the environment; another preservative, Bropol, is not suitable for children. Although it is widely used as a preservative in topical drugs and cosmetics, the fourth edition of "Handbook of Pharmaceutical Excipients" [Author: R.C. Luo; P.J. Page 71] stated that when administered topically or orally, Bropol can generate nitrite after decomposition, and nitrosamines can be generated in the presence of certain organic amines and nitrosamines, which has safety problems. suitable for children

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