CN112903986A - Liquid quality control material for dry chemical analysis of vaginal secretion and preparation method thereof - Google Patents

Liquid quality control material for dry chemical analysis of vaginal secretion and preparation method thereof Download PDF

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CN112903986A
CN112903986A CN202110079699.5A CN202110079699A CN112903986A CN 112903986 A CN112903986 A CN 112903986A CN 202110079699 A CN202110079699 A CN 202110079699A CN 112903986 A CN112903986 A CN 112903986A
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蒋泽军
刘云鹏
陈蕊瑶
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Urit Medical Electronic Co Ltd
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Abstract

The invention discloses a liquid quality control material for dry chemical analysis of vaginal secretion and a preparation method thereof, wherein a corresponding buffer system is prepared firstly, and then the buffer system is used as a solvent to add and dissolve a plurality of raw materials of a negative quality control material and a positive quality control material; when different components are added, the latter component can be added only after the former component is completely dissolved; in order to ensure the enzyme activity, liquid negative quality control substances and liquid positive quality control substances are prepared at the temperature of 4-15 ℃, so that the effect is better; after the preparation is finished, the freeze-dried powder is subpackaged and stored within 24 hours, 10 items such as coagulase, hydrogen peroxide, lactic acid, oxidase, glucuronidase, N-acetylhexosaminidase, neuraminidase, leukocyte esterase, proline aminopeptidase and pH value can be simultaneously controlled, the stability is good, the period is long, the use is convenient and quick, the complex step that the freeze-dried powder needs to be redissolved before use is omitted, the error caused by redissolution is reduced, and the freeze-dried powder has good practical application value.

Description

Liquid quality control material for dry chemical analysis of vaginal secretion and preparation method thereof
Technical Field
The invention relates to the technical field of clinical examination of vaginal secretion, in particular to a liquid quality control material for dry chemical analysis of vaginal secretion and a preparation method thereof.
Background
The existing dry chemical analysis quality control material for vaginal secretion is mainly a freeze-dried product or a single liquid quality control liquid, the freeze-dried product needs to be redissolved, uniformly mixed, reheated and the like in the using process, the quality control material is influenced by a plurality of factors, and the operation is complicated; and the single-item liquid quality control liquid has the problems of high possibility of confusion due to a large number of items, complex operation and the like in the multi-item quality control, so that the practical value is reduced.
Disclosure of Invention
The invention aims to provide a liquid quality control material for dry chemical analysis of vaginal secretion and a preparation method thereof, which improve the practical value.
In order to achieve the above objects, in a first aspect, the present invention provides a liquid quality control material for dry chemical analysis of vaginal discharge, the liquid quality control material for dry chemical analysis of vaginal secretion comprises a negative quality control material and a positive quality control material, the negative quality control substance comprises 50-500 mmol/L of a buffer system with the pH value of 3.5-5.0, 0.01-0.5 g/L of a preservative, 0.005-0.99 g/L of hydrogen peroxide, 0.01-0.5 g/L of lactic acid, 0-1.0U/mL of oxidase, 0-0.05U/mL of glucuronidase, 0-5.0U/L of N-acetylhexosaminidase, 0-0.5U/L of neuraminidase, 0-4.0U/mL of leukocyte esterase, 0-0.2U/mL of proline aminopeptidase and 0-2.0U/mL of coagulase;
the positive quality control substance comprises 50-500 mmol/L of a buffer system with the pH value of 4.5-6.0, 0.01-0.2 g/L of a preservative, 20-200 mmol/L of an enzyme activity stabilizer, 20-200 mmol/L of a protein protective agent, 0-0.003 g/mL of hydrogen peroxide, 0-0.05 g/mL of lactic acid, 2.0-15.0U/mL of oxidase, 0.05-20.0U/mL of glucuronidase, 5-200.0U/L of N-acetylhexosaminidase, 0.5-20.0U/L of neuraminidase, 5-500.0U/mL of leukocyte esterase, 0.2-50.0U/mL of proline aminopeptidase and 0.05-10.0U/mL of coagulase.
