JPS62261962A - Liquid control serum for lipid component - Google Patents

Liquid control serum for lipid component

Info

Publication number
JPS62261962A
JPS62261962A JP61106160A JP10616086A JPS62261962A JP S62261962 A JPS62261962 A JP S62261962A JP 61106160 A JP61106160 A JP 61106160A JP 10616086 A JP10616086 A JP 10616086A JP S62261962 A JPS62261962 A JP S62261962A
Authority
JP
Japan
Prior art keywords
serum
alanine
added
active agent
surface active
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Granted
Application number
JP61106160A
Other languages
Japanese (ja)
Other versions
JPH0588789B2 (en
Inventor
Yoshihide Furusawa
古澤 良秀
Katsuyoshi Shimada
嶋田 勝良
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Chemo Sero Therapeutic Research Institute Kaketsuken
Original Assignee
Chemo Sero Therapeutic Research Institute Kaketsuken
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Chemo Sero Therapeutic Research Institute Kaketsuken filed Critical Chemo Sero Therapeutic Research Institute Kaketsuken
Priority to JP61106160A priority Critical patent/JPS62261962A/en
Publication of JPS62261962A publication Critical patent/JPS62261962A/en
Publication of JPH0588789B2 publication Critical patent/JPH0588789B2/ja
Granted legal-status Critical Current

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  • Investigating Or Analysing Biological Materials (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)

Abstract

PURPOSE:To obtain a liquid control serum which has an excellent shelf life and does not hinder measurement by adding a prescribed of an alanine, ethylenediaminetetraacetic acid and prescribed surface active agent to a serum. CONSTITUTION:The alanine, ethylenediaminetetraacetic acid and polyoxyethylene ether type nonionic surface active agent are added to the serum. The amt. of the alanine to be added to the serum is 2.0-4.0wt%, more preferably about 3.0wt%. The amt. of the ethylenediaminetetraacetic acid to be added is 1.0-3.0wt%, more preferably about 1.5wt%. The amt. of the surface active agent to be added is 0.10-0.30wt%. The serum may be derived from human or animal. The control serum having a high effect of stabilizing lipid is obtd. by adding the alanine thereto. The preservation for a long period of time is permitted by the addition of the above-mentioned surface active agent.

Description

【発明の詳細な説明】 産 土の1 ノ 本発明は臨床化学検査の精度管理に用いられる管理血清
に間する。
DETAILED DESCRIPTION OF THE INVENTION The present invention relates to control serum used for quality control of clinical chemistry tests.

′、 の ′ とその、!1″ 臨床化学検査は、医師がその結果をもとに患者を診断し
治療するための1つの指針となる重要なものであるので
信頼できる正確な検査結果を報告することが要求される
。そのためには、検体が常に一定の範囲で精度良く検査
されていることが不可欠であり、このような精度管理の
もとで行われた臨床検査の結果を得て初めて、医師は、
正しく病状を判断し、診断・治療することができる。精
度管理のための最良の方法は、被測定成分の濃度が既知
の管理血清を用いる方法であると考えられ、この管理血
清の測定値の変動から、対象とする検体の検査に影響を
与える異常や変化を見出すことにより正確度と精密度の
高い検査をtii深することができる。
′, the ′ and the,! 1" Clinical chemistry tests are important as they serve as a guideline for doctors to diagnose and treat patients based on the results, so reporting reliable and accurate test results is required. For this purpose, it is essential that specimens are always tested accurately within a certain range, and only after obtaining the results of clinical tests conducted under such precision control can doctors...
Able to correctly judge, diagnose, and treat medical conditions. The best method for accuracy control is considered to be a method using controlled serum with known concentrations of the components to be measured, and fluctuations in the measured values of this controlled serum can be used to detect abnormalities that affect the testing of the target specimen. By discovering changes and changes, it is possible to carry out inspections with high accuracy and precision.

現在、管理血清は、臨床化学検査の精度管理のために必
須のものとなっており、多くのl!類が市販され、利用
されている。ところが、現在使用されているもののほと
んどは、凍結乾燥品であるために再溶解後、濁りが生じ
ることや、再溶解の際生じる容量誤差により正確度が左
右されるという欠点が指摘されている。この問題を解決
するため、再溶解をする必要のない液状の管理血清の開
発が強く望まれており、また、実際に、液状の管理血清
も市販されている。しかしながら、この市販の管理血清
は、保存性が必ずしも充分でなく、また、苛酷の条件下
においては透過率が低下するという欠点があり、測定結
果に影響を及ぼすことが懸念される。
Currently, control serum is essential for accuracy control of clinical chemistry tests, and many l! types are commercially available and in use. However, it has been pointed out that most of the products currently in use are freeze-dried products, which cause turbidity after re-dissolution, and that accuracy is affected by volume errors that occur during re-dissolution. In order to solve this problem, there is a strong desire to develop a liquid control serum that does not require reconstitution, and liquid control serums are actually commercially available. However, this commercially available controlled serum does not necessarily have a sufficient shelf life, and has the disadvantage that its transmittance decreases under severe conditions, which may affect the measurement results.

