CN1037817C - Manufacture method for medicine box of kidney-function developer - Google Patents
Manufacture method for medicine box of kidney-function developer Download PDFInfo
- Publication number
- CN1037817C CN1037817C CN 92113240 CN92113240A CN1037817C CN 1037817 C CN1037817 C CN 1037817C CN 92113240 CN92113240 CN 92113240 CN 92113240 A CN92113240 A CN 92113240A CN 1037817 C CN1037817 C CN 1037817C
- Authority
- CN
- China
- Prior art keywords
- medicine box
- milligram
- kidney
- function developer
- bulk drug
- 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.)
- Expired - Fee Related
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- 239000003814 drug Substances 0.000 title claims abstract description 48
- 230000003907 kidney function Effects 0.000 title claims abstract description 17
- 238000004519 manufacturing process Methods 0.000 title claims abstract description 13
- 238000000034 method Methods 0.000 title abstract description 11
- 229910021626 Tin(II) chloride Inorganic materials 0.000 claims abstract description 11
- XSQUKJJJFZCRTK-UHFFFAOYSA-N Urea Chemical compound NC(N)=O XSQUKJJJFZCRTK-UHFFFAOYSA-N 0.000 claims abstract description 11
- 229940079593 drug Drugs 0.000 claims abstract description 11
- 235000011150 stannous chloride Nutrition 0.000 claims abstract description 11
- TXUICONDJPYNPY-UHFFFAOYSA-N (1,10,13-trimethyl-3-oxo-4,5,6,7,8,9,11,12,14,15,16,17-dodecahydrocyclopenta[a]phenanthren-17-yl) heptanoate Chemical compound C1CC2CC(=O)C=C(C)C2(C)C2C1C1CCC(OC(=O)CCCCCC)C1(C)CC2 TXUICONDJPYNPY-UHFFFAOYSA-N 0.000 claims abstract description 10
- CIWBSHSKHKDKBQ-JLAZNSOCSA-N Ascorbic acid Chemical compound OC[C@H](O)[C@H]1OC(=O)C(O)=C1O CIWBSHSKHKDKBQ-JLAZNSOCSA-N 0.000 claims abstract description 10
- 239000001119 stannous chloride Substances 0.000 claims abstract description 10
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical compound O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims abstract description 6
- 235000010323 ascorbic acid Nutrition 0.000 claims abstract description 5
- 229960005070 ascorbic acid Drugs 0.000 claims abstract description 5
- 239000011668 ascorbic acid Substances 0.000 claims abstract description 5
- 235000013877 carbamide Nutrition 0.000 claims abstract description 5
- 239000004202 carbamide Substances 0.000 claims abstract description 5
- XUJNEKJLAYXESH-UHFFFAOYSA-N cysteine Natural products SCC(N)C(O)=O XUJNEKJLAYXESH-UHFFFAOYSA-N 0.000 claims abstract description 5
- 235000018417 cysteine Nutrition 0.000 claims abstract description 5
- 239000012153 distilled water Substances 0.000 claims abstract description 5
- NBIIXXVUZAFLBC-UHFFFAOYSA-K phosphate Chemical compound [O-]P([O-])([O-])=O NBIIXXVUZAFLBC-UHFFFAOYSA-K 0.000 claims abstract description 5
- 229910019142 PO4 Inorganic materials 0.000 claims abstract description 4
- 239000010452 phosphate Substances 0.000 claims abstract description 4
- 239000000243 solution Substances 0.000 claims description 9
- 238000002372 labelling Methods 0.000 claims description 7
- DGAQECJNVWCQMB-PUAWFVPOSA-M Ilexoside XXIX Chemical compound C[C@@H]1CC[C@@]2(CC[C@@]3(C(=CC[C@H]4[C@]3(CC[C@@H]5[C@@]4(CC[C@@H](C5(C)C)OS(=O)(=O)[O-])C)C)[C@@H]2[C@]1(C)O)C)C(=O)O[C@H]6[C@@H]([C@H]([C@@H]([C@H](O6)CO)O)O)O.[Na+] DGAQECJNVWCQMB-PUAWFVPOSA-M 0.000 claims description 5
- 229910052708 sodium Inorganic materials 0.000 claims description 5
