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Production method of compound potassium hydrogen phosphate injection

A compound potassium hydrogen phosphate and potassium hydrogen phosphate technology, which is applied in the direction of drug combination, pharmaceutical formula, phosphorus compound active ingredients, etc., can solve the problems of long production cycle, reduction of crystal nuclei, high production cost, etc., and achieve easy operation and simple production process , the effect of high yield

Inactive Publication Date: 2017-07-21
NANJING ZENKOM PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

This method has the disadvantages of incomplete reduction of crystal nuclei, compound potassium hydrogen phosphate injection will still have a certain probability of precipitation during storage, and the injection will naturally cool down to room temperature and bottle hot, resulting in a long production cycle and high production costs.

Method used

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  • Production method of compound potassium hydrogen phosphate injection
  • Production method of compound potassium hydrogen phosphate injection
  • Production method of compound potassium hydrogen phosphate injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0021]

[0022] Production method: Weigh the prescribed amount of potassium dihydrogen phosphate and dipotassium hydrogen phosphate (tri-crystal water), add water for injection at 40°C, stir to dissolve completely; add activated carbon, stir to decolorize, then use 0.45um, 0.22um, 0.10 um titanium rod filtration, the fine filtrate is heated to 60°C-80°C and kept for 1 hour; the fine filtrate is filled into cleaned and qualified ampoules and sealed; sterilized at 121°C for 15 minutes, leak detection, light inspection, printing, packaging, and storage.

Embodiment 2

[0024]

[0025] Production method: Weigh the prescribed amount of potassium dihydrogen phosphate and dipotassium hydrogen phosphate (tri-crystal water), add water for injection at 40°C, stir to dissolve completely; add activated carbon, stir and decolorize, then use 0.45um and 0.10um titanium rods in turn Filtrate, heat the fine filtrate to 70°C-80°C and keep it warm for 1 hour; fill the fine filtrate into cleaned and qualified ampoules and melt seal; sterilize at 121°C for 15 minutes, leak detection, light inspection, printing, packaging, and storage.

Embodiment 3

[0027]

[0028] Production method: Weigh the prescribed amount of potassium dihydrogen phosphate and dipotassium hydrogen phosphate (tri-crystal water), add water for injection at 40°C, stir to dissolve completely; add activated carbon, stir to decolorize, then use 0.22um, 0.22um, 0.10 um titanium rod filtration, the fine filtrate is heated to 75 ℃ ~ 80 ℃ and kept for 1 hour; the fine filtrate is filled into cleaned and qualified ampoules and sealed; sterilized at 121 ℃ for 15 minutes, leak detection, light inspection, printing, packaging, and storage.

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PUM

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Abstract

The invention relates to a production method of a compound potassium hydrogen phosphate injection, belongs to the field of new drug manufacturing technologies and particularly relates to a production method of the compound potassium hydrogen phosphate injection. According to the method, a titanium rod of 0.1 microns is adopted to finely filter a compound potassium hydrogen phosphate injection coarse filtrate under the condition of 40 DEG C, the fine filtrate is heated to 60-80 DEG C, heat is preserved for 1 hour, and the compound potassium hydrogen phosphate injection is produced. By adopting the production method of the compound potassium hydrogen phosphate injection, no crystal also precipitates in a shock chilling environment or in a low-temperature storage environment, and the product quality and usage performance are ensured.

Description

technical field [0001] The invention belongs to the field of new technology for medicine manufacture, and in particular relates to a production method of compound potassium hydrogen phosphate injection. Background technique [0002] Composite potassium hydrogen phosphate injection, the specification is 2ml: 0.639gK2HPO4·3H2O and 0.4354gKH2PO4, English name: Composite Potassium Hydrogen Phosphate Injection, Chinese pinyin: FuheLinsuanqingjia Zhusheye, mainly used as a phosphorus supplement in complete parenteral nutrition therapy, Phosphorus supplements for patients who need to fast for more than 5 days such as moderate surgery or other trauma. This product can also be used for hypophosphatemia caused by certain diseases. Phosphorus participates in sugar phosphorylation in sugar metabolism, constitutes phospholipids in membrane components, and is one of the important components of intracellular RNA, DNA and many coenzymes. Phosphorus is also involved in energy storage conve...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K33/42A61K9/08A61P3/12
CPCA61K33/42A61K9/0019A61K9/08A61K2300/00
Inventor 徐卓业
Owner NANJING ZENKOM PHARMA