Preparation method of antinuclear antibody freeze-drying quality control product

Abstract

The invention relates to the technical field of reagent preservation, in particular to a preparation method of an antinuclear antibody freeze-drying quality control product. The antinuclear antibody freeze-dried quality control product comprises various antibodies of antinuclear antibodies, a buffer substance, an excipient, a preservative, a coloring agent and the like. According to the invention, a plurality of antibody substances of the anti-nuclear antibody, the excipient and the protein protective agent are combined and subjected to freeze-drying treatment, so that long-term storage can be realized, and the function that one bottle of quality control product can be used for multiple items can also be realized. When the mixed quality control product is used, a certain volume of purified water is added for redissolving, and the mixture is uniformly mixed. The added coloring agent can be distinguished from colorless water, so that wrong sample addition or repeated dissolution is avoided. The method is convenient to use and store, economical and practical, and simple to prepare.

Description

Technical Field

[0001] The invention relates to the technical field of reagent preservation, and in particular to a method for preparing a freeze-dried anti-nuclear antibody quality control product. Background Art

[0002] Antinuclear antibodies (ANA), also known as anti-nucleic acid antigen antibodies, are a general term for a group of autoantibodies that use various components of their own eukaryotic cells, such as deoxyribonucleoprotein (DNP), DNA, extractable nuclear antigen (ENA) and RNA, as target antigens. They can react with the cell nuclei of all animals. They are mainly present in serum, but can also be present in pleural effusion, synovial fluid and urine. Antinuclear antibody detection is the main method for screening autoimmune diseases. Common antinuclear antibody detection items include: Anti-dsDNA, Anti-Scl-70, Anti-SS-A / Ro, Anti-Ro-52, Anti-Sm, Anti-nRNP / Sm, Anti-Jo-1, Anti-rib-P, Anti-CENP-B, Anti-Histone and other autoantibodies. At present, magnetic particle chemiluminescence detection kits for single antinuclear antibody items have been gradually developed on the market, and quality control has become more and more stringent, but quality control products for these detection kits have not yet been developed, or some developed quality control products are limited to quality control products for total antinuclear antibody detection, and most of them are liquid quality control products. Liquid quality control products have poor stability and are easily affected by high temperature and freezing during transportation and storage, causing evaporation or crystallization, which brings difficulties to transportation and storage. At the same time, it may cause deviations in the measurement results of quality control products, and it is impossible to strictly control the quality of the kits. Moreover, the quality control products commonly used in the market are mostly quality control products for a single antinuclear antibody detection item, while the quality control products for the total antinuclear antibody detection cannot perform quality inspection and control on the test kits for each single item. If quality control of each single item is required, quality control products for multiple items must be purchased separately. When multiple items are jointly quality controlled, cross-addition is prone to occur, and there is a possibility of adding the wrong quality control product. In addition, the cost of preparing and purchasing a single quality control product separately is high, and the cost of use is also high. Summary of the invention

[0003] In view of this, the present invention provides a method for preparing a freeze-dried anti-nuclear antibody quality control product. The quality control product of the present invention can be stored for a long time, is easy to use and store, is simple to prepare, and has more economical preparation and use costs.

[0004] In order to achieve the above-mentioned object of the invention, the present invention provides the following technical solutions:

[0005] The present invention provides a freeze-dried antinuclear antibody quality control product, comprising an antinuclear antibody, a buffer substance, an excipient, and a preservative;

[0006] The antinuclear antibodies include at least two of Anti-dsDNA, Anti-Sm, and Anti-rib-P;

[0007] The preservative may be at least one of Proclin 300 and MIT.

[0008] In some specific embodiments of the present invention, the antinuclear antibody of the above-mentioned antinuclear antibody freeze-dried quality control product also includes at least one of Anti-Scl-70, Anti-SS-A / Ro, Anti-Ro-52, Anti-nRNP / Sm, Anti-Jo-1, Anti-CENP-B, and Anti-Histone.

[0009] In some specific embodiments of the present invention, the buffer substance of the above-mentioned anti-nuclear antibody freeze-dried quality control product can be at least one of tris(hydroxymethyl)aminomethane, sodium chloride, and phosphate buffer.

[0010] In some specific embodiments of the present invention, the excipient of the above-mentioned anti-nuclear antibody freeze-dried quality control product can be at least one of bovine serum albumin, casein, and calf serum.

[0011] In some specific embodiments of the present invention, the above-mentioned antinuclear antibody freeze-dried quality control product comprises, by weight: 1 part of the preservative and 25 parts of the excipient.

