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Injection prescription of freeze-drying powder of ranitidine hydrochloric acid and preparation method

A technology of ranitidine hydrochloride and freeze-dried powder injection, which is applied in freeze-dried delivery, powder delivery, pharmaceutical formulation and other directions, can solve the complex production process of tablets and capsules, inconvenient transportation of injections, and high requirements for storage conditions, etc. problems, to achieve the effect of avoiding decomposition and deterioration, easy quality control, and simple preparation process

Inactive Publication Date: 2006-07-05
FUJIAN MINDONG REJUVENATION PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

At present, ranitidine hydrochloride is mainly used in three dosage forms of injection, tablet and capsule. Among them, the injection is inconvenient to transport, requires high storage conditions, and has unstable quality; while the manufacturing process of tablets and capsules is relatively complicated. higher cost

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0012] (1) Prescription

[0013] Ranitidine Hydrochloride 100g

[0014] Mannitol 100g

[0015] Disodium EDTA 0.2g

[0016] Sodium bisulfite 2g

[0017] Add water for injection to 2000ml

[0018] 1000 bottles

[0019] (2) Process

[0020] Solution preparation: Weigh mannitol, edetate disodium and sodium bisulfite according to the prescription amount, add water for injection to dissolve, then add the prescription amount of ranitidine hydrochloride, add water for injection to the full amount, slightly heat and stir to dissolve. Add 1.0 mol / L hydrochloric acid solution or 1.0 mol / L sodium hydroxide solution to adjust the pH value to 7.0, then add 0.5-2 g / L medicinal solution volume of charcoal for needles, stir and adsorb at room temperature for about 30 minutes, filter to remove charcoal, The filtrate is coarsely filtered with a 0.45um microporous membrane, and then finely filtered with a 0.22um microporous membrane to sterilize. Take the solution afte...

Embodiment 2

[0024] (1) Prescription

[0025] Ranitidine Hydrochloride 50g

[0026] Mannitol 50g

[0027] Sodium bisulfite 2g

[0028] Add water for injection to 1000ml

[0029] 1000 bottles

[0030] (2) Process

[0031] Solution preparation: Weigh mannitol and sodium bisulfite according to the prescription amount, add water for injection to dissolve, then add ranitidine hydrochloride in the prescription amount, add water for injection to the full amount, slightly heat and stir to dissolve. Add 1.0 mol / L hydrochloric acid solution or 1.0 mol / L sodium hydroxide solution to adjust the pH value to 7.0, then add / add 0.5-2 g / L medicinal liquid volume of charcoal for needles, stir and adsorb at room temperature for about 30 minutes, filter to remove Charcoal, the filtrate is coarsely filtered with a 0.45um microporous membrane, and then finely filtered with a 0.22um microporous membrane to sterilize. Take the solution after fine filtration to measure the content, and calcul...

Embodiment 3

[0035] (1) Prescription

[0036] Ranitidine Hydrochloride 50g

[0037] Sorbitol 100g

[0038] Add water for injection to 1000ml

[0039] 1000 bottles

[0040] (2) Process

[0041] Solution preparation: Weigh sorbitol according to the prescription amount, add water for injection to dissolve, then add ranitidine hydrochloride in the prescription amount, add water for injection to the full amount, slightly heat and stir to dissolve. Add 1.0 mol / L hydrochloric acid solution or 1.0 mol / L sodium hydroxide solution to adjust the pH value to 7.0, then add 0.5-2 g / L medicinal solution volume of charcoal for needles, stir and adsorb at room temperature for about 30 minutes, filter to remove charcoal, The filtrate is coarsely filtered with a 0.45um microporous membrane, and then finely filtered with a 0.22um microporous membrane to sterilize. Take the solution after fine filtration to measure the content, and calculate the filling volume.

[0042] Freeze-drying: Adj...

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PUM

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Abstract

A freeze-dried powder injection of ranitidine hydrochloride is proportionally prepared from ranitidine hydrochloride, freeze-drying supporting agent, stabilizer and pH regulator through proportionally dissolving the active component in the water for injection while stirring, regulating pH value until it becomes neutral, adding the carbon for injection, stirring, filtering for removing carbon, filtering with 0.45-micron micropore film and then with 0.22-micron micropore film, bottling, freeze-drying, and vacuum sealing.

Description

technical field [0001] The invention relates to a prescription and a preparation method of ranitidine hydrochloride freeze-dried powder injection. Background technique [0002] Ranitidine hydrochloride is extremely unstable when encountering heat, humidity and air, and the product is easily oxidized and easily decomposes and deteriorates during high heat. At present, ranitidine hydrochloride is mainly used in three dosage forms of injection, tablet and capsule. Among them, the injection is inconvenient to transport, requires high storage conditions, and unstable in quality; while the manufacturing process of tablets and capsules is more complicated. higher cost. Contents of the invention [0003] The object of the invention is to provide a ranitidine hydrochloride freeze-dried powder injection with stable quality, no pollution, convenient operation, storage and transportation and a preparation method. [0004] Ranitidine hydrochloride freeze-dried powder injection prescr...

Claims

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Application Information

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IPC IPC(8): A61K31/341A61K9/19A61P1/04
Inventor 陶岩弟金福冬
Owner FUJIAN MINDONG REJUVENATION PHARMA
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