CN114894911A - Method for controlling bovine serum product quality - Google Patents
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- 239000012888 bovine serum Substances 0.000 title claims abstract description 136
- 238000000034 method Methods 0.000 title claims abstract description 33
- 244000309466 calf Species 0.000 claims abstract description 111
- 210000002966 serum Anatomy 0.000 claims abstract description 111
- 108091003079 Bovine Serum Albumin Proteins 0.000 claims abstract description 64
- 229920000642 polymer Polymers 0.000 claims abstract description 63
- 239000012091 fetal bovine serum Substances 0.000 claims abstract description 34
- 238000001514 detection method Methods 0.000 claims abstract description 15
- 239000007788 liquid Substances 0.000 claims description 39
- 239000012894 fetal calf serum Substances 0.000 claims description 30
- 241000283690 Bos taurus Species 0.000 claims description 29
- 230000001605 fetal effect Effects 0.000 claims description 18
- 239000003085 diluting agent Substances 0.000 claims description 14
- 239000000243 solution Substances 0.000 claims description 13
- 239000012085 test solution Substances 0.000 claims description 11
- 238000004128 high performance liquid chromatography Methods 0.000 claims description 10
- KFZMGEQAYNKOFK-UHFFFAOYSA-N Isopropanol Chemical compound CC(C)O KFZMGEQAYNKOFK-UHFFFAOYSA-N 0.000 claims description 8
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 8
- 238000004458 analytical method Methods 0.000 claims description 6
- BNIILDVGGAEEIG-UHFFFAOYSA-L disodium hydrogen phosphate Chemical compound [Na+].[Na+].OP([O-])([O-])=O BNIILDVGGAEEIG-UHFFFAOYSA-L 0.000 claims description 6
- 229910000403 monosodium phosphate Inorganic materials 0.000 claims description 6
- 235000019799 monosodium phosphate Nutrition 0.000 claims description 6
- 238000003908 quality control method Methods 0.000 claims description 6
- AJPJDKMHJJGVTQ-UHFFFAOYSA-M sodium dihydrogen phosphate Chemical compound [Na+].OP(O)([O-])=O AJPJDKMHJJGVTQ-UHFFFAOYSA-M 0.000 claims description 6
- 238000012360 testing method Methods 0.000 claims description 6
- 239000000945 filler Substances 0.000 claims description 3
- 239000002994 raw material Substances 0.000 claims description 3
- 229960005486 vaccine Drugs 0.000 abstract description 4
- 210000004369 blood Anatomy 0.000 description 9
- 239000008280 blood Substances 0.000 description 9
- 108010074605 gamma-Globulins Proteins 0.000 description 9
- 238000002360 preparation method Methods 0.000 description 8
- 230000014759 maintenance of location Effects 0.000 description 5
- 239000000178 monomer Substances 0.000 description 5
- 230000000052 comparative effect Effects 0.000 description 3
- OOSZCNKVJAVHJI-UHFFFAOYSA-N 1-[(4-fluorophenyl)methyl]piperazine Chemical compound C1=CC(F)=CC=C1CN1CCNCC1 OOSZCNKVJAVHJI-UHFFFAOYSA-N 0.000 description 2
- DGLRDKLJZLEJCY-UHFFFAOYSA-L disodium hydrogenphosphate dodecahydrate Chemical compound O.O.O.O.O.O.O.O.O.O.O.O.[Na+].[Na+].OP([O-])([O-])=O DGLRDKLJZLEJCY-UHFFFAOYSA-L 0.000 description 2
- 239000000203 mixture Substances 0.000 description 2
- 238000010606 normalization Methods 0.000 description 2
- 235000015097 nutrients Nutrition 0.000 description 2
- 238000011160 research Methods 0.000 description 2
- 229940074545 sodium dihydrogen phosphate dihydrate Drugs 0.000 description 2
- 238000002835 absorbance Methods 0.000 description 1
- 230000009286 beneficial effect Effects 0.000 description 1
- 238000004364 calculation method Methods 0.000 description 1
- 230000010261 cell growth Effects 0.000 description 1
- 239000003795 chemical substances by application Substances 0.000 description 1
- 238000012937 correction Methods 0.000 description 1
- 238000007865 diluting Methods 0.000 description 1
- 239000012153 distilled water Substances 0.000 description 1
- 238000009826 distribution Methods 0.000 description 1
- 238000007710 freezing Methods 0.000 description 1
- 239000001963 growth medium Substances 0.000 description 1
- 238000000338 in vitro Methods 0.000 description 1
- 210000004072 lung Anatomy 0.000 description 1
- 238000004519 manufacturing process Methods 0.000 description 1
- 238000012986 modification Methods 0.000 description 1
- 230000004048 modification Effects 0.000 description 1
- 238000000926 separation method Methods 0.000 description 1
- BBMHARZCALWXSL-UHFFFAOYSA-M sodium dihydrogenphosphate monohydrate Chemical compound O.[Na+].OP(O)([O-])=O BBMHARZCALWXSL-UHFFFAOYSA-M 0.000 description 1
- 239000003643 water by type Substances 0.000 description 1
