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Zoledronic acid composition for injection and preparation method thereof

A technology of zoledronic acid and its composition, which is applied in the field of zoledronic acid composition and its preparation, can solve problems such as unresolved technical defects, and achieve avoidance of scrapping, good uniformity, elimination of quality differences between batches and decarbonization The effect of product quality

Active Publication Date: 2011-04-06
JIANGSU AOSAIKANG PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Chinese patent CN200510040094.6 discloses the inspection method of zoledronic acid raw material, lyophilization and its injection related substances and content, but does not solve the above-mentioned technical defects
Chinese patent CN200510038615.4 discloses a lyophilized preparation of bisphosphonic acid anti-bone pain drug zoledronic acid and its preparation method, which does not solve the above-mentioned technical defects

Method used

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  • Zoledronic acid composition for injection and preparation method thereof
  • Zoledronic acid composition for injection and preparation method thereof
  • Zoledronic acid composition for injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0066] Example 1 Preparation of zoledronic acid compositions for injection

[0067] prescription:

[0068] Zoledronic acid 80g

[0069] Sodium citrate 40g

[0070] Add water for injection to 20Kg

[0071] 1) Preparation of medicinal solution: Weigh zoledronic acid and citrate sodium salt and place in a preparation tank, add water for injection to 20Kg, stir to dissolve and mix evenly, and adjust the pH value of the solution to 4.5;

[0072] 2) Activated carbon finishing:

[0073] a. Weigh 1g of activated carbon, add 500g of water for injection, stir to disperse evenly, adjust the pH value of the solution to 4.5 with 1% sodium citrate solution, heat to 60°C and keep it warm for 30 minutes, and transport the activated carbon suspension while it is hot To titanium rod filter decarbonization;

[0074] B, then rinse the activated carbon collected by the titanium rod filter with water for injection until the pH value is greater than 5;

[0075] c. Use 0.1% ethylenediaminetetra...

Embodiment 2

[0080] Example 2 Preparation of zoledronic acid compositions for injection

[0081] prescription:

[0082] Zoledronic acid 80g

[0083] Sodium citrate 80g

[0084] Mannitol 1Kg

[0085] Add water for injection to 100Kg

[0086] 1) Preparation of medicinal solution: Weigh zoledronic acid, sodium citrate and mannitol and place in a preparation tank, add water for injection to 100Kg, stir to dissolve and mix evenly, and adjust the pH value of the solution to 5.0;

[0087] 2) Activated carbon finishing:

[0088] a. Weigh 5g of activated carbon, add 2.5Kg of water for injection, stir to disperse evenly, adjust the pH value of the solution to 5.0 with 1% sodium citrate solution, heat to 65°C and keep it warm for 30 minutes, and dissolve the activated carbon suspension while it is hot Transport to titanium rod filter for decarbonization;

[0089] B, then rinse the activated carbon collected by the titanium rod filter with water for injection until the pH value is greater than 5...

Embodiment 3

[0095] Example 3 Preparation of zoledronic acid compositions for injection

[0096] prescription:

[0097] Zoledronic acid 80g

[0098] Sodium citrate 160g

[0099] Lactose 500g

[0100] Add water for injection to 40Kg

[0101] 1) Preparation of medicinal solution: Weigh zoledronic acid, sodium citrate and lactose and place in a preparation tank, add water for injection to 40Kg, stir to dissolve and mix evenly, and adjust the pH value of the solution to 6.0;

[0102] 2) Activated carbon finishing:

[0103] a. Weigh 4g of activated carbon, add 2Kg of water for injection, stir to disperse evenly, adjust the pH value of the solution to 6.0 with 1% sodium citrate solution, heat to 70°C and keep it warm for 30 minutes, and transport the activated carbon suspension while it is hot To titanium rod filter decarbonization;

[0104] B, then rinse the activated carbon collected by the titanium rod filter with water for injection until the pH value is greater than 5;

[0105] c. Us...

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Abstract

The invention provides a zoledronic acid composition for injection. The zoledronic acid composition for injection is prepared by the following steps of: 1) preparing medicinal liquid, namely selecting zoledronic acid and trisodium citrate as raw materials according to the weight ratio of the zoledronic acid to the trisodium citrate of 1:0.5-2, weighing a proper amount of the raw materials and placing the raw materials into a preparation tank, adding water for injection until the weight of the solution is 250 to 1,250 times that of the zoledronic acid, stirring the solution to dissolve the raw materials and mixing the raw materials uniformly and adjusting the pH value of the solution to be 4.0 to 6.0; 2) performing active carbon finishing; 3) performing adsorption; 4) performing aseptic filtration and subpackaging; and 5) performing vacuum freeze drying to obtain the zoledronic acid composition for injection. By the zoledronic acid composition for injection and the preparation method thereof, for injection of which the clarity is influenced by active carbon greatly, such as the zoledronic acid and the like, the heat source, the clarity and insoluble particles of the product can meet the requirements of the injection.

Description

technical field [0001] The invention relates to a zoledronic acid composition for injection and a preparation method thereof, belonging to the technical field of medicine preparation. Background technique [0002] The chemical name of zoledronic acid is [1-hydroxy-2-(1-imidazolyl)ethylidene]diphosphate monohydrate. [0003] The structural formula is as follows: [0004] [0005] Molecular formula is C 5 h 10 N 2 o 7 P 2 ·H 2 O, molecular weight 290.1. [0006] Tumor bone metastasis is very common, 20% to 75% of advanced cancer patients have bone metastasis, especially breast cancer and prostate cancer patients, accounting for more than 80% of all bone metastasis patients. Tumor metastases to bone, accompanied by osteolytic bone destruction, with symptoms of bone pain, pathological fractures, spinal compression, and hypercalcemia. Clinical data show that the above-mentioned symptoms will appear once in an average of 3 to 4 months in breast cancer patients. Such b...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K31/675A61P19/08A61P35/00A61P3/14A61P19/10
Inventor 张建义叶东王孝雯
Owner JIANGSU AOSAIKANG PHARMA CO LTD
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