- 239000011734 sodium Substances 0.000 claims description 5
- 238000001914 filtration Methods 0.000 claims description 4
- 238000004108 freeze drying Methods 0.000 claims description 4
- 239000012982 microporous membrane Substances 0.000 claims description 4
- 238000005406 washing Methods 0.000 claims description 4
- 238000002347 injection Methods 0.000 claims description 2
- 239000007924 injection Substances 0.000 claims description 2
- 239000012467 final product Substances 0.000 claims 1
- 239000000203 mixture Substances 0.000 abstract description 5
- 210000004185 liver Anatomy 0.000 abstract description 3
- 239000004615 ingredient Substances 0.000 abstract 2
- 102000004506 Blood Proteins Human genes 0.000 abstract 1
- 108010017384 Blood Proteins Proteins 0.000 abstract 1
- XUJNEKJLAYXESH-REOHCLBHSA-N L-Cysteine Chemical compound SC[C@H](N)C(O)=O XUJNEKJLAYXESH-REOHCLBHSA-N 0.000 abstract 1
- 238000010521 absorption reaction Methods 0.000 abstract 1
- 238000004500 asepsis Methods 0.000 abstract 1
- 210000000936 intestine Anatomy 0.000 abstract 1
- 235000021317 phosphate Nutrition 0.000 abstract 1
- 239000002574 poison Substances 0.000 abstract 1
- 231100000614 poison Toxicity 0.000 abstract 1
- QGZKDVFQNNGYKY-UHFFFAOYSA-N Ammonia Chemical compound N QGZKDVFQNNGYKY-UHFFFAOYSA-N 0.000 description 8
- JKQOBWVOAYFWKG-UHFFFAOYSA-N molybdenum trioxide Chemical compound O=[Mo](=O)=O JKQOBWVOAYFWKG-UHFFFAOYSA-N 0.000 description 8
- GRYLNZFGIOXLOG-UHFFFAOYSA-N Nitric acid Chemical compound O[N+]([O-])=O GRYLNZFGIOXLOG-UHFFFAOYSA-N 0.000 description 6
- 229910017604 nitric acid Inorganic materials 0.000 description 6
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 description 5
- PNEYBMLMFCGWSK-UHFFFAOYSA-N Alumina Chemical compound [O-2].[O-2].[O-2].[Al+3].[Al+3] PNEYBMLMFCGWSK-UHFFFAOYSA-N 0.000 description 4
- VEXZGXHMUGYJMC-UHFFFAOYSA-N Hydrochloric acid Chemical compound Cl VEXZGXHMUGYJMC-UHFFFAOYSA-N 0.000 description 3
- 108010055917 Technetium Tc 99m Mertiatide Proteins 0.000 description 3
- 229910021529 ammonia Inorganic materials 0.000 description 3
- 238000002474 experimental method Methods 0.000 description 3
- 238000003384 imaging method Methods 0.000 description 3
- 239000011630 iodine Substances 0.000 description 3
- 229910052740 iodine Inorganic materials 0.000 description 3
- CORFWQGVBFFZHF-AKGSDVBQSA-N 2-[(2-iodanylbenzoyl)amino]acetic acid Chemical compound OC(=O)CNC(=O)C1=CC=CC=C1[131I] CORFWQGVBFFZHF-AKGSDVBQSA-N 0.000 description 2
- 229940055492 99 molybdenum Drugs 0.000 description 2
- ZOKXTWBITQBERF-AKLPVKDBSA-N Molybdenum Mo-99 Chemical compound [99Mo] ZOKXTWBITQBERF-AKLPVKDBSA-N 0.000 description 2
- 241000699670 Mus sp. Species 0.000 description 2
- ATJFFYVFTNAWJD-UHFFFAOYSA-N Tin Chemical compound [Sn] ATJFFYVFTNAWJD-UHFFFAOYSA-N 0.000 description 2
- 125000002777 acetyl group Chemical group [H]C([H])([H])C(*)=O 0.000 description 2
- 239000003463 adsorbent Substances 0.000 description 2
- 239000008280 blood Substances 0.000 description 2
- 210000004369 blood Anatomy 0.000 description 2
- 230000000694 effects Effects 0.000 description 2
- 108010067216 glycyl-glycyl-glycine Proteins 0.000 description 2
- XKUKSGPZAADMRA-UHFFFAOYSA-N glycyl-glycyl-glycine Natural products NCC(=O)NCC(=O)NCC(O)=O XKUKSGPZAADMRA-UHFFFAOYSA-N 0.000 description 2