Wherein the buffer system is one or more of citrate buffer solution, maleic acid-TRIS or borate buffer solution, TRIS-hydrochloric acid buffer solution or glycine-TRIS buffer solution.
Wherein the preservative is one or more of sorbic acid and salts thereof, benzoic acid and salts thereof, parabens, nitrite, 2-mercaptopyridine-1-sodium oxide salt, lactate or proclin 300.
Wherein the protein protective agent is one or more of bovine serum albumin, K30, K90, gelatin or globulin.
Wherein the enzyme activity stabilizer is one or more of lactose, trehalose, mannitol, glycerol and amino acid, and the amino acid is one or more of 4-hydroxyproline, 5-hydroxylysine, serine, cystine, methionine or polypeptide.
In a second aspect, the present invention provides a method for preparing a liquid quality control material for dry chemical analysis of vaginal secretion, which is suitable for the liquid quality control material for dry chemical analysis of vaginal secretion according to the first aspect, and comprises the following steps:
under the environment of 10-15 ℃, the prepared buffer system with the pH of 3.5-5.0 is taken as a solvent, the obtained multiple first raw materials are sequentially and respectively added, after complete dissolution, the pH of the first mixed solution is adjusted to 4.0, and after standing for two hours, the mixed solution is packaged by a brown glass bottle at the temperature of 2-8 ℃ and stored at low temperature, so as to obtain a negative quality control substance;
under the environment of 10-15 ℃, the prepared buffer system with the pH of 4.5-6.0 is taken as a solvent, an enzyme activity protective agent, a protein protective agent and a plurality of second raw materials are sequentially and respectively added, after complete dissolution, the pH of the first mixed solution is adjusted to 5.0, and after standing for two hours, the mixed solution is packaged by a brown glass bottle at the temperature of 2-8 ℃ and stored at low temperature, so that a positive quality control substance is obtained.
The invention relates to a liquid quality control material for dry chemical analysis of vaginal secretion and a preparation method thereof, wherein the liquid quality control material for dry chemical analysis of vaginal secretion comprises a negative quality control material and a positive quality control material, a corresponding buffer system is prepared firstly, and then the buffer system is used as a solvent to add and dissolve a plurality of raw materials of the negative quality control material and the positive quality control material; when different components are added, the latter component can be added only after the former component is completely dissolved; in order to ensure the enzyme activity, a negative quality control substance and a positive quality control substance are prepared in the environment of 4-15 ℃, and the effect is better; after the preparation is finished, the freeze-dried product is subpackaged and stored within 24 hours, 10 items such as coagulase, hydrogen peroxide, lactic acid, oxidase, glucuronidase, N-acetylhexosaminidase, neuraminidase, leukocyte esterase, proline aminopeptidase and pH value can be simultaneously subjected to quality control, the freeze-dried product contains a negative quality control substance and a positive quality control substance, is liquid, has good stability and long period, is convenient and quick to use, omits the complicated step of re-dissolving the freeze-dried product before use, reduces errors caused by re-dissolving, and has good practical application value.
Drawings
In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings used in the description of the embodiments or the prior art will be briefly described below, it is obvious that the drawings in the following description are only some embodiments of the present invention, and for those skilled in the art, other drawings can be obtained according to the drawings without creative efforts.
FIG. 1 is a schematic diagram of the steps of a method for preparing a liquid quality control material for dry chemical analysis of vaginal secretion provided by the invention.
Detailed Description
Reference will now be made in detail to embodiments of the present invention, examples of which are illustrated in the accompanying drawings, wherein like or similar reference numerals refer to the same or similar elements or elements having the same or similar function throughout. The embodiments described below with reference to the drawings are illustrative and intended to be illustrative of the invention and are not to be construed as limiting the invention.
In the description of the present invention, "a plurality" means two or more unless specifically defined otherwise.