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- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N30/00—Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation
- G01N30/02—Column chromatography
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N30/00—Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation
- G01N30/02—Column chromatography
- G01N30/04—Preparation or injection of sample to be analysed
- G01N30/06—Preparation
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Abstract
The application relates to the technical field of bovine serum detection, and particularly discloses a method for controlling bovine serum product quality, which comprises the following steps: SA, collecting bovine serum products; SB, detecting the content of IgG polymers in the bovine serum; and SC, determining the quality of the bovine serum product according to the content of the IgG polymer. The method for controlling the quality of the bovine serum product is based on the great and stable content difference of IgG polymers in the bovine serum of the same-source standard, and the content of the IgG polymers in the bovine serum is taken as the basis, so that whether calf serum, adult bovine serum and the like are mixed in the fetal bovine serum product and the newborn bovine serum product or not is conveniently determined, the quality of the fetal bovine serum product and the newborn bovine serum product is ensured, and the product quality of vaccine enterprises is further ensured.
Description
Technical Field
The application relates to the technical field of bovine serum detection, in particular to a method for controlling bovine serum product quality.
Background
Bovine serum can be classified into fetal bovine serum, newborn bovine serum, calf serum, and adult bovine serum according to age. Wherein the fetal calf serum is fetal calf serum, and the newborn calf serum is newborn calf serum; the calf serum is calf serum; adult bovine serum is serum of adult cattle. Compared with calf and adult calf, the contact of the fetal calf and the neonatal calf to the outside is less, so that the fetal calf serum and the neonatal calf serum contain less antibodies and complements, and the fetal calf and the neonatal calf serum not only have natural nutrient components necessary for cell growth, but also have rich natural nutrient components and almost do not contain components harmful to cells. Therefore, the fetal bovine serum product and the newborn bovine serum product are widely applied to important culture media, and the quality of the fetal bovine serum product and the newborn bovine serum product has important influence on the in vitro culture of cells of vaccine production enterprises. At present, no methods for providing fetal bovine serum products and newly-generated bovine serum product quality control are provided for manufacturers, and a method for controlling bovine serum product quality is urgently needed to be researched.
Disclosure of Invention
In order to evaluate the quality of fetal bovine serum products and newborn bovine serum products, the application provides a method for controlling the quality of the bovine serum products.
The following technical scheme is adopted:
a method for controlling the quality of bovine serum products comprises the following steps:
SA, collecting bovine serum products;
SB, detecting the content of IgG polymers in the bovine serum;
and SC, determining the quality of the bovine serum product according to the content of the IgG polymer.
Some enterprises may mix calf serum and adult bovine serum into fetal bovine serum products and newborn bovine serum products for some reasons, so that the quality of the fetal bovine serum products and the quality of the newborn bovine serum products are influenced. Based on this finding, the applicant has conducted a great deal of research to obtain the present application.
Through the research of this application, the great and stable of IgG polymer content difference in different source standard ox sera, simultaneously along with the increase of ox age, IgG polymer content in the ox sera increases, can confirm whether sneak into calf serum, adult bovine serum etc. in fetal bovine serum product, the new-born bovine serum product through measuring IgG polymer content in the ox sera, guarantees the quality of fetal bovine serum product, new-born bovine serum product, and then guarantees vaccine enterprise product quality.
Optionally, the bovine serum product source is fetal bovine serum, newborn bovine serum, calf serum, adult bovine serum.
