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Ranitidine hydrochloride composition freeze-dried powder injection for treating stomach illness

A technology of ranitidine hydrochloride and freeze-dried powder injection, which is applied in the field of medicine, can solve the problems of ranitidine hydrochloride is easy to deliquescence, drug effect decline, color darkening, etc., and achieves low content of insoluble particles and good stability , good fluidity effect

Inactive Publication Date: 2015-11-18
QINGDAO HUAZHICAO PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] Ranitidine hydrochloride is extremely deliquescent, causing instability after moisture absorption, darkening the color, decreasing the content, and decreasing the efficacy

Method used

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  • Ranitidine hydrochloride composition freeze-dried powder injection for treating stomach illness
  • Ranitidine hydrochloride composition freeze-dried powder injection for treating stomach illness
  • Ranitidine hydrochloride composition freeze-dried powder injection for treating stomach illness

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0028] Example 1: Preparation of ranitidine hydrochloride crystals

[0029] (1) Dissolve ranitidine hydrochloride in a mixed solvent of water and dimethyl sulfoxide, the required amount of solvent per gram of ranitidine hydrochloride is 90ml, and the volume ratio of water and dimethyl sulfoxide is 4: 1.5;

[0030] (2) After heating to 30°C to dissolve, add seed crystals after cooling to room temperature;

[0031] (3) Cool to below 0°C, stir and crystallize, the crystallization temperature is -10°C, filter, dry, collect crystals to obtain ranitidine hydrochloride crystals.

[0032] The X-ray powder diffraction figure that the prepared ranitidine hydrochloride crystal uses Cu-Kα ray measurement to obtain is as follows figure 1 shown.

Embodiment 2

[0033] Example 2: Preparation of ranitidine hydrochloride freeze-dried powder injection

[0034] Prescription: in parts by weight, 1 part of ranitidine hydrochloride crystalline compound prepared in Example 1, and 10 parts of trehalose.

[0035] Preparation method: take the prescribed amount of ranitidine hydrochloride compound, stir and dissolve it with water for injection, add the prescribed amount of excipients, adjust the pH value to 6.0-8.0, then stir until the pH remains constant, then add water for injection to the volume of the solution It is 100 times the weight of ranitidine hydrochloride, then coarsely filtered with activated carbon, sterilized and filtered through 1.0 μm, 0.45 μm, and 0.22 μm microporous membranes in turn, and filtered into a sterile room. Pack it, press half the stopper, put it into a freeze-drying box that has been cooled to -40°C, freeze-dry at low temperature, press the stopper out of the box, and roll the cap.

[0036] Preferably, the excip...

Embodiment 3

[0041] Example 3: Preparation of ranitidine hydrochloride freeze-dried powder injection

[0042] Prescription: in parts by weight, 1 part of ranitidine hydrochloride crystalline compound prepared in Example 1, 11 parts of trehalose.

[0043] Preparation method: take the prescribed amount of ranitidine hydrochloride compound, stir and dissolve it with water for injection, add the prescribed amount of excipients, adjust the pH value to 6.0-8.0, then stir until the pH remains constant, then add water for injection to the volume of the solution It is 100 times the weight of ranitidine hydrochloride, then coarsely filtered with activated carbon, sterilized and filtered through 1.0 μm, 0.45 μm, and 0.22 μm microporous membranes in turn, and filtered into a sterile room. Pack it, press half the stopper, put it into a freeze-drying box that has been cooled to -40°C, freeze-dry at low temperature, press the stopper out of the box, and roll the cap.

[0044] Preferably, the excipient...

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Abstract

The invention relates to a ranitidine hydrochloride composition freeze-dried powder injection for treating stomach illness and belongs to the technical field of medicine. The composition freeze-dried powder injection is prepared from ranitidine hydrochloride and an excipient. The excipient is mycose, the ranitidine hydrochloride is a new crystal form compound, and is ranitidine hydrochloride different from what is reported in the prior art by an X ray power diffraction pattern as shown in picuture 1 by using Cu-Kalpha ray measurement, through test, the new crystal form compound is high in purity, good in mobility and stability, low in impurity content and safe and reliable in clinical use, and does not easily absorb humidity, and the freeze-dried powder injection prepared by the new crystal form compound is good in stability after being matched with a solvent, extremely low in insoluble particle content and very suitable for clinical use.

Description

technical field [0001] The invention belongs to the technical field of medicine, and relates to a drug ranitidine hydrochloride composition freeze-dried powder injection for treating stomach diseases. Background technique [0002] Ranitidine, like cimetidine, is currently the most widely used drug for the treatment of ulcer disease. Developed by the British Glaxo (glaxo) company. It was synthesized by British Price in 1976, and its pharmacology was clarified by Bradshaw in 1979. In 1980, Berstad reported that it was effective for duodenal ulcer. Apps in hundreds of countries. my country was produced by Shanghai Sixth Pharmaceutical Factory in 1985. [0003] Ranitidine is a selective H2 receptor antagonist, which can effectively inhibit the gastric acid secretion caused by histamine, pentagastrin and food stimulation, reduce the activity of gastric acid and gastric enzymes, but has no effect on gastrin and The secretion of sex hormones was not affected. The effect is 5-8...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/341A61K9/19A61P1/04C07D307/52
Inventor 刘学键
Owner QINGDAO HUAZHICAO PHARMA CO LTD
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