CN102125558A - Compound sodium levofolinate fluorouracil antineoplastic medicament - Google Patents
Compound sodium levofolinate fluorouracil antineoplastic medicament Download PDFInfo
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- CN102125558A CN102125558A CN 201110003895 CN201110003895A CN102125558A CN 102125558 A CN102125558 A CN 102125558A CN 201110003895 CN201110003895 CN 201110003895 CN 201110003895 A CN201110003895 A CN 201110003895A CN 102125558 A CN102125558 A CN 102125558A
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- levofolinate
- fluorouracil
- sodium
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- sodium levofolinate
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Abstract
The invention relates to a compound sodium levofolinate fluorouracil antineoplastic medicament which comprises sodium levofolinate and fluorouracil. The weight ratio of the scalar quantity-levofolinate of the sodium levofolinate to the fluorouracil is 1:(2-30), preferably 1:(2-10). A preparation is freezing and drying injection or injection. A preparation auxiliary material is one or more of mannitol, dextran, glucose, sodium hydroxide and sodium chloride. Proved by the JiaCheng medical technology limited company of Guangzhou through experiments, the compound sodium levofolinate fluorouracil can more favorably exert the biological regulating effect of levofolinate compared with the staggered use of sodium levofolinate and 5-FU and the treatment on tumors is safer and more effective by the cooperation of the sodium levofolinate and 5-FU. The matching use has longer tumor progression time compared with staggered medicament application under same dosage, prolongs the total life cycle and reduces the toxic or side reaction. The reduction of toxicity ensures that a large dose of 5-FU can be used in clinic so as to achieve the effect of killing tumor cells.
Description
Technical field
The present invention relates to a kind of compound recipe sodium levofolinate fluorouracil antineoplastic agent.
Background technology
The discovery of nineteen fifty-seven fluorouracil (5-Fu) is a milestone of colorectal cancer chemotherapy, uses 5-Fu to appease chemotherapy in early days and can make improve significantly to 7.5-12 month from average 4-6 month the life cycle of colorectal cancer patients.From then on, cancer therapy drug 5-Fu is proved many tumors effective.To the later stages in the 1970's, the various mechanism of action of 5-Fu are set forth, and this just is being to use the biological regulator folinic acid to improve the starting point of the original effectiveness of 5-Fu.
5-Fu is present most widely used anti-miazines medicine, and the 5-Fu antitumor spectra is wide, is mainly used in treatment digestive tract tumor, also is usually used in treating breast carcinoma, ovarian cancer, chorionic epithelioma, cervical cancer, hepatocarcinoma, bladder cancer, skin carcinoma etc.
Regulating 5-Fu by folinic acid is the most effective now 5-Fu chemotherapy regimen, and the effect of oxaliplatin and irinotecan isoreactivity antitumor drug is also only embodied uniting under the situation of use with the 5-Fu/ folinic acid fully.
Folinic acid is a kind of folic acid supplementing preparation, it on its structure a kind of non-enantiomer mixture, after splitting, can obtain levo form and d-isomer respectively, d-isomer does not have physiologically active, the bioactive substance of folinic acid is that levo form is called l-leucovorin, clinically, the l-leucovorin and the l-leucovorin of half amount are bioequivalent; L-leucovorin is mainly used in the detoxifcation antagonist in the tumor pharmacother, l-leucovorin is by strengthening the inhibition to thymidylate synthetase (TSH), and the antitumor action of enhancing 5-Fu, can alleviate the caused toxicity of antifolate matter, to strengthen the cytotoxicity of antifolic thing, make chemotherapy have better choice simultaneously to cancerous cell.L-leucovorin and 5-Fu use in conjunction have higher therapeutic effect and survival rate than the independent application of 5-Fu.
As foregoing description, the biological adjusting of l-leucovorin 5-Fu is standard method now.From the oncobiology angle, while continuous infusion 5-Fu and l-leucovorin, in the hope of utilize thymine synthetase, 5-Fu metabolite fully in whole infusion process, and the l-leucovorin derivant forms and stablizes the effect that the tetrahedron complex is produced, and this also is the key mechanism that suppresses and destroy the fast breeding tumor cell.Yet normally used clinically l-leucovorin is a calcium salt, and the calcium levofolinate active component is a l-leucovorin, and calcium ion does not have pharmacological action, and activity is not had help.Use calcium levofolinate and 5-Fu simultaneously, can make transfusion produce precipitation, cause the obstruction of transfusion catheter.Clinically, calcium levofolinate must with the 5-Fu administration of staggering the time.
