Wuji gastric floating sustained-release pellet and preparation method thereof

Abstract

The invention relates to a pharmaceutical composition for treating liver-stomach disharmony, bitter taste, epigastric upset, vomiting, acid regurgitation, stomachache and dysentery, especially to an oral gastric floating pellet preparation prepared mainly on the basis of a set traditional Chinese medicine prescription. The pellet preparation is mainly composed of a lightweight drug-loaded pellet core and a retardant layer coating, wherein the lightweight drug-loaded pellet core comprises 10 to 15% of extract of a Wuji prescription, 0 to 20% of a filler, 60 to 65% of an adhesive, a skeletal material and a floating aid, 5 to 10% of a hydrophilic gel material and 5 to 10% of a floating sustaining agent, and the retardant layer coating comprises 90 to 95% of a coating material and 5 to 10% of an anti-adherent. According to the invention, a high-speed fusion and stirring method is employed to prepare a pellet; the prepared pellet floats upon entering water and continuously floats for 6 h, so drugs in the pellet are slowly released; the prepared pellet has the characteristics of a great distribution area, small local irritation, etc., and due to the floating characteristic of the pellet, retention time of the pellet in the stomach is substantially prolonged, which enables bioavailability of the drugs to be greatly improved; and since the high-speed fusion and stirring method is utilized to prepare the pellet, the advantages of easiness, economic performance and no risks of fire outbreak and explosion are obtained compared with a conventional wet-rolling preparation method.

Description

technical field [0001] The invention relates to the technical field of medicine, in particular to a pharmaceutical composition for treating liver and stomach disharmony, bitter and noisy mouth, vomiting and acid regurgitation, abdominal pain and diarrhea, and in particular to an oral stomach medicine prepared mainly from traditional Chinese medicine prescriptions. Floating pellet formulations. Background technique [0002] As a classic prescription for treating gastrointestinal diseases, especially gastric ulcer, Wuji Pill has high practical value. Gastrointestinal diseases are common in modern society. According to statistics, the incidence rate is about 10%. However, this prescription is in the form of a traditional pill, and it stays in the stomach for a short time after oral administration, only 2-3 hours or less. With the emptying of the stomach, the drug enters the small intestine, and cannot form on the surface of the gastric ulcer for a long time. Effective drug co...

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Problems solved by technology

[0005] Among the existing patents, the patents on the pentylhexyl gastric floating preparations all involve tablets. However, as a single unit system, the tablet has the disadvantage that it may produce burst release or the floating performance of individual preparations is not good, and it is rapidly absorbed by the stomach. Empty, can not achieve the expected sustained and controlled release effect, and due to the individual differences in the gastric emptying rate of patients, it often leads to the uncertainty and lack of reproducibility of the prolonged gastric residence time, so the individual differences in drug release are large

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