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

A technology of phencyclonyl hydrochloride, osmotic pump controlled release, applied in pharmaceutical formulations, medical preparations containing active ingredients, drug delivery, etc. Poor etc.

Active Publication Date: 2013-09-11
WUHAN GENERAL HOSPITAL OF GUANGZHOU MILITARY
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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, wh

Method used

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

Examples

Experimental program
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Effect test

Embodiment 1

[0079] Prescription composition: see Table 1.

[0080] Preparation process: see Figure 12 .

[0081] Dissolution determination method: get the phencyclonyl hydrochloride double-layer osmotic pump controlled-release tablet sample prepared in this embodiment, according to the release determination method (Chinese Pharmacopoeia 2010 edition two appendix X D first method), adopt the dissolution determination method ( Chinese Pharmacopoeia 2010 Edition, Part II Appendix X C Method 2), using 900mL of water as the release medium, the rotation speed is 50 revolutions per minute, the medium temperature is 37°C±0.5°C, operated according to the law, in 2h, 4h, 6h, 8h, 10h , 12h, 14h, 16h, 18h, and 24h, respectively take 4mL of the solution, filter it with a 0.45μm filter membrane, and take the subsequent filtrate as the test solution. Immediately after each sampling, add water of the same temperature and volume to each dissolution vessel. Another appropriate amount of phencyclonyl hy...

Embodiment 2

[0083] Prescription composition: see Table 1.

[0084] Preparation process: see Figure 13 .

[0085] Release measurement method: same as in Example 1, in vitro cumulative 24h release percentage-time curve see Figure 4 .

Embodiment 3

[0087] Prescription composition: see Table 1.

[0088] Preparation process: see Figure 14 .

[0089] Release measurement method: same as in Example 1, in vitro cumulative 24h release percentage-time curve see Figure 5 .

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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...

Claims

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Application Information

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IPC IPC(8): A61K9/44A61K31/439A61P25/16A61P1/08A61P25/08A61P27/16
Inventor 刘辉樊光辉聂岁锋刘宏汤韧杜蓉辛华雯陈文敏张芸卢立杨楚灏曾媛夏琼琼
Owner WUHAN GENERAL HOSPITAL OF GUANGZHOU MILITARY
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