CN105327352A - Platinum medicine composite preparation, preparing method thereof and application thereof - Google Patents
Platinum medicine composite preparation, preparing method thereof and application thereof Download PDFInfo
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- CN105327352A CN105327352A CN201510862573.XA CN201510862573A CN105327352A CN 105327352 A CN105327352 A CN 105327352A CN 201510862573 A CN201510862573 A CN 201510862573A CN 105327352 A CN105327352 A CN 105327352A
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
- A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/28—Compounds containing heavy metals
- A61K31/282—Platinum compounds
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
- A61K38/04—Peptides having up to 20 amino acids in a fully defined sequence; Derivatives thereof
- A61K38/06—Tripeptides
- A61K38/063—Glutathione
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- Gastroenterology & Hepatology (AREA)
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Abstract
The invention relates to a platinum medicine composite preparation, a preparing method thereof and an application thereof. The platinum medicine composite preparation comprises 65 parts to 85 parts of platinum compounds and 50 parts to 200 parts of reduced glutathione, and can further comprise pharmaceutic adjuvant. The preparing method of the platinum medicine composite preparation includes the steps that the platinum compounds and the reduced glutathione are added into tertiary butanol, stirred at the temperature of 30 DEG C to 40 DEG C and completely dissolved, then isopropanol is added, the mixture is stirred to be even, drying is carried out after filtering and filling, and the platinum medicine composite preparation is obtained. The platinum medicine composite preparation can be used for antitumor drugs and particularly can be used for liver cancer treating drugs. The platinum medicine composite preparation has the high curative effect and lower toxicity.
Description
Technical field
The present invention relates to drug world, particularly relate to a kind of platinum medicine combination preparation and its preparation method and application.
Background technology
Since it is found that cisplatin has active anticancer, the application and research of Platinum Anti-tumor Drugs obtains and develops rapidly.Nowadays, platinum medicine has become indispensable medicine in cancer chemotherapy.Being applied to clinical platinum antineoplastic medicine has cisplatin, carboplatin, oxaliplatin (Oxaliplatin), nedaplatin (nedaplatin), Lobaplatin (lobaplatin), eptalatin (Heptaplatin) etc. at present.
Miboplatin (MiriplatinHydrate) is a kind of novel liposoluble platinum series antineoplastic medicament of SUMITOMO CHEMICAL company exploitation.Wherein science of culture name is called (SP-4-2)-[(1R, 2R)-1,2 hexamethylene diamino-N, N '] two (tetradecylic acid-O) close platinum hydrate, English language Chemical name is called (SP-4-2)-[(1R, 2R)-Cyclohexane-1,2-diamine-N, N '] bis (tetradecanoatoO) platinummonohydrate, molecular formula is C
34h
68n
2o
4ptH
2o, molecular weight is 782.01, and chemical structural formula is as follows:
Research shows, Miboplatin is suspended in distal embolization agent iodized oil, Miboplatin-the lipiodol formed can the feeding artery of occlusion of bone tumors, medicine can be discharged lentamente again, but also optionally in liver cancer tissue, the drug level of remaining valid for a long time in hepatic tissue can be made by extended stationary periods, thromboembolism and chemotherapy are complemented each other, mutual promotion, can also reduce toxic and side effects and the drug resistance of other platinum series antineoplastic medicaments simultaneously effectively.
Miboplatin is the cancer therapy drug being dissolved in special lipiodol fatty-acid ethyl ester (iodized oil), intrahepatic arterial administration, the affinity of itself and lipiodol fatty-acid ethyl ester is high, and be stranded in tumor locus after intrahepatic arterial administration, platinum composition in suspension can enter in blood or tissue by slow releasing for a long time, platinum bivalent compound is combined with DNA, by stoping DNA to synthesize anticancer propagation, improve anticancer effect.
But although current platinum preparation is effective to Hepatoma therapy, how its preparation, to human body still toxic side effect, therefore, reduces toxic and side effects and plays the emphasis that high curative effect has become research at present.