The invention provides a liquid quality control material for dry chemical analysis of vaginal secretion, which comprises a negative quality control material and a positive quality control material, wherein the negative quality control material comprises 50-500 mmol/L of a buffer system with the pH of 3.5-5.0, 0.01-0.5 g/L of a preservative, 0.005-0.99 g/L of a hydrogen peroxide item, 0.01-0.5 g/L of a lactic acid item, 0-1.0U/mL of an oxidase item, 0-0.05U/mL of a glucuronidase item, 0-5.0U/L of an N-acetylhexosaminidase item, 0-0.5U/L of a neuraminidase item, 0-4.0U/mL of a leukocyte esterase item, 0-0.2U/mL of a proline aminopeptidase item and 0-2.0U/mL of a coagulase item;
the positive quality control substance comprises 50-500 mmol/L of a buffer system with the pH value of 4.5-6.0, 0.01-0.2 g/L of a preservative, 20-200 mmol/L of an enzyme activity stabilizer, 20-200 mmol/L of a protein protective agent, 0-0.003 g/mL of hydrogen peroxide, 0-0.05 g/mL of lactic acid, 2.0-15.0U/mL of oxidase, 0.05-20.0U/mL of glucuronidase, 5-200.0U/L of N-acetylhexosaminidase, 0.5-20.0U/L of neuraminidase, 5-500.0U/mL of leukocyte esterase, 0.2-50.0U/mL of proline aminopeptidase and 0.05-10.0U/mL of coagulase.
In this embodiment, the buffer system may be a citrate buffer, a maleic acid-TRIS or borate buffer, a TRIS-hydrochloric acid buffer, or a glycine-TRIS buffer, and one or more of them may be used in combination. The pH value range in the negative quality control material is 3.5-5.0, and the pH value range in the positive quality control material is 4.5-6.0. Preferably, the buffer solution is citrate buffer solution, glycine-tris and maleic acid-tris, and the concentration is 50-500 mmol/L; more preferably, the buffer solution is citrate buffer solution, and the concentration is 100-250 mol/L.
The antiseptic can be sorbic acid and its salt, benzoic acid and its salt, parabens, nitrite, 2-mercaptopyridine-1-sodium oxide salt, lactate or proclin 300. Preferably potassium sorbate, sodium nitrite, 2-mercaptopyridine-1-sodium oxide salt and proclin300, and the concentration is 0.02-0.4 g/L. More preferably, the sodium salt is 2-mercaptopyridine-1-oxide, and the concentration is 0.05-0.2 g/L. The preservative may be one or more thereof.
The protein protective agent can be bovine serum albumin, K30\ K90 (polyvinylpyrrolidone with molecular formula of (C6H9NO) n), gelatin, globulin, etc. Preferably K30, bovine serum albumin, at a concentration of 40-160 mmol/L. More preferably gelatin, at a concentration of between 80 and 120 mmol/L. The protein protective agent can be one or more of the protein protective agents.
The enzyme activity stabilizer can be lactose (a-lactose, b-lactose, d-galactose), trehalose, mannitol, glycerol, amino acid (4-hydroxyproline, 5-hydroxylysine, serine, cystine, methionine, polypeptide, etc., preferably trehalose, 5-hydroxylysine, serine, with concentration of 40-150mmol/L, more preferably 5-hydroxylysine, with concentration of 60-120mmol/L, and the enzyme activity stabilizer can be one or more of them.