■の ・、  および 本発明の目的は、保存性に優れ、測定を阻害しないよう
な液状管理血清を得ることにある。
(2) An object of the present invention is to obtain a liquid control serum that has excellent storage stability and does not interfere with measurements.

本発明者等は、管理血清を調整するにあたり添加される
種々添加剤について検討した結果、特定の数種の添加剤
を組み合わせて用いることにより、上記の問題を解決す
ることができ、特に脂質成分に用いられるのに優れてい
ることを見出し、本発明を導くに至った。
As a result of studying various additives added when preparing control serum, the present inventors found that the above problems can be solved by using a combination of several specific additives, and in particular lipid components. The present inventors have discovered that the present invention is excellent when used for.

即ち、本発明は、血清にアラニン、エチレンジアミン四
酢酸およびポリオキシエチレン系エーテル型非イオン性
界面活性剤を加え、特に、アラニン2.0〜4.0重量
%、好ましくは、約3.ol量%、エチレンジ7ミ’、
を四酢酸(E D T A) 1.0〜3.Oli量%
好ましくは、約1.5jIil1%、おAびポリオキシ
エチレン系エーテル型非イオン性界面活性剤0.10〜
0.30重量%を含有するように調整されて用いられる
ことを特徴とする脂質成分用の液状管理血清を提供する
。ここで、血清はヒト由来のものでも動物由来のものを
用いてもよい、こうして調整された液状管理血清は、い
かなる影響も与えず、BL(βリボ蛋白)、TL(総脂
質)、Tc(総コレステロール)、PL(りん脂質)、
TG(総グリセロール)、FC(遊離コレステロール)
、NEFA(非エステル結合型遊11などの脂質成分の
液状管理血清として使用することができる。また、測定
方法を問わず、いかなる方法で測定を行ってもよい、ま
た、液状であるため、再溶解後の濁りや、再溶解の原生
じる容量誤差といった、凍結乾燥品にみられる欠点はな
い。
That is, in the present invention, alanine, ethylenediaminetetraacetic acid, and a polyoxyethylene-based ether type nonionic surfactant are added to serum, and in particular, alanine is added at 2.0 to 4.0% by weight, preferably about 3.0% by weight. ol amount%, ethylenedi7mi',
Tetraacetic acid (EDTA) 1.0-3. Oli amount%
Preferably about 1.5jIil1%, A and polyoxyethylene ether type nonionic surfactant 0.10~
Provided is a liquid controlled serum for lipid components, which is used after being adjusted to contain 0.30% by weight. Here, the serum may be of human origin or animal origin.The liquid controlled serum prepared in this way does not have any influence on BL (β-riboprotein), TL (total lipid), Tc ( total cholesterol), PL (phospholipid),
TG (total glycerol), FC (free cholesterol)
It can be used as a liquid control serum for lipid components such as , NEFA (non-ester bond type 11).In addition, it can be measured by any method regardless of the measurement method, and since it is in liquid form, it cannot be reused. There are no disadvantages found in freeze-dried products, such as turbidity after dissolution or volume errors caused by redissolution.

本発明の管理血清は、アラニンを添加している点に特徴
がある。このアラニンは、脂質成分の安定化に寄与して
いるものと考えられる0例えば、37℃保存で経時試験
を行い、660nmで透過率を調べたところ、アラニン
を添加しない管理血清は、1週間で著しい透過率の低下
を示したが、アラニンを添加した管理血清は、3週閏経
過後も透過率の低下は僅かであるという結果を得ている
The controlled serum of the present invention is characterized by the addition of alanine. This alanine is thought to contribute to the stabilization of lipid components. Although a significant decrease in transmittance was observed, the control serum to which alanine had been added showed a slight decrease in transmittance even after a 3-week break.