[0012] In some specific embodiments of the present invention, the above-mentioned antinuclear antibody freeze-dried quality control product includes, by weight: 5.95 parts of tris(hydroxymethyl)aminomethane, 8.05 parts of sodium chloride, 1 part of MIT, and 25 parts of bovine serum albumin.

[0013] In some specific embodiments of the present invention, the above-mentioned anti-nuclear antibody freeze-dried quality control product further includes at least one of a stabilizer, a protein protectant, and a colorant.

[0014] In some specific embodiments of the present invention, the stabilizer of the above-mentioned anti-nuclear antibody freeze-dried quality control product can be trehalose and / or sucrose.

[0015] In some specific embodiments of the present invention, the protein protective agent of the above-mentioned anti-nuclear antibody freeze-dried quality control product can be ADP and / or BB2.

[0016] In some specific embodiments of the present invention, the colorant of the above-mentioned anti-nuclear antibody freeze-dried quality control product is at least one of sunset color (sunset yellow), lemon color (lemon yellow), and carmine color (carmine red).

[0017] In some specific embodiments of the present invention, the above-mentioned antinuclear antibody freeze-dried quality control product includes, by weight: 20 parts of the stabilizer, 1 part of the protein protectant, and 0.05-5.0 parts of the colorant.

[0018] In some specific embodiments of the present invention, the above-mentioned antinuclear antibody freeze-dried quality control product includes, by weight: 20 parts of trehalose, 1 part of ADP, 0.03 parts of sunset color, and 0.03 parts of lemon color.

[0019] The present invention also provides a method for preparing a freeze-dried anti-nuclear antibody quality control product, comprising the following steps:

[0020] Step (1): mixing a buffer substance with a solvent, adjusting the pH, and adjusting the concentration to obtain a buffer solution;

[0021] Step (2): mixing the auxiliary agent with the buffer to obtain a quality control dilution solution;

[0022] Step (3): mixing the antinuclear antibody with the quality control diluent to obtain a quality control solution;

[0023] Step (4): freeze-drying the quality control solution to obtain an antinuclear antibody freeze-dried quality control product;

[0024] The auxiliary agents include excipients and preservatives;

[0025] The preservative may be at least one of Proclin300 and MIT;

[0026] The antinuclear antibodies include at least two of Anti-dsDNA, Anti-Sm, and Anti-rib-P.

[0027] In some specific embodiments of the present invention, the buffer substance in the above preparation method can be at least one of tris(hydroxymethyl)aminomethane, sodium chloride, and phosphate buffer.

[0028] In some specific embodiments of the present invention, the auxiliary agent in the above preparation method also includes at least one of a stabilizer, a protein protective agent, and a colorant.

[0029] In some specific embodiments of the present invention, the excipient in the above preparation method can be at least one of bovine serum albumin, casein, and calf serum.

[0030] In some specific embodiments of the present invention, the stabilizer in the above preparation method may be trehalose and / or sucrose.

[0031] In some specific embodiments of the present invention, the protein protecting agent in the above preparation method may be ADP and / or BB2.

[0032] In some specific embodiments of the present invention, the colorant in the above preparation method includes at least one of sunset color, lemon color, and carmine color.

[0033] In some specific embodiments of the present invention, the antinuclear antibody in the above preparation method also includes at least one of Anti-Scl-70, Anti-SS-A / Ro, Anti-Ro-52, Anti-nRNP / Sm, Anti-Jo-1, Anti-CENP-B, and Anti-Histone.

[0034] In some specific embodiments of the present invention, in the above preparation method, the preservative is 1 part and the excipient is 25 parts by weight.

[0035] In some specific embodiments of the present invention, in the above preparation method, the stabilizer is 20 parts, the protein protective agent is 1 part, and the colorant is 0.05-5.0 parts by weight.

[0036] In some specific embodiments of the present invention, in the above preparation method, the tris(hydroxymethyl)aminomethane is 5.95 parts, the sodium chloride is 8.05 parts, the MIT is 1 part, and the bovine serum albumin is 25 parts by weight.

[0037] In some specific embodiments of the present invention, in the above preparation method, the trehalose is 20 parts, the ADP is 1 part, the sunset color is 0.03 parts, and the lemon color is 0.03 parts by weight.

[0038] In some specific embodiments of the present invention, the freeze-drying in the above preparation method includes the steps of pre-freezing and freeze-drying, and the pre-freezing condition is -50°C.

