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Roxatidine acetate hydrochloride used for injection and preparation method thereof

A technology for roxatidine hydrochloride acetate and injection, which is applied in the field of preparation of roxatidine hydrochloride acetate for injection, can solve the problems of affecting product quality, instability to light, unfavorable storage, etc., and achieve the effect of metabolism in vivo Small, strong gastric acid secretion inhibitory effect, easy to store

Inactive Publication Date: 2011-04-20
哈药集团人民同泰医药股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] However, roxatidine hydrochloride acetate has the characteristics of being unstable to light and easy to be hydrolyzed. The products prepared by conventional methods are very easy to degrade and have a short validity period, which is not conducive to storage.
However, if the preparation of freeze-dried powder injections does not use excipients or the type of excipients, the dosage is inappropriate, and the freeze-drying curve is unreasonable, the product will shrink and discolor, which will seriously affect the quality of the product. At present, there is no such product in China. effective solution

Method used

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  • Roxatidine acetate hydrochloride used for injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0026] prescription:

[0027] Roxatidine Hydrochloride Acetate 75g

[0028] Glycine 65g

[0029] Add water for injection to 2000ml

[0030] Made 1000 pieces

[0031] Process:

[0032] (1) Weigh Roxatidine Hydrochloride Acetate and Glycine according to the prescription ratio and mix evenly, add 1500ml of water for injection therein, stir to dissolve completely, add activated carbon, stir for 10 minutes, filter, and decarbonize to obtain System A.

[0033] (2) Add 2 mol / L hydrochloric acid solution dropwise to A while stirring, and adjust the pH to 3.0-5.0 to obtain system B.

[0034] (3) Add water for injection to B to the full amount, and stir evenly to obtain system C.

[0035] (4) After the C semi-finished product passes the inspection, it is filtered through a 0.22 μm microporous membrane in a 100-class laminar flow ultra-clean room according to the aseptic operation requirements, and then packed into 7ml control antibiotic bottles with a ventilated rubber stopper.

...

Embodiment 2

[0038] prescription:

[0039] Roxatidine Hydrochloride Acetate 75g

[0040] Mannitol 65g

[0041] Add water for injection to 2000ml

[0042] Made 1000 pieces

[0043] Process:

[0044] (1) Weigh roxatidine hydrochloride acetate and mannitol according to the prescription ratio and mix evenly, add 1500ml of water for injection therein, stir to dissolve completely, add activated carbon, stir for 10 minutes, filter, and decarbonize to obtain system A.

[0045] (2) Add 2 mol / L hydrochloric acid solution dropwise to A while stirring, and adjust the pH to 3.0-5.0 to obtain system B.

[0046] (3) Add water for injection to B to the full amount, and stir evenly to obtain system C.

[0047] (4) After the C semi-finished product passes the inspection, it is filtered through a 0.22 μm microporous membrane in a 100-class laminar flow ultra-clean room according to the aseptic operation requirements, and then packed into 7ml control antibiotic bottles with a ventilated rubber stopper. ...

Embodiment 3

[0050] prescription:

[0051] Roxatidine Hydrochloride Acetate 75g

[0052] Glycine 75g

[0053] Add water for injection to 2000ml

[0054] Made 1000 pieces

[0055] Process:

[0056] (1) Weigh Roxatidine Hydrochloride Acetate and Glycine according to the prescription ratio and mix evenly, add 1500ml of water for injection therein, stir to dissolve completely, add activated carbon, stir for 10 minutes, filter, and decarbonize to obtain System A.

[0057] (2) Add 2 mol / L hydrochloric acid solution dropwise to A while stirring, and adjust the pH to 3.0-5.0 to obtain system B.

[0058] (3) Add water for injection to B to the full amount, and stir evenly to obtain system C.

[0059] (4) After the C semi-finished product passes the inspection, it is filtered through a 0.22 μm microporous membrane in a 100-class laminar flow ultra-clean room according to the aseptic operation requirements, and then packed into 7ml control antibiotic bottles with a ventilated rubber stopper.

[0...

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Abstract

The invention provides roxatidine acetate hydrochloride used for injection and a preparation method thereof. The roxatidine acetate hydrochloride is prepared by taking the roxatidine acetate hydrochloride as a raw material; adding glycine or mannitol as an excipient; and freezing and drying after preparing the raw material and the excipient into a liquid medicament. The prepared roxatidine acetate hydrochloride used for the injection is used for upper gastrointestinal hemorrhage caused by gastric ulcer, stress ulcer and hemorrhagic gastritis and preanesthetic medication. The product obtained by the method has good quality, exact curative effect and stable quality.

Description

technical field [0001] The invention relates to a preparation method of freeze-dried powder injection, in particular to a preparation method of roxatidine hydrochloride acetate for injection. The roxatidine hydrochloride acetate for injection prepared by the method is used for upper gastrointestinal bleeding caused by gastric ulcer, stress ulcer and hemorrhagic gastritis and administration before anesthesia. Background technique [0002] Digestive system disease is one of the common frequently-occurring diseases, among which peptic ulcer is the main one, which is mainly caused by smoking, drinking, emotional stress, and drug stimulation. According to the statistics of the World Health Organization (WHO), the incidence of peptic ulcer accounts for about More than 10% of the world's population. With the development of society and the accelerated pace of life, the incidence of gastrointestinal diseases is still increasing year by year. In response to this situation, the develo...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K31/4453A61K47/26A61K47/18A61P1/04A61P7/04A61J3/02
Inventor 范宁房磊金焱
Owner 哈药集团人民同泰医药股份有限公司
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