こうして特にアラニン2.0〜4.0重量%を血清に添
加することにより、透過率に優れた脂質安定化効果の高
い管理血清が得られる。
In this way, especially by adding 2.0 to 4.0% by weight of alanine to serum, a controlled serum with excellent permeability and high lipid stabilizing effect can be obtained.

さらに、本発明は、EDTAを添加している点にも特徴
がある。管理血清の各脂質成分の経時的な1度変化を調
べると、TGやNEFAについては、副反応に起因する
ものと考えられる経時的な濃度の上昇が認められる。本
発明者は、このような副反応による測定誤差を防止する
ためには、EDTAを加えるとよいことを見出した。E
DTAは、その添加量が多いほど効果的ではあるが、添
加量が3.0重量%を越えると、りん脂質の測定反応に
、支障をきたすことから、1.0〜3.01 ffi 
%の範囲において、最も効果的である。
Furthermore, the present invention is also characterized in that EDTA is added. When examining changes over time in each lipid component of the control serum, an increase in the concentration over time of TG and NEFA, which is thought to be due to side reactions, is observed. The present inventors have found that in order to prevent measurement errors due to such side reactions, it is advisable to add EDTA. E
DTA is more effective as the amount added exceeds 3.0% by weight, but if the amount added exceeds 3.0% by weight, it will interfere with the phospholipid measurement reaction.
% is most effective.

また、本発明者は、ポリオキシエチレン系エーテル型非
イオン性界面活性剤を加えることにより、長期間の保存
が可能になることを見出している。
Furthermore, the present inventor has discovered that by adding a polyoxyethylene-based ether type nonionic surfactant, long-term storage becomes possible.

ポリオキシエチレン系エーテル型非イオン性界面活性剤
は、たとえば、Br1j30、Br1j35、Emar
genという商品名で市販されているものである。これ
らの界面活性剤は、測定反応を阻害することなく、透過
率に優れ、しかも不溶解物を抑制するという良好な結果
を得た。こうして得られた液状管理血清は、保存性に優
れ、長期間使用可能なものとなる。これらの効果を得る
ためには、ポリオキシエチレン系エーテル型非イオン性
界面活性剤は少なくとも0.10這量%添加されること
が好ましいが、実用的には0.15!1ffi%加える
と充分である。
Examples of polyoxyethylene-based ether type nonionic surfactants include Br1j30, Br1j35, and Emar.
It is commercially available under the trade name gen. These surfactants did not inhibit the measurement reaction, had excellent transmittance, and obtained good results in suppressing insoluble matter. The liquid control serum thus obtained has excellent storage stability and can be used for a long period of time. In order to obtain these effects, it is preferable that the polyoxyethylene-based ether type nonionic surfactant be added at least 0.10% by weight, but in practical terms, adding 0.15% to 1ffi% is sufficient. It is.

以下、本発明の特徴をさらに明らかにするため、実施例
に沿って本発明を説明する。
EXAMPLES Hereinafter, in order to further clarify the characteristics of the present invention, the present invention will be explained along with examples.

実施例1 ヒト由来血清にアラニン3.O3!i fi%、Br1
j350.15%を添加したものにEDTAを0.0.
5、!、0.1.5ffiffi%含有するように調整
し37℃の恒温槽中で保存して保存試験を行い、660
nmにおける透過率を測定することにより経時的なTG
の濃度変化を調べた。結果は第11!Iに示した。因よ
りEDTAの添加効果は、明らかである。
Example 1 Alanine 3. O3! i fi%, Br1
j350.15% was added with EDTA of 0.0.
5,! , 660
TG over time by measuring transmittance in nm
The change in concentration of was investigated. The result is 11th! Shown in I. For this reason, the effect of adding EDTA is obvious.

実施例2 アラニン3.0重量%、EDTAl、5重量%を含むヒ
ト由来血清に添加する保存安定剤の種類を変えて、実施
例1と同様の保存試験を行い、経時的な透過率の推移を
調べた。結果を第2図に示した。
Example 2 A storage test similar to Example 1 was conducted by changing the type of storage stabilizer added to human serum containing 3.0% by weight of alanine and 5% by weight of EDTAl, and the change in transmittance over time was conducted. I looked into it. The results are shown in Figure 2.

図かられかるように、非イオン性界面活性剤のポリオキ
シエチレン系のソルビタンモノアルキル型のT w e
 e nでは、1週間で透過率が著しく低下しているが
、同じポリオキシエチレン系のエーテル型のBr1j3
5、Emargenでは、Tweenに比べると透過率
の低下はずっと緩やかである。
As can be seen from the figure, T w e of the nonionic surfactant polyoxyethylene-based sorbitan monoalkyl type
In case of e n, the transmittance decreased significantly after one week, but the same polyoxyethylene-based ether type Br1j3
5. With Emargen, the decrease in transmittance is much more gradual than with Tween.