[0039] The present invention has the following beneficial effects:

[0040] The antinuclear antibody quality control product of the present invention is an antinuclear antibody mixed quality control product containing at least 5 or more of the following 10 antibodies: Anti-dsDNA, Anti-Scl-70, Anti-SS-A / Ro, Anti-Ro-52, Anti-Sm, Anti-nRNP / Sm, Anti-Jo-1, Anti-rib-P, Anti-CENP-B, Anti-Histone. The freeze-dried quality control product of the present invention is convenient to store and transport, and is economical and affordable. One-time addition can be used to control the quality of multiple items in the antinuclear antibody series, and the detection efficiency is high and easy to use. Experiments show that:

[0041] (1) The freeze-dried product prepared by the method of the present invention can be stored at 2-8°C for 2 years: after 14 days of thermal acceleration test at 37°C, the variation is less than 10%, and the shelf life is estimated to be 2 years according to the Arrhenius formula;

[0042] (2) The freeze-dried product prepared by the method of the present invention was tested for uniformity after reconstitution. Ten items of antinuclear antibodies were tested respectively, and the CV between bottles was within 10%. The freeze-dried quality control product of the present invention had good uniformity.

[0043] It can be seen that the freeze-dried quality control product prepared by mixing multiple antibodies of anti-nuclear antibodies and adding multiple protective agents can achieve long-term storage, and can realize simultaneous detection of multiple items by adding samples at one time, and by adding colorants, repeated dissolution and sample addition operation errors are avoided. When using the freeze-dried quality control product of the anti-nuclear antibody of the present invention, a certain volume of purified water is added for redissolution, and it can be used after mixing. This method is convenient to store, has a long storage period, is simple to prepare, and has low cost of use, which is economical and affordable. DETAILED DESCRIPTION

[0044] The present invention discloses a method for preparing a freeze-dried quality control product of an anti-nuclear antibody. Those skilled in the art can refer to the content of this article and appropriately improve the process parameters to achieve it. It should be particularly noted that all similar substitutions and modifications are obvious to those skilled in the art, and they are all considered to be included in the present invention. The methods and applications of the present invention have been described through preferred embodiments, and relevant personnel can obviously modify or appropriately change and combine the methods and applications described herein without departing from the content, spirit and scope of the present invention to implement and apply the technology of the present invention.

[0045] The invention provides an antinuclear antibody freeze-dried quality control product, which comprises multiple antibody components of antinuclear antibodies, a buffer substance, an excipient, a stabilizer, a protein protective agent, a preservative and a colorant.

[0046] Preferably, the various antibody components of the antinuclear antibody quality control product use high-value recombinant antibodies as raw materials, because high-value serum antibodies for Anti-dsDNA, Anti-Sm, and Anti-rib-P items are difficult to obtain, and the remaining raw materials use natural high-value serum samples. The high values ​​of each item are diluted with buffer substances to obtain quality control products with low positive or high positive results for each single item.

[0047] Preferably, the prepared low-positive quality control products are quality control products at the upper and lower limits of the reference interval of each item, and the high-positive quality control products are quality control products in the concentration range of 50% to 80% of the linear interval of each item.

[0048] Preferably, the buffer substance is selected from one of Tris buffer, Tris-NaCl buffer and PBS buffer, and the pH value is 7.2-7.4.

[0049] Preferably, the buffer substance is Tris-NaCl buffer with a pH value of 7.4.

[0050] Preferably, the excipient is selected from bovine serum albumin, casein, and calf serum, and the content of the excipient is 15-35 g per 1 L.

[0051] Preferably, bovine serum albumin is used as the excipient, and the content of the excipient is 25 g per 1 L.

[0052] Preferably, the stabilizer is selected from trehalose and sucrose, and the content of the stabilizer is 10-50 g per 1 L.

[0053] Preferably, trehalose is used as the stabilizer, and the content of the excipient is 20 g based on 1 L.

[0054] Preferably, the protein protective agent is selected from one or both of BB2 and ADP, and the content of the protein protective agent is 0.5-3 g per 1 L.

[0055] Preferably, the protein protective agent is ADP, and the content is 1 g per 1 L.

[0056] Preferably, the preservative is selected from one or both of Proclin 300 and MIT, and the content of the preservative is 0.5-3 g per 1 L.

[0057] Preferably, the preservative is selected from MIT, and the content of the preservative is 1 g based on 1 L.

