CN103751814B - Prepare long effect duration technetium [ 99mtc] method of methylene diphosphonate injection medicine - Google Patents

Prepare long effect duration technetium [ 99mtc] method of methylene diphosphonate injection medicine Download PDF

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Publication number
CN103751814B
CN103751814B CN201410002009.6A CN201410002009A CN103751814B CN 103751814 B CN103751814 B CN 103751814B CN 201410002009 A CN201410002009 A CN 201410002009A CN 103751814 B CN103751814 B CN 103751814B
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injection
technetium
methylene
methylene diphosphonate
vitamin
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CN103751814A (en
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陈飞
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SHANGHAI ATOM KEXING PHARMACEUTICAL CO Ltd
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SHANGHAI ATOM KEXING PHARMACEUTICAL CO Ltd
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Abstract

The present invention relates to a kind of prepare long effect duration technetium [ 99mtc] method of methylene diphosphonate injection medicine, specifically comprise the following steps: vitamin C injection is diluted on request 20-200 doubly; Extract high technetium [ 99mtc] sour sodium injection 10 ~ 200mCi, and be diluted to 4ml; Injection stannous chloride methylene diphosphate dried frozen aquatic products is taken out from refrigerator and is placed to room temperature; By high technetium [ 99mtc] sour sodium injection is disposable is expelled in stannous chloride methylene diphosphate dried frozen aquatic products, concussion, fully dissolves, static 5 minutes, obtain technetium [ 99mtc] methylene diphosphonate injection; By the vitamin C injection diluted with disposable sterilized use syringe extract 0.1ml inject prepare technetium [ 99mtc] in methylene diphosphonate injection, shake up.Compared with prior art, the present invention prepare technetium [ 99mtc] methylene diphosphonate injection medicine has effect duration long, the advantage such as transportation is not decomposed, imaging results is better.

Description

Prepare long effect duration technetium [ 99mtc] method of methylene diphosphonate injection medicine
Technical field
The present invention relates to field of pharmaceutical chemistry technology, especially relate to a kind of prepare long effect duration technetium [ 99mtc] method of methylene diphosphonate injection medicine.
Background technology
Technetium [ 99mtc] methylene diphosphonate injection is the ideal skeletal imaging agent of generally acknowledging at present, be by high technetium [ 99mtc] sour sodium and injection methylenediphsphonate and stannous chloride formulated by certain proportioning.Technetium [ 99mtc] methylene diphosphonate injection by chemisorbed be incorporated in the inorganic constituents of skeleton hydroxylapatite crystal surface, immature collagen in this dermoskeleton, also to technetium [ 99mtc] methylene diphosphonate injection has higher affinity.Affect the dense poly-technetium of skeleton [ 99mtc] principal element of methylene diphosphonate injection be skeleton blood for and the synthesis speed of new bone.
In addition technetium [ 99mtc] methylene two sees the myocardial cell or the soft tissue of calcification that hydrochlorate injection can also be positioned to block, and enters muscle, cartilage, blood vessel and internal organs.But technetium [ 99mtc] effect duration of methylene diphosphonate injection is only 6 hours, stops over slightly in transit, by expired, causes waste.
Chinese patent CN103203032A disclose a kind of technetium [ 99tc] methylene two sees hydrochlorate preparation and preparation method thereof.Technetium in this patent [ 99tc] methylene diphosphonate preparation is lyophilized injectable powder, contains in unit formulation: high technetium [ 99tc] sour sodium 0.05 μ g ~ 1 μ g (with 99tc counts), methylenediphosphonate 5mg ~ 100mg, stannous chloride 0.5mg ~ 5mg.This patent further disclose technetium [ 99tc] preparation method of methylene diphosphonate lyophilized injectable powder.In this patent, technetium [ 99tc] methylene diphosphonate lyophilized injectable powder effectively improves 99the complexation rate of Tc and methylenediphosphonate, improve technetium [ 99tc] stability of methylene diphosphonate preparation and effectiveness, avoid clinical before the risk of preparation microbiological contamination, reduce production cost.
Summary of the invention
Object of the present invention be exactly provide to overcome defect that above-mentioned prior art exists a kind of prepare long effect duration technetium [ 99mtc] methylene two sees the method for hydrochlorate injection medicine, and the method can make expiration date of drug long, and transportation is not decomposed, and imaging results is better.
Object of the present invention can be achieved through the following technical solutions:
A kind of prepare long effect duration technetium [ 99mtc] method of methylene diphosphonate injection medicine, obtained technetium [ 99mtc] after methylene diphosphonate injection, to technetium [ 99mtc] add vitamin C injection in methylene diphosphonate injection.
The method specifically comprises the following steps:
(1) vitamin C injection is diluted to 0.005g/L ~ 0.05g/L;
(2) extract high technetium [ 99mtc] sour sodium injection, and dilute;
(3) injection stannous chloride methylene diphosphate dried frozen aquatic products is placed to room temperature from refrigerator taking-up;
(4) by high technetium [ 99mtc] sour sodium injection is disposable is expelled in stannous chloride methylene diphosphate dried frozen aquatic products, concussion, fully dissolves, and leaves standstill, obtain technetium [ 99mtc] methylene diphosphonate injection;
(5) by the vitamin C injection diluted with disposable sterilized use syringe extract inject prepare technetium [ 99mtc] in methylene diphosphonate injection, shake up.
Described high technetium [ 99mtc] activity of sour sodium injection is 10 ~ 200mCi.
In step (4), high technetium [ 99mtc] proportionate relationship of sour sodium injection and stannous chloride methylene diphosphate is 4ml: 5mg.
In step (5), the addition of vitamin C injection and high technetium [ 99mtc] volume ratio of sour sodium injection is 0.1: 4.
Compared with prior art, the present invention has the following advantages and beneficial effect:
(1) technetium [ 99mtc] effect duration of methylene diphosphonate injection is 6 hours, substantially can keep stable, afterwards along with the prolongation of time within 6 hours, decompose aggravation, because vitamin C has reproducibility, inhibit after adding vitamin c solution high price technetium generation, make technetium [ 99mtc] methylene diphosphonate injection do not decompose, and quality is more stable, and is convenient to transport.
(2) and after adding vitamin C, technetium [ 99mtc] methylene diphosphonate injection do not decompose, and do not have a large amount of sodium pertechnetates after injection free out, assemble at thyroid position.When carrying out bone scanning, thyroid can not develop, make technetium [ 99mtc] methylene diphosphonate injection has better imaging results.
Detailed description of the invention
Below in conjunction with specific embodiment, the present invention is described in detail.
Embodiment 1
A kind of prepare long effect duration technetium [ 99mtc] method of methylene diphosphonate injection medicine, obtained technetium [ 99mtc] after methylene diphosphonate injection, to technetium [ 99mtc] add vitamin C injection in methylene diphosphonate injection.The method specifically comprises the following steps:
(1) vitamin C injection is diluted to 0.005g/L ~ 0.05g/L;
(2) extract high technetium [ 99mtc] sour sodium injection, activity is 10 ~ 200mCi, and is diluted to 4ml;
(3) the injection stannous chloride methylene diphosphate dried frozen aquatic products of 5mg/ bottle is placed to room temperature from refrigerator taking-up;
(4) by high technetium [ 99mtc] sour sodium injection is disposable is expelled in stannous chloride methylene diphosphate dried frozen aquatic products, concussion, fully dissolves, static 5 minutes, obtain technetium [ 99mtc] methylene diphosphonate injection;
(5) by the vitamin C injection diluted with disposable sterilized use syringe extract 0.1ml inject prepare technetium [ 99mtc] in methylene diphosphonate injection, shake up.
The technetium of the long effect duration adopting the present embodiment method to obtain [ 99mtc] methylene diphosphonate injection medicine (representing with the MDP adding vitamin c solution) and not vitaminize C technetium [ 99mtc] stability of methylene diphosphonate injection medicine (representing with the MDP of not vitaminize C) is as shown in table 1.Test method is: respectively sampling in 0,3,6,9,12 hour, calculate 99mTcO 4-penetrating property count ratio.
Table 1
The technetium of the long effect duration adopting the present embodiment method to obtain as seen from the above table [ 99mtc] methylene diphosphonate injection medicine kept stable in 6 hours, after 6 hours, owing to adding vitamin c solution, decomposed become slow.And do not add ascorbic technetium [ 99mtc] methylene diphosphonate injection medicine substantially can keep stable within 6 hours, afterwards along with the prolongation of time, decomposed aggravation.