- 239000012535 impurity Substances 0.000 description 2
- 230000000968 intestinal effect Effects 0.000 description 2
- 230000007935 neutral effect Effects 0.000 description 2
- MGFYIUFZLHCRTH-UHFFFAOYSA-N nitrilotriacetic acid Chemical compound OC(=O)CN(CC(O)=O)CC(O)=O MGFYIUFZLHCRTH-UHFFFAOYSA-N 0.000 description 2
- 238000003969 polarography Methods 0.000 description 2
- 230000005855 radiation Effects 0.000 description 2
- 239000011780 sodium chloride Substances 0.000 description 2
- 229910052713 technetium Inorganic materials 0.000 description 2
- GKLVYJBZJHMRIY-UHFFFAOYSA-N technetium atom Chemical compound [Tc] GKLVYJBZJHMRIY-UHFFFAOYSA-N 0.000 description 2
- 231100000041 toxicology testing Toxicity 0.000 description 2
- CORFWQGVBFFZHF-UHFFFAOYSA-N 2-iodohippuric acid Chemical compound OC(=O)CNC(=O)C1=CC=CC=C1I CORFWQGVBFFZHF-UHFFFAOYSA-N 0.000 description 1
- ZCYVEMRRCGMTRW-UHFFFAOYSA-N 7553-56-2 Chemical compound [I] ZCYVEMRRCGMTRW-UHFFFAOYSA-N 0.000 description 1
- 239000003638 chemical reducing agent Substances 0.000 description 1
- 150000001875 compounds Chemical class 0.000 description 1
- 229910052593 corundum Inorganic materials 0.000 description 1
- 239000011521 glass Substances 0.000 description 1
- KJZYNXUDTRRSPN-UHFFFAOYSA-N holmium atom Chemical compound [Ho] KJZYNXUDTRRSPN-UHFFFAOYSA-N 0.000 description 1
- 210000003734 kidney Anatomy 0.000 description 1
- 235000015250 liver sausages Nutrition 0.000 description 1
- MEFBJEMVZONFCJ-UHFFFAOYSA-N molybdate Chemical compound [O-][Mo]([O-])(=O)=O MEFBJEMVZONFCJ-UHFFFAOYSA-N 0.000 description 1
- 229910000069 nitrogen hydride Inorganic materials 0.000 description 1
- 231100000252 nontoxic Toxicity 0.000 description 1
- 230000003000 nontoxic effect Effects 0.000 description 1
- 238000009206 nuclear medicine Methods 0.000 description 1
- 239000000843 powder Substances 0.000 description 1
- 239000002510 pyrogen Substances 0.000 description 1
- 230000002285 radioactive effect Effects 0.000 description 1
- 210000002966 serum Anatomy 0.000 description 1
- 238000007493 shaping process Methods 0.000 description 1
- 230000004083 survival effect Effects 0.000 description 1
- AXZWODMDQAVCJE-UHFFFAOYSA-L tin(II) chloride (anhydrous) Chemical compound [Cl-].[Cl-].[Sn+2] AXZWODMDQAVCJE-UHFFFAOYSA-L 0.000 description 1
- 230000001988 toxicity Effects 0.000 description 1
- 231100000419 toxicity Toxicity 0.000 description 1
- 229910001845 yogo sapphire Inorganic materials 0.000 description 1
Images
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- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
Abstract
The present invention discloses a manufacture method for medicine boxes of kidney function developer using a bulk drug with a certain formula proportion under asepsis, non-heat source and room temperature conditions. The bulk drug has the ingredients of 2-ethene-L-dicysteine, stannous chloride, phosphate, urea, ascorbic acid or cysteine, etc. After the bulk drug is dissolved with distilled water to display alkalescence, the mixture is filtered through a millipore filter of smaller than 0.2 micrometer, and then is frozen, dried and shaped. The medicine box made by the present invention has the advantages of simple formula ingredient, no poison, high stability, easy and safe clinical application, low combination rate with plasma protein, low absorption by livers and intestines, etc.
