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Preparation method of roxatidine acetate hydrochloride for injection

A technology for roxatidine hydrochloride acetate and injection, which is applied in the field of preparation of roxatidine hydrochloride acetate for injection, can solve problems such as easy hydrolysis, short validity period, and impact on product quality, and achieve favorable preservation and quality Stable and quality-guaranteed effects

Inactive Publication Date: 2016-03-02
HARBIN PHARM GROUP SANJING PHARMACEUTICAL CO LTD
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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 it is prepared into a freeze-dried powder injection, if the type of excipients is not selected properly, or the amount of excipients is not selected properly, the quality of the product will be seriously affected.

Method used

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  • Preparation method of roxatidine acetate hydrochloride for injection
  • Preparation method of roxatidine acetate hydrochloride for injection
  • Preparation method of roxatidine acetate hydrochloride for injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0017] prescription:

[0018]

[0019] Process:

[0020] (1) Take by weighing roxatidine hydrochloride acetate and mix with glycine, mannitol, sodium sulfite, disodium edetate according to the prescription proportion, add 1000~2000ml of water for injection, stir to dissolve completely, add activated carbon, filter, Decarburization, to obtain system A;

[0021] (2) Add water for injection to the full amount in system A, and stir evenly to obtain system B;

[0022] (4) According to the requirements of aseptic operation in the 100-class laminar flow ultra-clean room, the system B is filtered by ultrafiltration, packed in controlled antibiotic bottles, added with a ventilated rubber stopper, pressed after freeze-drying, and added with an aluminum-plastic composite cover. have to.

Embodiment 2

[0024] prescription:

[0025]

[0026] Process:

[0027] (1) Take by weighing roxatidine hydrochloride acetate and mix with glycine, mannitol, sodium sulfite, disodium edetate according to the prescription proportion, add 1000~2000ml of water for injection, stir to dissolve completely, add activated carbon, filter, Decarburization, to obtain system A;

[0028] (2) Add water for injection to the full amount in system A, and stir evenly to obtain system B;

[0029] (4) According to the requirements of aseptic operation in the 100-class laminar flow ultra-clean room, the system B is filtered by ultrafiltration, packed in controlled antibiotic bottles, added with a ventilated rubber stopper, pressed after freeze-drying, and added with an aluminum-plastic composite cover. have to.

Embodiment 3

[0031] prescription:

[0032]

[0033] Process:

[0034] (1) Take by weighing roxatidine hydrochloride acetate and mix with glycine, mannitol, sodium sulfite, disodium edetate according to the prescription proportion, add 1000~2000ml of water for injection, stir to dissolve completely, add activated carbon, filter, Decarburization, to obtain system A;

[0035] (2) Add water for injection to the full amount in system A, and stir evenly to obtain system B;

[0036] (4) According to the requirements of aseptic operation in the 100-class laminar flow ultra-clean room, the system B is filtered by ultrafiltration, packed in controlled antibiotic bottles, added with a ventilated rubber stopper, pressed after freeze-drying, and added with an aluminum-plastic composite cover. have to.

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Abstract

The invention provides a preparation method of roxatidine acetate hydrochloride for injection. The preparation method includes: using roxatidine acetate hydrochloride as raw material and glycine, mannitol, sodium sulfite and edetate disodium as auxiliary materials to prepare liquid medicine, performing ultrafiltration on the liquid medicine, and freeze drying the liquid medicine to prepare a freeze-drying preparation. The prepared roxatidine acetate hydrochloride for injection is applicable to upper gastrointestinal hemorrhage caused by gastric ulcer, stress ulcer and hemorrhagic gastritis and preanesthetic medication. The preparation method has the advantages that the stability of the roxatidine acetate hydrochloride solution for injection is increased, the related substances of the roxatidine acetate hydrochloride for injection are evidently reduced during preparing, split charging and freeze drying, evident content change is avoided, and the prepared roxatidine acetate hydrochloride preparation for injection is good in stability during transportation and storage; the preparation method is simple in process, low in energy consumption and convenient to operate, and the roxatidine acetate hydrochloride preparation prepared by the method is good in quality, definite in curative effect and stable in 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 develop...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K31/4453A61K47/26A61K47/18A61K47/04A61P1/04A61P7/04A61J3/02
CPCA61K9/19A61J3/02A61K31/4453A61K47/02A61K47/183A61K47/26A61K2236/331A61K2236/51
Inventor 芦传有赵冬艳范宁房磊金炎俄丽丹
Owner HARBIN PHARM GROUP SANJING PHARMACEUTICAL CO LTD
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