CN103604766A - Biological quality control method of Shuxuetong injection - Google Patents
Biological quality control method of Shuxuetong injection Download PDFInfo
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Abstract
The invention provides a biological quality control method of a Shuxuetong injection. The biological quality control method is characterized in that a method for rapidly evaluating the antithrombin activity of the Shuxuetong injection in vitro is established by utilizing a fibrinogen and thrombin model through an ultraviolet method. The disadvantages of having personal error in titration end-point judgment, being high in cost of an APTT (Activated Partial Thromboplastin Time) kit and PT (Prothrombin Time) kit method, complex for operation, easily influenced by blood nature and the like in the existing antithrombin activity evaluating and measuring method through the thrombin titrimetric method (appearance method) are overcome. The biological quality control method disclosed by the invention has the advantages of being rapid, simple and convenient for operation, high in sensitivity and good in repeatability; the reliable and rapid biological quality control method is provided for the Shuxuetong injection; the biological quality control method disclosed by the invention is beneficial to increasing the quality controllability of products and ensuring the clinical curative effect of the products.
Description
Technical field
The present invention relates to a kind of biology quality control method of SHUXUETONG ZHUSHEYE, utilize fibrinogen and fibrin ferment model, use ultraviolet method to set up a kind of method of external Fast Evaluation SHUXUETONG ZHUSHEYE antithrombin activity, belong to the field of medicine technology.
Background technology
SHUXUETONG ZHUSHEYE is that leech and earthworm are the traditional Chinese medicine injection that raw material is made, promoting blood circulation and removing blood stasis, clearing and activating the channels and collaterals; For the apoplexy apoplex involving the channels and collaterals acute stage due to obstruction of collaterals by blood stasis, disease is seen hemiplegia, and dispute is crooked, speech is not smoothgoing puckery; Patients With Acute Cerebral Infarction is shown in above-mentioned patient; There is anti-bolt, thrombolysis, the sanguimotor effect of improvement.Granted publication CN1192782C, on March 16 2005 day for announcing, the patent of invention of denomination of invention " manufacture method of the injection for the treatment of cardiovascular and cerebrovascular disease and products thereof " discloses this traditional Chinese medicine and preparation method thereof.
SHUXUETONG ZHUSHEYE belongs to anticoagulant, has antithrombin activity; But still lack at present a kind of quality control method of biology fast and effectively.The evaluating and measuring method of existing antithrombin activity comprises fibrin ferment titrimetry (ocular estimate), APTT (activated partial thromboplastin) kit and PT (prothrombin time) kit method etc.But because identifier's eyes are different to solidifying the standard of terminal point determining, there is certain artificial difference in fibrin ferment titrimetry (ocular estimate), the accuracy of measurement result is brought to impact; And APTT kit and PT kit method cost are high, complicated operation, be subject to blood properties impact.Therefore, for SHUXUETONG ZHUSHEYE finds a kind of not only accurate antithrombin activity evaluation method sensitive but also fast, economical imperative as its biology quality control method.
Summary of the invention
The object of the present invention is to provide a kind of biology quality control method of SHUXUETONG ZHUSHEYE, the method is utilized fibrinogen and fibrin ferment model, is used ultraviolet method to set up a kind of method of external Fast Evaluation SHUXUETONG ZHUSHEYE antithrombin activity.
In order to realize the object of the invention, the present invention adopts following technical scheme and step to realize:
1, open ultraviolet spectrophotometer, make sample chamber temperature constant at 37 ℃, standby;
2, get 1 quartz colorimetric utensil, add 2.0mg/ml fibrinogen solution 450 μ l, SHUXUETONG ZHUSHEYE 10 μ l, physiological saline 540 μ l, jump a queue (lid) shakes up, and puts preheating on the constant temperature support of sample chamber, as reference solution;
3, separately get 1 quartz colorimetric utensil, add 2.0mg/ml fibrinogen solution 450 μ l, SHUXUETONG ZHUSHEYE 10 μ l, physiological saline 440 μ l, the preheating on the constant temperature support of (lid) rearmounted sample chamber of jumping a queue, open plug (lid), add 12U/ml thrombin solution 100 μ l, jump a queue rapidly (lid) shakes up and timing at once;
4, use ultraviolet-visible pectrophotometer, Selective determination wavelength 250nm, records enzyme kinetics curve in 37 ℃, and it is reaction time of 1.00 o'clock that record reaches absorbance, as the presetting period of SHUXUETONG ZHUSHEYE example reaction thing;
5, with the presetting period and 55 seconds (not adding the presetting period of dredging the logical blank sample of blood) of the SHUXUETONG ZHUSHEYE example reaction thing that reads, make comparisons, evaluate the antithrombin activity (presetting period is longer, and its antithrombin activity is stronger) of SHUXUETONG ZHUSHEYE; The reactant presetting period of drafting SHUXUETONG ZHUSHEYE is not less than 80 seconds.
