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Production process of zoledronic acid injection

A technology for the production of zoledronic acid, which is applied in the field of production technology for zoledronic acid injection, can solve the problems of unfavorable large-scale production and complicated procedures, and achieve the effects of high production efficiency, simple procedures and good stability

Inactive Publication Date: 2020-02-21
YANGTZE RIVER PHARM GRP SICHUAN HAIRONG PHARM CO LTD +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] There are some problems in the preparation method and production process of the existing zoledronic acid injection: in the prescription, in addition to adjusting the proportion of the original drug, in order to stabilize the injection, the degradation product of zoledronic acid imidazole acetic acid and / or imidazole ( CN201310709854.2) and replacing sodium citrate with sodium acetate (CN201510624755.3, CN201810355879.X), undoubtedly challenged the safety, effectiveness and bioequivalence of injections; in production, water vapor, liquid nitrogen The method of cooling and gamma-ray irradiation to prolong the shelf life of injection (CN201811570770.4) is a complex process that is not conducive to large-scale production

Method used

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  • Production process of zoledronic acid injection
  • Production process of zoledronic acid injection
  • Production process of zoledronic acid injection

Examples

Experimental program
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Effect test

Embodiment 1

[0030] The production process one of embodiment 1 zoledronic acid injection:

[0031] (1) Preparation process

[0032] Concentrated formulation: Inject 40% of the prescribed amount of fresh water for injection into the concentrated formulation tank, wet the weighed mannitol with fresh water for injection, transfer it to the concentrated formulation tank, stir until visually dissolved, and press 0.03 of the total volume % (W / V) Add medicinal charcoal, set the volume to the concentrated volume (60% of the prescription volume), stir at 70°C for 25 minutes, decarbonize in circulation for 15 minutes, and cool the liquid to 50°C. Pour all the liquid medicine into the dilute tank. Rinse the concentrated preparation tank with 150L water for injection and put it into the thin preparation tank.

[0033] Dilute preparation: Pour zoledronic acid and sodium citrate into a stainless steel barrel, stir and dissolve with fresh water for injection (less than 40% of the prescription volume). ...

Embodiment 2

[0042] The production process two of embodiment 2 zoledronic acid injection:

[0043] (1) Preparation process

[0044] Concentrated formulation: Inject 40% of the prescribed amount of fresh water for injection into the concentrated formulation tank, wet the weighed mannitol with fresh water for injection, transfer it to the concentrated formulation tank, stir until visually dissolved, and press 0.03 of the total volume % (W / V) Add medicinal charcoal, set the volume to the concentrated volume (60% of the prescription volume), stir at 75°C for 20min, decarbonize in circulation for 20min, and cool the liquid to 55°C. Pour all the liquid medicine into the dilute tank. Rinse the concentrated preparation tank with 150L water for injection and put it into the thin preparation tank.

[0045] Dilute preparation: Pour zoledronic acid and sodium citrate into a stainless steel barrel, stir and dissolve with fresh water for injection (less than 40% of the prescription volume). Transfer ...

Embodiment 3

[0054] Embodiment 3 Production process three of zoledronic acid injection:

[0055] (1) Preparation process

[0056] Concentrated formulation: Inject 40% of the prescribed amount of fresh water for injection into the concentrated formulation tank, wet the weighed mannitol with fresh water for injection, transfer it to the concentrated formulation tank, stir until visually dissolved, and press 0.03 of the total volume % (W / V) Add medicinal charcoal, set the volume to the concentrated volume (60% of the prescription volume), stir at 80°C for 15 minutes, decarbonize in circulation for 25 minutes, and cool the liquid to 60°C. Pour all the liquid medicine into the dilute tank. Rinse the concentrated preparation tank with 150L water for injection and put it into the thin preparation tank.

[0057] Dilute preparation: Pour zoledronic acid and sodium citrate into a stainless steel barrel, stir and dissolve with fresh water for injection (less than 40% of the prescription volume). T...

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Abstract

The invention provides a production process of a zoledronic acid injection. The production process comprises the following steps of (1) preparing an osmotic pressure regulating agent solution: dissolving a prescription amount of an osmotic pressure regulating agent by water for injection, adding medicinal charcoal, and performing decarbonization to obtain the osmotic pressure regulating agent solution; (2) preparing a zoledronic acid and pH regulating agent solution: dissolving a prescription amount of zoledronic acid and a pH regulating agent by the water for injection to obtain the zoledronic acid and pH regulating agent solution; (3) preparing a prescription solution: uniformly mixing the obtained osmotic pressure regulating agent solution and the zoledronic acid and pH regulating agentsolution, dissolving the solution to a constant volume of a prescription volume by using the water for injection, and performing filtration to obtain the zoledronic acid prescription solution with apH value being 6.2 to 6.8; and (4) performing sterilization and packaging: taking the zoledronic acid prescription solution obtained in the step (3), and performing sterilization and packaging to obtain the zoledronic acid injection. The production process of the zoledronic acid injection provided by the invention has the advantages that the stability is high; work procedures are simple; the production efficiency is high; the quality is controllable; and the industrialization can be easily realized.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and in particular relates to a production process of zoledronic acid injection. Background technique [0002] Osteoporosis (osteoporosis), as the most common metabolic bone disease, has more than 200 million people in the world, and has been recognized as the second largest health killer after cardiovascular disease. Osteoporosis is generally divided into two types: primary and secondary. Among them, primary osteoporosis is more common, and it is further divided into postmenopausal osteoporosis (type I) and senile osteoporosis. syndrome (Type II). At present, the treatment drugs for osteoporosis at home and abroad mainly include bone resorption inhibitors for primary type I and bone formation accelerators for primary type II. [0003] According to IMS MIDAS statistics, the entire osteoporosis drug market is still dominated by bisphosphonates. Bisphosphonates, as a bone resorption inh...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K31/675A61K47/26A61P19/10
CPCA61K9/0019A61K9/08A61K31/675A61K47/26A61P19/10
Inventor 周锦刘艳霞
Owner YANGTZE RIVER PHARM GRP SICHUAN HAIRONG PHARM CO LTD
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