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Parecoxib sodium freeze-dried powder injection and preparation method thereof

A technology of parecoxib sodium jelly and parecoxib sodium, which is applied in the field of parecoxib sodium freeze-dried powder injection, can solve the problems of large impact on the final product, many ice crystals in appearance, low solubility and the like, and achieves good Chemical stability, good reconstitution properties, and uniform solution clarification

Active Publication Date: 2015-07-15
NANJING SANHOME PHARMACEUTICAL CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] However, parecoxib sodium will be partially converted into valdecoxib with very low solubility in water, so parecoxib sodium is not suitable for developing as water for injection, but for making freeze-dried powder injection
However, the preparation process of freeze-dried powder injection is relatively complicated, and the formula and process have a greater impact on the final product. Sometimes the freeze-dried product may have many problems such as collapse, shrinkage, and more ice crystals on the appearance. It may change due to physical and chemical effects during the freeze-drying process, resulting in unnecessary impurities and resulting in product failure, etc.

Method used

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  • Parecoxib sodium freeze-dried powder injection and preparation method thereof
  • Parecoxib sodium freeze-dried powder injection and preparation method thereof
  • Parecoxib sodium freeze-dried powder injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0036] This example investigates the chemical stability of freeze-dried powder prepared with different excipients, and the content of valdecoxib is used as the index of chemical stability.

[0037] Table 1: Prescription

[0038]

[0039]

[0040] Step a dosing: Dissolve the disodium hydrogen phosphate dodecahydrate in Table 1 and the corresponding excipients of each prescription in an appropriate volume of water for injection, and if necessary, dissolve the obtained solution with 1M phosphoric acid solution or 1N sodium hydroxide solution. Adjust the pH of the solution to about 8.0-9.0, add the prescribed amount of parecoxib sodium, measure the pH, and if necessary, adjust the pH of the resulting solution to about 8.0-9.0 with 1M phosphoric acid solution or 1N sodium hydroxide solution , add water, and adjust the volume of the solution to the target volume to form a solution for lyophilization.

[0041] Step b decolorization: add the prescribed amount of activated carbo...

Embodiment 2

[0051] This example investigates the influence of the excipient sodium chloride in the freeze-dried powder injection of parecoxib sodium on the appearance and stability of the powder injection.

[0052] Table 3 Prescription

[0053]

[0054] Step a dosing: Dissolve disodium hydrogen phosphate dodecahydrate and sodium chloride corresponding to each prescription in an appropriate volume of water for injection. After completely dissolving, measure the pH. If necessary, use 1M phosphoric acid solution or 1N sodium hydroxide Solution Adjust the pH of the obtained solution to 8.0-9.0, add parecoxib sodium to dissolve in the solution, measure the pH, if necessary, adjust the pH of the obtained solution to 8.0-9.0 with 1M phosphoric acid solution or 1N sodium hydroxide solution, Water for injection was added to adjust the volume of the solution to the target volume to form a solution for lyophilization.

[0055] The method of step b and step c of Example 1 was used to prepare pare...

Embodiment 3

[0066] This example investigates the effect of the concentration of the buffering agent in the freeze-dried powder injection of parecoxib sodium on the pH of the powder injection.

[0067] Table 6: Prescription

[0068]

[0069] Dissolve disodium hydrogen phosphate dodecahydrate and sodium chloride in an appropriate volume of water for injection. After completely dissolving, adjust the pH of the resulting solution to 8.0-9.0 with 1M phosphoric acid solution or 1N sodium hydroxide solution. Parecoxib Dissolve sodium in this solution, measure the pH, if necessary, adjust the pH of the resulting solution to 8.0-9.0 with 1M phosphoric acid solution or 1N sodium hydroxide solution, add water, adjust the solution volume to the target volume, and form a solution. The method of step b and step c of Example 1 was used to prepare parecoxib sodium freeze-dried powder injection. The influence of the buffering agent in the freeze-dried powder injection of parecoxib sodium on pH and st...

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Abstract

The invention belongs to the field of pharmaceutical preparation, and in particular, relates to a parecoxib sodium freeze-dried powder injection containing sodium chloride and a preparation method thereof. The parecoxib sodium freeze-dried powder injection for injection has the advantages of uniform color and luster, smooth surface, no dusting and wall sticking phenomena, no collapse and no crimping, has the most significant effects in good stability, re-dissolution after being placed for a long period of time and quite little valdecoxib conversion amount, and ensures the product injection safety.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, in particular to a parecoxib sodium freeze-dried powder injection containing sodium chloride and a preparation method of the freeze-dried powder injection. Background technique [0002] Parecoxib sodium is the prodrug of valdecoxib. It is a cyclooxygenase-2 (COX-2) specific inhibitor developed by Pharmacia Company. It has definite analgesic effect and its chemical name is N- [[4-(5-Methyl-3-phenyl-4-isoxazolyl)phenyl]sulfonyl]propionamide sodium salt, the structure is shown in formula A. It can be quickly distributed throughout the body in the body, and is suitable for development as an injection preparation with rapid onset of action. It is mainly used in the treatment of acute postoperative pain in clinical practice. [0003] [0004] However, parecoxib sodium will be partially converted into valdecoxib with very low solubility in water, so parecoxib sodium is not suitable for dev...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K31/42A61K47/04A61P29/00
Inventor 王勇杜爽张迪张仓
Owner NANJING SANHOME PHARMACEUTICAL CO LTD
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