CN102028962A - 99mTc-MIBI labeled lyophilized product medicine box and preparation method thereof - Google Patents

99mTc-MIBI labeled lyophilized product medicine box and preparation method thereof Download PDF

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Publication number
CN102028962A
CN102028962A CN 201010593618 CN201010593618A CN102028962A CN 102028962 A CN102028962 A CN 102028962A CN 201010593618 CN201010593618 CN 201010593618 CN 201010593618 A CN201010593618 A CN 201010593618A CN 102028962 A CN102028962 A CN 102028962A
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mibi
weight portions
preparation
freeze drying
medicine box
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朱霖
杜风华
吴静晓
李淑艳
国毓智
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Beijing Xinkesida Pharma Tech Co Ltd
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Beijing Xinkesida Pharma Tech Co Ltd
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Abstract

The invention relates to a 99mTc-MIBI labeled lyophilized product medicine box and a preparation method thereof. The formulation of the medicine box comprises the following main components in part by weight: 20-200 parts of MIBI, 2-20 parts of stannous chloride dehydrate, 80-800 parts of glutathione and 1,000-3,000 parts of mannitol. The invention successfully applies GSH to the preparation of the MIBI medicine box for the first time, optimizes the formulation of the medicine box, effectively solves the problem of too fast decomposition of stannous chloride during the labeling of MIBI, prolongs the quality guarantee period of the medicine box and increases the stability of the medicine box.

Description

99mTc-MIBI mark freeze drying article medicinal box and preparation method thereof
Technical field
The present invention relates to a kind of 99mTc-MIBI (Technetium[99m] Methoxy isobutyl isonitrile, technetium [99m] methoxy isonitrile) mark freeze drying article medicinal box and preparation method thereof.
Background technology
Radiopharmaceutical (radiopharmaceuticals) is meant the radionuclide that can be used for clinical diagnosis or treatment or simple substance, chemical compound and the biological preparation of its labelling.Utilize it and corresponding nuclear medicine image equipment, can on molecular level, realize early diagnosis, improve accuracy rate and success rate greatly the prevention and the treatment of this type of disease to cardiovascular, cerebral nervous system disease and tumor.Because radiopharmaceutic particularity (have radioactivity and unstability, the half-life is short, effect duration is short etc.), its fast preparation method and preparation manufacture easily and effectively thereof are its important steps of moving towards market, also be the focus and the difficult point of current international radiopharmaceutical research and development, become the important content of radiopharmaceutical applied research, market prospect is wide.
Because 99mThe Tc nucleic has good nulcear properties (ray energy of short and 140Kev of 6.02h half-life), with the form supply of generator, easy to use, cheap etc., in nuclear medicine SPECT video picture, irreplaceable superiority is arranged. 99mTc has colourful chemical property, and its chemical valence state can form miscellaneous metal complex with various parts, therefore from positive septivalency to negative monovalence 99mThe research of Tc labeled drug is a very active field always. 99mThe Tc labeled drug is to offer hospital or nuclear pharmacy (radiopharmaceuticals instant supply enterprise) with the supporting kit form of dried frozen aquatic products, by them with supporting medicine box and radiosiotope 99mBehind the Tc labelling, offer hospital's nuclear medicine clinical practice immediately.It is the radiopharmaceutical of tense marker that this mode is applicable to various, can effectively ensure drug quality.
Problems of the prior art are as follows:
99mThe Tc mark freeze drying article medicinal box: what be made up of various ingredients is tense marker medication box; in the prescription except that main material and Ya Xi Reducing agent; mainly comprise excipient, exchange part, cosolvent or dispersant and protective agent etc., to guarantee the radiochemical purity of labeled drug.But medicine box is stable bad usually, effect duration has only 3～6 months, wherein the oxidized inefficacy of Reducing agent (as inferior stannum, organic reducing agent etc.) is a common problem, therefore the selection of prescription just seems and is even more important, and should guarantee the stability of medicine box so that store and transportation, the quality that guarantees instant labeled drug again satisfy clinical instructions for use.
