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Formula of Reynoldazine hydrochloride prepn.

A technology of ranolazine hydrochloride and ranolazine hydrochloride, which is applied in the field of ranolazine hydrochloride tablets, and can solve problems such as poor dissolution, difficult operation, and poor fluidity

Inactive Publication Date: 2009-01-28
HARBIN PHARMA GRP CO LTD GENERAL PHARMA FACTORY
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0011] Due to its molecular structure, ranolazine hydrochloride contains a certain amount of crystal water and is easy to absorb moisture. Therefore, it is unstable when made into ordinary preparations. It will not dissolve well when left at room temperature for a certain period of time. At the same time, due to its hygroscopicity, its fluidity is poor. Poor, it is difficult to operate when making preparations, tablets need to be coated and packed in sealed bottles, capsules should be sealed with capsule shells, and require protection from moisture and oxygen, which affects drug storage

Method used

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  • Formula of Reynoldazine hydrochloride prepn.
  • Formula of Reynoldazine hydrochloride prepn.
  • Formula of Reynoldazine hydrochloride prepn.

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0113] Ranolazine hydrochloride 200g (equivalent to hydrated 203.6g)

[0114] Hypromellose E 15 15g

[0115] 8% Povidone K 30 Ethanol solution 150ml

[0116] Magnesium Stearate 3g

[0117]

[0118] Makes 1000 pieces

[0119] Crush ranolazine hydrochloride, pass through 80 mesh sieve, take prescription amount of ranolazine hydrochloride and prescription amount of hypromellose E 15 Mix evenly, add 8% povidone ethanol solution to make soft material, pass through 18 mesh sieve to make granules, and dry at 60°C (the obtained granules should be held tightly with hands, and the hands should be loosened so that the granules should not stick together, nor should the palm of the hand. If there is fine powder adhered or twisted with the index finger and thumb, it should be crushed immediately, without a sense of dampness) and granulated, added with magnesium stearate, mixed evenly, pressed into tablets, and coated with film.

Embodiment 2

[0121] Ranolazine hydrochloride 400g (equivalent to hydrated 407.2g)

[0122] Hypromellose E 15 30g

[0123] 8% Povidone K 30 Ethanol solution 300ml

[0124]Magnesium Stearate 6g

[0125]

[0126] Makes 1000 pieces

[0127] Crush ranolazine hydrochloride, pass through 80 mesh sieve, take prescription amount of ranolazine hydrochloride and prescription amount of hypromellose E 15 Mix evenly, add 8% povidone ethanol solution to make soft material, pass through 18 mesh sieve to make granules, and dry at 60°C (the obtained granules should be held tightly with hands, and the hands should be loosened so that the granules should not stick together, nor should the palm of the hand. If there is fine powder adhered or rubbed with the index finger and thumb, it should be crushed immediately, without a sense of dampness) whole grain, add magnesium stearate, mix well, press into tablets, and coat with film.

Embodiment 3

[0129] Ranolazine hydrochloride 200g (equivalent to hydrated 203.6g)

[0130] Hypromellose E 15 45g

[0131] 8% Povidone K 30 Ethanol solution 80ml

[0132] Magnesium Stearate 3g

[0133]

[0134] Makes 1000 pieces

[0135] Crush ranolazine hydrochloride, pass through 80 mesh sieve, take prescription amount of ranolazine hydrochloride and prescription amount of hypromellose E 15 Mix evenly, add 8% povidone ethanol solution to make soft material, pass through 18 mesh sieve to make granules, and dry at 60°C (the obtained granules should be held tightly with hands, and the hands should be loosened so that the granules should not stick together, nor should the palm of the hand. If there is fine powder adhered or rubbed with the index finger and thumb, it should be crushed immediately, without a sense of dampness) whole grain, add magnesium stearate, mix well, press into tablets, and coat with film.

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Abstract

A compound reynoldazine hydrochloride is prepared from the reynoldazine hydrochloride and the assistant chosen from diluent, adhesive and lubricant.

Description

Technical field: [0001] The invention relates to a new drug preparation for treating angina pectoris, in particular to a new formula and preparation process of ranolazine hydrochloride tablets. Background technique: [0002] Angina pectoris (Angina Pectoris) is a clinical syndrome caused by the imbalance of blood oxygen supply and demand caused by the oxygen supply capacity of coronary blood flow unable to meet the myocardial demand for oxygen. It is the most common clinical disease of coronary heart disease. The accumulation of metabolites such as lactic acid, histamine, and potassium ions produced by myocardial hypoxic metabolism stimulates the afferent center of the sympathetic nerve. When the attack occurs, it manifests as paroxysmal colic or dull pain in the precordial area or intrasternal and posterior, and the pain can radiate. To the base of the neck, left shoulder, left upper arm, upper abdomen or back. The severity varies, and the outbreak is repeated intermittent...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/495A61K9/20A61K47/34A61K47/36A61K47/04A61K47/26A61P9/10A61K47/32A61K47/38
Inventor 朱彦民景士云赵民喜周丽梅牟春福石晓晶周淑清王艳户巧芬庄须国
Owner HARBIN PHARMA GRP CO LTD GENERAL PHARMA FACTORY