Phencynonate hydrochloride double-layer osmotic pump controlled-release tablet and preparation method thereof

Abstract

The invention provides a phencynonate hydrochloride double-layer osmotic pump controlled release tablet and a preparation method thereof. The tablet comprises, from interior to exterior, a double-layer tablet core prepared through compaction of a drug-containing layer and a boosting layer, a semipermeable coating film with drug releasing holes and a moistureproof coating film, wherein the drug-containing layer contains an effective amount of phencynonate hydrochloride, a suspending aid, an osmotic pressure promoter and other pharmaceutic adjuvants, the boosting layer contains a propellant, an osmotic pressure promoter, a sustained releasing agent and other pharmaceutic adjuvants, and the semipermeable coating film is perforated with more than one drug releasing hole in one side close to the drug-containing layer. According to the invention, the phencynonate hydrochloride double-layer osmotic pump controlled release tablet has a substantial zero order drug release characteristic and enables drugs to enter into a human body at a constant speed; drug release behavior is not affected by gastrointestinal peristalses, pH values, food effects and the like, individual difference of the drug release behavior is small, and blood concentration is steady; the tablet has long-lasting drug effects, is taken once per day, has little toxic and side effects and good compliance in administration and can be used for preventing or treating motion sickness syndrome, Parkinson' disease, Parkinson' disease syndrome, acute attack of vertigo and epilepsy.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and specifically relates to a phencyclonate hydrochloride double-layer osmotic pump controlled-release tablet and a preparation method thereof. It enters the gastrointestinal tract at a high rate, and can be used to prevent or treat acute attacks of vertigo such as motion sickness syndrome, Parkinson's disease and Parkinson's syndrome, Meniere's syndrome and positional vertigo, and epilepsy. Background technique [0002] Phencyclononyl hydrochloride (chemical name: phenylcyclopentyl glycolic acid [N-methyl-3-azabicyclo(3,3,1)nonyl]-9α-ester hydrochloride) is a self-developed A new class of central anticholinergic drug with intellectual property rights (Chinese patent CN1039623C), which is used to prevent and treat motion sickness syndrome. It is an efficient and safe anti-motion sickness new drug. Phencynonate hydrochloride ordinary tablet (approval number: Guoyao Zhunzi H10...

AI Technical Summary

Problems solved by technology

[0005] Due to the short half-life of phencyclonate hydrochloride, the drug effect can only last for 4 to 5 hours, but the clinical treatment of Parkinson's disease and Parkinson's syndrome, epilepsy, and vertigo attacks requires long-term medication, and there are varying degrees of swallowing Clinical symptoms such as impaired cognition and poor cognition make it difficult to take medication frequently every day, which is not conducive to patients' compliance with the treatment plan

In addition, ordinary tablets of phencyclonate hydrochloride release the drug quickly after oral administration, and dizziness and epilepsy due to different etiologies can also cause abnormal gastrointestinal motility, resulting in large individual differences in drug efficacy, which will also affect the clinical therapeutic effect of the drug to play

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