Antitumor pharmaceutical composition and preparation method thereof

Abstract

The invention provides a preparation method of an antitumor pharmaceutical composition. The preparation method is characterized by comprising the following steps: selecting ginseng to prepare ginseng extractum, preparing the ginseng extractum into ginseng extract, preparing astragalus into astragalus extractum, preparing the astragalus extractum into astragalus extract, preparing the ginseng extract, the astragalus extract and kushenin into extractum, preparing the extractum obtained from the ginseng extract, the astragalus extract, and the kushenin into injection, sterilizing at a temperature of 100 DEG C for 30 minutes, carrying out lamp detecting and packaging to prepare a finished product of the antitumor pharmaceutical composition. The preparation method has reasonable flow, the obtained finished product has the advantages of high purity, good quality stability, scientific formula, extract curative effect, capability of significantly improving the KPS score, the clinical symptom score and the QOL score of a patient with advanced malignant tumor, reducing the weight loss, perfecting the living quality of the patient and relieving the clinical symptoms, and low occurrence rate of such adverse reactions as allergy.

Description

technical field [0001] The invention relates to the field of traditional Chinese medicine, and relates to an antitumor drug composition and a preparation method thereof. Background technique [0002] Traditional Chinese medicine is one of the four national quintessences of China. New dosage forms such as tablets, capsules, and injections have been introduced on the basis of traditional dosage forms such as pills, powders, ointments, and pills. Traditional Chinese medicine injections are regarded as an extension of the modernization of traditional Chinese medicine. However, due to the relatively recent history of its preparation technology, the prepared product has complex components and more macromolecular impurities, and its safety and stability are much inferior to those of western medicine. [0003] Traditional Chinese medicine injections are divided into three categories according to their ingredients. One is the monomer (single compound) extracted from traditional Chine...

AI Technical Summary

Problems solved by technology

Traditional Chinese medicine injections are regarded as an extension of the modernization of traditional Chinese medicine. However, due to the relatively recent history of its preparation technology, the prepared product has complex components and more macromolecular impurities, and its safety and stability are inferior to those of western medicine.

[0003] Traditional Chinese medicine injections are divided into three categories according to their ingredients. One is the monomer (single compound) extracted from traditional Chinese medicine with a single chemical structure, such as puerarin injection. Franose-4', 7-dihydroxyisoflavone, the extraction process is more complicated, but the preparation process is simpler, and the product quality is relatively stable; the second is prepared from the effective parts of traditional Chinese medicine, and it is composed of one or more types of ingredients Composition, the components are basically clear, and the controllable components reach more than 60%, such as Xuesaitong injection, which is an antithrombotic drug prepared from the effective part of Panax notoginseng saponins; another Rutong must injection is composed of four An analgesic prepared from the effective parts extracted from a variety of traditional Chinese medicines; the third is an injection prepared from a mixture of two or more Chinese medicinal materials, such as Shenmai injection, which is prepared from ginseng and Ophiopogon japonicus as main raw materials The composition is the most complex and the preparation is the most difficult; for example, Kangai injection is composed of ginseng, astragalus and matrine, the composition is relatively complicated and the preparation is very difficult

During the long-term production and use of Kangai Injection, some factors affecting product quality were gradually discovered, such as flocculents, turbidity, allergies, infusion reactions and other quality problems, resulting in unstable product quality and shortened shelf life, which seriously affected the company. The production and use of the product, the reason is that the preparation process is not good enough, the obtained ingredients are complex, and contain relatively many macromolecular impurities such as oil, tannin, protein, etc., which lead to the occurrence of these problems

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