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A kind of lomerizine hydrochloride osmotic pump tablet and preparation method thereof

A technology of lomerizine hydrochloride and osmotic pump tablets, which is applied in the direction of pharmaceutical formulations, medical preparations with non-active ingredients, medical preparations containing active ingredients, etc., can solve the problem of not providing the solubility and absorption properties of active pharmaceutical ingredients, reducing the Patient compliance, recrystallization and precipitation and other issues, to achieve the effect of prolonging drug action time, improving patient compliance, and improving absorption properties

Active Publication Date: 2022-07-22
四川省百草生物药业有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] Yet there are some shortcomings in existing lomerizine hydrochloride preparations: on the one hand, the lomerizine hydrochloride preparations on the market are all tablets and capsules, because the elimination half-life of lomerizine hydrochloride in the human body is shorter, In order to maintain the long-term high-efficiency blood drug concentration in the patient's body and improve the efficacy of the drug, it is often necessary to administer it multiple times a day, thereby reducing the patient's compliance
On the other hand, since the release of the drug starts from the stomach, the drug ingredients are prone to recrystallization and precipitation before reaching the absorption site, so conventional lomerizine hydrochloride formulations cannot provide sufficient solubility and absorption properties of the active drug ingredient

Method used

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  • A kind of lomerizine hydrochloride osmotic pump tablet and preparation method thereof
  • A kind of lomerizine hydrochloride osmotic pump tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0047] 1. a lomerizine hydrochloride osmotic pump tablet, comprising a tablet core, and a coating layer wrapped on the outside of the tablet core; the tablet core comprises a drug layer and a booster layer, and the coating layer is to perform a coating layer on the tablet core by the coating liquid. The result of coating treatment;

[0048] Among them, the mass ratio of the tablet core to the coating layer is 1:0.1, and the mass ratio of the drug layer to the booster layer is 3:2;

[0049] By weight, the drug layer includes 1 part of Lomerizine Hydrochloride solid dispersion and 8 parts of microcrystalline cellulose;

[0050] By weight, the booster layer includes 5 parts of sodium chloride, 1 part of polyoxyethylene and 0.05 part of magnesium stearate;

[0051]By weight, the coating liquid includes 30 parts of cellulose acetate, 3 parts of hydroxypropyl methylcellulose, 3 parts of propylene glycol, 3 parts of hydroxypropyl methylcellulose phthalate, 765 parts of isopropyl alc...

Embodiment 2

[0062] 1. a lomerizine hydrochloride osmotic pump tablet, comprising a tablet core, and a coating layer wrapped on the outside of the tablet core; the tablet core comprises a drug layer and a booster layer, and the coating layer is to perform a coating layer on the tablet core by the coating liquid. The result of coating treatment;

[0063] Among them, the mass ratio of the tablet core to the coating layer is 1:0.3, and the mass ratio of the drug layer to the booster layer is 4:1.5;

[0064] By weight, the drug layer includes 1 part of Lomerizine Hydrochloride solid dispersion and 10 parts of lactose;

[0065] By weight, the booster layer includes 7 parts of sorbitol, 3 parts of croscarmellose sodium and 0.2 parts of micropowder silica gel;

[0066] In parts by weight, the coating liquid includes 30 parts of ethyl cellulose, 6 parts of polyethylene glycol, 15 parts of triethyl citrate, 15 parts of polyvinylpyrrolidone and 1000 parts of ethanol.

[0067] 2. the preparation me...

Embodiment 3

[0077] 1. a lomerizine hydrochloride osmotic pump tablet, comprising a tablet core, and a coating layer wrapped on the outside of the tablet core; the tablet core comprises a drug layer and a booster layer, and the coating layer is to perform a coating layer on the tablet core by the coating liquid. The result of coating treatment;

[0078] Wherein, the mass ratio of the tablet core to the coating layer is 1:0.2, and the mass ratio of the drug layer to the booster layer is 2:1;

[0079] By weight, the drug layer includes 1 part of Lomerizine Hydrochloride solid dispersion and 9 parts of pregelatinized starch;

[0080] By weight, the booster layer includes 6 parts of glucose, 2 parts of polyvinylpyrrolidone and 0.15 part of glyceryl behenate;

[0081] In parts by weight, the coating liquid includes 30 parts of cellulose acetate, 5 parts of hydroxypropyl methylcellulose, 9 parts of triglycerides, 20009 parts of polyethylene glycol and 900 parts of isopropanol.

[0082] 2. the ...

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Abstract

The invention relates to the technical field of pharmaceutical engineering, and specifically discloses a lomerizine hydrochloride osmotic pump tablet, comprising a tablet core and a coating layer wrapped on the outside of the tablet core; the tablet core includes a drug layer and a booster layer , the coating layer is obtained by coating the tablet core with the coating liquid; in parts by weight, the drug layer includes 1 part of lomerizine hydrochloride solid dispersion and 8-10 parts of filler; In parts by weight, the booster layer includes 5-7 parts of osmotic pressure enhancer, 1-3 parts of swelling material and 0.05-0.2 parts of lubricant; in parts by weight, the coating liquid includes 30 parts of semi-permeable membrane material , 3-6 parts of permeability regulator, 3-15 parts of plasticizer, 3-15 parts of porogen and 800-1000 parts of solvent; the invention also discloses a preparation method of the lomerizine hydrochloride osmotic pump tablet; The invention combines the solid dispersion solubilization technology with the osmotic pump tablet controlled release technology, which can not only significantly prolong the drug constant-speed release time, but also improve the solubility and absorption properties of the active drug components.

Description

technical field [0001] The invention relates to the technical field of pharmaceutical engineering, in particular to a lomerizine hydrochloride osmotic pump tablet and a preparation method thereof. Background technique [0002] Migraine is a common chronic neurovascular disease, clinically characterized by episodic moderate-to-severe, throbbing headaches, mostly unilateral, generally lasting 4 to 72 hours, and may be accompanied by nausea, vomiting, etc. symptom. my country is a high-incidence area of ​​migraine. At the same time, with the acceleration of the pace of life and the increase of work pressure, the incidence of migraine is also increasing, which makes the treatment of migraine have broad market prospects. [0003] Lomerizine hydrochloride is a diphenylpiperazine calcium channel blocker, which can selectively increase the blood flow of cerebral blood vessels, and has little effect on peripheral blood vessels, and can also inhibit the propagating nerve The occurre...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/36A61K31/495A61K47/38A61K9/32A61P25/06
CPCA61K31/495A61K9/2072A61K9/2866A61K9/2054A61K9/2027A61P25/06
Inventor 杨文朱祖全熊与丰
Owner 四川省百草生物药业有限公司