A kind of quality detection method of penicillin skin test freeze-dried powder

Abstract

The invention discloses a quality detection method of lyophilized powder for a penicillin skin test. The quality detection method comprises the following steps: firstly, precisely weighing 0.02g of a penicillin sodium standard substance, dissolving and fixing the volume by using acetonitrile, mixing for dissolving, preparing into a solution with the concentration of 0.2 to 2mg / ml, storing into a brown glass bottle, and standing and storing under the condition that the temperature is 2 to 8DEG C; secondly, taking 0.2g of the lyophilized powder for the penicillin skin test, precisely weighing, putting a proper amount of the lyophilized powder into a measuring flask, adding the acetonitrile for dissolving fine powder, fixing the volume to be 2ml, uniformly shaking, filtering, and taking subsequent filtrate as a solution for a testing product; thirdly, detecting by adopting high performance liquid chromatography. The quality detection method of the lyophilized powder for the penicillin skin test, provided by the invention, is high in specificity, good in reproducibility and high in generality; a main peak and an accessory peak of penicillin sodium can be effectively separated, an detection result is accurate, the quality control level of the lyophilized powder for the penicillin skin test is greatly improved, and the safety of clinical medication is guaranteed.

Description

technical field [0001] The invention relates to the technical field of pharmacy and drug analysis, in particular to a quality detection method for penicillin skin test freeze-dried powder. Background technique [0002] Penicillins (Penicillins) is a general term for a class of β-lactam antibiotics. Because of its high efficiency and low toxicity, it is one of the most popular drugs in clinical medicine. Although penicillins themselves are not very toxic to the body , but it is easy to cause drug allergic reaction, which is the most of all kinds of allergic drugs. The cause of penicillin allergic reaction is mainly the degradation products of penicillin, penicilloic acid, penicilloic acid and its polymers. These substances enter the human body as haptens and combine with proteins or polypeptide molecules to form whole antigens, the most important of which is penicillin. protein, which is the main cause of allergic reactions in most people. Therefore, the skin allergy test m...

AI Technical Summary

Problems solved by technology

The skin test freeze-dried powder provided by this patent has the advantages of better preparation stability and lower false positive rate compared with traditional medical skin test reagents. It is a kind of penicillin skin test freeze-dried powder to replace traditional skin test injections. The idea of ​​drug development, but its shortcomings are: the patent does not involve the method of determination of related substances and content determination of skin test freeze-dried powder, and in the production of preparations, how to quickly and accurately detect the content of related substances Controlling within the scope of drug standards plays a very important role in the industrialization of penicillin skin test freeze-dried powder and the safety of clinical medication

When the inventor applied the pharmacopoeia method to the quality detection of the penicillin sodium skin test freeze-dried powder, he found that there were the following technical defects: 1. using the pharmacopoeia method, the main peak retention time of its chromatographic system was shorter, and the excipient peaks overlapped with the impurity peaks. Poor, there is interference in the integral; ②The stability of the detection system of the Pharmacopoeia method is not good, the reproducibility of the test results is poor, and there is no stability indicator

[0013] It can be seen from the above that most of the currently commercially available and self-made penicillin skin reagents in hospitals are injections, and there are few freeze-dried powders, and: ① There is no accurate quality inspection standard for freeze-dried powders, and we can only learn from the quality inspection methods of injections to improve ; ②Compared with injections, lyophilized powders have different excipients and different preparation processes. The requirements for stability control of lyophilized preparations are higher, and there are many types of impurities. The technical difficulty is higher; ③ Different manufacturers and different preparation processes have a greater impact on the quality of penicillin skin test freeze-dried powder, so the existing quality detection methods have poor versatility and low sensitivity, which is not conducive to product quality control, which greatly increases the safety of clinical medication sexual risk

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