Description
The present invention relates to a kind of radioelement technetium (Tc) that utilizes, make the method for production of new medicine box of kidney-function developer.
For many years, be extensive use of iodine labeling (131-iodine)-o-iodohippuric acid (131I-OIH) and be used for clinical renal functional imaging, higher because of its γ photon energy, and contain ray, be unsuitable for the video picture of γ camera, and patient's absorbed radiation dosage is big, particularly be unsuitable for the child; The U.S. develops the chemical compound 99m-technetium-sulfydryl acetyl group triglycine (99mTc-MAG3) of radioactive technetium labelling as medicine box of kidney-function developer in recent years; the clinical practice good stability; serum removes fast; the liver sausage uptake ratio is low; once be considered to best kidney-function developer at present, but the method for production of its medicine box is maintained secrecy.Use the new medicine box of kidney-function developer that method of the present invention is manufactured, promptly 99m-technetium-2-ethylene-L-ethylenedicysteine (99mTc-EC) is better than 131I-OIH and has overcome its energy height, and the shortcoming that radiation damage is big is used safety and reliability; Compare with 99mTc-MAG3, the stability of 99mTc-EC is better, and is clinical easy to prepare rapid, do not need heated and boiled, can do kidney figure and renal functional imaging with it at any time, and blood clearance rate and lower liver, intestinal uptake ratio are faster arranged.
The objective of the invention is to obtain blood clearance rate and lower liver, intestinal uptake ratio faster, and at ambient temperature, the method for production of the medicine box of kidney-function developer that can use immediately.
To achieve the above object, the invention provides a kind of method for production of new medicine box of kidney-function developer, adopted unique new prescription: promptly under the condition of aseptic, apyrogeneity and room temperature, adopted 2-ethylene-L-ethylenedicysteine (EC crude drug) 0.5-5 milligram, stannous chloride (sncl
2) the 20-100 microgram, phosphate 10-25 milligram, carbamide 5-20 milligram, ascorbic acid (or cysteine) 0.5-1 milligram, be alkalescence (its pH value is at 10-11) with solution behind the dissolved in distilled water,, make after the lyophilization through filtering with microporous membrane less than 0.2 micron diameter.
About the method for production of the labelling of medicine box is that sodium pertechnetate with the new drip washing of 2-6 milliliter injects medicine box, fully shakes up, and room temperature is placed and can be used in 5 minutes.
In the method for production of medicine box labelling, the sodium pertechnetate of new drip washing, be earlier with 99-molybdenum (99MO) with molybdate (MOO
4 2-) form, from nitric acid (HNO3) solution, be adsorbed on aluminium sesquioxide (Al
2O
3) on the post, with rare nitric acid (HNO3) eluting, can obtain pertechnetate (99mTcO4) before using.Or make target with molybdenum trioxide (MOO3) powder, postradiation molybdenum trioxide (MOO3) is dissolved in ammonia (NH
3H
2O) in, boil off excess ammonia, be adjusted to neutral solution, be adsorbed on the alumina column, use 0.1 mol hydrochloric acid or 0.9% sodium chloride (NaCl) eluant solution 99m-technetium (99mTc) at last.
