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Method for sufficient irradiation sterilization for hollow capsule through low-dose electron beam

A technology of electron beam irradiation and hollow capsules, which is applied in irradiation, disinfection, etc., can solve the problems of electron beam weakening, uneven irradiation dose, and sterilization, so as to maintain uniformity, avoid capsule material deterioration, and fully sterilize Effect of bacteria prevention

Active Publication Date: 2019-09-10
广东强基药业有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0013] In the present invention, the electron beam irradiation method is used for the first time to sterilize hollow capsules in the process of production, storage, etc.; and it solves the problem of uneven electron beam intensity that may occur in the hollow capsule sterilization process, and the weakening of electron beams near the capsule packaging center makes it difficult to Problems with Effective Sterilization of Capsule Packaging Centers
[0014] Furthermore, this application aims at the problem of uneven irradiation doses at various parts of the sample, and realizes a method of uniformly and fully sterilizing medicinal hollow capsules at a lower irradiation dose

Method used

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  • Method for sufficient irradiation sterilization for hollow capsule through low-dose electron beam
  • Method for sufficient irradiation sterilization for hollow capsule through low-dose electron beam
  • Method for sufficient irradiation sterilization for hollow capsule through low-dose electron beam

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0027] Example 1 Single side irradiation 6.0kGy, mass thickness 2.26g / cm 2

[0028] Seal 6.5 kg of enteric-coated empty capsules (colon-coated capsules) to be sterilized with a sterile bag, and place them evenly in the packing box. The bottom area is: 60*48=2880cm 2 . At this time, the mass thickness of the capsule = 6.5*1000 / (60*48) = 2.26g / cm 2 .

[0029] Place the packing box containing the capsules on the sample pallet of the electron accelerator irradiation device, and one pallet is loaded with one box of samples. Arrange dosimeters at appropriate positions in the box. Used to determine the radiation dose received by each part. Given a single dose of 6kGy, other irradiation parameters are: current intensity: 1469uA, scanning current 3.06A, beam velocity: 104mm / s; pulse repetition frequency: 601pps.

[0030] The results are shown in Table 1; each part of the samples before and after irradiation were subjected to bacteriological investigation. The results are shown ...

Embodiment 2

[0041] Example 2 single side irradiation 3.0kGy, mass thickness 2.78g / cm 2

[0042] Seal 8 kg of enteric-coated hollow capsules to be sterilized with a sterile bag, and place them evenly in the packing box. The length and width of the packing box are 60x48x37cm (the middle position is 18.5cm high); =2880cm 2 . At this time, the mass thickness of the capsule = 8*1000 / (60*48) = 2.78g / cm 2 .

[0043] Place the packing box containing the capsules on the sample pallet of the electron accelerator irradiation device, and one pallet is loaded with one box of samples. Arrange dosimeters at appropriate positions in the box. Used to determine the radiation dose received by each part. The single dose is 3.0kGy, other irradiation parameters are: current intensity: 1469uA, scanning current 3.06A, beam velocity: 104mm / s; pulse repetition frequency: 601pps. The irradiation results are shown in Table 1; the samples before and after irradiation were subjected to bacteriological investiga...

Embodiment 3

[0045] Embodiment 3 double-sided irradiation: single dose 2.5kGy, mass thickness 2.08g / cm 2

[0046] Seal 6kg of enteric-coated empty capsules to be sterilized with a sterile bag, and place them evenly in the packing box. The length and width of the packing box are 60x48x37cm (18.5cm height in the middle); =2880cm 2 . At this time, the mass thickness of the capsule=6*1000 / (60*48)=2.08g / cm 2 .

[0047] Place the packing box containing the capsules on the sample pallet of the electron accelerator irradiation device, and one pallet is loaded with one box of samples. A single dose of 2.5kGy is given; after one irradiation, the packing box is turned upside down (making the bottom surface the surface) and irradiated once again with a dose of 2.5kGy. Other irradiation parameters are current intensity: 1469uA, scanning current 3.06A, beam velocity: 104mm / s; pulse repetition frequency: 601pps. Dosimeters are arranged at appropriate positions in the box. It is used to determine th...

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Abstract

The invention belongs to the field of sterilization for medical auxiliary materials and particularly provides a method for sterilization for a medical hollow capsule through electron beam irradiation.Under the condition of exerting the advantages of physical sterilization of an electron beam, the method further realizes even and sufficient sterilization for the medical hollow capsule under the condition of a low irradiation dose in order to solve the possible problem of an uneven irradiation dose of all parts of samples. On one hand, the situation can be avoided that since part of samples cannot receive an effective irradiation dose, bacterium residues exist; on the other hand, the problem can also be solved that the single use of increasing an irradiation dose may cause capsule materialdenaturation. According to the method, sufficient sterilization for the medical capsule and prevention of capsule material denaturation are both considered, and the uniformity of the capsule samples is maintained.

Description

technical field [0001] This application belongs to the field of sterilization of pharmaceutical excipients, and specifically proposes the application and method of using electron beam irradiation to sterilize medicinal hollow capsules; furthermore, it proposes a capsule sterilization method that can fully sterilize and ensure quality. bacteria method. Background technique [0002] Medicines are related to the health of the people. If the microbial limit of medicines exceeds the standard, it will easily cause adverse reactions in patients and affect the safety of medicines. Therefore, adequate sterilization of medicines is an aspect to ensure the quality of medicines. For a long time, the focus of research has been mainly on the sterilization of pharmaceutical raw materials and preparations themselves, while higher expectations have been placed on materials such as pharmaceutical excipients and packaging materials that are in direct contact with pharmaceuticals, such as hollo...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61L2/08
CPCA61L2/007A61L2202/21
Inventor 龚莉李煜龙许锐鹏李桂龙许舜金陈贵浩林燕玲许少燕陈桂歆
Owner 广东强基药业有限公司