For the hypercalcemia that overcomes calcium levofolinate, vascular stimulation, heart damage and drip side effect such as speed is limited, the l-leucovorin sodium injection has gone on the market, the usage of sodium levofolinate is identical with calcium levofolinate, is: after intravenous injection this product, then with the quiet notes of 5-FU.
Summary of the invention
The objective of the invention is at above-mentioned present situation, aim to provide a kind of compound recipe sodium levofolinate fluorouracil antineoplastic agent that can give full play to the biological regulating action of l-leucovorin.
The implementation of the object of the invention is, a kind of compound recipe sodium levofolinate fluorouracil antineoplastic agent is made up of sodium levofolinate and fluorouracil, and the scalar-l-leucovorin of sodium levofolinate and the weight ratio of fluorouracil are 1: 2-30.
Guangzhou addition Pharmaceutical Technology Co., Ltd proves that by experiment compound recipe l-leucovorin fluorouracil can better be brought into play the biological regulating action of l-leucovorin than the use of staggering the time of sodium levofolinate and 5-FU, and both work in coordination with and make tumor treatment safer and effective.Under the Isodose, compatibility uses the administration of staggering the time that the longer tumour progression time is arranged, and prolong overall life cycle, and toxicity reduces, and the risk of medicine secondary pollution also reduces.Toxic reduction makes and can use heavy dose of 5-FU clinically, to reach the effect of killing tumor cell.
The specific embodiment
The applicant finds, sodium levofolinate is than levofolinate, other salt that comprises calcium salt, has higher biocompatibility, sodium levofolinate can with 5-FU (water, glucose solution, normal saline solution) stable existence in solution, even this solution is through being frozen into solid, after reheat redissolves, still can stablize coexistence, indexs such as its content, related substance all do not change; Use sodium levofolinate and 5-FU can keep the high concentration of 2 kinds of medicines in the cell simultaneously, utilized the biological regulating action of l-leucovorin to greatest extent.So the applicant makes compound preparation with sodium levofolinate and fluorouracil.
The present invention is made up of sodium levofolinate and fluorouracil, and the scalar-l-leucovorin of sodium levofolinate and the weight ratio of fluorouracil are 1: 2-30.Scalar-the l-leucovorin of sodium levofolinate and the preferred weight ratio of fluorouracil are 1: 2-10.
Preparation is lyophilized injection or injection, and pharmaceutical adjunct is one or more in mannitol, dextran, glucose, sodium hydroxide, the sodium chloride.The dosage of pharmaceutical adjunct is the needed amount of dosage form.
Preparation is lyophilized injection preferably, and freezing in the adjuvant of injection is in mannitol, dextran, the sodium hydroxide one or more, and the dosage of pharmaceutical adjunct is the needed amount of dosage form.
The scalar of the sodium levofolinate that the present invention is pointed provides with l-leucovorin.As: the sodium levofolinate of 50mg is meant the sodium levofolinate that contains the 50mg l-leucovorin.
The molecular weight of sodium levofolinate is 607.48, and the molecular weight of l-leucovorin is 473.44; That is: the 64.2g sodium levofolinate contains the 50g l-leucovorin.
For the clinical therapeutic efficacy that confirms medicine is better than the clinical effectiveness that both stagger the time and use, addition Pharmaceutical Technology Co., Ltd in Guangzhou has made the contrast test of both clinical therapeutic efficacies, and test situation is as follows.
Experimental example: Adrucil and l-leucovorin sodium injection compatibility infusion and both uses of staggering the time.
The experimenter: transitivity or inoperable colorectal cancer, do not do chemotherapy before, greater than 18 years old, physical state WHO0-2
Adopt the case (treatment group) of the present invention's treatment: 20 examples,
The case (reference group) that employing is staggered the time and treated: 18 examples.
Therapeutic Method:
Treatment group: sodium levofolinate 250mg/m
2With 5-Fu 2600mg/m
2Mixed venous instiled 24 hours, repeated weekly, totally 4 cycles.
Matched group: sodium levofolinate 250mg/m
2Intravenous drip 2 hours, 5-Fu 2600mg/m then
2Instiled in 24 hours, and repeated weekly, totally 4 cycles.
Therapeutic effect sees Table 1, and the untoward reaction situation sees Table 2.