Advantage of the present invention is: the invention provides a kind of biology quality control method of SHUXUETONG ZHUSHEYE, utilize fibrinogen and fibrin ferment model, use ultraviolet method to set up the method for external Fast Evaluation SHUXUETONG ZHUSHEYE antithrombin activity.SHUXUETONG ZHUSHEYE when test sampling amount few, without concentrating, the sample pre-treatments such as dilution, spectrophotometric used is counted laboratory conventional instrument, and process is simple, easy operating.The method that the present invention sets up has higher accuracy and good stability, and cost is lower; Having overcome fibrin ferment titrimetry (ocular estimate) exists and solidifies that artificial difference, APTT (activated partial thromboplastin) kit and PT (prothrombin time) the kit method cost of terminal point determining is high, complicated operation, is subject to the defect of the existing antithrombin activity evaluating and measuring methods such as blood properties impact.Biology quality control method provided by the invention, contributes to improve the quality controllability of SHUXUETONG ZHUSHEYE, ensures the clinical efficacy of product.
Accompanying drawing explanation
Fig. 1 ocular estimate is measured the thrombin activity examination criteria curve of variable concentrations fibrin ferment and 1.00mg/ml fibrinogen (not adding SHUXUETONG ZHUSHEYE)
Fig. 2 fibrinogen solution full wavelength scanner figure (190～800nm)
Fig. 3 thrombin solution full wavelength scanner figure (190～800nm)
Fig. 4 fibrinogen and thin blood lead to mixed liquor full wavelength scanner figure (190～800nm)
Fig. 5 does not add the enzyme kinetics curve of SHUXUETONG ZHUSHEYE
Fig. 6 adds the enzyme kinetics curve of SHUXUETONG ZHUSHEYE
Fig. 7 adds SHUXUETONG ZHUSHEYE and enzyme kinetics curve comparison (stack) figure that does not add SHUXUETONG ZHUSHEYE
Fig. 8 ultraviolet method is measured the thrombin activity examination criteria curve of variable concentrations thrombin solution
Embodiment
In order illustrating better, further to explain the present invention below by embodiment, but not to be construed as limiting the invention.
In following examples, correlation test instrument used and reagent are as follows:
Agilent Cary60 ultraviolet-visible pectrophotometer (WinUV software); AY1200 type ten thousand/analytical balance (SHIMADZU Japan Shimadzu company); Eppendorf pipettor (2-20 μ l; 200 μ l; 1000 μ l); DSY-1-6 hole electric-heated thermostatic water bath (Beijing Guo Hua medical apparatus and instruments factory); Goldspink board J9-2II type electronic stopclock (Shanghai No.5 Watch Factory).
Fibrin ferment (Biosharp, 1000u, lot number: BOOBK031600), (ox blood) fibrinogen (Biosharp, lot number: BOOBK031600); It is pure that other reagent are analysis.
SHUXUETONG ZHUSHEYE, Mudanjiang You Bo medicine company incorporated company produces, lot number: 11091211,11102022,11110312,111111211,12022011,12031611,12040312,12051821,13012611,13071321.
The foundation of embodiment 1 SHUXUETONG ZHUSHEYE biology quality control method
1, the preparation of solution
The preparation of thrombin solution: get fibrin ferment standard items, take physiological saline as solvent is mixed with respectively 2.0,4.0,8.0,12.0, the thrombin solution (facing with now joining) of 16.0U/ml.
The preparation of fibrinogen solution: get fibrinogen standard items, take physiological saline as solvent is mixed with respectively 0.10,0.25,0.50,0.75, the fibrinogen solution (facing with now joining) of 1.00mg/ml.