Optionally, the fetal calf serum is serum of a fetal calf born by caesarean section; the newborn bovine serum is serum of a newborn bovine after birth for 24 hours or less; the calf serum is the serum of calf between 24h-12 months; the adult bovine serum is the serum of adult cattle born for 12 months or more.
Through adopting above-mentioned technical scheme, be convenient for divide the bovine serum source according to the age of ox.
Optionally, in step SC, the basis for determining the quality of the bovine serum derived product is specifically: IgG multimer content in standard fetal calf serum: x Fetal calf Less than 1.5 percent; IgG multimer content in standard neonatal bovine serum: x is more than or equal to 1.5% Fetal calf Less than 4.5 percent; IgG polymer content in standard calf serum: x is more than or equal to 4.5% Calf Is less than 10.5 percent; content of IgG multimers in standard adult bovine serum: x Adult cattle ≥10.5％。
By adopting the technical scheme, the quality determination of fetal bovine serum products, newborn bovine serum products and calf serum products is provided with basis.
Optionally, in step SC, determining the quality of the fetal bovine serum product specifically comprises: if the content of IgG polymer in the fetal calf serum product is more than or equal to 1.5%, the fetal calf serum product is mixed with one or more of newborn calf serum, calf serum and adult calf serum.
Optionally, in step SC, determining the quality of the newborn bovine serum product specifically comprises: if the content of IgG polymer in the newborn calf serum product is more than or equal to 4.5 percent, the newborn calf serum product is mixed with one or more of calf serum and adult calf serum.
Optionally, in step SC, determining the quality of the calf serum product specifically comprises: if the content of IgG polymer in the calf serum product is more than or equal to 10.5 percent, the calf serum product is mixed into calf serum.
By adopting the technical scheme, whether the fetal bovine serum product provided by the manufacturer is mixed with newborn bovine serum, calf serum and adult bovine serum or not can be determined, and whether the fetal bovine serum product and the newborn bovine serum product are mixed with the newborn bovine serum or not can also be determined, so that the quality of the fetal bovine serum product and the quality of the newborn bovine serum product can be conveniently controlled. Meanwhile, whether the calf serum product provided by the manufacturer is mixed with adult serum can be determined, so that the quality of the calf serum product can be controlled conveniently.
Alternatively, in step SB, the content of IgG multimers is detected by high performance liquid chromatography.
By adopting the technical scheme, the accuracy of detecting the content of the IgG polymer in the bovine serum product is improved.
Optionally, in step SB, the following method is used for detecting the content of IgG multimers, and the method comprises the following steps:
s1, preparing a computer test solution: uniformly mixing the diluent and the bovine serum to obtain an upper computer to-be-detected liquid;
s2, performing on-machine analysis: performing on-machine analysis on the on-machine to-be-detected liquid by using a high performance liquid chromatograph to obtain the content of IgG polymers in the bovine serum;
and the testing conditions of the high performance liquid chromatograph are as follows: TSK gel G3000 SW gel chromatographic column, the gel chromatographic column is 7.5mm multiplied by 60cm, and the grain diameter of the filler is 10 μm; the detection wavelength was 280 nm.
By adopting the technical scheme, the testing conditions of the high performance liquid chromatograph are optimized, and the accuracy of the testing conditions of the high performance liquid chromatograph on the content detection of the IgG polymers in the bovine serum is improved.
Optionally, the diluent is mainly prepared from the following raw materials in parts by volume: 220 parts of sodium dihydrogen phosphate solution, 440 parts of disodium hydrogen phosphate solution, 13-18 parts of isopropanol and 930 parts of water 900;
the molar concentration of the sodium dihydrogen phosphate solution is 0.4-0.6mol/L, and the molar concentration of the disodium hydrogen phosphate is 0.4-0.6 mol/L.
By adopting the technical scheme, the diluent is mixed with the bovine serum to obtain the upper computer to-be-detected liquid, so that the separation of IgG polymers, IgG dimers and IgG monomers in the bovine serum is facilitated, and the content detection accuracy of the IgG polymers in the bovine serum is improved.