また、界面活性剤の添加量を検討するためBr1j35
の濃度を変えて添加したアラニン3ii量%、E D 
T A 1.5重量%を含むヒト血清を室温で振どうを
1日30万回行い、7日問にわたって毎日透過率を測定
した。結果を第3図に示した。 0.1511量%程度
より添加の効果を示しはじめる。
In addition, in order to examine the amount of surfactant added, Br1j35
Alanine 3ii amount% added with varying concentrations, E D
Human serum containing 1.5% by weight of TA was shaken 300,000 times a day at room temperature, and the transmittance was measured every day for 7 days. The results are shown in Figure 3. The effect of addition begins to show from around 0.1511% by weight.

実施例3 本発明による液状管理血清(ヒト由来血清にアラニン3
%、E D T A 1.5%、B r i j 35
0.15%を添加したもの)と、現在市販されている液
状の管理血清の比較試験を行った。試験方法は、37℃
保存での4週間にわたる経時試験、および室温での7日
間にわたる振どうでの経時試験により行い、660nm
で透過率を測定した。結果を第4図に示した。この結果
かられかるように、本発明による液状管理血清は市販の
ものと比べてはるかに優れた品質のものであることがわ
かる。
Example 3 Liquid control serum according to the present invention (human-derived serum containing alanine 3
%, EDT A 1.5%, B rij 35
A comparative test was conducted between serum containing 0.15% of serum and liquid controlled serum currently available on the market. The test method is 37℃
660nm
The transmittance was measured. The results are shown in Figure 4. As can be seen from these results, it can be seen that the liquid controlled serum according to the present invention is of far superior quality compared to commercially available serums.

実施例4 本発明の液状管理血清(ヒト由来血清にアラニン3%、
E D T A 1.5%、B r i j 350.
15%を添加したもの)を4℃で保存して各成分の安定
性を8ケ月にわたり試験した。第5図はその結果を示し
ている0本発明の管理血清を用いると、各成分とも長期
間安定であることがわかる。
Example 4 Liquid control serum of the present invention (human-derived serum containing 3% alanine,
EDT A 1.5%, B rij 350.
The stability of each component was tested over a period of 8 months by storing it at 4°C. FIG. 5 shows the results. It can be seen that when the controlled serum of the present invention is used, each component is stable for a long period of time.

【図面の簡単な説明】[Brief explanation of drawings]

第1図は、本発明に従う管理血清のEDTA添加の効果
示すグラフである。 第2図は、本発明に従い特定の非イオン性界面活性剤を
した場合の効果を示すグラフである。 第3図は、本発明に従う管理血清の界面活性剤の添加効
果を示すグラフである。 第4図は、本発明の管理血清の品質を市販の管理血清と
比較して示すグラフである。 第5図は、本発明の管理血清を用いた場合の各種脂質成
分の安定性を示すグラフである。 第1図 1     2    3 (通) 、。7゜     第8図 第4図 T’10(660rm) 1   lJ  4(週)1  5 ′37(日)第5
図 2  4  6  8 (月)
FIG. 1 is a graph showing the effect of adding EDTA to controlled serum according to the present invention. FIG. 2 is a graph showing the effect of using certain nonionic surfactants in accordance with the present invention. FIG. 3 is a graph showing the effect of adding a surfactant to controlled serum according to the present invention. FIG. 4 is a graph showing the quality of the controlled serum of the present invention in comparison with commercially available controlled serum. FIG. 5 is a graph showing the stability of various lipid components when using the controlled serum of the present invention. Figure 1 123 (letter). 7゜ Figure 8 Figure 4 T'10 (660rm) 1 lJ 4 (Week) 1 5 '37 (Sun) 5th
Figure 2 4 6 8 (Monday)

Claims (2)

