CN205295301U - Heparin enzyme process detects according to promise liquaemin 1. 6 - acid anhydride content kit - Google Patents
Heparin enzyme process detects according to promise liquaemin 1. 6 - acid anhydride content kit Download PDFInfo
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- CN205295301U CN205295301U CN201520486250.0U CN201520486250U CN205295301U CN 205295301 U CN205295301 U CN 205295301U CN 201520486250 U CN201520486250 U CN 201520486250U CN 205295301 U CN205295301 U CN 205295301U
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- solution
- test kit
- acid anhydride
- anhydride content
- enzyme process
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- 229920000669 heparin Polymers 0.000 title claims abstract description 22
- HTTJABKRGRZYRN-UHFFFAOYSA-N Heparin Chemical compound OC1C(NC(=O)C)C(O)OC(COS(O)(=O)=O)C1OC1C(OS(O)(=O)=O)C(O)C(OC2C(C(OS(O)(=O)=O)C(OC3C(C(O)C(O)C(O3)C(O)=O)OS(O)(=O)=O)C(CO)O2)NS(O)(=O)=O)C(C(O)=O)O1 HTTJABKRGRZYRN-UHFFFAOYSA-N 0.000 title claims abstract description 20
- 229960002897 heparin Drugs 0.000 title claims abstract description 17
- 238000000034 method Methods 0.000 title claims abstract description 16
- 108090000790 Enzymes Proteins 0.000 title claims abstract description 14
- 102000004190 Enzymes Human genes 0.000 title claims abstract description 14
- 238000012360 testing method Methods 0.000 claims abstract description 31
- 238000002474 experimental method Methods 0.000 claims abstract description 12
- 239000000463 material Substances 0.000 claims abstract description 11
- 239000007788 liquid Substances 0.000 claims abstract description 4
- 229960005153 enoxaparin sodium Drugs 0.000 claims description 14
- CIJQTPFWFXOSEO-NDMITSJXSA-J tetrasodium;(2r,3r,4s)-2-[(2r,3s,4r,5r,6s)-5-acetamido-6-[(1r,2r,3r,4r)-4-[(2r,3s,4r,5r,6r)-5-acetamido-6-[(4r,5r,6r)-2-carboxylato-4,5-dihydroxy-6-[[(1r,3r,4r,5r)-3-hydroxy-4-(sulfonatoamino)-6,8-dioxabicyclo[3.2.1]octan-2-yl]oxy]oxan-3-yl]oxy-2-(hydroxy Chemical compound [Na+].[Na+].[Na+].[Na+].O([C@@H]1[C@@H](COS(O)(=O)=O)O[C@@H]([C@@H]([C@H]1O)NC(C)=O)O[C@@H]1C(C[C@H]([C@@H]([C@H]1O)O)O[C@@H]1[C@@H](CO)O[C@H](OC2C(O[C@@H](OC3[C@@H]([C@@H](NS([O-])(=O)=O)[C@@H]4OC[C@H]3O4)O)[C@H](O)[C@H]2O)C([O-])=O)[C@H](NC(C)=O)[C@H]1C)C([O-])=O)[C@@H]1OC(C([O-])=O)=C[C@H](O)[C@H]1O CIJQTPFWFXOSEO-NDMITSJXSA-J 0.000 claims description 14
- 238000001514 detection method Methods 0.000 claims description 13
- 239000003153 chemical reaction reagent Substances 0.000 claims description 12
- 230000002255 enzymatic effect Effects 0.000 claims description 3
- 238000004321 preservation Methods 0.000 claims description 3
- 108010022901 Heparin Lyase Proteins 0.000 abstract description 8
- 238000013461 design Methods 0.000 abstract description 3
- 230000007774 longterm Effects 0.000 abstract 1
- 239000000243 solution Substances 0.000 description 26
- 239000012086 standard solution Substances 0.000 description 13
- 239000012085 test solution Substances 0.000 description 10
- 238000004128 high performance liquid chromatography Methods 0.000 description 5
- VSGNNIFQASZAOI-UHFFFAOYSA-L calcium acetate Chemical compound [Ca+2].CC([O-])=O.CC([O-])=O VSGNNIFQASZAOI-UHFFFAOYSA-L 0.000 description 3
- 229960005147 calcium acetate Drugs 0.000 description 3
- 235000011092 calcium acetate Nutrition 0.000 description 3
- 239000001639 calcium acetate Substances 0.000 description 3
- 150000002016 disaccharides Chemical class 0.000 description 3
- 239000011259 mixed solution Substances 0.000 description 3