CN1634017A discloses a kind of pharmaceutical composition of anti entity tumour, it comprises anticancer effective component and pharmaceutic adjuvant, anticancer effective component is platinum-like compounds, pharmaceutic adjuvant is mainly the macromolecule polymer that bio-capacitivity degradable absorbs, by cancer therapy drug slow releasing in tumor by local, therefore while obviously reducing its general toxic reaction, also active drug concentration can be maintained in tumor by local in the process of its degraded and absorbed.But its effect playing high curative effect for platinum-like compounds especially Miboplatin is still less.
Summary of the invention
For solving the above-mentioned deficiency of prior art, the invention provides a kind of platinum medicine combination preparation and its preparation method and application, particularly a kind for the treatment of the liver cancer drug Miboplatin combination preparation and its preparation method and application.Platinum medicine combination preparation provided by the invention farthest can play the drug action of platinum-like compounds and make it have lower toxic and side effects.
For reaching this object, present invention employs following technical scheme:
First aspect, the invention provides a kind of platinum medicine combination preparation, described preparation comprises following active ingredient by weight:
(1) platinum-like compounds 65-85 part;
(2) reduced glutathion 50-200 part.
Platinum-like compounds in the present invention can be selected from the mixture of any one or at least two kinds in Eptaplatin, DNA-2114, enloplatin, sulfatodiamino cyclohexane platinum, Spiroplatin, dexormaplatin, iproplatin, lobaplatin, Miboplatin, nedaplatin, ormaplatin, oxaliplatin or sebriplatin, be preferably the mixture of any one or at least two kinds in oxaliplatin, lobaplatin or Miboplatin, more preferably Miboplatin.
Platinum-like compounds in the present invention content is in the formulation 65-85 weight portion, can be such as 65 weight portions, 67 weight portions, 70 weight portions, 71 weight portions, 72 weight portions, 73 weight portions, 74 weight portions, 75 weight portions, 76 weight portions, 77 weight portions, 78 weight portions, 79 weight portions, 80 weight portions, 83 weight portions, 85 weight portions, be preferably 72-80 weight portion.
Reduced glutathion in the present invention content is in the formulation 50-200 weight portion, can be such as 50 weight portions, 60 weight portions, 70 weight portions, 80 weight portions, 90 weight portions, 110 weight portions, 120 weight portions, 130 weight portions, 140 weight portions, 150 weight portions, 170 weight portions, 190 weight portions, 200 weight portions, be preferably 100-180 weight portion.
By increasing reduced glutathion component in platinum medicine preparation in the present invention, can play synergism with platinum-like compounds, it is as reducing agent, has inside and outside antioxidation, Hardy dwarfing, can alleviate the toxic and side effects of platinum-like compounds; The most important thing is, adding of reduced glutathion has blood circulation promoting and blood stasis dispelling, strengthening liver's microcirculation and normal liver cell regeneration, itself and platinum-like compounds, especially after Miboplatin interacts, the platinum-like compounds especially drug effect of Miboplatin in antitumor drug can be strengthened further, especially for Hepatoma therapy, it has better curative effect.
As preferred technical scheme, preparation described in the present invention comprises following active ingredient by weight:
(1) Miboplatin, with C
34h
68n
2o
4pt counts, 65-85 part;
(2) reduced glutathion 50-200 part.
The present invention combines by adopting Miboplatin and reduced glutathion, it can be made to play synergism, adding of reduced glutathion has blood circulation promoting and blood stasis dispelling, strengthening liver's microcirculation and normal liver cell regeneration, collaborative Miboplatin cures hepatocarcinoma, reduced glutathion also has inside and outside antioxidation, Hardy dwarfing, can improve curative effect simultaneously and alleviate toxic and side effects.
Miboplatin in the present invention can adopt injection Miboplatin, or Miboplatin compound is mixed with injection form, is not particularly limited at this.
In the present invention, described preparation is also containing pharmaceutic adjuvant, and preferably, described pharmaceutic adjuvant is that a) molecular weight is the polylactic acid of 5000-15000,10000-20000,25000-35000 or 30000-50000; B) molecular weight is the polyglycolic acid of 5000-15000,10000-20000,25000-35000 or 30000-50000 and the copolymer of hydroxyacetic acid; C) ethylene vinyl acetate copolymer; Or d) to the copolymer of carboxy phenyl propane and SA, be wherein 10:90,20:80,30:70,40:60,50:50 or 60:40 to the weight ratio of carboxy phenyl propane and SA.