2, the selection of fibrinogen solution concentration
Get internal diameter 1cm, 5, the test tube of long 10cm, add respectively prepared 0.10,0.25,0.50,0.75, each 900 μ l of the fibrinogen solution of 1.00mg/ml, be placed in 37 ℃ of water-baths and be incubated 3min.In 5 test tubes, adding respectively concentration is the thrombin solution 100 μ l of 12U/ml, and timing simultaneously, shakes up immediately, puts in water-bath, observes (ocular estimate) record the presetting period with eye, surveys 3 times average (in Table 1) for every group.For guaranteeing that follow-up interpolation has after the SHUXUETONG ZHUSHEYE of antithrombin activity, the presetting period of its reactant can not be oversize, and the concentration (being 1.00mg/ml) of the fibrinogen solution of preferred presetting period between 40-60s is as the fibrinogen solution compound concentration of follow-up method herein.
Table 1 ocular estimate is measured the presetting period (not adding SHUXUETONG ZHUSHEYE) of variable concentrations fibrinogen and 12U/ml thrombin solution
3, ocular estimate was investigated variable concentrations thrombin solution presetting period and linear relationship
Get internal diameter 1cm, 5, the test tube of long 10cm, adds respectively each 900 μ l of fibrinogen solution of 1.00mg/ml, is placed in 37 ℃ of water-baths and is incubated 3min.In 5 test tubes, add respectively 2.0,4.0,8.0,12.0, the thrombin solution 100 μ l of 16.0U/ml, timing simultaneously, shakes up immediately, put in water-bath, with eye, observe (ocular estimate) and record the presetting period, survey 3 times average (in Table 2) for every group.
Table 2 ocular estimate is measured variable concentrations fibrin ferment and 1.00mg/ml fibrinogenic presetting period (not adding SHUXUETONG ZHUSHEYE)
The logarithm value of thrombin solution concentration of take is horizontal ordinate, and the logarithm of presetting period mean value of take is ordinate, drawing standard curve (Fig. 1), and linear equation is Y=-0.6350X+2.3974, related coefficient (R
2) be 0.9753, linear dependence is not that very high main cause is to utilize naked eyes to have personal error to the judgement in reaction presetting period, this error cannot be avoided.But the determination data in these presetting periods can be the foundation of follow-up ultraviolet method effective reference and checking is provided.
4, ocular estimate is measured the presetting period of adding SHUXUETONG ZHUSHEYE sample
Get internal diameter 1cm, the test tube of long 10cm, adds 2.0mg/ml fibrinogen solution 450 μ l, SHUXUETONG ZHUSHEYE 10 μ l, physiological saline 440 μ l, is placed in 37 ℃ of water-baths and is incubated 3min; Adding concentration is the thrombin solution 100 μ l of 12U/ml, and timing simultaneously, shakes up immediately, puts in water-bath, observes (ocular estimate) record the presetting period with eye, surveys 3 times, averages for every group; Respectively the presetting period of 10 batches of SHUXUETONG ZHUSHEYE sample solutions is measured to (in Table 3).
Note: for making to add fibrinogenic addition in SHUXUETONG ZHUSHEYE sample, be consistent with previous (1.0mg/ml adds 900 μ l), add 2.0mg/ml fibrinogen solution 450 μ l herein; The exploitation of follow-up ultraviolet method, its fibrinogenic solution concentration also adopts 2.0mg/ml.
Table 3 ocular estimate is measured the presetting period of 10 batches of SHUXUETONG ZHUSHEYEs
5, the foundation of ultraviolet method
(1) detect the selection of wavelength
Open Agilent Cary60 ultraviolet-visible pectrophotometer, make sample chamber temperature constant at 37 ℃; Subsequently the logical mixed liquor (2.0mg/ml fibrinogen solution 450 μ l, SHUXUETONG ZHUSHEYE 10 μ l, physiological saline 440 μ l) of fibrinogen solution (1.0mg/ml), thrombin solution (12U/ml), fibrinogen and thin blood be take respectively to physiological saline as reference carries out full wavelength scanner (190～800nm), obtain the absorption spectrum (seeing Fig. 2, Fig. 3 and Fig. 4) of 3 kinds of materials.
As seen from Figure 3, under 220～800nm wavelength, the absorbance of thrombin solution is minimum, can ignore, so thrombin solution to the selection of measuring wavelength without consideration.