- 229910000033 sodium borohydride Inorganic materials 0.000 description 3
- 239000012279 sodium borohydride Substances 0.000 description 3
- 229910021642 ultra pure water Inorganic materials 0.000 description 3
- 239000012498 ultrapure water Substances 0.000 description 3
- 238000013459 approach Methods 0.000 description 2
- 238000001914 filtration Methods 0.000 description 2
- ZFGMDIBRIDKWMY-PASTXAENSA-N heparin Chemical compound CC(O)=N[C@@H]1[C@@H](O)[C@H](O)[C@@H](COS(O)(=O)=O)O[C@@H]1O[C@@H]1[C@@H](C(O)=O)O[C@@H](O[C@H]2[C@@H]([C@@H](OS(O)(=O)=O)[C@@H](O[C@@H]3[C@@H](OC(O)[C@H](OS(O)(=O)=O)[C@H]3O)C(O)=O)O[C@@H]2O)CS(O)(=O)=O)[C@H](O)[C@H]1O ZFGMDIBRIDKWMY-PASTXAENSA-N 0.000 description 2
- 229960001008 heparin sodium Drugs 0.000 description 2
- 239000000126 substance Substances 0.000 description 2
- 239000006228 supernatant Substances 0.000 description 2
- 239000012490 blank solution Substances 0.000 description 1
- 239000003055 low molecular weight heparin Substances 0.000 description 1
- 239000000376 reactant Substances 0.000 description 1
- 238000005303 weighing Methods 0.000 description 1
Abstract
The utility model discloses a heparin enzyme process detects according to promise liquaemin 1.6 - acid anhydride content kit, include each one kit A and B, the A box is for testing consumptive material and solution A, solution B, and room temperature long -term storage, B box are liquid heparinase solution, need - 20 DEG C or - 80 DEG C of saves. The utility model discloses a heparin enzyme process detects according to promise liquaemin 1.6 - acid anhydride content kit, structural design is simple, saves a large amount of experiment time of preparation of the experimenter, and the test is convenient, high -efficient reliable fast, and the test result is stable.
Description
Technical field
This utility model relates to a kind of heparin enzyme process detection Enoxaparin Sodium 1.6-acid anhydride content test kit.
Background technology
Existing Europe/American Pharmacopeia, in Enoxaparin Sodium, 1.6-acid anhydride content is the important indicator evaluating Enoxaparin Sodium (Low molecular heparin) quality. The method includes the processes such as Heparinase I, II, III combination degraded and sodium borohydride reduction, complex operation step, required reagent, consumptive material kind are more, need to expend the substantial amounts of time and efforts of experimenter, and easily owing to manual operation reason causes, error in data is big, experimental repeatability is poor, there is presently no set of heparinase detection kit.
Utility model content
Main purpose of the present utility model is in that to simplify Enoxaparin Sodium 1.6-acid anhydride content detection operational approach, and provides a kind of heparin enzyme process detection Enoxaparin Sodium 1.6-acid anhydride content test kit.
For reaching above-mentioned purpose, the technical solution of the utility model provides a kind of heparin enzyme process detection Enoxaparin Sodium 1.6-acid anhydride content test kit, including test kit A and B each one, A box is experiment consumptive material and solution A, solution B, room temperature preserves for a long time, B box is liquid heparin enzymatic solution, needs-20 DEG C or-80 DEG C preservations.
Further, described test kit A, it is divided into upper and lower two-layer, upper strata is Reagent Tube, and lower floor is solution A, solution B and experiment consumptive material.
