Newly packed naloxone hydrochloride injection and its producing method

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 ...

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