As myocardial imaging 99mTc-MIBI (structure is as follows), its part MIBI (molecular formula [Cu (MIBI) 4] BF 4Below all represent with MIBI) and supporting freeze drying article medicinal box product, make and obtain FDA approval listing by du pont company in 80～nineties of last century invention at first, China also with imitation products listing in the ratifying state first in 1993, promoted China's nuclear medicine career development.So far, vast amount of clinical and application have been done both at home and abroad, become pillar medicine (Biological studies of a new class of technetium complex:the hexakis (alkylisonitrile) technetium (I) cations.J.Nucl.Med.Biol. of nuclear medicine, 11,225-34,1984).
Figure BSA00000389721000021
As developer 99mThe supporting MIBI medicine box of Tc-MIBI, its performance and quality are 99mTc-MIBI preparation and the successful key of using.At present, MIBI medicine box composition has nothing in common with each other both at home and abroad:
Du pont company prescription (UNITED STATES PHARMACOPEIAL CONVENTION, Technetium Tc-99m sestamibi injection, United States Pharmacopeia 30, USPConvention, Rockville, MD (2006) 3286-3287.EUROPEAN DIRECTORATE FOR THE QUALITY OF MEDICINES, Technetium (99mTc) sestamibi injection, European Pharmacopoeia, 5th edn, EDQM, Council of Europe, Strasbourg (2005) 863):
—MIBI：1.0mg；
—Stannous?chloride?dihydrate(SnCl 2·2H 2O)：0.075mg；
-L-cysteine hydrochloride monohydrate (L-cysteine hydrochloride monohydrate): 1.0mg;
-Sodium citrate dehydrate (anhydrous citric acid sodium): 2.6mg;
-D-mannitol (D-mannitol): 20mg.
In domestic two kinds of prescriptions having ratified to go on the market, a kind of the same with E.I.Du Pont Company, another is:
—MIBI：1.0mg；
-FSA (dioxy thiourea): 0.2-0.5mg;
-sodium hydrogen phosphate: 0.8mg;
-sodium dihydrogen phosphate: 4.55mg;
-mannitol: 20mg
Because 99mThe labelling of Tc-MIBI need be 100 degrees centigrade of heating, and the medicine box effectiveness is subjected to the influence of its component to seem extremely important, except imitated du pont company prescription, domestic manufacturer mainly select organic reducing agent dioxy thiourea FSA replace inferior stannum reach the high technetium of reduction [ 99mTc] purpose, though kit components is simplified relatively, but because organic reducing agent FSA is to thermoae its sensitivity, heat stability is very poor, 40 degrees centigrade of several hrs get final product the decomposition failure (stability study of dioxy thiourea in the MIBI, nuclear technology, 1999 22 volumes, No.5,263-267), when depositing under cold preservation and the room temperature, the amount of Reducing agent FSA can constantly be decomposed and reduced, and again because the excessive meeting of FSA red precipitate occurs with the reduction of the cupric in the MIBI part, this just makes that the amount of adding FSA is restricted in the medicine box, finally cause under the medicine box refrigerated storage temperature storage life to have only 3 months, and can't transport summer.Up to now, also there are crucial quality and technical problem aspect preparing at the MIBI medicine box, do not obtain fine solution, various countries are also constantly at research new prescription and improvement (Preparation and Evaluation of Modified Composition for Lyophilized Kits of[Cu (MIBI) 4] BF 4For[ 99mTc] Technetium Labeling, Brazilian Archives of Biology and Technology, Vol.48, Special:pp.1-8, October 2005.The Effect of Selected Preparation Variables on the Radiochemical Purity of 99mTc-Sestamibi, J Nucl Med Technol 2005; 33:34-41), for example: how to stop micro-stannous inefficacy in the medicine box, prolong the medicine box shelf-life, how how the MIBI consumption is selected the stablizing, preventing its interaction of each component in the effective stabilizer guarantee medicine box and is reduced problem such as labeled drug radiochemical purity and demand effective solution urgently to save cost but prevent its catabolite simultaneously or radioimpurity radioactive impurity (radiocolloid and high technetium) influence video picture (the liver picked-up is high) in the safe and effective minimizing medicine box.
