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Sodium hyaluronate injection sterilization method for guaranteeing aseptic packaging

A technology of sodium hyaluronate and sterilization methods, applied in heating and other directions, can solve the problems of destroying the airtightness of aseptic packaging, burst bottles, drug contamination and long bacteria, and achieve the effect of avoiding syringe bursting and less degradation

Inactive Publication Date: 2012-06-13
SHANGHAI JINGFENG PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] 1. During the sterilization process, the pressure in the inner chamber of the sterilizer is lower than the expansion force of the liquid medicine itself, and the bottle bursts
[0008] 2. The rubber stopper and protective cap are prone to displacement during the sterilization process, which destroys the airtightness of the aseptic packaging, and there is a risk of drug contamination and bacterial growth in the later product storage

Method used

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  • Sodium hyaluronate injection sterilization method for guaranteeing aseptic packaging
  • Sodium hyaluronate injection sterilization method for guaranteeing aseptic packaging

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0018] Take 200 bottles of 2.5ml:25mg sodium hyaluronate injection, put them on the shelf in the steam-air sterilization cabinet, set the sterilization temperature to 121℃, sterilize for 10 minutes, and test the sodium hyaluronate solution under these conditions The swelling force value is 0.12MPa, the internal chamber pressure parameter in the back pressure program of the sterilization cabinet is set to 0.16MPa, and the same batch of 200 sodium hyaluronate injections is taken for automatic control sterilization.

Embodiment 2

[0020] Take 200 bottles of 0.5ml:7mg sodium hyaluronate injection, put them on the shelf in the steam-air sterilization cabinet, set the sterilization temperature to 123℃ and sterilize for 10 minutes, and test the sodium hyaluronate solution under these conditions The expansion force value is 0.14MPa, the internal chamber pressure parameter in the back pressure program of the sterilizer is set to 0.19MPa, and another 200 pieces of sodium hyaluronate injection from the same batch are taken for automatic control sterilization.

Embodiment 3

[0022] Take 200 bottles of 2.5ml: 25mg sodium hyaluronate injection, put them on the shelf in the steam-air sterilization cabinet, set the sterilization temperature to 126℃ for 10 minutes, and test the sodium hyaluronate solution under these conditions The swelling force value is 0.13MPa, the internal chamber pressure parameter in the back pressure program of the sterilizer is set to 0.18MPa, and another 200 sodium hyaluronate injections of the same batch are taken for automatic control sterilization.

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Abstract

The invention relates to a sodium hyaluronate injection sterilization method for guaranteeing aseptic packaging, and the method comprises the following steps: firstly, determining sterilization parameters for the fewest degradation of sodium hyaluronates in different concentrations and specifications, and determining the temperature and the time when a certain sterilization effect is achieved; then, under the condition of the temperature and the acting time, obtaining expansive acting force curves of sodium hyaluronate injections (in different concentrations and specifications) in an aseptic packaging type prefillable syringe; setting the acting force value of each expansive acting force curve into a control program of sterilization equipment, thereby obtaining automatic back-pressing control programs for product sterilization in different concentrations and specifications; and in the process of sterilization, introducing a certain proportion of compressed air to carry out back pressing, so that the pressure of a sterilizing chamber is controlled so as to prevent aseptic packaging from being damaged due to the displacement of a rubber plug.

Description

Technical field: [0001] The invention relates to a method for sterilizing sodium hyaluronate injection with aseptic packaging. Background technique: [0002] Hyaluronic acid (HA for short) is composed of (1→3)-2-acetylamino-2-deoxy-β-D-glucose-(1→4)-O-β-D-glucuronic acid A linear polysaccharide composed of sugar repeating units, the molecular formula is (C 14 H 21 NO 11 )n, depending on the source of the tissue, the range of molecular weight is 2×10 5 ~7×10 6 , The number of disaccharide units is 300 to 11,000 pairs. [0003] [0004] Commercial hyaluronic acid is generally in the form of sodium salt, white fibrous or powdery solid, with strong hygroscopicity, soluble in water but insoluble in organic solvents. The macromolecular network structure of sodium hyaluronate passes through the H 2 O forms hydrogen bonds to bind a large amount of water, and has the functions of forming a variety of substrates in the body, regulating osmotic pressure, regulating the transport of macromole...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61L2/07
Inventor 马贤鹏张云汪洋陈亮
Owner SHANGHAI JINGFENG PHARMA
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