In summary, the present application has the following beneficial effects:
1. the method for controlling the quality of the bovine serum product determines the quality of the bovine serum product according to the content of IgG polymer in the bovine serum. Further, if the content of IgG polymer in the fetal calf serum product is more than or equal to 1.5%, the fetal calf serum product is mixed with one or more of newborn calf serum, calf serum and adult calf serum; if the content of IgG polymer in the newborn calf serum product is more than or equal to 4.5 percent, the newborn calf serum product is mixed with one or more of calf serum and adult calf serum. Whether sneak into calf serum, adult's serum etc. in being convenient for confirm fetal calf serum product, the newborn calf serum product, guarantee the quality of fetal calf serum product, newborn calf serum product, and then guarantee vaccine enterprise product quality.
2. The content of the IgG polymer is detected by adopting a high performance liquid chromatography, so that the accuracy of the content detection of the IgG polymer in a bovine serum product is improved.
Drawings
FIG. 1 is a liquid chromatogram of a fetal bovine serum as a standard A.
FIG. 2 is a liquid chromatogram of a standard B fetal bovine serum.
FIG. 3 is a liquid chromatogram of standard C newborn calf serum.
FIG. 4 is a liquid chromatogram of newborn bovine serum of standard D.
FIG. 5 is a liquid chromatogram of standard E in bovine serum.
FIG. 6 is a liquid chromatogram of control bovine blood gamma-globulin.
Detailed Description
The present application will be described in further detail with reference to examples.
The bovine serum product source is fetal bovine serum, newborn bovine serum, calf serum and adult bovine serum, and the fetal bovine serum is the serum of a fetal calf born by cesarean section; the newborn bovine serum is serum of a newborn bovine after birth for 24 hours or less; the calf serum is the serum of calf between 24h-12 months; the adult bovine serum is the serum of adult cattle born for 12 months or more.
Examples
Example 1
The high performance liquid chromatography detection method of the standard sample A fetal calf serum comprises the following steps:
preparing a diluent: the diluent is prepared by mixing the following raw materials: 200mL of sodium dihydrogen phosphate solution, 450mL of disodium hydrogen phosphate solution, 15.5mL of isopropanol and 914.5mL of water.
Wherein the molar concentration of the sodium dihydrogen phosphate solution is 0.5mol/L, and the sodium dihydrogen phosphate dihydrate and water are mixed to obtain the sodium dihydrogen phosphate-water mixture; the molar concentration of the disodium hydrogen phosphate is 0.5mol/L, and the disodium hydrogen phosphate dodecahydrate and water are mixed to obtain the water-based anti-freezing agent.
And, the sodium dihydrogen phosphate dihydrate is analytically pure; disodium hydrogen phosphate dodecahydrate was analytically pure; the isopropanol is chromatographically pure; the water is triple-effect distilled water.
Preparing a sample: standard a fetal bovine serum, supplied by Hyclone, lot number: SF 0007004.
Preparing a machine liquid to be tested: and uniformly mixing the diluent and the fetal calf serum of the standard sample A to obtain the liquid to be tested on the standard sample A, wherein the content of the fetal calf serum in the liquid to be tested on the standard sample A is 12 mg/mL.
And (3) computer analysis: performing on-machine analysis on the on-machine liquid to be tested by adopting a Waters e2695 high performance liquid chromatograph, wherein the testing conditions of the high performance liquid chromatograph are as follows:
the test system comprises: the Empower 3 system;
detection wavelength: 280 nm;
a chromatographic column: TSK gel G3000 SW gel chromatographic column, the gel chromatographic column is 7.5mm multiplied by 60cm, and the grain diameter of the filler is 10 μm;
mobile phase: diluting the solution;
flow rate: 0.6 mL/min;
sample introduction amount: 20 μ L.
Example 2
The HPLC detection method of the fetal bovine serum as the standard sample B is different from that of the example 1 in that the preparation of the sample and the preparation of the test solution on the computer are different.
Preparing a sample: standard B fetal bovine serum, supplied by Gibco, lot number: 1997802C.
Preparing a machine liquid to be tested: and uniformly mixing the diluent and the fetal calf serum of the standard sample B to obtain the liquid to be tested on the standard sample B, wherein the content of the fetal calf serum in the liquid to be tested on the standard sample B is 12 mg/mL.
Example 3
The HPLC detection method of the newborn bovine serum as the standard sample C is different from that of example 1 in that the preparation of the sample and the preparation of the test solution on the computer are different.
Preparing a sample: standard C newborn bovine serum, bright and bright, lot no: 20190406-1.
