Newly packed naloxone hydrochloride injection and its producing method

A technology of naloxone hydrochloride and its production method, which is applied in the fields of pharmaceutical formulations, anti-toxins, antipyretics, etc., can solve the problem of poor chemical and thermal stability and the ability to withstand severe temperature changes, and that grade B materials are not suitable , poor material quality and other issues, to reduce the incidence of debris, avoid bacterial and debris pollution, and reduce the effect of operating steps

Inactive Publication Date: 2006-03-22
BEIJING KAWIN TECH SHARE HLDG
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] (1) High breaking rate: the breaking rate is as high as 10% during the filling process;
[0005] (2) The quality of the material is poor: the material of the internationally used ampoule glass is the international neutral class I glass (that is, the domestically referred to as Class A material), while the material of the domestic ampoule glass is the domestic neutral glass (commonly referred to as the second class material). grade material), while the chemical stability and thermal stability of grade B material and the ability to withstand severe temperature changes are worse than grade A material.
Since the pH value of naloxone hydrochloride injection is 3.0-4.0, the packaging material is required to be acid-resistant and not chemically react with the liquid medicine, and grade B materials are not suitable for this requirement;
[0006] (3) Fragility: (a) Although the rate of using fragile ampoules in China has increased, it is still reported from time to time that medical staff are scratched by ampoule fragments; There are even reports of death, and data show that when an ampoule is broken, more than 20,000 particles larger than 0.5 microns can be inhaled; A headache for all three parties

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0041] In this example, the stability of the finished product was tested for the naloxone hydrochloride injection prepared according to the method of the present invention.

[0042] According to the Chinese Pharmacopoeia 2000 Edition, Appendix XIX C "Guiding Principles of Drug Stability Test", combined with the quality standards of this product, the key investigation items of the stability test are determined as: appearance color, content, pH value, clarity and related substances.

[0043] accelerated test

[0044] Take three batches of developed naloxone hydrochloride injection (batch numbers: 031001, 031002, 031003) each about 600 bottles, according to commercially available packaging, put 40 ℃ ± 2 ℃, relative humidity 75% ± 5% incubator to investigate 6 Month, samples were taken in January, February, March, and June respectively, and investigated according to the key inspection items of the stability test, and the data were compared with the data in 0 month. The inspection...

Embodiment 2

[0056] In this embodiment, the number of insoluble particles in the naloxone hydrochloride injection prepared according to the method of the present invention is tested.

[0057] After testing, in the naloxone hydrochloride injection, there are less than 50 particles of 10 μm or more, and less than 5 particles of 25 μm or more.

[0058]According to the provisions of the 2005 edition of the "Chinese Pharmacopoeia", the standard for insoluble particles is that each container of the test product must contain no more than 6,000 particles of 10 μm or more, and no more than 600 particles of 25 μm or more.

[0059] It can be seen that the number of insoluble particles in the naloxone hydrochloride injection prepared according to the method of the present invention is significantly less than the regulation of "Chinese Pharmacopoeia", and the product quality is obviously better than the regulation of "Chinese Pharmacopoeia".

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Abstract

The process of producing naloxone hydrochloride injection in new package includes the following steps: preparing naloxone hydrochloride injection intermediate; bacteria-free filtering the intermediate to obtain filtrate; bacteria-free packing the filtrate in Schering bottle; and sterilizing with flowing steam. While bacteria-free filtering, the insoluble particles in the medicine liquid are also eliminated, and this can greatly reduce the phlebitis attacking probability. The product is safe and reliable.

Description

technical field [0001] The present invention relates to medicinal injection and production method thereof, more specifically, relate to a kind of newly packaged naloxone hydrochloride injection and production method thereof. Background technique [0002] Naloxone hydrochloride is an antipyretic and analgesic and non-steroidal anti-inflammatory analgesic. Naloxone Hydrochloride Injection is currently the most widely used opioid receptor antagonist in clinical practice. It is mainly used for: (1) rescuing acute poisoning of narcotic analgesics, antagonizing the respiratory depression of such drugs, and making the patient wake up; (2) ) to antagonize the residual effect of narcotic analgesics, and this product can be used to antagonize the neonatal respiratory depression caused by the influence of narcotic analgesics in its mother; (3) to rescue acute alcohol poisoning: intravenous injection of naloxone 0.4-0.6mg , can make the patient wake up; (4) For those who are suspected ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/485A61K9/08A61P29/00A61P39/02
Inventor 张春丽
Owner BEIJING KAWIN TECH SHARE HLDG
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