Claims (3)

1. the technetium preparing long effect duration [ 99mtc] method of methylene diphosphonate injection medicine, it is characterized in that, obtained technetium [ 99mtc] after methylene diphosphonate injection, to technetium [ 99mtc] add vitamin C injection in methylene diphosphonate injection;
The method specifically comprises the following steps:
(1) vitamin C injection is diluted to 0.005g/L ~ 0.05g/L;
(2) extract high technetium [ 99mtc] sour sodium injection, and dilute;
(3) injection stannous chloride methylene diphosphate dried frozen aquatic products is placed to room temperature from refrigerator taking-up;
(4) by high technetium [ 99mtc] sour sodium injection is disposable is expelled in stannous chloride methylene diphosphate dried frozen aquatic products, concussion, fully dissolves, and leaves standstill, obtain technetium [ 99mtc] methylene diphosphonate injection;
(5) by the vitamin C injection diluted with disposable sterilized use syringe extract inject prepare technetium [ 99mtc] in methylene diphosphonate injection, the addition of vitamin C injection and high technetium [ 99mtc] volume ratio of sour sodium injection is 0.1:4, shakes up.
2. according to claim 1 a kind of prepare long effect duration technetium [ 99mtc] method of methylene diphosphonate injection medicine, it is characterized in that, described high technetium [ 99mtc] activity of sour sodium injection is 10 ~ 200mCi.
3. according to claim 1 a kind of prepare long effect duration technetium [ 99mtc] method of methylene diphosphonate injection medicine, it is characterized in that, in step (4), high technetium [ 99mtc] proportionate relationship of sour sodium injection and stannous chloride methylene diphosphate is 4ml:5mg.
CN201410002009.6A 2014-01-02 2014-01-02 Prepare long effect duration technetium [ 99mtc] method of methylene diphosphonate injection medicine Active CN103751814B (en)

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Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1302655A (en) * 2000-12-29 2001-07-11 广西大学 Compound buccal lozenge of lectuce tea and its preparing process
CN103203032A (en) * 2012-01-12 2013-07-17 成都云克药业有限责任公司 Technetium [99Tc] methylenediphosphonate preparation and preparation method thereof

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1302655A (en) * 2000-12-29 2001-07-11 广西大学 Compound buccal lozenge of lectuce tea and its preparing process
CN103203032A (en) * 2012-01-12 2013-07-17 成都云克药业有限责任公司 Technetium [99Tc] methylenediphosphonate preparation and preparation method thereof

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