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Hydrochloric acid diltiazem freeze-dried powder injection for injections and preparation method thereof

A technique for diltiazem hydrochloride and freeze-dried powder injection, which is applied in the field of diltiazem hydrochloride freeze-dried powder injection for injection and its preparation, and can solve problems such as poor clarity and stability, no preparation method mentioned, high content of related substances, etc.

Active Publication Date: 2008-12-24
HAINAN JINRUI PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] The prior art shows that there are no relevant domestic and foreign patents and documents of diltiazem hydrochloride freeze-dried powder injection for injection at present. Although diltiazem hydrochloride freeze-dried powder injection for injection has been sold on the market, the preparation method of the product is not mentioned. Moreover, the clarity and stability of commercially available products are not good, and the main drug content is low, while the content of related substances is high. In order to improve the above-mentioned properties of diltiazem hydrochloride, researchers of the present invention, through long-term experimental research, found that by changing the formula and freeze-drying process , combined with some changes in the preparation method, can overcome the above-mentioned defects, obtain a freeze-dried powder injection with good clarity and stability, high main drug content, and related substance content. Therefore, the present invention is proposed

Method used

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  • Hydrochloric acid diltiazem freeze-dried powder injection for injections and preparation method thereof
  • Hydrochloric acid diltiazem freeze-dried powder injection for injections and preparation method thereof
  • Hydrochloric acid diltiazem freeze-dried powder injection for injections and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0077] Composition of diltiazem hydrochloride freeze-dried powder for injection

[0078] Prescription 1: (Specification: 50mg)

[0079] Component Content

[0080] Diltiazem Hydrochloride 51.0g(50mg)

[0081] Mannitol 75.0g

[0082] Water for injection 2000mL

[0083] Makes 1000 bottles

[0084] The preparation method of diltiazem hydrochloride freeze-dried powder injection for injection is as follows:

[0085] (1) Weigh the diltiazem hydrochloride and mannitol of the prescribed amount, place them in a liquid preparation tank, add 50°C water for injection accounting for 1 / 2 of the total amount of water for injection to completely dissolve it, and obtain a mixed solution;

[0086] (2) Add 0.15mol / l sodium hydroxide solution to the above mixed solution to adjust its pH value to 5.00;

[0087] (3) add medicinal active carbon in the solution of step (2) gained, the add-on of medicinal active carbon is 0.05% of solution weight, after stirring 20 minutes to solution evenly, lea...

Embodiment 2

[0091] Composition of diltiazem hydrochloride freeze-dried powder for injection

[0092] Prescription 1: (Specification: 10mg)

[0093] Component Content

[0094] Diltiazem Hydrochloride 10.2g

[0095] Mannitol 70.0g

[0096] Water for injection 2000ml

[0097] Makes 1000 bottles

[0098] The preparation method of diltiazem hydrochloride freeze-dried powder injection for injection is as follows:

[0099] (1) Weigh the diltiazem hydrochloride and mannitol of the prescribed amount, place them in the liquid preparation tank, add 60°C water for injection, which accounts for 2 / 3 of the total water for injection, to completely dissolve it, and obtain a mixed solution;

[0100] (2) Add 0.05mol / l sodium hydroxide solution to the above mixed solution to adjust its pH value to 4.95;

[0101] (3) add medicinal active carbon in the solution of step (2) gained, the add-on of medicinal active carbon is 0.05% of solution weight, after stirring 30 minutes to solution evenly, leave standst...

Embodiment 3

[0105] Composition of diltiazem hydrochloride freeze-dried powder for injection

[0106] Prescription 1: (Specification: 10mg)

[0107] Component Content

[0108] Diltiazem Hydrochloride 10.2g

[0109] Mannitol 70.0g

[0110] Water for injection 2000ml

[0111] 0.1mol / l sodium hydroxide solution appropriate amount (pH regulator)

[0112] Made 1000 bottles 1000 bottles

[0113] The preparation method of diltiazem hydrochloride freeze-dried powder injection for injection is as follows:

[0114] (1) Weigh the diltiazem hydrochloride and mannitol of the prescribed amount, place them in the liquid preparation tank, add 70°C water for injection accounting for 1 / 2 of the total water for injection to completely dissolve it, and obtain a mixed solution;

[0115] (2) Add 0.1mol / l sodium hydroxide solution to the above mixed solution to adjust its pH value to 4.95;

[0116] (3) add medicinal active carbon in the solution of step (2) gained, the add-on of medicinal active carbon is...

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Abstract

The invention provides a diltiazem hydrochloride freeze-dried powder injection for injection and a preparation method thereof. The freeze-dried powder injection comprises diltiazem hydrochloride and mannite, the proportion by weight of diltiazem hydrochloride and mannite is 1: 1 to 8. The freeze-dried powder injection has favorable clarity and stability and high content of main drug, thereby being freeze-dried powder injection with good quality.

Description

technical field [0001] The invention belongs to the technical field of pharmacy, in particular to a diltiazem hydrochloride freeze-dried powder injection for injection and a preparation method thereof. Background technique [0002] Diltiazem hydrochloride, chemical name cis-(+)-5-[(2-dimethylamino)ethyl]-2-(4-methoxyphenyl)-3-acetoxy-2,3-dihydro -1,5-Benzothiazepine-4(5H)-one hydrochloride, the molecular formula is: C 22 h 26 N 2 o 4 S; the molecular weight is 450.98, and its chemical structural formula is: [0003] [0004] Diltiazem hydrochloride is a calcium ion channel blocker, which can effectively dilate the epicardial and subendocardial coronary arteries, relieve spontaneous angina pectoris or angina pectoris caused by ergonovine-induced coronary artery spasm; by slowing heart rate and lowering blood pressure , reduce myocardial oxygen demand, increase exercise tolerance and relieve exertional angina pectoris; it can relax vascular smooth muscle, reduce periph...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K31/554A61K47/10A61P9/10A61P9/12
Inventor 罗韬
Owner HAINAN JINRUI PHARMA
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