Therefore, select effective inferior stannum protective agent, prevent from that micro-inferior stannum lost efficacy in the medicine box, stablize each component of medicine box will solve and perfect problem with regard to becoming this technical field urgent need with the freeze drying article medicinal box that prolongs the medicine box shelf-life.
Summary of the invention
One of purpose of the present invention provides a kind of 99mTc-MIBI mark freeze drying article medicinal box, this medicine box contain effective coordination stabilizing agent, form coordination compound and improve stannous stability with inferior stannum, thereby prevent that micro-inferior stannum lost efficacy, prolongs the medicine box shelf-life in the medicine box.
Above-mentioned purpose of the present invention reaches by the following technical programs:
A kind of 99mThe Tc-MIBI mark freeze drying article medicinal box, the main component of its prescription is as follows: the MIBI of 20～200 weight portions, the stannous chloride dihydrate (SnCl of 2～20 weight portions 22H 2O), the glutathion of 80～800 weight portions (GSH), the mannitol of 1000～3000 weight portions.
A kind of optimal technical scheme is characterized in that: described MIBI is 100 weight portions, described stannous chloride dihydrate (SnCl 22H 2O) be 10 weight portions, described GSH is 400 weight portions, and described mannitol is 2000 weight portions.
A kind of optimal technical scheme is characterized in that: described GSH is a reduced glutathion.
99mAlso comprise an amount of pH regulator agent in the Tc-MIBI mark freeze drying article medicinal box, the pH regulator agent is NaOH, HCl solution or phosphate buffer, and the pH value of transferring solution is between 5～7.
Another object of the present invention provides a kind of above-mentioned 99mThe preparation method of Tc-MIBI mark freeze drying article medicinal box, its step is as follows:
(1) solution preparation:
A.20～200 the mannitol of the glutathion (GSH) of the MIBI of weight portion, 80～800 weight portions and 1000～3000 weight portions is dissolved in 10000 weight parts waters;
B. take by weighing the stannous chloride dihydrate (SnCl of 2～20 weight portions 22H 2O) be dissolved in the HCl solution of 0.1M of 1000 weight portions;
C. after step B gained solution being joined the mixing of steps A gained solution, the HCl solution of NaOH, the 0.1N of usefulness 0.1N or phosphate buffer adjust pH add water to 100000 weight portions then between 5～7;
(2) filter packing:
D. with step C gained solution with 0.22 μ m aseptic filtration membrane filtration;
E. install in the cillin bottle with 1.0ml/ bottle branch;
(3) lyophilization:
F. step e gained cillin bottle was placed in the freezer dryer lyophilization 24～48 hours,
G. charge into nitrogen, gland taking-up, obtain freeze drying article medicinal box.
A kind of 99mThe preparation method of Tc-MIBI mark freeze drying article medicinal box, its step is as follows:
(1) solution preparation:
A.20～200 milligram MIBI, 80～800 milligrams glutathion (GSH) and the mannitol of 1～3 gram are dissolved in the 10ml water;
B. take by weighing 2～20 milligrams stannous chloride dihydrate (SnCl 22H 2O) be dissolved in the HCl solution of 0.1M of 1.0ml;
C. after step B gained solution being joined the mixing of steps A gained solution, the HCl solution of NaOH, the 0.1N of usefulness 0.1N or phosphate buffer adjust pH add water to 100.0ml then between 5～7;
(2) filter packing:
D. with step C gained solution with 0.22 μ m aseptic filtration membrane filtration;
E. install in the cillin bottle with 1.0ml/ bottle branch;
(3) lyophilization:
F. step e gained cillin bottle was placed in the freezer dryer lyophilization 24～48 hours,
G. charge into nitrogen, gland taking-up, obtain freeze drying article medicinal box.
A kind of optimal technical scheme is characterized in that: described glutathion (GSH) is a reduced glutathion.