Further, upper strata, described Reagent Tube, often group is respectively as follows: 0��2ml centrifuge tube, 0��1.5ml screw conical bottom tube.
Further, lower floor, described solution A, solution B, filtered calcium acetate solution including 0��100ml ultra-pure water, 0��50ml.
Further, lower floor, described experiment consumptive material, including 2ml syringe, ting model filter, cursory.
Further, described test kit B is the mixed solution of Heparinase I, II, III.
Compared with prior art, the utility model has the advantage of: structural design is simple, saving experimenter's substantial amounts of Preparatory work of experiment time, test quick and convenient, high efficient and reliable, test result is stable.
Accompanying drawing explanation
Fig. 1 is the structural representation on a kind of heparin enzyme process detection of this utility model Enoxaparin Sodium 1.6-acid anhydride content test kit A box upper strata.
Fig. 2 is the structural representation of a kind of heparin enzyme process of this utility model detection Enoxaparin Sodium 1.6-acid anhydride content test kit A box lower floor.
Fig. 3 is the structural representation of a kind of heparin enzyme process detection Enoxaparin Sodium 1.6-acid anhydride content test kit B box of this utility model.
Wherein Fig. 1: 10 group reagent pipe, 3 is 0��2ml centrifuge tube, and 4 is 0��1.5ml screw conical bottom tube;Wherein Fig. 2: wrap 1 syringe, wraps 2 ting model filters, and 1 is cursory, and A is ultra-pure water, and B is for filtering calcium acetate solution; Wherein Fig. 3: 2 is the mixed solution of 20 Heparinase Is, II, III.
Detailed description of the invention
Below in conjunction with drawings and Examples, detailed description of the invention of the present utility model is described in further detail. Following example are used for illustrating this utility model, but are not limited to scope of the present utility model.
The structure of a kind of heparin enzyme process detection Enoxaparin Sodium 1.6-acid anhydride content test kit of the present embodiment is as shown in Figure 1, including test kit A and B each one, A box is experiment consumptive material and solution A, solution B, and room temperature preserves for a long time, B box is liquid heparin enzymatic solution, needs-20 DEG C or-80 DEG C preservations.
Described test kit A, is divided into upper and lower two-layer, and upper strata is Reagent Tube, and lower floor is solution A, solution B and experiment consumptive material.
Test kit A upper strata, described Reagent Tube, often group is respectively as follows: 0��2ml centrifuge tube, 0��1.5ml screw conical bottom tube.
Test kit A lower floor, described solution A, solution B, filtered calcium acetate solution including 0��100ml ultra-pure water, 0��50ml.
Test kit A lower floor, described experiment consumptive material, including 2ml syringe, ting model filter, cursory.
Described test kit B is the mixed solution of Heparinase I, II, III.
Operational approach:
Step 1 disaccharide standard solution: use 0-2ml centrifuge tube in A box upper strata 10 group reagent pipe, precision weighing standard substance, dissolve by the solution A of A box lower floor; HPLC analyzes and records collection of illustrative plates.
Step 2 reduces disaccharide standard solution: use 0-2ml centrifuge tube in the group reagent pipe of A box upper strata 10, dissolves by the solution A of A box lower floor, then pipettes 10ul to the 60ul disaccharide standard solution of step 1; Mixing, room temperature reaction more than 24 hours; HPLC analyzes and records collection of illustrative plates.
Step 3 blank solution: use 0-2ml centrifuge tube in A box upper strata 10 group reagent pipe, adds the solution A of 20ulA box lower floor; Add the solution B of 70ulA box lower floor; B box heparinase 1 is managed and all adds in this 0-2ml centrifuge tube; 25 DEG C are reacted more than 48 hours; Pipette the sodium borohydride solution of 60ul reactant liquor and 10ul step 2 to trace screw socket pipe; Mixing, room temperature reaction more than 24 hours; HPLC analyzes and records collection of illustrative plates.
