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Ribavirin small-capacity injection preparation and preparation method thereof

A ribavirin and small-capacity technology, applied in the field of medicine, can solve problems such as high loss and affecting content, and achieve high yield, reduce pain, and safe clinical use

Inactive Publication Date: 2013-05-22
YANGZHOU ZHONGBAO PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] At present, in the production process of ribavirin small-volume injection preparations, the main method is to add activated carbon to absorb pyrogens, pigments, and impurities. However, in the actual production process, the addition of activated carbon greatly affects the quality of the main drug ribavirin. Lin content, application number 201110294985.X, the patent name is Ribavirin Injection and its production process by adjusting the amount of medicinal activated carbon and the actual treatment to adsorb pyrogens, pigments and impurities, etc., but in the actual operation process To a certain extent, the loss of the main drug ribavirin is still relatively large, so the present invention is to solve the above-mentioned defects, ensure product quality, and reduce the loss of raw materials by conducting research on the preparation technology of small-volume injection preparations of ribavirin Improve the qualified rate of finished products, so that the therapeutic effect of ribavirin can be fully exerted

Method used

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  • Ribavirin small-capacity injection preparation and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0023] A small volume injection of ribavirin comprises the following components by weight percentage:

[0024] 500 sticks (2ml: 0.25g)

[0025] Ribavirin 12.5%,

[0026] Activated carbon 0.01%,

[0027] Benzyl Alcohol 4%,

[0028] Add water for injection to 100%;

[0029] Acetic acid-sodium acetate buffer Adjust the pH to 5.0.

[0030] The production method is as follows:

[0031] (1) Weigh 50% of the water for injection of the formula and cool it to about 40°C;

[0032] (2) Dissolve ribavirin and analgesic benzyl alcohol in the cooled water for injection in step (1) in the formulated amount;

[0033] (3) Weigh the amount of activated carbon in the formula and add it to the solution obtained in step (2), stir well and let it stand for 15 minutes, filter and decarbonize, and add water for injection to the full amount;

[0034] (4) Filter the solution obtained in step (3) with a titanium rod filter and circulate for 25 minutes;

[0035] (5) After filtering the solution o...

Embodiment 2

[0038] A small volume injection of ribavirin comprises the following components by weight percentage:

[0039] 1000 sticks (1ml: 0.1g)

[0040] Ribavirin 10%;

[0041] Activated carbon 0.015%;

[0042] Benzyl alcohol 2%;

[0043] Add water for injection to 100%;

[0044] Disodium hydrogen phosphate-sodium dihydrogen phosphate buffer to adjust the pH to 5.8.

[0045] The production method is as follows:

[0046] (1) Weigh 50% of the water for injection of the formula and cool it to about 40°C;

[0047] (2) Dissolve ribavirin and analgesic benzyl alcohol in the cooled water for injection in step (1) in the formulated amount;

[0048] (3) Weigh the amount of activated carbon in the formula and add it to the solution obtained in step (2), stir well and let it stand for 15 minutes, filter and decarbonize, and add water for injection to the full amount;

[0049] (4) Filter the solution obtained in step (3) with a titanium rod filter and circulate for 30 minutes;

[0050] (5)...

Embodiment 3

[0052] Embodiment 3: The inspection result of yield rate.

[0053] Product yield and raw material consumption rate of ribavirin small-capacity injection (according to 1L volume) prepared by Example 1, 2 and the current conventional process method (what process, please cite references, or briefly describe!) As shown in the following table:

[0054]

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Abstract

The invention discloses a ribavirin small-capacity injection preparation. The ribavirin small-capacity injection preparation comprises the following components in percentage by weight: 5%-15% of ribavirin, 1%-4% of anodyne, 0.01%-0.03% of active carbon, and water being supplemented to 100% by weight, wherein the pH value is regulated to 5.0-6.0 by a buffer solution. The invention further discloses a preparation method of the ribavirin small-capacity injection preparation. The ribavirin small-capacity injection preparation is detected and checked by regulating the dosage ratio of the anodyne, active carbon and the buffer solution in the prescription, and carrying out primary filtration, intermediate filtration and refined filtration by adopting a titanium rod filter, a 0.65-micron polypropylene filter core and a 0.22-micron polyether sulfone filter core in sequence, so that the defects of large primary medicine consumption and low percent of pass during the preparation process of the ribavirin small-capacity injection preparation are effectively solved. Besides, the prescription is simple, the yield is high, the clinical application is safe, the pain feeling is small, and the large-scale industrial production is convenient.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a ribavirin small-capacity injection preparation and a preparation method thereof. Background technique [0002] Ribavirin (Ribavirin, RIB, ribavirin, ribavirin) is a broad-spectrum antiviral drug, which has obvious inhibitory effects on a variety of DNA and RNA viruses, and is widely used in the treatment of viral diseases and tumors at home and abroad. treat. There are injections, tablets, oral liquids, effervescent granules, nasal drops and other dosage forms used in clinical practice, but ribavirin has relatively high toxic and side effects, and high-dose application can inhibit the bone marrow. [0003] At present, in the production process of ribavirin small-volume injection preparations, the main method is to add activated carbon to absorb pyrogens, pigments, and impurities. However, in the actual production process, the addition of activated carbon greatly a...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K45/00A61K31/7056A61K9/08A61P31/12A61P35/00
Inventor 葛海涛唐俊
Owner YANGZHOU ZHONGBAO PHARMA
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