Advantage of the present invention is that (1) uses new medicine box of kidney-function developer that this method manufactures owing to adopted unique new prescription, make the composition of medicine box simple, inferior stannum content is few, be the 20-100 microgram, domestic other medicine box is made the content of Reducing agent all greater than 100 micrograms with stannous chloride, consider the toxicity of stannous chloride, require its content should be lower than 100 micrograms abroad usually.Product of the present invention confirms nontoxic harmless through zoopery and toxicological study.(2) the new medicine box of kidney-function developer that adopts the method for the invention to produce does not contain other impurity, safe in utilization, easy, its mark rate height fast.(3), its good stability of new medicine box of the method for the invention, measure and with EC crude drug and the stannous chloride Determination on content of oscilloscopic polarography by mark rate adopting in the medicine box, confirm EC crude drug medicine box good stability, under 40 ℃ of lucifuge conditions, placed one month, mark rate does not have significant change, places half a year down for 25 ℃, places after 1 year for 4 ℃, mark rate has no significant change, and the loss amount of the stannous chloride all content less than the 20%EC crude drug is constant substantially.Experiment showed, that medicine box is suitable for the long-distance transport in summer fully.The present invention provides convenience for China's southern area and backwoodsman use.
Below by accompanying drawing embodiments of the invention are described further.
Fig. 1 is the method for production process chart of the new medicine box of kidney-function developer of the present invention.
Fig. 2 is the structural formula of (131-iodine) o-iodohippuric acid.
Fig. 3 is 99m-technetium-sulfydryl acetyl group triglycine (99mTc-MAG3) structural formula.
Fig. 4 is 99m-technetium-2-ethylene-L-ethylenedicysteine (99mTc-EC) structural formula.
Among the above-mentioned figure:
1,2-ethylene-L-ethylenedicysteine (EC crude drug)
2, stannous chloride (SnCl2)
3, phosphate
4, carbamide
5, ascorbic acid (or cysteine)
6, dissolved in distilled water
7, filtering with microporous membrane
8, lyophilization
9, medicine box is shaped
10, sodium pertechnetate
11, add radioisotope labeling
12, inject the kidney-function developer of human body
13, inject human body
14, γ camera merit attitude video picture
15, be represented by dotted lines the flow process in hospital clinical stage
The method for production process chart that is the new medicine box of kidney-function developer of the present invention as shown in Figure 1 is promptly under the condition of aseptic apyrogeneity room temperature, whenever-medicine box will be with EC crude drug (2-ethylene-L-ethylenedicysteine) (1) 0.5-5 milligram, protochloride WU (2) 20-100 microgram, phosphate (3) 10-25 milligram, carbamide (4) 5-20 milligram, ascorbic acid (or cysteine) (5) 0.5-1 milligram, after with dissolved in distilled water (6), solution is alkalescence (its pH value is in 10-11), and to be less than 0.2 micron filtering with microporous membrane (7) lyophilization (8) that mixture should be frozen into through diameter solid-state, makes medicine box shaping (9) at the solid-state moisture content of draining down.
See the technological process (15) that is represented by dotted lines the hospital clinical stage among Fig. 1 about the radioisotope labeling (11) of medicine box, be in sodium pertechnetate (10) the injection medicine box (9) with the new drip washing of 2-6 milliliter, through fully shaking up, the room temperature placement can obtain injecting the kidney-function developer (12) of human body in 5 minutes after injecting human body (13), promptly available γ camera dynamic imaging (14).
By the new medicine box of kidney-function developer that above-mentioned process is made, be characterized in that composition is simple, inferior stannum content few (for the 20-100 microgram) does not contain other harmful composition and impurity yet, so safe in utilization easy to be quick; Through zoopery and toxicological study, more than 1000 times, untoward reaction is not seen in the whole survivals of the mice of experiment to the mice safe dose of experiment greater than the human body consumption, and family exempts to test pyrogen reaction and all is negative.