Table 1
| The example number | CR | PR | SD/NC | TTP | Overall life cycle | |
| The treatment group | 20 | 15％ | 45％ | 40％ | 9m | 18m |
| Matched group | 18 | 11％ | 39％ | 50％ | 6m | 12m |
In the table: CR-is alleviated PR-fully, and partly to alleviate SD/NC-stable or do not change the TTP-tumour progression time
As seen from Table 1, treatment group curative effect is a little more than matched group, and the tumour progression time obviously prolongs, and prolong overall life cycle.
Table 2
| The example number | Diarrhoea | Brothers' disease | Feel sick | Vomiting | Cardiac toxicity | |
| The treatment group | 20 | 9 | 6 | 2 | 2 | 0 |
| Matched group | 18 | 11 | 7 | 6 | 4 | 0 |
The untoward reaction situation of treatment group as seen from Table 2, is lower than matched group.
This shows, the present invention and traditional stagger the time infusion 5-FU and comparison of l-leucovorin Therapeutic Method, remission rate is improved, and toxicity reduces, and especially the tumour progression time (TTP) prolongs to some extent, and improved overall life cycle.
Enumerate specific embodiments of the invention below.
Embodiment one, the 50g l-leucovorin that takes by weighing recipe quantity add in 60 ℃ the water for injection makes suspension, Dropwise 5 %NaOH 8ml, stirring makes dissolving, the control pH value is between 8.0-9.0, add 100g fluorouracil and 50g mannitol, stirring makes dissolving, and the control pH value adds 0.1% active carbon 1.2g again between 8.0-9.0, stirred 15 minutes, filter carbon removal, filtrate is through the extremely clarification of 0.8u filtering with microporous membrane, again through the 0.22u filtering with microporous membrane, put cold, add water for injection to 1200ml, stir mixing.Measure intermediate content, aseptic subpackaged in 1000 cillin bottles, determine loading amount according to the intermediate measurement result for every bottle, the false add plug, send the freeze dryer lyophilization, cover tight plug, roll aluminium lid, pack.Every injection sodium levofolinate fluorouracil antineoplastic agent contains l-leucovorin 50mg, fluorouracil 100mg,
Embodiment two: take by weighing 32.1g sodium levofolinate, 50g fluorouracil and the 25g mannitol of recipe quantity respectively, add in 60 ℃ the water for injection, stir and make dissolving, Dropwise 5 %NaOH solution to regulate pH value between 8.0-9.0, adds 0.1% active carbon 1.2g more in case of necessity, stirred 15 minutes, filter carbon removal, filtrate is through the extremely clarification of 0.8u filtering with microporous membrane, again through the 0.22u filtering with microporous membrane, put cold, add water for injection to 1200ml, stir mixing.Measure intermediate content, aseptic subpackaged in 1000 cillin bottles, determine loading amount according to the intermediate measurement result for every bottle, the false add plug, send the freeze dryer lyophilization, cover tight plug, roll aluminium lid, pack.Every injection sodium levofolinate fluorouracil antineoplastic agent contains l-leucovorin 25mg, fluorouracil 50mg.
Embodiment three: take by weighing 64.2g sodium levofolinate, 100g fluorouracil and the 100g glucose of recipe quantity respectively, add in 60 ℃ the water for injection, stir and make dissolving, Dropwise 5 %NaOH solution to regulate pH value between 7.0-8.0, adds 0.1% active carbon 1.2g more in case of necessity, stirred 15 minutes, filter carbon removal, filtrate is through the extremely clarification of 0.8u filtering with microporous membrane, again through the 0.22u filtering with microporous membrane, put cold, add water for injection to 1200ml, stir mixing.Measure intermediate content, aseptic subpackaged in 1000 cillin bottles, determine loading amount according to the intermediate measurement result for every bottle, the false add plug, send the freeze dryer lyophilization, cover tight plug, roll aluminium lid, pack.Every injection sodium levofolinate fluorouracil antineoplastic agent contains l-leucovorin 50mg, fluorouracil 100mg.