[0058] Preferably, the colorant is selected from one or more of sunset color, lemon color or carmine color, and the content of the colorant is 0.05-5.0 g per 1 L.

[0059] Preferably, the colorant is a mixture of sunset color and lemon color, and the content of the two colorants is 0.03 g per 1 L.

[0060] The present invention also provides a method for preparing the above-mentioned antinuclear antibody freeze-dried quality control product, the process is as follows:

[0061] (1) preparing a buffer solution according to the preferred formula described above;

[0062] (2) Use the single-item test kits of the antinuclear antibody series produced by Antu Biotechnology to configure the required low positive quality control and high positive quality control concentrations;

[0063] (3) The prepared liquid quality control product is packaged and pre-frozen at -50°C for 6 hours. After pre-freezing, vacuum drying is performed.

[0064] The invention provides a method for preparing a freeze-dried quality control product of an antinuclear antibody, which comprises a plurality of antibodies of the antinuclear antibody, a buffer substance, an excipient, a protein protective agent, a preservative, and a colorant.

[0065] It should be understood that the expression "one or more of..." includes each of the items recited after the expression individually and in various different combinations of two or more of the recited items, unless otherwise understood from the context and usage. The expression "and / or" in combination with three or more recited items should be understood to have the same meaning, unless otherwise understood from the context.

[0066] The use of the terms "comprising", "having" or "containing", including their grammatical synonyms, should generally be understood as open and non-restrictive, for example not excluding other unrecited elements or steps, unless otherwise specifically stated or otherwise understood from the context.

[0067] It should be understood that the order of steps or the order in which certain actions are performed is not important as long as the application is still operable. In addition, two or more steps or actions can be performed simultaneously.

[0068] The use of any and all examples or exemplary language such as "for example" or "including" herein is intended only to better illustrate the present application and is not intended to limit the scope of the present application. No language in this specification should be construed as indicating that any unclaimed element is essential to the practice of the present application.

[0069] In addition, the numerical ranges and parameters used to define the present application are approximate values, and the relevant values ​​in the specific embodiments have been presented as accurately as possible. However, any numerical value inherently inevitably contains standard deviations due to individual test methods. Therefore, unless otherwise expressly stated, it should be understood that all ranges, quantities, values ​​and percentages used in this disclosure are modified by "about". Here, "about" generally refers to the actual value within plus or minus 10%, 5%, 1% or 0.5% of a specific value or range.

[0070] The terms used in the present invention are explained as follows.

[0071] ANA: antinuclear antibody;

[0072] Anti-dsDNA: Anti-double-stranded DNA antibody;

[0073] Anti-Scl-70: Anti-Scl-70 antibody;

[0074] Anti-SS-A / Ro: anti-SS-A / Ro antibody;

[0075] Anti-Ro-52: Anti-Ro-52 antibody;

[0076] Anti-Sm: Anti-Sm antibody;

[0077] Anti-nRNP / Sm: Anti-nRNP / Sm antibody;

[0078] Anti-Jo-1: Anti-Jo-1 antibody;

[0079] Anti-rib-P: Anti-rib-P antibody;

[0080] Anti-CENP-B: anti-centromere B antibody;

[0081] Anti-Histone: anti-histone antibody.

[0082] Unless otherwise specified, the raw materials, reagents, consumables and instruments involved in the present invention are all common commercial products and can be purchased from the market.

[0083] The present invention will be further described below in conjunction with the embodiments.

[0084] Example 1: Preparation of Tris-NaCl buffer solution (taking 1 L as an example)

[0085] Accurately weigh 5.95 g of Tris and 8.05 g of sodium chloride, add purified water accounting for about 80% of the total mass of the buffer solution into a container, then add accurately weighed Tris and sodium chloride, and stir thoroughly to dissolve; adjust the pH value of the solution to pH=7.40±0.05 (measured using a pH meter) with 6 mol / L hydrochloric acid; add purified water to the total mass of the buffer solution.

[0086] Example 2: Preparation of quality control dilution solution (taking 1L as an example)

[0087] Accurately measure 1 L of Tris-NaCl buffer solution, add 1 g of MIT 2682-20-4, 25 g of bovine serum albumin, 0.03 g of sunset color, and 0.03 g of lemon colorant. Stir well and store at 2-8°C.

