Oleanolic acid osmotic pump tablet and preparation method thereof

Abstract

The invention belongs to the field of medicinal preparation and discloses an oleanolic acid osmotic pump tablet and a preparation method thereof. The oleanolic acid osmotic pump tablet comprises three parts, namely, a medicine-containing layer, a boosting layer and a coating layer, and is prepared by adopting a single punch tablet press and a two-time filling and two-time pressurizing method to press and prepare two-layer tablet core, and opening a medicine-releasing hole on the surface of one side of the medicine-containing layer. The medicine-containing layer comprises a main medicine, a suspending agent, a binding agent, a penetrating agent, an osmotic pressure active substance, a lubricating agent and the like. The boosting layer comprises a high-molecular swelling agent, the osmotic pressure active substance, the binding agent, the lubricating agent and the like. The coating layer mainly comprises a film-forming material, a plasticizer, a hole-forming agent and the like. In the invention, the preparation takes zero-order release dynamics as a characteristic, the medicine is released constantly, the concentrations of the blood and the medicine are stable, the effective time is long and the purpose of releasing the medicine in 24 hours, i.e. taking the medicine once everyday is achieved.

Description

technical field [0001] The invention belongs to the controlled-release preparation in the field of pharmaceutical preparations, and relates to a medicine for treating diseases such as acute and chronic hepatitis and liver cirrhosis, in particular to an oleanolic acid double-layer osmotic pump tablet and a preparation method thereof. The preparation can improve the release degree and bioavailability of the poorly soluble oleanolic acid, make the drug release at a zero-order rate, control the blood drug concentration level, and reduce toxic and side effects. Background technique [0002] Oleanocid Acid (OA) is a natural product component in the plant kingdom, which is widely found in food and medical herbs, and belongs to the oleanoic acid alkyl type pentacyclic triterpenoids. It is white crystalline powder, odorless and tasteless. Insoluble in water, soluble in ethanol, ether, chloroform, methanol, acetone and other organic solvents, unstable to acid and alkali. [0003] Ol...

AI Technical Summary

Problems solved by technology

Due to its strong fat solubility, the commercially available common preparations are easily absorbed by the body quickly to achieve a high blood concentration, the half-life is short, and the elimination speed in the body is fast. In addition, its strong hydrophobicity affects its gastrointestinal function The release and absorption of the channel makes the bioavailability generally low

In order to maintain long-term high-efficiency blood drug concentration in the body, patients need to take multiple doses of medicine every day, which brings troubles to patients, and the blood drug concentration fluctuates too much, making it difficult to control the efficacy and toxicity

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