Method for determining biological activity of leech by slope ratio method
A technology of biological activity and slope ratio, applied in the field of medicine, can solve the problems that the effectiveness and safety of clinical medication cannot be well guaranteed, the effect of leech decoction pieces cannot be measured, and there is no antithrombin activity.
Pending Publication Date: 2021-08-06
北京市药品检验研究院(北京市疫苗检验中心)
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Problems solved by technology
There are many varieties of leeches, and three varieties of leeches, leeches and willow-leaf leeches are specified in the Pharmacopoeia alone. A large number of documents show that the anticoagulant substances in the dry body of leeches (three varieties) are not only hirudin, but also other components ; Therefore, whether the results of thrombin titration are correlated with its biological activity in vivo has not yet been proven
For example, the 2020 edition of the "Chinese Pharmacopoeia" stipulates that every 1g of leeches and willow leaf leeches should not be less than 3.0U antithrombin activity, which is actually equivalent to almost no antithrombin activity, and it cannot be measured clinically. The effect of leech decoction pieces (mainly leech and willow leaf leech) widely used in medicine, and thus the effectiveness and safety of clinical medication cannot be well guaranteed
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[0070] The present invention will be further described below through specific embodiments / experimental examples, but it should be understood that these embodiments and experimental examples are only used for more detailed description, and should not be interpreted as being used to limit the present invention in any form .
[0071] The present invention provides general and / or specific descriptions of the materials and test methods used in the tests. While many of the materials and methods of manipulation which are employed for the purposes of the invention are well known in the art, the invention has been described here in as much detail as possible. It will be clear to those skilled in the art that in the following, unless otherwise specified, the materials and operation methods used in the present invention are well known in the art.
[0072] One, the general operation of assay method of the present invention
[0073] The present invention uses slope ratio method to meas...
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The invention relates to a method for determining the biological activity of leeches by a slope ratio method, in particular to a method for comparing and judging the biological activity of the leeches. Specifically, the invention relates to a method for comparing biological activities of leeches in different samples and judging the quality condition of the leeches according to the biological activities, and the method comprises the following steps: (1) preparing leech leach liquor, and preparing test solutions with a series of concentrations; (2) preparing animal plasma, and measuring the time of partially activating prothrombin after the animal plasma is added into the leech leach liquor with different concentrations; and (3) according to a slope ratio method calculation mode, calculating the activity of one sample leech to be equivalent to the relative strength of the activity of another leech control sample, for example, the activity is equivalent to 85% of the activity of another sample; and (4) if the other control sample is a standard substance (or a control medicinal material), specifying the quality standard of the leech by limiting the relative value equivalent to the control medicinal material, and formulating the quality standard of the leech medicinal material or the leech-containing medicine. The method disclosed by the invention has excellent technical effects described in the specification.
Description
technical field [0001] The invention belongs to the technical field of medicine and relates to a method for comparing and judging the biological activity of leeches. Specifically, in order to measure the partial activated prothrombin time at different concentrations of the leech extract by preparing a series of concentrations of the leech extract, by comparing the slopes of the curves of the different concentrations of the two samples with the measured index values, two A method for calculating the relative magnitude of the activity of two samples. Background technique [0002] A leech is the dried whole body of the leech (Whitmania pigra Whitman), leech (Hirudo nipponica Whitman), or willow-leaf leech (Whitmania acranulata Whitman) of the leech family. Leech was first recorded in "Shen Nong's Materia Medica". It tastes salty, bitter, flat in nature, slightly poisonous, and returns to the liver meridian. Modern pharmacological studies have shown that leeches have obvious e...
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Login to View More IPC IPC(8): C12Q1/56G01N33/86G16C20/50
CPCC12Q1/56G01N33/86G01N33/94G16C20/50
Inventor胡宇驰肖斯婷郭玉东曹春然孙圆媛朱春玥李雪梅高晓新赵晋燕王佳帅李爽林铌刘洪艳陈薪宇杨文良
Owner北京市药品检验研究院(北京市疫苗检验中心)