The hydrogen peroxide is one or more of hydrogen peroxide, carbamide peroxide, MnO2, KMnO4, K2Cr2O7, KClO3, HClO and the like. The lactic acid item is one or more of lactic acid, sodium lactate, potassium lactate, magnesium lactate, calcium lactate, sodium pyruvate, potassium pyruvate, magnesium pyruvate, lactate dehydrogenase, polylactic acid and the like. The oxidase item is one or more of urate oxidase, D-amino acid oxidase, L-amino acid oxidase, cytochrome oxidase, L-alpha-hydroxy acid oxidase, etc. The glucuronidase item is one or more of galacturonase, polygalacturonase, hyaluronidase, pectinesterase and the like. The N-acetylhexosaminidase item is one or more of alpha-glucosidase, beta-glucosidase, alpha-mannosidase, arabinosidase, beta-xylosidase, chitotriosidase, thioglycosidase and the like. The neuraminidase item is one or more of neuraminidase, purine nucleoside phosphorylase, aprotinin, chymotrypsin, acetylcholinesterase, elastase, cholesterol oxidase and the like. The proline aminopeptidase item is one or more of aminopeptidase, dipeptidase, dipeptidylpeptidase, peptidyl dipeptidase, serine type carboxypeptidase, metallo carboxypeptidase, cysteine type carboxypeptidase, serine endopeptidase, cysteine endopeptidase, xanthine oxidase, aspartic endopeptidase, metallo endopeptidase, threonine endopeptidase and the like. The coagulase project is one or more of protease, pepsin, trypsin, cathepsin, papain, subtilisin and the like.
Referring to fig. 1, the present invention provides a method for preparing a liquid quality control material for dry chemical analysis of vaginal secretion, which is suitable for the liquid quality control material for dry chemical analysis of vaginal secretion,
negative quality control substance:
pH 4.0, citric acid buffer 100mmol/L, potassium sorbate: 0.01g/L, sodium nitrite: 0.05g/L, KMnO 4: 0.005g/L, sodium lactate: 0.02g/L
Positive quality control substance:
pH 5.0, citric acid buffer system 200mmol/L, sodium nitrite: 0.05g/L, mercaptopyridine-1-sodium oxide salt: 0.01g/L, trehalose: 50mmol/L, mannitol: 80mmol/L, 5-hydroxylysine: 60mmol/L, bovine serum albumin: 200mmol/L, gelatin: 0.05g/L, lactate dehydrogenase: 2.0U/mL, L-amino acid oxidase: 3.0U/mL, galacturonase: 8.0U/mL, alpha-mannosidase 50.0U/L, chymotrypsin 6.0U/L, leukocyte esterase 125.0U/mL, aspartic endopeptidase: 18.0U/mL, protease: 3.0U/mL
The method comprises the following steps:
s101, under the environment of 10-15 ℃, the prepared buffer system with the pH of 3.5-5.0 is used as a solvent, the obtained multiple first raw materials are sequentially and respectively added, after complete dissolution, the pH of the first mixed solution is adjusted to 4.0, and after standing for two hours, the mixed solution is packaged by a brown glass bottle at the temperature of 2-8 ℃ and stored at low temperature, so that a negative quality control substance is obtained.
Specifically, the embodiment is operated in a 10 ten thousand grade clean workshop, the operation temperature is controlled to be 10-15 ℃, the preparation of the negative quality control solution is carried out by firstly preparing a buffer system with the pH value of 4.0 and then respectively adding the first raw materials into the buffer system as a solvent for dissolution. When different components are added, the former component is required to be completely dissolved before the latter component can be added. Wherein the first raw material comprises: sodium nitrite: 0.05g/L, mercaptopyridine-1-sodium oxide salt: 0.01g/L, trehalose: 50mmol/L, mannitol: 80mmol/L, 5-hydroxylysine: 60mmol/L, bovine serum albumin: 200mmol/L, gelatin: 0.05g/L, lactate dehydrogenase: 2.0U/mL, L-amino acid oxidase: 3.0U/mL, galacturonase: 8.0U/mL, alpha-mannosidase 50.0U/L, chymotrypsin 6.0U/L, leukocyte esterase 125.0U/mL, aspartic endopeptidase: 18.0U/mL, protease: 3.0U/mL; and finally, adjusting the pH value of the first mixed solution to 4.0 by using citric acid. Standing for 2 hr, packaging with brown screw bottle, and storing in refrigerator at 2-8 deg.C.