The made medicine box of the present invention measure by mark rate and with oscilloscopic polarography to EC crude drug in the medicine box and stannous chloride Determination on content, confirmed that EC medicine box stability is fine, under 40 ℃ of lucifuge conditions, placed one month, mark rate does not have significant change; Place down in half a year, 4 ℃ of refrigerators for 25 ℃ and place after 1 year, mark rate has no significant change, and promptly the mark rate of EC medicine box is through measuring all greater than 98% repeatedly.The loss amount of stannous chloride is all less than 20%, experimental results show that medicine box that the present invention manufactures is suitable for the long-distance transport in summer fully, for China south and outlying district provide service condition.
About radionuclide generator: it is that parent radionuclide from certain long half-lift separates a kind of special arrangement that obtains short-decayed daughter activity nucleic to produce the short-half-life medical radionuclide.
Way: the parent radionuclide is adsorbed on the interior adsorbent of special glass pipe, and the daughter activity nucleic that its decay back generates uses the eluant of selecting to elute from adsorbent, uses for clinical nuclear medicine.
99mTc produces from the 99MO-99mTc nuclide generator, earlier with 99Mo with MoO
4 -2Formation is adsorbed on from HNO3 solution and can obtains 99mTcO4 with rare HNO3 eluting before the Al2O3 post uses.
Perhaps make target with the MoO3 powder, postradiation MoO3 is dissolved in NH3.Among the H2O, boil off excess ammonia, be adjusted to neutral solution, be adsorbed on the alumina column, use 0.1 mol HCl or 0.9%NaCl eluant solution 99mTc at last.
Claims (1)
1. the method for production of a new medicine box of kidney-function developer, it is characterized in that: under the condition of aseptic, apyrogeneity, room temperature, adopt EC crude drug 2-ethylene-L-ethylenedicysteine 05-5 milligram, stannous chloride 20-100 microgram, phosphate 10-25 milligram, carbamide 5-20 milligram, ascorbic acid 0.5-1 milligram or cysteine 0.5-1 milligram, behind dissolved in distilled water, solution is its pH value of alkalescence in 10-11, through the filtering with microporous membrane of diameter, make after the lyophilization less than 0.2 micron; The labelling method for production of this medicine box is with the sodium pertechnetate injection medicine box of the new drip washing of 2-6 milliliter, fully shakes up, and room temperature is placed and got final product in 5 minutes.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 92113240 CN1037817C (en) | 1992-12-04 | 1992-12-04 | Manufacture method for medicine box of kidney-function developer |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 92113240 CN1037817C (en) | 1992-12-04 | 1992-12-04 | Manufacture method for medicine box of kidney-function developer |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN1087546A CN1087546A (en) | 1994-06-08 |
| CN1037817C true CN1037817C (en) | 1998-03-25 |
Family
ID=4946312
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN 92113240 Expired - Fee Related CN1037817C (en) | 1992-12-04 | 1992-12-04 | Manufacture method for medicine box of kidney-function developer |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN1037817C (en) |
Families Citing this family (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1065770C (en) * | 1998-09-04 | 2001-05-16 | 中国原子能科学研究院 | 99MTc-N, N' -diamineethyl propane diamine hexaacetic acid developer and its application |
| CN111295184A (en) * | 2018-10-06 | 2020-06-16 | 朱比兰特通用有限公司 | Sulfur colloid pharmaceutical composition and method thereof |
| CN112999369B (en) * | 2021-03-03 | 2022-02-25 | 江苏元本生物科技有限公司 | HER2 affinity radionuclide marker composition and application thereof |
-
1992
- 1992-12-04 CN CN 92113240 patent/CN1037817C/en not_active Expired - Fee Related
Also Published As
| Publication number | Publication date |
|---|---|
| CN1087546A (en) | 1994-06-08 |
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