[0088] Example 3: Preparation of freeze-dried antinuclear antibody quality control

[0089] (1) Preparation of antinuclear antibody freeze-dried quality control solution

[0090] The quality control diluent prepared in Example 2 above was used in combination with 10 antinuclear antibody single-item detection kits (Anti-dsDNA; Anti-Scl-70; Anti-SS-A / Ro; Anti-Ro-52; Anti-Sm; Anti-nRNP / Sm; Anti-Jo-1; Anti-rib-P; Anti-CENP-B; Anti-Histone) produced by Antu Biological, and each high-value serum sample was diluted according to the low positive concentration and high positive concentration of its single-item antibody detection kit. The low positive concentration range was controlled near the reference interval range, and the high positive quality control concentration was controlled in the linear interval of 50% to 80%, to obtain 10 antinuclear antibody freeze-dried quality control solutions.

[0091] (2) Preparation of freeze-dried antinuclear antibody quality control

[0092] The prepared mixed quality control solutions were fully mixed and set aside. After preparation, they were divided into 1 mL / bottle as needed, placed in 3 mL transparent glass bottles, and pre-frozen at -50°C before freeze-drying. After pre-freezing, they were placed in a freeze dryer for freeze-drying.

[0093] Effect Example 1: Stability Assessment

[0094] Two different concentrations of antinuclear antibody freeze-dried quality control products prepared in Example 3 and two different concentrations of antinuclear antibody liquid quality control products were placed in an oven at 37°C for 7 d and 14 d, respectively, and compared with the detection concentration values ​​at 2~8°C (detected using Antu Biotech A2000Plus instrument with 10 single-item detection kits).

[0095] The test results are shown in Table 1. The liquid quality control products accelerated for 14 days cannot meet the bias within ±10% for 10 single items compared with the test results at 2-8℃. The freeze-dried quality control products accelerated for 14 days can meet the bias within ±10% for 10 single items compared with the test results at 2-8℃.

[0096] Calculation according to the Arrhenius formula shows that the freeze-dried quality control product prepared by the present invention can be stably stored at 2-8° C. for 2 years, and the freeze-dried quality control product has a longer shelf life than the liquid quality control product.

[0097] Table 1

[0098]

[0099] Effect example 2: Assessment between different batches

[0100] Using the same preparation method as shown in Example 3, 3 batches of 10 items of low-positive freeze-dried quality control products and high-positive freeze-dried quality control products were prepared at different time periods; 1 bottle of each of the 3 batches of low-positive freeze-dried quality control products and high-positive freeze-dried quality control products were taken and reconstituted at the same time. The antinuclear antibody 10-item single-item kit was used for detection, and the concentration value deviations of the 3 batches of freeze-dried quality control products from the target value were calculated.

[0101] The test results are shown in Table 2. The deviation between the mean values ​​of the three batches and the target value is within ±15%, and the CV variation of the three batches is within 10%, which proves that the three batches of quality control products are good and the process is stable.

[0102] Table 2

[0103]

[0104] Effect Example 3: Uniformity Assessment of Freeze-dried Anti-nuclear Antibody Quality Control Products

[0105] The quality control product prepared by the method shown in Example 3 was tested for uniformity according to the following method, and the coefficient of variation between bottles was calculated ( ).

[0106] Take 10 bottles of quality control products of the same batch number and each level, test each bottle of quality control product once with the corresponding test kit, and calculate the average value of the 10 test results according to formula 1 and formula 2 ( ) and standard deviation S 1 ; Use one of the 10 bottles of quality control products to test 10 times in a row, and calculate the average of the 10 test results ( ) and standard deviation S 2 ; Calculate the bottle-to-bottle repeatability (CV, %) according to the following formula. The test results should not be greater than 10.0%.

[0107] Formula 1:

[0108] Formula 2:

[0109] Formula 3:

[0110] Formula 4: (%)=

[0111] When S 1 <S 2 season =0.

[0112] Where: ----average value;

[0113] S----standard deviation;

[0114] n----Number of measurements;

[0115] x i ----Specify the i-th measurement value of the parameter.

[0116] The test results are shown in Table 3. The results of the simultaneous testing of high and low quality control products by the above method for the 10 single-item test kits of antinuclear antibodies showed that the CV variation between bottles was within 10%, indicating that the uniformity of the freeze-dried quality control product of the present invention was good.

[0117] Table 3

[0118]

[0119]

[0120] Comparative Example: Effects of different formula components on the stability of composite quality control products after reconstitution

[0121] Specific experimental process: Use the quality control diluent prepared according to the method shown in Example 2, the quality control diluent using sodium azide as a preservative, and the quality control diluent using glucose as a stabilizer to prepare low-value and high-value quality control products prepared with 10 kinds of antibodies, respectively, and freeze-dry them. The freeze-dried quality control products are placed in an oven at 37°C for 7 d, 10 d, and 14 d, respectively, and the concentration values ​​are compared with those of the current dissolved quality control products stored at 2-8°C.

