Preparation method of anti-Mullerian hormone quality control substance
What is Al technical title?
Al technical title is built by PatSnap Al team. It summarizes the technical point description of the patent document.
A quality and hormone technology, applied in the field of preparation of anti-Mullerian hormone quality control products, can solve the problems of affecting detection, plasma matrix precipitation, etc., and achieve the effect of high consistency, good stability and stable performance
Inactive Publication Date: 2019-02-15
郑州标源生物科技有限公司
View PDF8 Cites 1 Cited by
Summary
Abstract
Description
Claims
Application Information
AI Technical Summary
This helps you quickly interpret patents by identifying the three key elements:
Problems solved by technology
Method used
Benefits of technology
Problems solved by technology
Since the treated human plasma is used as the matrix fluid, although it is relatively similar to the type of human test samples, the plasma matrix is prone to precipitation after repeated freezing and thawing, which affects the detection
Method used
the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
View more
Image
Smart Image Click on the blue labels to locate them in the text.
Viewing Examples
Smart Image
Click on the blue label to locate the original text in one second.
Reading with bidirectional positioning of images and text.
Smart Image
Examples
Experimental program
Comparison scheme
Effect test
Embodiment 1
[0025] Example 1 Preparation of Anti-Müllerian Hormone Quality Control Products
[0026] The first step is to use commercial hormone-free serum to measure HBsAg, hepatitis C antibody, syphilis antibody, and HIV antibody in the serum respectively;
[0027] In the second step, select hormone-free serum that is negative for HBsAg, hepatitis C antibody, syphilis antibody, and HIV antibody, and then add 0.2% sodium azide, 0.2% Proclin300, 0.2% gentamicin sulfate, and 0.2% thimerosal , 5% trehalose, and mix well;
[0028] The third step is to measure the background value of anti-Müllerian hormone and store it temporarily at 2-8°C;
[0029] In the fourth step, according to the background value determined in the third step, anti-Müllerian hormone-positive substances are added, and the concentrations are 1.0ng / ml, 5.0ng / ml, and 15.0ng / ml respectively;
[0030] The fifth step is to store the substance obtained in the fourth step at a temperature of 2-8°C for 3-14 days, so that the com...
Embodiment 2
[0031] The performance measurement of the quality control product prepared in embodiment 2 embodiment 1
[0032] 1. Stability
[0033] Three-level (1.0ng / ml, 5.0ng / ml, 15.0ng / ml) quality control products were tested in turn by storing them at 2-8°C after reconstitution, accelerating at 37°C in a freeze-dried state, and testing the number of freeze-thaw cycles after reconstitution. The test data are shown in Table 1 below:
[0034] Table 1
[0035]
[0036] From the data in the table, it can be seen that the anti-Müllerian hormone quality control product was opened and reconstituted, stored at 2-8°C for 14 days, heat-accelerated at 37°C for 14 days, and after repeated freezing and thawing for 5 times, the decrease was less than 5%. The stability meets the requirements.
[0037] 2. Check the consistency between platforms
[0038] Three-level (1.0ng / ml, 5.0ng / ml, 15.0ng / ml) quality control substances were tested on mainstream platforms (Roche, Beckman) respectively. The te...
the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
Login to view more
PUM
Login to view more
Abstract
The invention discloses a preparation method of an anti-Mullerian hormone quality control substance. The preparation method comprises the following steps: selecting hormone removing blood serum meeting the demand; adding Proclin300, gentamicin sulfate, sodium azide, thiomersalate and trehalose to be uniformly mixed; first, measuring a background value of the anti-Mullerian hormone; then adding ananti-Mullerian hormone positive substance to the set value 0.5-20.0 ng / mL; and sub-packaging the substance obtained in the S4 in a specification of 1.0 ml / bottle in a 4 ml brown glass bottle for vacuum freezing and drying to obtain the anti-Mullerian hormone quality control substance and storing the anti-Mullerian hormone quality control substance at 2-8 DEG C. The quality control substance selects the hormone removing blood serum and can be in commercial production. Meanwhile, as the anti-Mullerian hormone quality control substance is high in consistence to a normal human sample, the matrix effect is reduced to the maximum extent, so that the anti-Mullerian hormone quality control substance is suitable for instruments and reagents of mainstream factories. The quality control substance isa freeze-dried quality control substance which is high in stability, is not affected by factors such as transportation and temperature, and is stable in performance.
Description
technical field [0001] The invention relates to biological products, in particular to a preparation method of an anti-Müllerian hormone quality control product. Background technique [0002] Serum anti-Mullerian hormone (Anti-Mullerian Hormone, AMH) is a dimeric glycoprotein secreted by female follicular granulosa cells and male testicular Sertoli cells, which can inhibit the recruitment and growth of female follicles and regulate the function of male testicular Leydig cells . Most of the articles published so far describe its clinical application. For example, detecting serum AMH levels can be used to evaluate ovarian reserve, predict ovarian response in assisted reproduction, evaluate ovarian reserve in tumor patients, and assist in the diagnosis of polycystic ovary syndrome, ovarian cancer, and ovarian cancer. Premature aging and predicting menopause, etc. [0003] The level of AMH is not affected by pituitary gonadotropins, and the value changes little throughout the m...
Claims
the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
Login to view more
Application Information
Patent Timeline
Application Date:The date an application was filed.
Publication Date:The date a patent or application was officially published.
First Publication Date:The earliest publication date of a patent with the same application number.
Issue Date:Publication date of the patent grant document.
PCT Entry Date:The Entry date of PCT National Phase.
Estimated Expiry Date:The statutory expiry date of a patent right according to the Patent Law, and it is the longest term of protection that the patent right can achieve without the termination of the patent right due to other reasons(Term extension factor has been taken into account ).
Invalid Date:Actual expiry date is based on effective date or publication date of legal transaction data of invalid patent.
Login to view more 
Login to view more