A kind of optimal technical scheme is characterized in that: in the step C gained solution, described MIBI is 0.2～2.0mg/ml, described SnCl 22H 2O is 20～200 μ g/ml, and described GSH is 0.8～8mg/ml, described mannitol 10～30mg/ml.
A kind of optimal technical scheme is characterized in that: in the step C gained solution, described MIBI is 1.0mg/ml, described SnCl 22H 2O is 100 μ g/ml, and described GSH is 4.0mg/ml, and described mannitol is 20mg/ml.
Beneficial effect of the present invention:
Of the present invention 99mThe Tc-MIBI mark freeze drying article medicinal box selects (reduced form) GSH to make stabilizing agent first, under the prerequisite that ensures radiochemical purity, has reduced the complexity that medicine box is made, and increases the stability of medicine box.Specifically, because the adding of GSH makes freeze drying article medicinal box of the present invention have following advantage:
(1) component is simple, reasonable; (2) preparation is easy, quality control is simple and convenient; (3) good stability, be easy to the transportation; (4) kept the effectiveness of marked product.
In a word, in this medicine box component, selecting GSH first is inferior stannum protective agent, efficiently solves MIBI stannous too quick decomposition and prolongation medicine box shelf-life when labelling.
The present invention will be further described below by the drawings and specific embodiments, but and do not mean that limiting the scope of the invention.
Description of drawings
Fig. 1 is the amount of GSH among the present invention and the graph of a relation between the radio chemistry purity (putting of abbreviation is pure).
Fig. 2 is pH and the putting graph of a relation between pure among the present invention.
Fig. 3 is the addition of MIBI among the present invention and the putting graph of a relation between pure.
Fig. 4 is SnCl among the present invention 22H 2Graph of a relation between the addition of O and putting are pure.
The specific embodiment
1.GSH the MIBI medicine box best composition under existing is determined:
At first determine the amount of GSH: according to the general requirement of froze-dried kit, the inventor for the consumption of GSH to putting pure influence test, result's demonstration all can reach above-mentioned requirements between 0.8～12mg, does not influence drug labelling.Take all factors into consideration the effect of GSH in medicine box, select 0.8～8mg/ml.
1.1GSH amount to the influence of MIBI labelling
The MIBI solution to be marked of preparation certain volume: every mL contains 1.0mg MIBI, 100 μ g SnCl 22H 2The PBS of O (phosphate-buffered) solution (pH6.0) is sub-packed in every bottle of 1.0mL of above-mentioned solution in some 10mL cillin bottles, and not commensurability GSH is added respectively in above-mentioned each cillin bottle, every bottle contains GSH 0.0～12mg, adds the new drip washing of 1.0mL more respectively 99mTcO 4 -(5～10mCi/mL) (cumulative volume is 2.0mL) place boiling water bath heating 10 minutes to solution immediately, take out the back room temperature and place cooling, use TLC (thin layer chromatography method) and HPLC to measure the radiochemical purity of product respectively.Relation between the addition of GSH and putting are pure as shown in Figure 1.As can be seen from Figure 1, the amount of GSH all can obtain satisfied result from 0.8～12mg.
1.2pH influence to labelling
Prepare the PBS solution of different pH value (2～8) respectively, select suitable prescription, be mixed with the solution to be marked of different pH value, add the new drip washing of 1.0mL respectively according to above-mentioned each amounts of components 99mTcO 4 -(5～10mCi/mL) (cumulative volume is 2.0mL) place boiling water bath heating 10 minutes to solution immediately, take out the back room temperature and place cooling, measure the radiochemical purity of product respectively with TLC and HPLC method.Relation between pH value and putting are pure as shown in Figure 2, as seen from Figure 2, the optimum of pH is 5～7.
