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Injection octreotide acetate lyophilized composition and preparation method thereof

A technology of octreotide acetate and composition, applied in the field of octreotide acetate freeze-dried composition for injection and preparation thereof, can solve the problems of difficult industrialization, microbial contamination, poor stability and the like, achieve easy industrial production, simple preparation process, high quality stable effect

Active Publication Date: 2014-07-23
南京易亨制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Since the Chinese Pharmacopoeia stipulates that no antibacterial agents can be added to intravenous injections, Novartis, the manufacturer of Sunning, improved the formula and used lactic acid and mannitol as auxiliary materials to obtain Octreotide Acetate Injection. It is required to keep away from light at 2-8°C, and it can only be stored for two weeks at room temperature. The stability is poor, which is not conducive to storage and transportation
[0005] CN101647773B discloses a kind of octreotide acetate injection, and inactive component has mannitol, Tween 80 and citric acid, adds Tween-80 and citric acid in prescription to improve solution stability, but the injection described in this invention It has not been terminally sterilized. Although there is a sterilizing and filtering process, there are hidden dangers of microbial contamination during liquid storage, and the product has not taken effective protective measures against oxidation.
However, the liposome preparation process is complicated, and there are not many products on the domestic market at present, the industrialization is difficult, and low temperature storage is required

Method used

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  • Injection octreotide acetate lyophilized composition and preparation method thereof
  • Injection octreotide acetate lyophilized composition and preparation method thereof
  • Injection octreotide acetate lyophilized composition and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0023]

[0024] Preparation Process:

[0025] Bottle washing, sterilizing and drying: the vials are first cleaned by an ultrasonic bottle washing machine, then sterilized and dried by a sterilizing dryer, and sent to the filling room for later use.

[0026] Butyl rubber stopper treatment: After the butyl rubber stopper is cleaned by a rubber stopper cleaning machine, it is sterilized by steam at 121°C for 30 minutes, and dried for later use.

[0027] Aluminum-plastic cover treatment: wash the aluminum-plastic cover with an aluminum cover washing machine, sterilize, dry, and take it out for use.

[0028] Preparation of the liquid medicine: Weigh the prescribed amount of octreotide acetate and trometamol into water for injection cooled to 15°C, stir to dissolve, add an appropriate amount of maleic acid, adjust the pH value of the liquid medicine to 4.5, circulate and filter, and send samples to test the semi-finished product For the content of the liquid medicine, the liquid...

Embodiment 2

[0032]

[0033] Preparation Process:

[0034] Bottle washing, sterilizing and drying: the vials are first cleaned by an ultrasonic bottle washing machine, then sterilized and dried by a sterilizing dryer, and sent to the filling room for later use.

[0035] Butyl rubber stopper treatment: After the butyl rubber stopper is cleaned by a rubber stopper cleaning machine, it is sterilized by steam at 121°C for 30 minutes, and dried for later use.

[0036] Aluminum-plastic cover treatment: wash the aluminum-plastic cover with an aluminum cover washing machine, sterilize, dry, and take it out for use.

[0037] Preparation of the liquid medicine: Weigh the prescribed amount of octreotide acetate and trometamol into the water for injection cooled to 20°C, stir to dissolve, add an appropriate amount of maleic acid, adjust the pH value of the liquid medicine to 5.0, circulate and filter, and send samples to test the semi-finished products For the content of the liquid medicine, the l...

Embodiment 3

[0041]

[0042] Preparation Process:

[0043] Bottle washing, sterilizing and drying: the vials are first cleaned by an ultrasonic bottle washing machine, then sterilized and dried by a sterilizing dryer, and sent to the filling room for later use.

[0044] Butyl rubber stopper treatment: After the butyl rubber stopper is cleaned by a rubber stopper cleaning machine, it is sterilized by steam at 121°C for 30 minutes, and dried for later use.

[0045] Aluminum-plastic cover treatment: wash the aluminum-plastic cover with an aluminum cover washing machine, sterilize, dry, and take it out for use.

[0046] Preparation of the liquid medicine: Weigh the prescribed amount of octreotide acetate and trometamol into the water for injection cooled to 15°C, stir to dissolve, add an appropriate amount of maleic acid, adjust the pH value of the liquid medicine to 4.5, circulate and filter, and send samples for testing For the content of the semi-finished product, the liquid with a cert...

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PUM

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Abstract

The invention discloses an injection octreotide acetate lyophilized composition and a preparation method thereof. The lyophilized composition comprises octreotide acetate, tromethamine and maleic acid. The preparation method comprises the following steps: weighing octreotide acetate and tromethamine, adding into injection water which is cooled to 10-20 DEG C, and stirring to dissolve; regulating the pH of the liquid medicine to be 4.0-5.0 with maleic acid, filtering, filling and lyophilizing. Compared with the prior art, the lyophilized composition is stable in quality, few in auxiliary varieties and simple in preparation process.

Description

technical field [0001] The invention belongs to the technical field of chemical preparations, and in particular relates to a freeze-dried composition of octreotide acetate for injection and a preparation method thereof. Background technique [0002] In 1982, the Swiss Sandoz Pharmaceutical Company (now Novartis Co.) synthesized a new generation of long-acting somatostatin analog octreotide acetate. It is a cyclic 8-peptide synthesized with the active fragment of ST as the backbone. The sequence of 4 amino acids determining biological activity in its molecular structure is the same as that of ST, and 6 amino acids in ST are removed. It can bind to ST receptors widely present in the central nervous system, pituitary and pancreatic β cells to produce biological effects, and inhibit growth hormone (GH), insulin, glucagon, and gastric acid secretion stronger than ST, specific Sex is also higher. At the same time, since the 1st and 4th L-amino acids are replaced by the correspon...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K38/08A61K47/18A61K47/12
Inventor 严白双
Owner 南京易亨制药有限公司
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