【特許請求の範囲】[Claims] (1)血清にアラニン、エチレンジアミン四酢酸および
ポリオキシエチレン系エーテル型非イオン性界面活性剤
を加えたことを特徴とする脂質成分用液状管理血清。
(1) A liquid control serum for lipid components, characterized in that alanine, ethylenediaminetetraacetic acid, and a polyoxyethylene ether type nonionic surfactant are added to the serum.
(2)血清に添加するアラニンの濃度が2.0〜4.0
重量%、エチレンジアミン四酢酸の濃度が1.0〜3.
0重量%、ポリオキシエチレン系エーテル型非イオン性
界面活性剤の濃度が0.10〜0.30重量%である特
許請求の範囲第(1)項記載の管理血清。
(2) The concentration of alanine added to serum is 2.0 to 4.0
% by weight, the concentration of ethylenediaminetetraacetic acid is 1.0 to 3.
0% by weight, and the concentration of the polyoxyethylene ether type nonionic surfactant is 0.10 to 0.30% by weight.
JP61106160A 1986-05-08 1986-05-08 Liquid control serum for lipid component Granted JPS62261962A (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
JP61106160A JPS62261962A (en) 1986-05-08 1986-05-08 Liquid control serum for lipid component

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
JP61106160A JPS62261962A (en) 1986-05-08 1986-05-08 Liquid control serum for lipid component

Publications (2)

Publication Number Publication Date
JPS62261962A true JPS62261962A (en) 1987-11-14
JPH0588789B2 JPH0588789B2 (en) 1993-12-24

Family

ID=14426536

Family Applications (1)

Application Number Title Priority Date Filing Date
JP61106160A Granted JPS62261962A (en) 1986-05-08 1986-05-08 Liquid control serum for lipid component

Country Status (1)

Country Link
JP (1) JPS62261962A (en)

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
AT400199B (en) * 1993-10-11 1995-10-25 Immuno Ag TREATMENT OF LIPOPROTE CONTAINING SAMPLES
US5770451A (en) * 1995-03-30 1998-06-23 Streck Laboratories, Inc. Liquid lipoprotein control
CN101995476A (en) * 2009-08-10 2011-03-30 中国医学科学院北京协和医院 Liquid quality control serum for clinical chemical detection
WO2011105257A1 (en) * 2010-02-23 2011-09-01 テルモ株式会社 Additive for erythrocyte-rich solution, and container for medical purposes

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS5784356A (en) * 1980-11-13 1982-05-26 Toyobo Co Ltd Water soluble standard solution for measurement of fatty substance
JPS57163500A (en) * 1981-03-31 1982-10-07 Shinotesuto Kenkyusho:Kk Determination of total cholesterol
JPS585200A (en) * 1973-12-07 1983-01-12 ベ−リンガ−・マンハイム・ゲゼルシヤフト・ミツト・ベシユレンクテル・ハフツング Diagnostic material for detecting and measuring cholesterine and cholesterine ester in blood
JPS58141797A (en) * 1982-02-17 1983-08-23 Hitachi Ltd Reagent for automatic analysis
JPS59122952A (en) * 1983-04-07 1984-07-16 ベツクマン・インスツルメンツ・インコ−ポレ−テツド Method of lengthening life of storage of serum bilirubin standard composition and its generating composition

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS585200A (en) * 1973-12-07 1983-01-12 ベ−リンガ−・マンハイム・ゲゼルシヤフト・ミツト・ベシユレンクテル・ハフツング Diagnostic material for detecting and measuring cholesterine and cholesterine ester in blood
JPS5784356A (en) * 1980-11-13 1982-05-26 Toyobo Co Ltd Water soluble standard solution for measurement of fatty substance
JPS57163500A (en) * 1981-03-31 1982-10-07 Shinotesuto Kenkyusho:Kk Determination of total cholesterol
JPS58141797A (en) * 1982-02-17 1983-08-23 Hitachi Ltd Reagent for automatic analysis
JPS59122952A (en) * 1983-04-07 1984-07-16 ベツクマン・インスツルメンツ・インコ−ポレ−テツド Method of lengthening life of storage of serum bilirubin standard composition and its generating composition

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
AT400199B (en) * 1993-10-11 1995-10-25 Immuno Ag TREATMENT OF LIPOPROTE CONTAINING SAMPLES
US5770451A (en) * 1995-03-30 1998-06-23 Streck Laboratories, Inc. Liquid lipoprotein control
CN101995476A (en) * 2009-08-10 2011-03-30 中国医学科学院北京协和医院 Liquid quality control serum for clinical chemical detection
WO2011105257A1 (en) * 2010-02-23 2011-09-01 テルモ株式会社 Additive for erythrocyte-rich solution, and container for medical purposes
US8889237B2 (en) 2010-02-23 2014-11-18 Terumo Kabushiki Kaisha Excipient system and medical container for erythrocyte enriched liquid

Also Published As

Publication number Publication date
JPH0588789B2 (en) 1993-12-24

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