1.3MIBI amount to the influence of labelling
Prepare solution methods to be marked with 1.2, just change MIBI content, carry out labelling, relatively the amount of MIBI is to the influence of labelling.The amount of MIBI and the relation between the radiochemical purity as shown in Figure 3, as can be seen, during the content 0.1mg of MIBI, 99mThe radiochemical purity of Tc-MIBI is promptly greater than 90%.
1.4 the amount of stannous chloride is to the influence of labelling
Prepare solution methods to be marked with 1.2, just change stannous chloride content, carry out labelling, relatively the amount of stannous chloride is to the influence of labelling.SnCl 22H 2Relation between the addition of O and putting are pure as shown in Figure 4, as can be seen, SnCl 22H 2When the content of O is 10 μ g, can satisfy the requirement of labelling.
2.MIBI medicine box preparation and stability test thereof
2.1 the medicine box preparation reaches 99mThe quality control of Tc marked product
[1] prescription 1:
(1) medicine box prescription 1 and preparation technology's flow process:
MIBI 0.2mg
GSH 0.8mg
SnCl 2·2H 2O 10μg
Mannitol 10mg
Phosphate buffer is transferred pH5;
Froze-dried kit preparation flow (100 bottles):
● the solution preparation:
A. according to prescription 1 MIBI, GSH and mannitol be dissolved in the 10ml water;
B. take by weighing the SnCl of prescription 1 ormal weight 22H 2O is dissolved in 1.0ml HCl solution (0.1M);
C. after B being joined the A mixing, between HCl adjust pH 5～6, add water to 100.0ml then;
● filter packing:
D. with C solution with 0.22 μ m aseptic filtration membrane filtration;
E. install in the 10ml cillin bottle with 1.0ml/ bottle branch;
● lyophilization:
F. E was placed in the freezer dryer lyophilization 24～48 hours;
G. take out after charging into nitrogen, gland, obtain freeze drying article medicinal box behind the pressure enclosing cover.
(2) labeling method of medicine box and radiochemical purity are measured
● 99mThe Tc-MIBI labeling method:
Get one of above-mentioned froze-dried kit, with the high technetium of new drip washing [ 99mTc] the about 1850MBq of sour sodium injection 1～3ml (50mCi) injects medicine box, and shake well makes the lyophilized products dissolving, puts into boiling water bath immediately and heats 10～15 minutes, takes out and is cooled to room temperature, can obtain 99mTc-MIBI (1).
[2] prescription 2:
(1) medicine box prescription 2 and preparation technology's flow process:
●MIBI 1mg
●GSH 4mg
●SnCl 2·2H 2O 100μg
● mannitol 20mg
● phosphate buffer pH6
Froze-dried kit preparation flow (100 bottles):
● the solution preparation:
A. according to prescription MIBI, GSH and mannitol are dissolved in the 10ml water;
B. take by weighing the SnCl of formula ratio 22H 2O is dissolved in 1.0ml HCl solution (0.1M);
C. after B being joined the A mixing, between phosphate buffer adjust pH 5～6, add water to 100.0ml then;
● filter packing:
D. with C solution with 0.22 μ m aseptic filtration membrane filtration;
E. install in the 10ml cillin bottle with 1.0ml/ bottle branch;
● lyophilization:
F. E was placed in the freezer dryer lyophilization 24～48 hours;
G. take out after charging into nitrogen, gland, obtain freeze drying article medicinal box behind the pressure enclosing cover.
(2) labeling method of medicine box and radiochemical purity are measured
● 99mThe Tc-MIBI labeling method:
Get one of above-mentioned froze-dried kit, with the high technetium of new drip washing [ 99mTc] the about 1850MBq of sour sodium injection 1～3ml (50mCi) injects medicine box, and shake well makes the lyophilized products dissolving, puts into boiling water bath immediately and heats 10～15 minutes, takes out and is cooled to room temperature, can obtain 99mTc-MIBI (2).