The fibrinogen of solubility is converted into insoluble fibrin under the catalysis of fibrin ferment, in this enzymatic reaction process, the absorbance of reactant increases along with the increase in reaction time, after proceeding to a certain degree, absorbance is not obvious and be tending towards a more constant maximal value (the enzyme kinetics curve by Fig. 5 and Fig. 6 also can be found out this trend) over time.The reason of the maximal value that background absorbance based on reaction substrate (fibrinogen, dredge blood logical) can not be too large and enzymatic reaction thing reaches in useful range, and in conjunction with the abosrption spectrogram of Fig. 2 and Fig. 3, preferably 250nm is as detection wavelength.
(2) mensuration of enzymatic reaction curve
A, do not add the enzyme kinetics curve determination of SHUXUETONG ZHUSHEYE
Open ultraviolet spectrophotometer, make sample chamber temperature constant at 37 ℃, standby; Get 2 quartz colorimetric utensils, add respectively 1mg/ml fibrinogen solution 900 μ l, put preheating on the constant temperature support of sample chamber, wherein 1 adds physiological saline 100 μ l, and jump a queue (lid) shakes up, as reference solution; Another 1 adds 12U/ml thrombin solution 100 μ l, and jump a queue rapidly (lid) shakes up and timing at once; Use ultraviolet-visible pectrophotometer, Selective determination wavelength 250nm, records enzyme kinetics curve (seeing Fig. 5) in 37 ℃.
B, add the enzyme kinetics curve determination of SHUXUETONG ZHUSHEYE
Open ultraviolet spectrophotometer, make sample chamber temperature constant at 37 ℃, standby; Get 1 quartz colorimetric utensil, add 2.0mg/ml fibrinogen solution 450 μ l, SHUXUETONG ZHUSHEYE (sample lot number 12051821) 10 μ l, physiological saline 540 μ l, jump a queue (lid) shake up, put preheating on the constant temperature support of sample chamber, as reference solution; Separately get 1 quartz colorimetric utensil, add 2.0mg/ml fibrinogen solution 450 μ l, SHUXUETONG ZHUSHEYE 10 μ l, physiological saline 440 μ l, the preheating on the constant temperature support of (lid) rearmounted sample chamber of jumping a queue, open plug (lid), add 12U/ml thrombin solution 100 μ l, jump a queue rapidly (lid) shakes up and timing at once; Use ultraviolet-visible pectrophotometer, Selective determination wavelength 250nm, records enzyme kinetics curve (seeing Fig. 6) in 37 ℃.
(3) selection in presetting period
From Fig. 5 (the enzyme kinetics curve that does not add SHUXUETONG ZHUSHEYE), Fig. 6 (the enzyme kinetics curve that adds SHUXUETONG ZHUSHEYE) and Fig. 7 (adding SHUXUETONG ZHUSHEYE and enzyme kinetics curve comparison (stack) figure that does not add SHUXUETONG ZHUSHEYE), initial reaction stage, the absorbance of reactant increases rapidly along with the increase in reaction time, if reaction time corresponding to certain absorbance within this stage, error was larger as the presetting period; And after the reaction time proceeds to a certain degree (after about 10min), absorbance is not obvious and be tending towards a more constant maximal value (absorbance is all 2.0 left and right over time, now approached reaction end), therefore, should not choose the absorbance now criterion as the presetting period yet.We find, when absorbance reaches 1.00, be absorbance reach maximum absorbance value (reaction end) 50% time, reaction rate is now of moderate size, basically identical (can being obtained by Fig. 5 of true presetting period of corresponding reaction time and ocular estimate gained, when absorbance is 1.00, the reaction time is 54.98s, and ocular estimate is 51.96s; By Fig. 6, can be obtained, when absorbance is 1.00, the reaction time is 126.26s, and ocular estimate is 124.47s), therefore, choose absorbance and be the reaction time of 1.00 o'clock as presetting period of sample, error is less, thereby has eliminated the personal error of ocular estimate endpoint.
By the comparison diagram of Fig. 7 and the determination data of ocular estimate, can be drawn: SHUXUETONG ZHUSHEYE sample can significantly reduce the reaction rate of enzymatic reaction, extend the presetting period of reactant, SHUXUETONG ZHUSHEYE has significant antithrombin activity.
