Ranitidine hydrochloride freeze-dried powder injection compound for treatment of digestive system diseases

A technology for ranitidine hydrochloride and digestive system diseases, applied in the field of medicine, can solve the problems of tissue hypoxia, high production cost of freeze-dried powder injection, poor quality of finished products, etc., and achieve small changes in the number of insoluble particles and a small number of insoluble particles , Solve the effect of extremely deliquescent

Inactive Publication Date: 2015-08-12
苗怡文
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  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] Both of the above two patents provide ranitidine hydrochloride freeze-dried powder injection and its preparation method, but due to the instability of ranitidine hydrochloride in aqueous solution, discoloration will also occur during the preparation of liquid medicine and freeze-drying process, resulting in The quality of the finished product is poor, and the production cost of freeze-dried powder injection is high, and the environmental requirements are also high
At the same time, it was found through experiments that the number of insoluble particles in the preparation was not very optimistic
Insoluble particles in intravenous infusion can cause harm to the human body. For example, larger insoluble particles can cause local circulation disorders and cause vascular embolism; too many particles can cause local blockage and insufficient blood supply, and further lead to tissue hypoxia and edema. And phlebitis, can also cause granuloma, allergic reaction, pyrogen-like reaction, etc., all of which can cause harm to the human body
[0008] Based on this, the inventors started from the crude drug ranitidine hydrochloride, and through a large number of experimental studies, a new crystal compound of ranitidine hydrochloride was prepared. The freeze-dried powder injection prepared by the new crystal form compound of ranitidine hydrochloride Compared with the ranitidine hydrochloride freeze-dried powder injection of the prior art, it not only solves the problems of ranitidine hydrochloride's easy deliquescence, moisture absorption, discoloration, and poor stability, but also has simple components. The number of insoluble particles is small, and the number of insoluble particles changes little within 4 hours after compatibility

Method used

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  • Ranitidine hydrochloride freeze-dried powder injection compound for treatment of digestive system diseases
  • Ranitidine hydrochloride freeze-dried powder injection compound for treatment of digestive system diseases
  • Ranitidine hydrochloride freeze-dried powder injection compound for treatment of digestive system diseases

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0027] Example 1: Preparation of Ranitidine Hydrochloride Crystal

[0028] (1) Add the crude ranitidine hydrochloride to a mixed solution of methanol, carbon tetrachloride and dichloromethane whose volume is 7 times the weight of ranitidine hydrochloride. The volume ratio is 4.5:2.5:1, the temperature is raised to 35°C, and it is stirred until it is completely dissolved;

[0029] (2) Under a sound field with a frequency of 25KHz and an output power of 45W, add a mixed solution of acetone, ethanol and chloroform with a volume of 8 times the weight of ranitidine hydrochloride while stirring. The volume ratio of acetone, ethanol and chloroform is 3.5 :1:1, the stirring speed is 250 rpm;

[0030] (3) After adding the mixed solution of acetone, ethanol and chloroform, in a sound field with a frequency of 30KHz and an output power of 20W, the temperature is reduced to -2°C at 12°C / hour, the crystals are grown for 3 hours, washed, and vacuum dried to obtain Ranitidine hydrochloride compo...

Embodiment 2

[0032] Example 2: Preparation of Ranitidine Hydrochloride Lyophilized Powder Injection:

[0033] Prescription: in parts by weight: 1 part of the ranitidine hydrochloride crystal compound prepared in Example 1 and 1.6 parts of low molecular dextran.

[0034] Take the ranitidine hydrochloride compound of the present invention, stir and dissolve it with water for injection, add a prescription amount of low molecular dextran, adjust the pH to 5.5-6.5, and then stir until the pH does not change, then add water for injection until the volume of the solution is hydrochloric acid 100 times the weight of ranitidine, then coarsely filter with activated carbon, sterilize and filter through 1.0μm, 0.45μm, 0.22μm microporous membranes in sequence, filter into a sterile room, measure the pH and content and then fill it, Press a half plug, put it in a freeze-drying box that has been cooled to -45°C, freeze-dry at low temperature, press the plug out of the box, and roll the lid.

[0035] The freez...

Embodiment 3

[0036] Example 3: Preparation of Ranitidine Hydrochloride Lyophilized Powder Injection:

[0037] Prescription: in parts by weight: 1 part of the ranitidine hydrochloride crystal compound prepared in Example 1 and 0.8 parts of low molecular dextran.

[0038] Take the ranitidine hydrochloride compound of the present invention, stir and dissolve it with water for injection, add a prescription amount of low molecular dextran, adjust the pH to 5.5-6.5, and then stir until the pH does not change, then add water for injection until the volume of the solution is hydrochloric acid 100 times the weight of ranitidine, then coarsely filter with activated carbon, sterilize and filter through 1.0μm, 0.45μm, 0.22μm microporous membranes in sequence, filter into a sterile room, measure the pH and content and then fill it, Press a half plug, put it in a freeze-drying box that has been cooled to -45°C, freeze-dry at low temperature, press the plug out of the box, and roll the lid.

[0039] The freez...

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Abstract

The invention belongs to the technical field of medicament and discloses a ranitidine hydrochloride freeze-dried powder injection compound for treatment of digestive system diseases. The ranitidine hydrochloride freeze-dried powder injection compound is composed of ranitidine hydrochloride and an excipient, wherein low-molecular-weight dextran serves as the excipient, the ranitidine hydrochloride is a novel crystal compound and different from ranitidine hydrochloride in the prior art, and an X-ray powder diffraction pattern of the ranitidine hydrochloride is obtained by Cu-K alpha ray measurement and shown as a diagram 1. According to experiment results, compared with freeze-dried powder injections prepared from the ranitidine hydrochloride in the prior art, freeze-dried powder injections prepared from the ranitidine hydrochloride which is the novel crystal compound have the advantages that the problems of proneness to deliquescence, moisture absorption and discoloration and poor stability of the ranitidine hydrochloride are solved, component simplicity is realized, insoluble particles are less after the ranitidine hydrochloride freeze-dried powder injection is compatibly used with four injections, and insoluble particle amount changes slightly in 4h after compatible application.

Description

technical field [0001] The invention belongs to the technical field of medicines and relates to a medicine for treating diseases of the digestive system, in particular to a ranitidine hydrochloride freeze-dried powder injection composition. 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 hormo...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/341C07D307/52A61P1/04A61K9/19A61K47/26
Inventor 刘学键
Owner 苗怡文
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