[3] prescription 3:
(1) medicine box prescription and preparation technology's flow process:
●MIBI 2.0mg
●GSH 6.0mg
●SnCl 2·2H 2O 100μg
● mannitol 30mg
● phosphate buffer pH 7
Froze-dried kit preparation flow (100 bottles):
● the solution preparation:
A. according to prescription MIBI, GSH and mannitol are dissolved in the 10ml water;
B. take by weighing the SnCl of formula ratio 22H 2O is dissolved in 10ml HCl solution (0.1M);
C. after B being joined the A mixing, between phosphate buffer adjust pH 6～7, add water to 100.0ml then;
● filter packing:
D. with C solution with 0.22 μ m aseptic filtration membrane filtration;
E. install in the 10ml cillin bottle with 1.0ml/ bottle branch;
● lyophilization:
F. E was placed in the freezer dryer lyophilization 24～48 hours;
G. take out after charging into nitrogen, gland, obtain freeze drying article medicinal box behind the pressure enclosing cover.
(2) labeling method of medicine box and radiochemical purity are measured
● 99mThe Tc-MIBI labeling method:
Get one of above-mentioned froze-dried kit, with the high technetium of new drip washing [ 99mTc] the about 1850MBq of sour sodium injection 1～3ml (50mCi) injects medicine box, and shake well makes the lyophilized products dissolving, puts into boiling water bath immediately and heats 10～15 minutes, takes out and is cooled to room temperature, can obtain 99mTc-MIBI (3).
● radiochemical purity is measured:
Select for use thin layer chromatography to measure the radiochemical purity of marked product:
Chromatographic solution: acetonitrile
Holder: polyamide sheet
Rf value: 99mTcO 4 -, 99mTcO 2With 99mThe Rf value of Tc-GSH is 0;
99mThe Rf value of Tc-MIBI is 0.9～1.0;
Radiochemical purity (%)=(forward position counting * 100%) ÷ grand total.
2.2 the stability experiment of medicine box and marked product
(1) medicine box storage temperature and time
Above-mentioned froze-dried kit is deposited respectively at 4,25 and 40 degrees centigrade, and different time takes out at interval, the radiochemical purity of certification mark thing.
The result shows: according to the prepared MIBI medicine box of above-mentioned prescription, at room temperature deposit three months, stored refrigerated more than 7 months, 40 degrees centigrade preserve weeks, still can reach the radio chemistry purity 90% or more, satisfy summer and transport and clinical instructions for use; By contrast, do not contain the medicine box of GSH, the radio chemistry purity under the similarity condition has only 0～70%, can not satisfy clinical instructions for use (greater than 90%).
(2) marked product stability
Select TLC for use, measure marked product 99mThe radiochemical purity of Tc-MIBI is with situation of change standing time.
The result shows: room temperature was placed after 6 hours, and putting is pure all greater than 90%, satisfies clinical instructions for use.
The present invention successfully is used for GSH the preparation of MIBI medicine box first, has optimized the medicine box prescription, efficiently solves MIBI stannous too quick decomposition and prolongation medicine box shelf-life when labelling, has improved medicine box stability, accomplishes the end in view.

Claims (8)

1. one kind 99mThe Tc-MIBI mark freeze drying article medicinal box, the main component of its prescription is as follows: the MIBI of 20～200 weight portions, the stannous chloride dihydrate of 2～20 weight portions, the glutathion of 80～800 weight portions, the mannitol of 1000～3000 weight portions.
2. according to claim 1 99mThe Tc-MIBI mark freeze drying article medicinal box is characterized in that: described MIBI is 100 weight portions, and described stannous chloride dihydrate is 10 weight portions, and described glutathion is 400 weight portions, and described mannitol is 2000 weight portions.
3. according to claim 1 99mThe Tc-MIBI mark freeze drying article medicinal box is characterized in that: described glutathion is a reduced glutathion.