(4) ultraviolet method was investigated variable concentrations thrombin solution presetting period and linear relationship
Accuracy for the checking ultraviolet method gained presetting period, use this method to investigate variable concentrations thrombin solution presetting period and linear relationship, contrast with the related data of " 3 ocular estimates were investigated variable concentrations thrombin solution presetting period and linear relationship " subsequently.
Open ultraviolet spectrophotometer, make sample chamber temperature constant at 37 ℃, standby; Get 2 quartz colorimetric utensils, add respectively 1.0mg/ml fibrinogen solution 900 μ l, put preheating on the constant temperature support of sample chamber, wherein 1 adds physiological saline 100 μ l, and jump a queue (lid) shakes up, as reference solution; Another 1 adds 2.0U/ml thrombin solution 100 μ l, and jump a queue rapidly (lid) shakes up and timing at once; Use ultraviolet-visible pectrophotometer, Selective determination wavelength 250nm, records enzyme kinetics curve in 37 ℃; It is reaction time of 1.00 o'clock that record reaches absorbance, as the presetting period of reactant under this concentration of thrombin, surveys 3 times, averages.Same reference solution, measures that thrombin solution is respectively 4.0,8.0,12.0, the presetting period of 16.0U/ml, surveys 3 times average (in Table 4) for every group.
Table 4 ultraviolet method is measured the presetting period of variable concentrations thrombin solution
By table 4 and table 2 relatively, presetting period and the ocular estimate of variable concentrations fibrin ferment are more or less the same, and the deviation of respectively organizing data is less than ocular estimate.
The logarithm value of thrombin solution concentration of take is horizontal ordinate, and the logarithm of presetting period mean value of take is ordinate, drawing standard curve (Fig. 8), and linear equation is Y=-0.6118X+2.3961, related coefficient (R
2) be 0.9950, linear dependence is better than the ocular estimate (coefficient R of ocular estimate
2be 0.9753).
6, precision (repeatability in batch) is investigated
Get same lot number and dredge the logical sample (lot number 12051821) of blood, the enzyme kinetics curve that adds SHUXUETONG ZHUSHEYE according to ultraviolet method " 5-2.-B " lower operation acquisition, it is reaction time of 1.00 o'clock that record reaches absorbance, as the presetting period of reactant under this concentration of thrombin, replication 6 times, can be calculated RSD is 0.53%, shows that the precision (repeatability in batch) of experimental technique is good.
The precision that table 5 SHUXUETONG ZHUSHEYE ultraviolet method is measured is investigated
7, SHUXUETONG ZHUSHEYE biology quality control method determines
By above-mentioned experiment, determine that the step of biology quality control method of SHUXUETONG ZHUSHEYE is as follows:
(1) open ultraviolet spectrophotometer, make sample chamber temperature constant at 37 ℃, standby;
(2) get 1 quartz colorimetric utensil, add 2.0mg/ml fibrinogen solution 450 μ l, SHUXUETONG ZHUSHEYE 10 μ l, physiological saline 540 μ l, jump a queue (lid) shakes up, and puts preheating on the constant temperature support of sample chamber, as reference solution;
(3) separately get 1 quartz colorimetric utensil, add 2.0mg/ml fibrinogen solution 450 μ l, SHUXUETONG ZHUSHEYE 10 μ l, physiological saline 440 μ l, the preheating on the constant temperature support of (lid) rearmounted sample chamber of jumping a queue, open plug (lid), add 12U/ml thrombin solution 100 μ l, jump a queue rapidly (lid) shakes up and timing at once;
(4) use ultraviolet-visible pectrophotometer, Selective determination wavelength 250nm, records enzyme kinetics curve in 37 ℃, and it is reaction time of 1.00 o'clock that record reaches absorbance, as the presetting period of SHUXUETONG ZHUSHEYE example reaction thing;
(5) with the presetting period and 55 seconds (not adding the presetting period of dredging the logical blank sample of blood) of the SHUXUETONG ZHUSHEYE example reaction thing that reads, make comparisons, evaluate the antithrombin activity (presetting period is longer, and its antithrombin activity is stronger) of SHUXUETONG ZHUSHEYE.
The mensuration of 210 batches of SHUXUETONG ZHUSHEYEs of embodiment
Use the biology quality control method of setting up, with ultraviolet method, measured 10 batches of SHUXUETONG ZHUSHEYE samples; And contrast with the antithrombin activity data that fibrin ferment titrimetry (improved method) is measured.Can find out, between the anticoagulating active data that the average presetting period that the biology quality control method (ultraviolet method) of newly-established SHUXUETONG ZHUSHEYE records and fibrin ferment titrimetry (improved method) record, present good positive correlation, the method can be good at the real antithrombin activity of reflection (evaluation) SHUXUETONG ZHUSHEYE sample.