Step 4 test solution 1/ standard solution 1: use 0-2ml centrifuge tube in the group reagent pipe of A box upper strata 10, weighs heparin sodium/heparin sodium standard substance to this centrifuge tube; The solution A using A box lower floor is dissolved; It is test solution 1/ standard solution 1 after filtration, does Duplicate Samples.
Step 5 test solution 2/ standard solution 2: pipette in test solution 1/ standard solution 1 to A box upper strata 0��1.5ml screw conical bottom tube of 20ul step 4, do Duplicate Samples; Add the solution B of 70ulA box lower floor, do Duplicate Samples; B box heparinase 1 is managed and all adds in this 0-1.5ml screw conical bottom tube, do Duplicate Samples; 25 DEG C are reacted more than 48 hours, as test solution 2/ standard solution 2; By test solution 2/ standard solution 2 centrifuging and taking supernatant; HPLC analyzes and records collection of illustrative plates.
Step 6 test solution 3/ standard solution 3: pipette in test solution 2/ standard solution 2 to A box upper strata 0��1.5ml screw conical bottom tube of 60ul step 5, do Duplicate Samples; Add the sodium borohydride solution of 10ul step 2, do Duplicate Samples; Room temperature reaction more than 24 hours, as test solution 3/ standard solution 3; By test solution 3/ standard solution 3 centrifuging and taking supernatant; HPLC analyzes and records collection of illustrative plates.
The utility model has the advantage of: structural design is simple, saving experimenter's substantial amounts of Preparatory work of experiment time, test quick and convenient, high efficient and reliable, test result is stable.
The above is only preferred implementation of the present utility model; it should be pointed out that, for those skilled in the art, under the premise without departing from this utility model know-why; can also making some improvement, these improvement also should be regarded as protection domain of the present utility model.
Claims (3)
1. a heparin enzyme process detection Enoxaparin Sodium 1.6-acid anhydride content test kit, it is characterized in that, including test kit A and B each one, A box is experiment consumptive material and solution A (A), solution B (B), room temperature preserves for a long time, B box is liquid heparin enzymatic solution, needs-20 DEG C or-80 DEG C preservations; Described test kit A is divided into upper and lower two-layer, and upper strata is Reagent Tube, and lower floor is solution A (A), solution B (B) and experiment consumptive material.
2. heparin enzyme process according to claim 1 detection Enoxaparin Sodium 1.6-acid anhydride content test kit, it is characterized in that, test kit A upper strata, described Reagent Tube, often organize respectively 0��2ml centrifuge tube (3), 0��1.5ml screw conical bottom tube (4).
3. heparin enzyme process according to claim 1 detection Enoxaparin Sodium 1.6-acid anhydride content test kit, it is characterised in that test kit A lower floor, described experiment consumptive material, including 2ml syringe, ting model filter, cursory (1).
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201520486250.0U CN205295301U (en) | 2015-07-08 | 2015-07-08 | Heparin enzyme process detects according to promise liquaemin 1. 6 - acid anhydride content kit |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201520486250.0U CN205295301U (en) | 2015-07-08 | 2015-07-08 | Heparin enzyme process detects according to promise liquaemin 1. 6 - acid anhydride content kit |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN205295301U true CN205295301U (en) | 2016-06-08 |
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Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201520486250.0U Active CN205295301U (en) | 2015-07-08 | 2015-07-08 | Heparin enzyme process detects according to promise liquaemin 1. 6 - acid anhydride content kit |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN205295301U (en) |
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- 2015-07-08 CN CN201520486250.0U patent/CN205295301U/en active Active
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Address after: Room A417, 4th Floor, No. 5 Pioneer Road, Haidian District, Beijing 100085 Patentee after: BEIJING BIOKANGTAI MEDICINE SCIENCE & TECHNOLOGY CO.,LTD. Address before: Room B402, 4th Floor, No. 5 Kaifeng Road, Haidian District, Beijing 100085 Patentee before: BEIJING BIOKANGTAI MEDICINE SCIENCE & TECHNOLOGY CO.,LTD. |
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Addressee: Zhou Qianqian Document name: payment instructions |
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Addressee: Zhou Qianqian Document name: Notice of Termination of Patent Rights |