Novel penicillin skin test freeze-dried powder and preparation process thereof

Abstract

The invention discloses novel penicillin skin test freeze-dried powder and a preparation process thereof. The skin test freeze-dried powder in each bottle or each tube mainly comprises 1000-10000 units of penicillin sodium salt. The preparation process comprises the following steps: diluting the raw material medicine penicillin sodium salt by using water for injection, adding an excipient in a specified ratio, and preparing the freeze-dried powder according to an optimized process. The freeze-dried powder is stable and controllable in quality and is suitable for industrial production. During clinical use, only is a certain amount of normal saline needed to be injected and is uniformly mixed, and a penicillin skin test solution with the concentration of 500 units can be prepared. Compared with a traditional method for preparing the skin test agent, the process has the advantages that the preparation is high in solubility and simple in operation, the preparation time is obviously shortened, the dose accuracy of the prepared liquid medicine is high, the error range is narrow, the pharmacopoeia requirements are met, the false positive of clinical medicines such as penicillin can be effectively reduced, and the method has obvious advantages and can replace the traditional method. The skin test agent prepared by the process disclosed by the invention is suitable for allergen detection of various medicines such as penicillin.

Description

technical field [0001] The invention relates to a penicillin skin test reagent, in particular to a novel penicillin skin test freeze-dried powder and a preparation process. Background technique [0002] Penicillins (Penicillins) is the general term for β-lactam antibiotics, which are divided into natural penicillins and synthetic penicillins. The former obtains secondary metabolites from the culture medium of Penicillins notat (unit m), mainly containing F and G , X, V, etc. Among them, penicillin G has high yield, stable properties, good and wide effect, and can inhibit or kill various pathogenic bacteria at a very low concentration to achieve the purpose of treating diseases. It is currently the most widely used clinically. antibiotics, but its incidence rate of allergic reactions ranks first among all kinds of drugs. The root cause of penicillin allergy lies in the impurity of drug quality. It accounts for 0.7%~10% of the population, and the incidence of death caused by ...

AI Technical Summary

Problems solved by technology

It can be seen that the traditional method has the following defects: 1. Because the molecular structure of penicillins determines that penicillins are unstable, easy to degrade and lose efficacy, generally the newly configured skin test solution should be refrigerated, and the service life is generally within one week. If the preparation time is too long, it is easy to decompose into allergic substances such as penicillin thiazole and penicillonic acid, and if it is left for too long, repeated extractions, air bubbles poured back and forth will also cause pollution, especially after the summer skin test, it is easy to cause False positive reaction; 2. Through repeated extraction and mixing, the skin test solution containing 500 units per ml was gradually prepared. Due to the large penicillin unit in this preparation method, the dissolution was insufficient, which directly led to inaccurate concentration of the skin test solution and affected the result of the skin test. For infants and young children, it will significantly increase the false positive rate and delay the time of treatment. 3. Use 800,000 units / support of penicillin drugs to prepare 500 units of skin reagents, resulting in a great waste of drugs

The first two defects are an important reason for the occurrence of false positive reactions

[0004] In addition, penicillin drugs of different varieties, different manufacturers, different technological processes, and different batch numbers are circulating in the domestic market, resulting in different types and contents of allergens contained in them.

In order to ensure the safety of the drug, if children stop using penicillin for more than 3 days and adults for more than 7 days, when adding or changing the batch number of the variety, it is necessary to do a skin test again to prevent accidents. This will not only cause the workload of the medical staff, but more seriously increased patient suffering

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