S102, under the environment of 10-15 ℃, sequentially and respectively adding an enzyme activity protective agent, a protein protective agent and a plurality of second raw materials into a buffer system with the pH value of 4.5-6.0 which is obtained by preparation as a solvent, adjusting the pH value of the first mixed solution to 5.0 after complete dissolution, and after standing for two hours, storing the mixture at the low temperature of 2-8 ℃ by using a brown glass bottle for packaging to obtain the positive quality control substance.
Specifically, a buffer system with a pH of 5.0 is prepared, then an enzyme activity protective agent (5-hydroxylysine: 60mmol/L, trehalose: 50mmol/L, mannitol: 80mmol/L) and a protein protective agent (bovine serum albumin: 200mmol/L, gelatin: 0.05g/L) are added with the buffer system as a solvent, and then a plurality of second raw materials are added one by one. When different components are added, the former component is required to be completely dissolved before the latter component can be added. Wherein the second raw material is as follows: sodium nitrite: 0.05g/L, mercaptopyridine-1-sodium oxide salt: 0.01g/L, lactate dehydrogenase: 2.0U/mL, L-amino acid oxidase: 3.0U/mL, galacturonase: 8.0U/mL, alpha-mannosidase 50.0U/L, chymotrypsin 6.0U/L, leukocyte esterase 125.0U/mL, aspartic endopeptidase: 18.0U/mL, protease: 3.0U/mL; finally, citric acid is used for adjusting the pH value to 5.0. Standing for 2 hr, packaging with brown screw bottle, and storing in refrigerator at 2-8 deg.C, wherein the second material is other than enzyme activity protectant and protein protectant.
The dry chemical analysis quality control material for vaginal secretion prepared according to the embodiment comprises a negative quality control material and a positive quality control material, and is stored in a refrigerator at the temperature of 2-8 ℃.2 items of oxidase and lactic acid are subjected to long-term stability monitoring through a Dirui GMD-S600 gynecological secretion analysis system, and coagulase, hydrogen peroxide, glucuronidase, N-acetylhexosaminidase, neuraminidase, leukocyte esterase, proline aminopeptidase and pH value are subjected to long-term stability monitoring through an ampere chart Autowo MO full-automatic genital tract secretion workstation. The monitoring results are shown in table 1:
TABLE 1 examination of quality control substance for dry chemical analysis of vaginal discharge
Figure BDA0002908706180000061
Figure BDA0002908706180000071
The quality control range of the dry chemical analysis quality control material of the vaginal secretion is shown in table 2:
TABLE 2 Dry chemical analysis of vaginal secretions quality control Range of quality control
Figure BDA0002908706180000072
In conclusion, the invention provides a liquid vaginal secretion dry chemical analysis quality control substance, which can simultaneously control the quality of 10 items such as coagulase, hydrogen peroxide, lactic acid, oxidase, glucuronidase, N-acetylhexosaminidase, neuraminidase, leukocyte esterase, proline aminopeptidase, pH value and the like, has good stability, is convenient and simple to use, and has good practical value.
The invention relates to a liquid quality control material for dry chemical analysis of vaginal secretion and a preparation method thereof, wherein the liquid quality control material for dry chemical analysis of vaginal secretion comprises a negative quality control material and a positive quality control material, a corresponding buffer system is prepared firstly, and then the buffer system is used as a solvent to add and dissolve a plurality of raw materials of the negative quality control material and the positive quality control material; when different components are added, the latter component can be added only after the former component is completely dissolved; in order to ensure the enzyme activity, a negative quality control substance and a positive quality control substance are prepared in the environment of 4-15 ℃, and the effect is better; after the preparation is finished, the freeze-dried product is subpackaged and stored within 24 hours, 10 items such as coagulase, hydrogen peroxide, lactic acid, oxidase, glucuronidase, N-acetylhexosaminidase, neuraminidase, leukocyte esterase, proline aminopeptidase and pH value can be simultaneously subjected to quality control, the freeze-dried product contains a negative quality control substance and a positive quality control substance, is liquid, has good stability and long period, is convenient and quick to use, omits the complex step of re-dissolving the freeze-dried product before use, reduces errors caused by re-dissolving, and has good practical application value.