The mensuration in 10 batches of SHUXUETONG ZHUSHEYE presetting periods of table 6 (ultraviolet method) and with the contrast of fibrin ferment titrimetry (improved method)
Embodiment explanation, the biology quality control method of SHUXUETONG ZHUSHEYE provided by the invention can be evaluated SHUXUETONG ZHUSHEYE antithrombin activity effectively, fast, truly.According to the measurement result of multiple batches of sample, the ultraviolet method presetting period of SHUXUETONG ZHUSHEYE sample mainly concentrates on 107～148 seconds.Therefore this biology quality control method was made comparisons with the presetting period and 55 seconds (not adding the presetting period of dredging the logical blank sample of blood) of SHUXUETONG ZHUSHEYE sample, evaluate the antithrombin activity of SHUXUETONG ZHUSHEYE, presetting period is longer, and its antithrombin activity is stronger; The reactant presetting period of drafting SHUXUETONG ZHUSHEYE is not less than 80 seconds.
In sum, the present invention has overcome that ocular estimate exists titration end-point judgement personal error, APTT kit and PT kit method cost is high, complicated operation, has been subject to the defect of the existing antithrombin activity evaluating and measuring methods such as blood properties impact.The method operation is fast and convenient, highly sensitive, reproducible, for SHUXUETONG ZHUSHEYE provide a kind of reliably, biology quality control method fast, contribute to improve the quality controllability of product, ensure the clinical efficacy of product.
Although the present invention is described in detail above to have used general explanation and specific embodiment, on basis of the present invention, can make some modifications or improvement to it, this will be apparent to those skilled in the art.Therefore, these modifications or improvements, all belong to the scope of protection of present invention without departing from theon the basis of the spirit of the present invention.
Claims (8)
1. a biology quality control method for SHUXUETONG ZHUSHEYE, is characterized in that:
(1) get suitable vessel, each is appropriate to add 0.5～5mg/ml fibrinogen solution, SHUXUETONG ZHUSHEYE and physiological saline, jump a queue (lid) shake up, put preheating on constant temperature (20～50 ℃) support, open plug (lid), add 1～50U/ml thrombin solution appropriate, jump a queue rapidly (lid) shakes up and timing at once;
(2) adopt ultraviolet-visible pectrophotometer, Selective determination wavelength 200～400nm, measures enzyme kinetics curve, records absorbance and reaches the reaction time of 0.2～2.0 o'clock, as the presetting period of SHUXUETONG ZHUSHEYE example reaction thing.
2. the method for claim 1, is characterized in that the concentration nearlyer one of the fibrinogen solution of use in the method step (1) is optimized for 1～3mg/ml.
3. the method for claim 1, is characterized in that the concentration nearlyer one of the thrombin solution of use in the method step (1) is optimized for 10～20U/ml.
4. the method for claim 1, is characterized in that in the method step (1), the nearlyer one-step optimization of steady temperature is 30～40 ℃.
5. the method for claim 1, is characterized in that using the wavelength of UV-detector to be further optimized for 200～300nm in the method step (2).
6. the method for claim 1, is characterized in that using the wavelength of UV-detector to be further optimized for 200～300nm in the method step (2).
7. the method for claim 1, is characterized in that the absorbance in the presetting period of SHUXUETONG ZHUSHEYE example reaction thing in the method step (2) is further optimized for 0.5～1.5.
8. the method for claim 1, is characterized in that in the method step (1), the additional proportion between fibrinogen solution, SHUXUETONG ZHUSHEYE, physiological saline and thrombin solution is optimized for 30～60:0.5～5:30～60:5～20.
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| CN104034900A (en) * | 2014-04-21 | 2014-09-10 | 牡丹江友搏药业股份有限公司 | Novel method for determination of cytoprotection biological activity in traditional Chinese medicinal materials or traditional Chinese medicine preparations |
| CN114062220A (en) * | 2021-10-19 | 2022-02-18 | 重庆永仁心医疗器械有限公司 | Method for testing filtering performance of pure water sealing component |
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