Preparation method for phosphate buffer solution

A phosphate buffer and buffer solution technology, which is applied in the direction of pharmaceutical formulations, medical preparations containing active ingredients, inorganic non-active ingredients, etc., can solve problems such as red blood cell atrophy, affect the efficacy of sodium hyaluronate, dehydration, etc., and shorten the service life , reduce clinical redness and pain, improve product quality

Inactive Publication Date: 2014-05-28
SHANGHAI JINGFENG PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

On the one hand, the drug is diluted, which affects the curative effect of sodium hyaluronate, on the other hand, it leads to red blood cell atrophy and severe dehydration

Method used

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  • Preparation method for phosphate buffer solution

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Experimental program
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Effect test

Embodiment 1

[0026] Add 60kg of water for injection into the liquid preparation tank, set the stirring frequency to 40HZ, start stirring, and the stirring speed is 100 rpm, weigh 480g of sodium chloride and add it to the PBS tank, stir while adding, and then add the , 15.0 g of disodium hydrogen phosphate and 1.8 g of sodium dihydrogen phosphate after 2 hours of dry heat treatment, stirred for 5 minutes, and 30 kg of phosphate buffer solution was sterilized and filtered through two series-connected filters of 0.2 μm in diameter Bacteria preparation tank, sampling inspection. Weigh 306g of dry and purified sterile sodium hyaluronate and slowly add it into the buffer solution. After dissolving evenly, the pre-filling solution is obtained. Take samples for testing and make three batches in succession. The batch numbers are 20130601, 20130602, and 20130603. The buffer solution of batch number 20130601 has an osmotic pressure of 274mOsmol / L, a pH of 7.5, and bacterial endotoxins less than 0.25E...

Embodiment 2

[0028] Add 60kg of water for injection into the liquid preparation tank, set the stirring frequency to 45HZ, start stirring, and the stirring speed is 125 rpm, weigh 495g of sodium chloride and add it to the PBS tank, stir while adding, and then add the 16.8 g of disodium hydrogen phosphate and 2.4 g of sodium dihydrogen phosphate after 2 hours of dry heat treatment were stirred for 8 minutes, and 30 kg of phosphate buffer solution was sterilized and filtered through two series-connected filters of 0.2 μm in diameter. Bacteria preparation tank, sampling inspection. Weigh 306g of dry and purified sterile sodium hyaluronate and slowly add it to the buffer solution. After dissolving evenly, the pre-filling solution is obtained. Samples are taken for testing and three batches are made in succession. The batch numbers are 20130604, 20130605, and 20130606. The buffer solution of batch number 20130604 has an osmotic pressure of 285mOsmol / L, a pH of 7.5, and bacterial endotoxins less ...

Embodiment 3

[0030] Add 60kg of water for injection into the liquid preparation tank, set the stirring frequency to 50HZ, start stirring, and the stirring speed is 150 rpm, weigh 510g of sodium chloride and add it to the PBS tank, stir while adding, and then add dihydrogen phosphate Sodium 18.0g and sodium dihydrogen phosphate 3.0g were stirred for 10 minutes, and 30kg of phosphate buffer solution was sterilized and filtered through two series-connected filters with a pore size of 0.2um, and poured into a sterile liquid preparation tank for sampling and inspection. Weigh 306g of dry and purified sterile sodium hyaluronate and slowly add it into the buffer solution. After dissolving evenly, the pre-filling solution is obtained. Samples are taken for testing, and three batches are made in succession. The batch numbers are 20130607, 20130608, and 20130609. The buffer solution of batch number 20130607 has an osmotic pressure of 295mOsmol / L, a pH of 7.5, and bacterial endotoxins less than 0.25EU...

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Abstract

The invention relates to a preparation method for a phosphate buffer solution with relatively low osmotic pressure. The preparation method comprises the following steps: firstly, adding water for injection into a liquid blending tank, and stirring; adding 0.003-0.005% of sodium dihydrogen phosphate, 0.025-0.030% of disodium hydrogen phosphate, 0.80-0.85% of sodium chloride while stirring is performed at a low rotation speed; closing a charging opening after addition, continuously stirring for 5-10 minutes, and after stirring is completed, and sterilizing and filtering the solution, so that the phosphate buffer solution with the relatively low osmotic pressure is obtained. The phosphate buffer solution prepared through the preparation method is sterile, and can be used as a solvent for drugs such as sodium hyaluronate injection, sodium hyaluronate gel and the like, which make a certain contribution to the osmotic pressure of solutions, so that adverse drug reactions caused by large osmotic pressure fluctuation can be greatly reduced and the product quality can be improved.

Description

Technical field: [0001] The invention relates to a preparation method of a phosphate buffer solution with a lower osmotic pressure. Background technique: [0002] Sodium hyaluronate is a white fibrous or powdery solid with strong hygroscopicity, soluble in water, insoluble in organic solvents, and can be used as an adjuvant drug for ophthalmic surgery and adjuvant treatment for deformed knee joint disease and shoulder periarthritis. It also has important physiological functions in tissue generation, wound healing, tumor invasion and regulation of cell function. Sodium hyaluronate is mainly used as a raw material for medical sodium hyaluronate gel for ophthalmic surgery and sodium hyaluronate injection for orthopedic medicine. [0003] The medical sodium hyaluronate gel is generally 0.5ml / branch or 1ml / branch, and the sodium hyaluronate injection is generally 2.0ml / branch or 2.5ml / branch. Sodium hyaluronate for medicine generally contains 0.14-0.15% sodium hyaluronate, and ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K47/02A61K31/728A61P27/02A61P19/02A61P17/02A61P35/00
Inventor 钱正祥金修建黄小音何文汇
Owner SHANGHAI JINGFENG PHARMA
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