Preparing a machine liquid to be tested: and uniformly mixing the diluent and the newborn calf serum of the standard sample C to obtain the liquid to be tested on the standard sample C, wherein the content of the newborn calf serum in the liquid to be tested on the standard sample C is 12 mg/mL.
Example 4
The HPLC detection method of the newborn bovine serum as the standard sample D is different from that of the embodiment 1 in that the preparation of the sample and the preparation of the computer test solution are different.
Preparing a sample: standard D newborn bovine serum, supplied by Taiyuan Lung, lot 210311200.
Preparing a machine liquid to be tested: and uniformly mixing the diluent and the newborn calf serum of the standard sample D to obtain the liquid to be tested on the standard sample D, wherein the content of the newborn calf serum in the liquid to be tested on the standard sample D is 12 mg/mL.
Example 5
The HPLC detection method for bovine serum from the standard sample E is different from that of example 1 in that the preparation of the sample and the preparation of the test solution on the computer are different.
Preparing a sample: standard E was bovine serum, supplied by taiyuan run, lot No.: N/A (12 months).
Preparing a liquid to be tested on a computer: and uniformly mixing the diluent and the standard sample E to obtain a sample E on-machine solution to be tested, wherein the content of the bovine serum in the sample E on-machine solution to be tested is 12 mg/mL.
Comparative example
The method for detecting the gamma-globulin in the control bovine blood by the high performance liquid chromatography is different from that in the example 1 in that a sample is prepared and a solution to be detected is prepared.
Preparing a sample: bovine blood gamma-globulin, supplied by Solarbio; batch number: 3171031.
preparing a machine liquid to be tested: and uniformly mixing the diluent and the control bovine blood gamma-globulin to obtain a control upper computer test solution, wherein the content of the bovine blood gamma-globulin in the control upper computer test solution is 12 mg/mL.
In examples 1 to 5 and comparative example, liquid chromatograms of a standard sample A fetal bovine serum, a standard sample B fetal bovine serum, a standard sample C newborn bovine serum, a standard sample D newborn bovine serum, a standard sample E adult bovine serum and a comparative bovine blood gamma-globulin are sequentially shown in FIGS. 1 to 6, and the abscissa in the liquid chromatogram represents retention time/min and the ordinate represents absorbance/AU.
As shown in FIG. 6, the major peaks of the control bovine blood gamma-globulin are IgG multimer, IgG dimer, and IgG monomer. And the peak corresponding to the retention time of 16.7min is IgG multimer; the peak corresponding to the retention time of 20.7min is IgG dimer; the peak corresponding to retention time 24.7min is IgG monomer. And determining peaks of IgG polymer, IgG dimer and IgG monomer in the control bovine blood gamma-globulin main peak by using the retention time of the control bovine blood gamma-globulin main peak. Each peak in the liquid chromatogram is bounded by a vertical line from the lowest point between the two peaks to the baseline.
The peak areas of IgG multimers, IgG dimers, and IgG monomers of the bovine fetal serum of Standard A, the bovine fetal serum of Standard B, the newborn bovine serum of Standard C, the newborn bovine serum of Standard D, and the adult bovine serum of Standard E obtained in examples 1 to 5 are shown in Table 1.
TABLE 1 bovine serum lgG molecular weight distribution
From table 1, with reference to fig. 1 to 6, it can be seen that the peak area ratios of IgG multimers in the standard fetal bovine serum, the standard neonatal bovine serum, and the standard adult bovine serum are significantly different and stable.
The peak area ratio of the IgG polymer in the serum of the standard fetal calf is less than that of the IgG polymer in the serum of the standard newborn calf and less than that of the IgG polymer in the serum of the standard adult calf. The peak area ratio of IgG polymer in the serum of the standard sample E adult cows is 7.35 times of that of the IgG polymer in the serum of the standard sample A fetal cows and 8.26 times of that of the IgG polymer in the serum of the standard sample B fetal cows. The peak area ratio of the IgG polymer in the standard sample E adult bovine serum is 2.63 times of that of the IgG polymer in the standard sample C newborn bovine serum, and is 2.40 times of that of the IgG polymer in the standard sample D newborn bovine serum. Indicating that the content of IgG polymers in the bovine serum increases with the age of the cattle.
Based on the fact that the content of IgG polymers in the cattle serum increases along with the increase of the cattle age, and the content difference of the IgG polymers in the cattle serum from different sources is large and stable, the quality of a cattle serum product can be determined by measuring the content of the IgG polymers in the cattle serum.