Embodiment four: take by weighing 32.1g sodium levofolinate, 200g fluorouracil and the 100g mannitol of recipe quantity respectively, add in 60 ℃ the water for injection, stir and make dissolving, Dropwise 5 %NaOH solution to regulate pH value between 8.0-9.0, adds 0.1% active carbon 2.4g more in case of necessity, stirred 15 minutes, filter carbon removal, filtrate is through the extremely clarification of 0.8u filtering with microporous membrane, again through the 0.22u filtering with microporous membrane, put cold, add water for injection to 2400ml, stir mixing.Measure intermediate content, aseptic subpackaged in 1000 cillin bottles, determine loading amount according to the intermediate measurement result for every bottle, the false add plug, send the freeze dryer lyophilization, cover tight plug, roll aluminium lid, pack.Every injection sodium levofolinate fluorouracil antineoplastic agent contains l-leucovorin 25mg, fluorouracil 200mg.
Embodiment five: take by weighing 32.1g sodium levofolinate, 300g fluorouracil and the 150g mannitol of recipe quantity respectively, add in 60 ℃ the water for injection, stir and make dissolving, Dropwise 5 %NaOH solution to regulate pH value between 8.0-9.0, adds 0.1% active carbon 3.6g more in case of necessity, stirred 15 minutes, filter carbon removal, filtrate is through the extremely clarification of 0.8u filtering with microporous membrane, again through the 0.22u filtering with microporous membrane, put cold, add water for injection to 3600ml, stir mixing.Measure intermediate content, aseptic subpackaged in 1000 cillin bottles, determine loading amount according to the intermediate measurement result for every bottle, the false add plug, send the freeze dryer lyophilization, cover tight plug, roll aluminium lid, pack.Every injection sodium levofolinate fluorouracil antineoplastic agent contains l-leucovorin 25mg, fluorouracil 300mg.
Embodiment six: the 50g l-leucovorin that takes by weighing recipe quantity adds in 60 ℃ the water for injection makes suspension, Dropwise 5 %NaOH 8ml, stirring makes dissolving, the control pH value is between 8.0-9.0, add 500g fluorouracil and 100g dextran, stirring makes dissolving, and the control pH value adds 0.1% active carbon 5g again between 8.0-9.0, stirred 15 minutes, filter carbon removal, filtrate is through the extremely clarification of 0.8u filtering with microporous membrane, again through the 0.22u filtering with microporous membrane, put cold, add water for injection to 5000ml, stir mixing.Measure intermediate content, aseptic subpackaged in 1000 cillin bottles, determine loading amount according to the intermediate measurement result for every bottle, the false add plug, send the freeze dryer lyophilization, cover tight plug, roll aluminium lid, pack.Every injection sodium levofolinate fluorouracil antineoplastic agent contains l-leucovorin 50mg, fluorouracil 500mg.
Embodiment seven: take by weighing 64.2g sodium levofolinate, 500g fluorouracil and the 100g dextran of recipe quantity respectively, add in 60 ℃ the water for injection, stir and make dissolving, Dropwise 5 %NaOH solution between 8.0-9.0, adds 0.1% active carbon 5g with the control pH value more in case of necessity, stirred 15 minutes, filter carbon removal, filtrate is through the extremely clarification of 0.8u filtering with microporous membrane, again through the 0.22u filtering with microporous membrane, put cold, add water for injection to 5000ml, stir mixing.Measure intermediate content, aseptic subpackaged in 1000 cillin bottles, determine loading amount according to the intermediate measurement result for every bottle, the false add plug, send the freeze dryer lyophilization, cover tight plug, roll aluminium lid, pack.Every injection sodium levofolinate fluorouracil antineoplastic agent contains l-leucovorin 50mg, fluorouracil 500mg.
Embodiment eight: the l-leucovorin that takes by weighing recipe quantity 50g adds in 60 ℃ the water for injection makes suspension, and Dropwise 5 %NaOH 8ml stirs and makes dissolving, the control pH value adds the fluorouracil of recipe quantity 100g between 8.0-9.0, stir and make dissolving, the control pH value adds 0.1% active carbon 1.2g again between 8.0-9.0, stirred 15 minutes, filter carbon removal, filtrate is through the extremely clarification of 0.8u filtering with microporous membrane, again through the 0.22u filtering with microporous membrane, put cold, add water for injection to 1200ml, stir mixing.Measure intermediate content, aseptic and fill and be sub-packed in 1000 ampoule bottles sealing by fusing under the nitrogen.Every sodium levofolinate Fluorouracil Injection antineoplastic agent contains l-leucovorin 50mg, fluorouracil 100mg.
