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Diltiazem hydrochloride controlled-release pill and preparation method thereof

A technology of diltiazem hydrochloride and controlled-release pills, which is applied in the directions of pill delivery, pharmaceutical formulations, and medical preparations with inactive ingredients, etc., can solve problems such as poor controlled-release properties and difficulty in maintaining the health of those taking the medicine.

Pending Publication Date: 2021-07-27
HAINAN JINRUI PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] The application provides a diltiazem hydrochloride controlled-release pill and a preparation method thereof, which are used to solve the problem that the existing diltiazem hydrochloride controlled-release pill has poor controlled-release performance during the whole period, and it is difficult to continuously and effectively maintain the health of the person taking the medicine for 24 hours. technical problem

Method used

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  • Diltiazem hydrochloride controlled-release pill and preparation method thereof
  • Diltiazem hydrochloride controlled-release pill and preparation method thereof

Examples

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Effect test

Embodiment 1

[0036] For ease of understanding, see figure 1, the application provides an embodiment of a diltiazem hydrochloride controlled-release pill, comprising: a pill core 1, a controlled-release layer 2 and an immediate-release layer 3 arranged sequentially from the inside to the outside, and in the prescription, by parts by weight, Pill core 1 includes: 15-80 parts of diltiazem hydrochloride, 10-85 parts of filling excipients, 3-15 parts of lubricant, 2-12 parts of binder, 2-14 parts of swelling agent and 4-15 parts of osmotic pressure active substances; Based on the total weight of the pill core 1, the controlled release layer 2 includes: 8%-20% controlled release film material, 4%-12% porogen and 2%-8% plasticizer; Gross weight, immediate-release layer 3 comprises: 12%-30% diltiazem hydrochloride, 5%-15% immediate-release film material and 1%-4% adhesive; Diltiazem hydrochloride content in immediate-release layer 3 is higher than pill The content of diltiazem hydrochloride in co...

Embodiment 2

[0040] As a further improvement to Example 1, the present application provides an example of a diltiazem hydrochloride controlled-release pill. Optionally, the filling excipient is one or more of lactose, calcium carbonate and sodium bicarbonate. The lubricant is one or more of magnesium stearate, stearic acid, zinc stearate or polyethylene glycol; the controlled-release layer 2 and / or the immediate-release layer 3 include the lubricant. The binder is crospovidone, polyvinylpyrrolidone, methylcellulose or absolute alcohol. The swelling agent is polyoxyethylene or hydroxypropylmethylcellulose. The osmotic pressure active substance is one or more of sodium chloride, potassium chloride, mannitol, lactose and sorbitol. The controlled-release membrane material and the immediate-release membrane material are Eudragit RS / RL, Eudragit NE 30D, hypromellose, ethyl cellulose or cellulose acetate. The plasticizer is one or more of phthalates, triethyl citrate and glycerol. The porogen ...

Embodiment 3

[0043] The application also provides a preparation method of diltiazem hydrochloride controlled-release pills, comprising the following steps:

[0044] Step 1, material preparation: According to the prescription, prepare pill core 1 material, controlled-release layer 2 material, and quick-release layer 3 material, wherein, diltiazem hydrochloride is crushed with a pulverizer and passed through a 80-90 mesh sieve, and the osmotic pressure active substance is passed through a 75-85 mesh sieve. Mesh sieve;

[0045] Step 2. Mixing to make a pill core 1: After uniformly mixing filling materials, binders, swelling agents, sieved diltiazem hydrochloride and osmotic pressure active substances, the drug-containing granules are made into drug-containing granules through a granulator, and the drug-containing granules are mixed and added After the lubricant, the pill core 1 is formed by pressing the tablet machine, wherein the pill core 1 includes: 15-80 parts of diltiazem hydrochloride, ...

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Abstract

The invention discloses a diltiazem hydrochloride controlled-release pill and a preparation method thereof. The controlled-release pill is sequentially composed of a pill core, a controlled-release layer and a quick-release layer from inside to outside, the whole controlled-release pill can be regarded as an osmotic pump preparation, and the drug effect release speed in the pill core is mainly controlled by the controlled-release layer serving as an inner-layer diaphragm; and diltiazem hydrochloride in the quick-release layer is mainly used for preventing and treating sudden unexpected illness conditions endangering body health of a user in the initial stage after the medicine is taken. In conclusion, the diltiazem hydrochloride controlled-release pill provided by the invention is good in overall period controlled-release property after being taken, the trouble of multiple times of medicine taking can be reduced, and the technical problems that the overall period controlled-release property of an existing diltiazem hydrochloride controlled-release pill is poor, and the body health of a medicine taking person is difficult to maintain continuously and effectively for 24 hours are solved.

Description

technical field [0001] The application relates to the technical field of pharmaceutical preparations, in particular to a diltiazem hydrochloride controlled-release pill and a preparation method thereof. Background technique [0002] Diltiazem hydrochloride, as a calcium ion antagonist, can relax vascular smooth muscle, reduce peripheral vascular resistance, and lower blood pressure. Epicardial and subendocardial coronary arteries, relieve angina; reduce myocardial oxygen demand, increase exercise tolerance and relieve exertional angina by slowing heart rate and lowering blood pressure. Diltiazem hydrochloride is an effective drug for preventing and treating angina pectoris, hypertension and other cardiovascular and cerebrovascular diseases, with mild side effects and no drug resistance after long-term use. [0003] Most of the existing diltiazem hydrochloride preparations are diltiazem hydrochloride controlled-release pills, which often need to be taken during peak blood pr...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/24A61K9/44A61K47/32A61K9/48A61K31/554A61P9/12A61P9/10
CPCA61K9/2095A61K9/2072A61K9/209A61K9/2027A61K9/4808A61K9/4866A61K31/554A61P9/12A61P9/10
Inventor 黄月娜王进宇潘淑华王寿春王玉英
Owner HAINAN JINRUI PHARMA CO LTD
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