Calculating the content of IgG polymers in the bovine serum by using a liquid chromatogram according to an area normalization method, wherein the calculation formula of the normalization method is as follows: y ═ fX;
in the formula, X is the peak area ratio of IgG polymer, and the unit is%;
y is the IgG multimer content in units;
f is the quantitative correction factor for the IgG multimer peak, f is 0.5.
The IgG multimer contents of the bovine serum derived from examples 1-5, for example, the bovine serum derived from Standard A, B, C, D, and E, are shown in Table 2.
TABLE 2 bovine serum lgG Polymer content
| Detecting items | IgG multimer peak area ratio/(%) | IgG multimer content/(%) |
| Standard sample A fetal bovine serum | 2.91 | 1.46 |
| Standard sample B fetal bovine serum | 2.59 | 1.30 |
| Standard sample C newborn bovine serum | 8.14 | 4.07 |
| Standard sample D newborn calf serum | 8.93 | 4.47 |
| Standard sample E into bovine serum | 21.39 | 10.70 |
According to the detection of the content of the IgG polymers in the table 2, the content of the IgG polymers in standard fetal calf serum, standard newborn calf serum, standard calf serum and standard adult calf serum is divided, and the method specifically comprises the following steps: IgG multimer content in standard fetal calf serum: x Fetal calf Less than 1.5 percent; IgG multimer content in standard neonatal bovine serum: x is more than or equal to 1.5% Fetal calf Less than 4.5 percent; IgG multimer content in standard calf serum: x is more than or equal to 4.5% Calf Less than 10.5 percent; content of IgG multimers in standard adult bovine serum: x Adult cattle ≥10.5％。
The quality of a bovine serum product provided by a manufacturer is determined by utilizing the content of IgG polymers in the bovine serum:
based on the content of IgG polymers in standard fetal calf serum: x Fetal calf Is less than 1.5 percent. If the content of IgG polymer in the fetal calf serum product is more than or equal to 1.5%, the fetal calf serum product is mixed with one or more of newborn calf serum, calf serum and adult calf serum.
Based on the IgG multimer content in standard newborn bovine serum: x is more than or equal to 1.5% Fetal calf Is less than 4.5 percent. If the content of IgG polymer in the newborn calf serum product is more than or equal to 4.5 percent, the newborn calf serum product is mixed with one or more of calf serum and adult calf serum.
Based on the content of IgG polymers in standard calf serum: x is more than or equal to 4.5% Calf Is less than 10.5 percent. If the content of IgG polymer in the calf serum product is more than or equal to 10.5 percent, the calf serum product is mixed into calf serum.
Application example
Application example 1
A method for controlling the quality of bovine serum products comprises the following steps:
and SA, collecting a bovine serum product.
Wherein, the bovine serum product is fetal bovine serum provided by a certain manufacturer.
SB, the content of IgG polymers in the bovine serum is detected, the high performance liquid chromatography detection method of the standard sample A fetal bovine serum of the embodiment 1 is adopted, and the method is different from the embodiment 1 in that a sample is prepared and a computer test solution is prepared.
Preparing a sample: fetal bovine serum from the manufacturer.
Preparing a liquid to be tested on a computer: and uniformly mixing the diluent and the fetal calf serum to obtain the upper computer test solution, wherein the content of the fetal calf serum in the upper computer test solution is 12 mg/mL.
And SC, determining the quality of the bovine serum product according to the content of the IgG polymer.
Wherein, the content of IgG polymer in the fetal calf serum product provided by the manufacturer is 1.38 percent, and the content of IgG polymer is less than 1.5 percent. The fetal calf serum product provided by the manufacturer is not mixed with any one of newborn calf serum, calf serum and adult calf serum, and the fetal calf serum product provided by the manufacturer is better in quality.
Application example 2
A method for controlling the quality of bovine serum products, which is different from application example 1 in that the bovine serum products are newborn bovine serum provided by a certain manufacturer. And the newborn bovine serum product provided by the manufacturer has the IgG polymer content of 6.4 percent and the IgG polymer content of more than 4.5 percent. One or more of calf serum and adult bovine serum are mixed into the newborn bovine serum product provided by the manufacturer. Further, the quality of the newborn bovine serum product provided by the manufacturer is poor.