While the invention has been described with reference to a preferred embodiment, it will be understood by those skilled in the art that various changes in form and detail may be made therein without departing from the spirit and scope of the invention as defined by the appended claims.

Claims (6)

1. A liquid quality control material for dry chemical analysis of vaginal secretion, which is characterized in that,
the liquid quality control material for dry chemical analysis of the vaginal secretion comprises a negative quality control material and a positive quality control material, wherein the negative quality control material comprises 50-500 mmol/L of a buffer system with the pH value of 3.5-5.0, 0.01-0.5 g/L of a preservative, 0.005-0.99 g/L of a hydrogen peroxide item, 0.01-0.5 g/L of a lactic acid item, 0-1.0U/mL of an oxidase item, 0-0.05U/mL of a glucuronidase item, 0-5.0U/L of an N-acetylhexosaminidase item, 0-0.5U/L of a neuraminidase item, 0-4.0U/mL of a leukocyte esterase item, 0-0.2U/mL of a proline aminopeptidase item and 0-2.0U/mL of a coagulase item;
the positive quality control substance comprises 50-500 mmol/L of a buffer system with the pH value of 4.5-6.0, 0.01-0.2 g/L of a preservative, 20-200 mmol/L of an enzyme activity stabilizer, 20-200 mmol/L of a protein protective agent, 0-0.003 g/mL of hydrogen peroxide, 0-0.05 g/mL of lactic acid, 2.0-15.0U/mL of oxidase, 0.05-20.0U/mL of glucuronidase, 5-200.0U/L of N-acetylhexosaminidase, 0.5-20.0U/L of neuraminidase, 5-500.0U/mL of leukocyte esterase, 0.2-50.0U/mL of proline aminopeptidase and 0.05-10.0U/mL of coagulase.
2. The liquid quality control material for dry chemical analysis of vaginal discharge according to claim 1,
the buffer system is one or more of citrate buffer solution, maleic acid-TRIS or borate buffer solution, TRIS-hydrochloric acid buffer solution or glycine-TRIS buffer solution.
3. The liquid quality control material for dry chemical analysis of vaginal discharge according to claim 1,
the preservative is one or more of sorbic acid and salts thereof, benzoic acid and salts thereof, parabens, nitrite, 2-mercaptopyridine-1-sodium oxide salt, lactate or proclin 300.
4. The liquid quality control material for dry chemical analysis of vaginal discharge according to claim 1,
the protein protective agent is one or more of bovine serum albumin, K30, K90, gelatin or globulin.
5. The liquid quality control material for dry chemical analysis of vaginal discharge according to claim 1,
the enzyme activity stabilizer is one or more of lactose, trehalose, mannitol, glycerol and amino acid, and the amino acid is one or more of 4-hydroxyproline, 5-hydroxylysine, serine, cystine, methionine or polypeptide.
6. A method for preparing a liquid quality control material for dry chemical analysis of vaginal secretion, which is suitable for the liquid quality control material for dry chemical analysis of vaginal secretion as claimed in any one of claims 1 to 5, and comprises the following steps:
under the environment of 10-15 ℃, the prepared buffer system with the pH of 3.5-5.0 is taken as a solvent, the obtained multiple first raw materials are sequentially and respectively added, after complete dissolution, the pH of the first mixed solution is adjusted to 4.0, and after standing for two hours, the mixed solution is packaged by a brown glass bottle at the temperature of 2-8 ℃ and stored at low temperature, so as to obtain a negative quality control substance;
under the environment of 10-15 ℃, the prepared buffer system with the pH of 4.5-6.0 is taken as a solvent, an enzyme activity protective agent, a protein protective agent and a plurality of second raw materials are sequentially and respectively added, after complete dissolution, the pH of the first mixed solution is adjusted to 5.0, and after standing for two hours, the mixed solution is packaged by a brown glass bottle at the temperature of 2-8 ℃ and stored at low temperature, so that a positive quality control substance is obtained.
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