4. one kind 99mThe preparation method of Tc-MIBI mark freeze drying article medicinal box, its step is as follows:
(1) solution preparation:
A.20～200 the mannitol of the glutathion of the MIBI of weight portion, 80～800 weight portions and 1000～3000 weight portions is dissolved in 10000 weight parts waters;
B. the stannous chloride dihydrate that takes by weighing 2～20 weight portions is dissolved in the HCl solution of 0.1M of 1000 weight portions;
C. after step B gained solution being joined the mixing of steps A gained solution, the HCl solution of NaOH, the 0.1N of usefulness 0.1N or phosphate buffer adjust pH add water to 100000 weight portions then between 5～7;
(2) filter packing:
D. with step C gained solution with 0.22 μ m aseptic filtration membrane filtration;
E. install in the cillin bottle with 1.0ml/ bottle branch;
(3) lyophilization:
F. step e gained cillin bottle was placed in the freezer dryer lyophilization 24～48 hours,
G. charge into nitrogen, gland taking-up, obtain freeze drying article medicinal box.
5. one kind 99mThe preparation method of Tc-MIBI mark freeze drying article medicinal box, its step is as follows:
(1) solution preparation:
A.20～200 milligram MIBI, 80～800 milligrams glutathion and the mannitol of 1～3 gram are dissolved in the 10ml water;
B. taking by weighing 2～20 milligrams stannous chloride dihydrate is dissolved in the HCl solution of 0.1M of 1.0ml;
C. after step B gained solution being joined the mixing of steps A gained solution, the HCl solution of NaOH, the 0.1N of usefulness 0.1N or phosphate buffer adjust pH add water to 100.0ml then between 5～7;
(2) filter packing:
D. with step C gained solution with 0.22 μ m aseptic filtration membrane filtration;
E. install in the cillin bottle with 1.0ml/ bottle branch;
(3) lyophilization:
F. step e gained cillin bottle was placed in the freezer dryer lyophilization 24～48 hours,
G. charge into nitrogen, gland taking-up, obtain freeze drying article medicinal box.
6. described according to claim 4 or 5 99mThe preparation method of Tc-MIBI mark freeze drying article medicinal box is characterized in that: described glutathion is a reduced glutathion.
7. described according to claim 4 or 5 99mThe preparation method of Tc-MIBI mark freeze drying article medicinal box is characterized in that: in the step C gained solution, described MIBI is 0.2～2.0mg/ml, described SnCl 22H 2O is 20～200 μ g/ml, and described GSH is 0.8～8mg/ml, described mannitol 10～30mg/ml.
8. according to claim 7 99mThe preparation method of Tc-MIBI mark freeze drying article medicinal box is characterized in that: in the step C gained solution, described MIBI is 1.0mg/ml, described SnCl 22H 2O is 100 μ g/ml, and described GSH is 4.0mg/ml, and described mannitol is 20mg/ml.
CN 201010593618 2010-12-09 2010-12-09 99mTc-MIBI labeled lyophilized product medicine box and preparation method thereof Pending CN102028962A (en)

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2015118498A1 (en) * 2014-02-07 2015-08-13 The South African Nuclear Energy Corporation Limited A kit for preparing a radiopharmaceutical

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《泸州医学院学报》 19980430 陈跃等 《99m Tc-谷胱甘肽药盒的制备和实验研究》 第267-271页 1-8 第21卷, 第4期 2 *

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2015118498A1 (en) * 2014-02-07 2015-08-13 The South African Nuclear Energy Corporation Limited A kit for preparing a radiopharmaceutical
CN106414471A (en) * 2014-02-07 2017-02-15 南非核能源有限公司 A kit for preparing a radiopharmaceutical
AU2015213553B2 (en) * 2014-02-07 2019-01-31 The South African Nuclear Energy Corporation Limited A kit for preparing a radiopharmaceutical

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