肝素钠生物效价测定中血浆凝固度形态判定方法介绍

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在肝素钠生产实践中,生物效价测定一般采用血浆法,其中内插法、面积法都以美国药典五级凝固度标准为实验设计判定依据,而美国药典五级凝固度标准是建立在13×100mm具塞试管为试验条件的基础上的。一般正常情况下是能区别各凝固度级变化的,由于美国药典没有具体地描述各凝固度级的形态特征,因此,在检测实际中,判定各凝固度级差的变化观差异较大,加上所采用的具塞试管管径不一定标准等因素,较难正确地反应肝素钠的实际生物效价。为了尽量减少主观差异、采用形态判定法作为凝固度级的参考判定依据,能较好地体现美国药典五级凝固度对比判定的含意,如形态示意图:1.凝固度“1.0”级,试管在手掌鱼脊上振动后、将试管横直,血凝块完整附于试管内壁,试管中线上下血凝块相等或几乎相等。2.凝固度“0.75”级,试管在手掌鱼脊上振动后,将试管横直,血凝块松动,试管中线上下血凝块不对称,上部份血凝块脱离或极少触及试管内壁,并可有极少量液体。3.凝固度“0.5”级,试管在手掌鱼脊上 In the heparin sodium production practice, the biological potency determination generally adopts the plasma method, wherein the interpolation method and the area method all take the United States Pharmacopoeia five-level solidification standard as the experimental design to determine the basis, and the United States Pharmacopoeia five-level solidification standard is based on the 13 × 100mm plugged test tube based on the test conditions. Under normal circumstances, it is possible to distinguish between changes in the degree of solidification. Since the U.S. Pharmacopoeia does not specifically describe the morphological characteristics of each degree of solidification, the change in the degree of solidification varies greatly in the actual test. The plug with the test tube diameter is not necessarily the standard and other factors, the more difficult to correctly reflect the actual biological potency of heparin sodium. In order to minimize the subjective differences, the morphological determination method is used as a reference to determine the degree of solidification, which can better reflect the meaning of comparison and determination of the solidification degree of the fifth grade of the USP. For example, After vibrating on the palm fish spine, the test tube is straightened and the blood clot is completely attached to the inner wall of the test tube. The blood clots above and below the test tube are equal or almost equal. 2. Solidification degree “0.75” level, the test tube in the palm of the fish after vibration, the test tube horizontal straight, clot loosening, test tube in the upper and lower blood clots asymmetry, the upper part of the blood clot detachment or rarely touch the tube wall, And can have a very small amount of liquid. 3. Solidification degree “0.5” level, the test tube in the palm of the fish ridge
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