[0122] The test results showed that for the control products prepared with sodium azide as preservative and glucose as stabilizer in the control product diluent, the test results of Anti-Scl-70, Anti-SS-A / Ro, Anti-Ro-52, Anti-nRNP / Sm, Anti-Jo-1, Anti-CENP-B, and Anti-Histone projects were not biased much when accelerated for 7 days and at 2-8℃.

[0123] However, the bias of the Anti-dsDNA, Anti-Sm, and Anti-rib-P items after accelerated placement for 7 days was greater than 10% compared with the detection results at 2-8°C, and the longer the thermal acceleration time, the more the concentration value decreased and the greater the bias (as shown in Table 4).

[0124] Table 4

[0125]

[0126] The above is only a preferred embodiment of the present invention. It should be pointed out that for ordinary technicians in this technical field, several improvements and modifications can be made without departing from the principle of the present invention. These improvements and modifications should also be regarded as the scope of protection of the present invention.

Claims

1. A freeze-dried antinuclear antibody quality control product, characterized in that: Including antinuclear antibodies, buffer substances, excipients, preservatives; The antinuclear antibodies include at least two of Anti-dsDNA, Anti-Sm, and Anti-rib-P; The preservative includes MIT.

2. The antinuclear antibody freeze-dried quality control product according to claim 1, characterized in that: The antinuclear antibodies also include at least one of Anti-Scl-70, Anti-SS-A / Ro, Anti-Ro-52, Anti-nRNP / Sm, Anti-Jo-1, Anti-CENP-B, and Anti-Histone.

3. The antinuclear antibody freeze-dried quality control product according to claim 1 or 2, characterized in that: The buffer substances are tris(hydroxymethyl)aminomethane and sodium chloride.

4. The antinuclear antibody freeze-dried quality control product according to any one of claims 1 to 3, characterized in that: The excipient is bovine serum albumin.

5. The antinuclear antibody freeze-dried quality control product according to claim 4, characterized in that: In parts by weight, it comprises: 5.95 parts of tris(hydroxymethyl)aminomethane, 8.05 parts of sodium chloride, 1 part of MIT, and 25 parts of bovine serum albumin.

6. The antinuclear antibody freeze-dried quality control product according to any one of claims 1 to 5, characterized in that: It also includes at least one of a stabilizer, a protein protectant, and a colorant.

7. The antinuclear antibody freeze-dried quality control product according to claim 6, characterized in that: The stabilizer is trehalose; and / or The protein protective agent is ADP; and / or The colorant is at least one of sunset color, lemon color, and rouge color.

8. The antinuclear antibody freeze-dried quality control product according to claim 7, characterized in that: In parts by weight, it comprises: 20 parts of the trehalose, 1 part of the ADP, 0.03 parts of the sunset color, and 0.03 parts of the lemon color.

9. A method for preparing a freeze-dried antinuclear antibody quality control product, characterized in that: The following steps are involved: Step (1): mixing a buffer substance with a solvent, adjusting the pH, and adjusting the concentration to obtain a buffer solution; Step (2): mixing the auxiliary agent with the buffer to obtain a quality control dilution solution; Step (3): mixing the antinuclear antibody with the quality control diluent to obtain a quality control solution; Step (4): freeze-drying the quality control solution to obtain an antinuclear antibody freeze-dried quality control product; The auxiliary agents include excipients and preservatives; The preservative includes MIT; The antinuclear antibodies include at least two of Anti-dsDNA, Anti-Sm, and Anti-rib-P.

10. The preparation method according to claim 9, characterized in that: The buffer substance comprises tris(hydroxymethyl)aminomethane and sodium chloride; and / or The auxiliary agent also includes at least one of a stabilizer, a protein protectant, and a colorant; and / or The excipient comprises bovine serum albumin; and / or The stabilizer comprises trehalose; and / or The protein protecting agent comprises ADP; and / or The colorant includes at least one of sunset, lemon, and carmine; and / or The antinuclear antibodies also include at least one of Anti-Scl-70, Anti-SS-A / Ro, Anti-Ro-52, Anti-nRNP / Sm, Anti-Jo-1, Anti-CENP-B, and Anti-Histone.

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