Embodiment nine: the sodium levofolinate, 1500g fluorouracil, 900g sodium chloride that takes by weighing recipe quantity 64.2g adds in 60 ℃ the water for injection, stirs and makes dissolving, Dropwise 5 %NaOH in case of necessity, to control the solution pH value between 7.0-8.0, add 0.1% active carbon 100g again, stirred 15 minutes, filter carbon removal, filtrate is through the extremely clarification of 0.8u filtering with microporous membrane, again through the 0.22u filtering with microporous membrane, put coldly, add water for injection to 100000ml, stir mixing.Measure intermediate content, aseptic and fill and be sub-packed in 1000 ampoule bottles sealing by fusing under the nitrogen.Every sodium levofolinate Fluorouracil Injection antineoplastic agent contains l-leucovorin 50mg, fluorouracil 1500mg.
Claims (4)
1. a compound recipe sodium levofolinate fluorouracil antineoplastic agent is characterized in that being made up of sodium levofolinate and fluorouracil, and scalar one l-leucovorin of sodium levofolinate and the weight ratio of fluorouracil are 1: 2-30.
2. a kind of compound recipe sodium levofolinate fluorouracil antineoplastic agent according to claim 1 is characterized in that the scalar-l-leucovorin of sodium levofolinate and the weight ratio of fluorouracil are 1: 2-10.
3. a kind of compound recipe sodium levofolinate fluorouracil antineoplastic agent according to claim 1, it is characterized in that preparation is lyophilized injection or injection, pharmaceutical adjunct is one or more in mannitol, dextran, glucose, sodium hydroxide, the sodium chloride, and the dosage of pharmaceutical adjunct is the needed amount of dosage form.
4. a kind of compound recipe sodium levofolinate fluorouracil antineoplastic agent according to claim 1, it is characterized in that preparation is a lyophilized injection, adjuvant is one or more in mannitol, dextran, the sodium hydroxide, and the dosage of pharmaceutical adjunct is the needed amount of dosage form.
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103393687A (en) * | 2013-08-02 | 2013-11-20 | 海南灵康制药有限公司 | Pharmaceutical composition containing calcium levofolinate and fluorouracil |
| CN112691107A (en) * | 2021-02-03 | 2021-04-23 | 北京斯利安药业有限公司 | Pharmaceutical composition and application thereof |
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| CN1799546A (en) * | 2005-06-14 | 2006-07-12 | 凯基贸易有限公司 | Sodium folinate injection and preparation method thereof |
| CN101229167A (en) * | 2008-02-21 | 2008-07-30 | 齐建新 | Method of preparing sodium levofolinate and applications thereof on preparing tumour-curing medicines |
| CN101792444A (en) * | 2009-02-02 | 2010-08-04 | 天津康鸿医药科技发展有限公司 | Sodium levofolinate and preparation method and drug combination thereof |
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2011
- 2011-01-10 CN CN 201110003895 patent/CN102125558A/en active Pending
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1799546A (en) * | 2005-06-14 | 2006-07-12 | 凯基贸易有限公司 | Sodium folinate injection and preparation method thereof |
| CN101229167A (en) * | 2008-02-21 | 2008-07-30 | 齐建新 | Method of preparing sodium levofolinate and applications thereof on preparing tumour-curing medicines |
| CN101792444A (en) * | 2009-02-02 | 2010-08-04 | 天津康鸿医药科技发展有限公司 | Sodium levofolinate and preparation method and drug combination thereof |
Non-Patent Citations (2)
| Title |
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| 《ONKOLOGIE》 20011031 Hartung, G et al Phase II study of a weekly 24-hour infusion with 5-fluorouracil and simultaneous sodium-folinic acid in the first-line treatment of metastatic colorectal cancer 457-462 1-4 第24卷, 第5期 2 * |
| 《第三届中国肿瘤内科大会教育集暨论文集》 20091231 何友兼等 氟尿嘧啶类药物的研发历程和临床证据 51-56 1-4 , 2 * |
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103393687A (en) * | 2013-08-02 | 2013-11-20 | 海南灵康制药有限公司 | Pharmaceutical composition containing calcium levofolinate and fluorouracil |
| CN103393687B (en) * | 2013-08-02 | 2015-11-25 | 海南灵康制药有限公司 | A kind of pharmaceutical composition containing calcium levofolinate and fluorouracil |
| CN112691107A (en) * | 2021-02-03 | 2021-04-23 | 北京斯利安药业有限公司 | Pharmaceutical composition and application thereof |
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Application publication date: 20110720 |