Macromolecular substances in traditional Chinese medicine injections (TCMIs) are expected to be a main dangerous factor causing anaphylactic or anaphylactoid reaction. The main aim of the study was to verify the macromolecular substances’ anaphylactic or anaphylactoid reaction in guinea pigs and establish a size-exclusive chromatographic method to detect them. The macromolecular substances from six TCMIs (Danshen injection, Dengzhanxixin injection, Honghua injection, Qingkailing injection, Shuanghuanglian injection and Shuxuening injection) were prepared by removing substances with molecular weight less than 10 kDa with an ultra-filter. The anaphylactic and anaphylactoid reactions caused by original TCMIs, injections rich in or free of macromolecules were assayed in guinea pigs. The relationship between the amount of the macromolecular substances and peak area of chromatogram was established by size-exclusive chromatography. Injections free of macromolecules were not likely to cause anaphylactic and anaphylactoid reactions, but injections rich in macromolecular substances were more likely to do so. If the macromolecular substances with molecular weight bigger than 10 kDa were removed, the signal of macromolecular substances in TCMIs was quantitatively reduced. All the results suggested that macromolecular substances in TCMIs are a dangerous factor causing safety problems, and the macromolecular substances can be quantitatively detected with size-exclusive chromatography.

中文翻译：

---

大分子物质是中药注射剂中的危险因素，通过体积排阻色谱法确定。

中药注射剂（TCMI）中的大分子物质有望成为引起过敏性或类过敏反应的主要危险因素。该研究的主要目的是验证豚鼠中大分子物质的过敏反应或类过敏反应，并建立一种尺寸排阻色谱法对其进行检测。通过用超滤器去除分子量小于10 kDa的物质，制备了6种TCMIs（丹参注射液，登站西新注射液，红花注射液，清开灵注射液，双黄连注射液和舒序宁注射液）中的大分子物质。在豚鼠中测定了由原始TCMI（富含或不含大分子的注射液）引起的过敏和类过敏反应。大分子物质的量与色谱峰面积的关系通过尺寸排阻色谱法建立。不含大分子的注射剂不太可能引起过敏反应和类过敏反应，但是富含大分子物质的注射剂更可能引起过敏反应和类过敏反应。如果去除分子量大于10 kDa的大分子物质，则TCMIs中大分子物质的信号会定量降低。所有结果表明，TCMI中的大分子物质是引起安全问题的危险因素，并且可以通过尺寸排阻色谱法定量检测大分子物质。不含大分子的注射剂不太可能引起过敏反应和类过敏反应，但是富含大分子物质的注射剂更可能引起过敏反应和类过敏反应。如果去除分子量大于10 kDa的大分子物质，则TCMIs中大分子物质的信号会定量降低。所有结果表明，TCMI中的大分子物质是引起安全问题的危险因素，并且可以通过尺寸排阻色谱法定量检测大分子物质。不含大分子的注射剂不太可能引起过敏反应和类过敏反应，但是富含大分子物质的注射剂更可能引起过敏反应和类过敏反应。如果去除分子量大于10 kDa的大分子物质，则TCMIs中大分子物质的信号会定量降低。所有结果表明，TCMI中的大分子物质是引起安全问题的危险因素，并且可以通过尺寸排阻色谱法定量检测大分子物质。