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| Study on Test Method of Ornithine Aspartate Bacterial Endotoxin |
| MA Yun-tao,JI Zeng |
| Zhongnuo Pharmaceutical (Shijiazhuang) Corporation Ltd. of Shiyao Group, Shijiazhuang 050000, China |
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Abstract The test method of ornithine aspartate bacterial endotoxin was established. Ornithine aspartate is originally an oral preparation of non-aseptic active ingredient without examining pyrogen or endotoxin. Along with the newest research and development of the drugs, ornithine aspartate is promoted into injection. According to People's Republic of China new drug declaration and registration requirements: except for six kinds of new drugs, other kinds of injection new drug must establish the endotoxin inspection item. Ornithine aspartate injection is the third new medicine, the test for bacterial endotoxins should be established. The interference experiment was carried out according to the bacterium endotoxin limiting value which calculated from clinical dosage, the sensitivity melted tachypleus amebocyte lysate and non-interfering concentration were discovered, the bacterium endotoxin inspection method was established.
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