The invention belongs to the field of medicines, and particularly relates to a method for analyzing
quality safety of a
traditional Chinese medicine injection and a
medicine preparation. According to the invention, the
traditional Chinese medicine injection serves as an object of study, a Qingkailing injection, a Chuanhuning injection and a Shenmai injection serve as representatives, a
mast cell membrane stabilizer and other anti-allergic medicines are added into the
traditional Chinese medicine injection to inhibit various immune
toxicity reactions induced by the traditional Chinese
medicine injection, and the capability of inducing various hypersensitivities and
anaphylactoid reactions is detected, so that the result proves the feasibility of the method for
quality control of
immunity safety of the traditional Chinese
medicine injection. The method provides a novel solution for the main adverse reaction, namely immunotoxicity, of the traditional Chinese medicine injection applied to clinic. A method for detecting the
immunity safety control of the traditional Chinese medicine injection is established to control the clinical adverse reactions of the traditional Chinese medicine injection; the
mechanism of action is studied, so that the selection and basis are provided for the method for detecting the
immunity safety control of the traditional Chinese medicine injection in the new version of pharmacopeia, and the reference is provided for establishing novel
guiding principles of immunity safety evaluation for new drugs in China.