Application example 3
A method for controlling the quality of bovine serum products, which is different from application example 1 in that bovine serum products are calf serum provided by a certain manufacturer. And the content of IgG polymer in the calf serum product provided by the manufacturer is 8.6%, and the content of IgG polymer is less than 10.5%. The calf serum product provided by the manufacturer is not mixed with bovine serum. Further, the calf serum product provided by the manufacturer has better quality.
The present embodiment is only for explaining the present application, and it is not limited to the present application, and those skilled in the art can make modifications of the present embodiment without inventive contribution as needed after reading the present specification, but all of them are protected by patent law within the scope of the claims of the present application.
Claims (10)
1. A method for controlling the quality of bovine serum products is characterized in that: the method comprises the following steps:
SA, collecting bovine serum products;
SB, detecting the content of IgG polymers in the bovine serum;
and SC, determining the quality of the bovine serum product according to the content of the IgG polymer.
2. The method of claim 1, wherein the method comprises: the bovine serum product is derived from fetal bovine serum, newborn bovine serum, calf serum and adult bovine serum.
3. The method of claim 2, wherein the bovine serum product quality control method comprises: the fetal calf serum is serum of a fetal calf born by caesarean section; the newborn calf serum is the serum of a newborn calf which is postnatal and less than or equal to 24 h; the calf serum is the serum of calf between 24h-12 months; the adult bovine serum is the serum of adult cattle born for 12 months or more.
4. The method of claim 2, wherein the bovine serum product quality control method comprises: in step SC, the basis for determining the quality of bovine serum derived products is specifically as follows: IgG multimer content in standard fetal calf serum: x Fetal calf Less than 1.5 percent; IgG multimer content in standard neonatal bovine serum: x is more than or equal to 1.5% Fetal calf Less than 4.5 percent; IgG multimer content in standard calf serum: x is more than or equal to 4.5% Calf Less than 10.5 percent; content of IgG multimers in standard adult bovine serum: x Adult cattle ≥10.5%。
5. The method of claim 2, wherein the bovine serum product quality control method comprises: in step SC, the quality of the fetal bovine serum product is determined as follows: if the content of IgG polymer in the fetal calf serum product is more than or equal to 1.5%, the fetal calf serum product is mixed with one or more of newborn calf serum, calf serum and adult calf serum.
6. The method of claim 2, wherein the bovine serum product quality control method comprises: in step SC, the quality of the newborn bovine serum product is determined as follows: if the content of IgG polymer in the newborn calf serum product is more than or equal to 4.5 percent, the newborn calf serum product is mixed with one or more of calf serum and adult calf serum.
7. The method of claim 2, wherein the bovine serum product quality control method comprises: in step SC, the quality of calf serum products is determined as follows: if the content of IgG polymer in the calf serum product is more than or equal to 10.5 percent, the calf serum product is mixed into calf serum.
8. The method of claim 1, wherein the method comprises: in the step SB, the content of IgG polymer is detected by high performance liquid chromatography.
9. The method of claim 8, wherein the step of controlling the quality of the bovine serum product comprises: in the step SB, the following method is adopted for detecting the content of the IgG multimer, and the method comprises the following steps:
s1, preparing a computer test solution: uniformly mixing the diluent and the bovine serum to obtain an upper computer to-be-detected liquid;
s2, performing on-machine analysis: performing on-machine analysis on the on-machine to-be-detected liquid by using a high performance liquid chromatograph to obtain the content of IgG polymers in the bovine serum;
and the testing conditions of the high performance liquid chromatograph are as follows: TSK gel G3000 SW gel chromatographic column, the gel chromatographic column is 7.5mm multiplied by 60cm, and the grain diameter of the filler is 10 μm; the detection wavelength was 280 nm.
10. The method of claim 9, wherein the step of controlling the quality of the bovine serum product comprises: the diluent is mainly prepared from the following raw materials in parts by volume: 220 parts of sodium dihydrogen phosphate solution, 440 parts of disodium hydrogen phosphate solution, 13-18 parts of isopropanol and 930 parts of water 900;
the molar concentration of the sodium dihydrogen phosphate solution is 0.4-0.6mol/L, and the molar concentration of the disodium hydrogen phosphate is 0.4-0.6 mol/L.
Priority Applications (1)
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