Second aspect, present invention also offers the preparation method of platinum medicine preparation as described in relation to the first aspect, comprises the following steps:
(1) platinum-like compounds, reduced glutathion are joined in the tert-butyl alcohol, stir at 30-40 DEG C of temperature after making to dissolve completely, then add isopropyl alcohol and stir;
(2) after filtration, fill, dry, to obtain final product.
The present invention adopts the tert-butyl alcohol and isopropyl alcohol platinum-like compounds and reduced glutathion to be dissolved as solvent, can reduce toxic and side effects further.
In step of the present invention (1), the addition of the described tert-butyl alcohol is 13900-16500g, such as, can be 13900g, 13950g, 14000g, 14050g, 15000g, 15500g, 15800g, 16500g; The addition of described isopropyl alcohol is 450-550g, such as, can be 450g, 460g, 480g, 490g, 500g, 520g, 550g.
Preferably, described stirring is ultrasonic agitation.
In step of the present invention (2), described filtration 0.22 μm of filter membrane aseptic filtration.
In step of the present invention (2), described fill is for after intermediate detection is qualified, and liquid medicine filling, in 40mL cillin bottle, is partly jumped a queue;
In step of the present invention (2), described drying comprises: a) lyophilization: freeze drying box empty van is cooled to less than-40 DEG C, is put by sample in freeze drying box ,-40 DEG C of pre-freezes, keeps 3-4h; B) sublimation drying: shelf temperature is warming up to-25 DEG C with 5 DEG C/h ,-25 DEG C keep 12h; C) parsing-desiccation: shelf temperature is warming up to-1 DEG C with 10 DEG C/h, keeps 6h, is warming up to 25 DEG C with 10 DEG C/h, keeps 24h.
Above-mentioned dried sample is rolled lid, and namely tamponade outlet, rolls lid, and lamp inspection, platinum medicine preparation of the present invention can be obtained.
Above-mentioned platinum medicine preparation can be made acceptable any dosage form on pharmaceutics by the present invention, such as, can be lyophilized injection, oral formulations, spray etc.
As preferred technical scheme, the preparation method of described preparation comprises the following steps:
(1) weigh: take Miboplatin, reduced glutathion, the tert-butyl alcohol and isopropyl alcohol;
(2) prepare: Miboplatin, reduced glutathion are joined in the tert-butyl alcohol, after ultrasonic agitation makes to dissolve completely at 30-40 DEG C of temperature, then add isopropyl alcohol and stir;
(3) filter: with 0.22 μm of filter membrane aseptic filtration;
(4) fill: after intermediate detection is qualified, liquid medicine filling, in 40mL cillin bottle, is partly jumped a queue;
(5) dry: a) lyophilization: freeze drying box empty van is cooled to less than-40 DEG C, sample is put in freeze drying box ,-40 DEG C of pre-freezes, keep 3-4h; B) sublimation drying: shelf temperature is warming up to-25 DEG C with 5 DEG C/h ,-25 DEG C keep 12h; C) parsing-desiccation: shelf temperature is warming up to-1 DEG C with 10 DEG C/h, keeps 6h, is warming up to 25 DEG C with 10 DEG C/h, keeps 24h;
(6) roll lid: tamponade outlet, roll lid;
(7) lamp inspection.
The third aspect, present invention also offers platinum medicine preparation as described in relation to the first aspect for the preparation of the application in antitumor especially Hepatoma therapy medicine.
By platinum medicine preparation of the present invention, when especially Miboplatin pharmaceutical preparation is applied in Hepatoma therapy medicine, by the synergism of Miboplatin compound and reduced glutathion, makes it have more excellent curative effect and there is lower toxic and side effects.
Compared with prior art, the present invention at least has following beneficial effect:
By increasing reduced glutathion component in platinum medicine preparation in the present invention, can play synergism with platinum-like compounds, it is as reducing agent, has inside and outside antioxidation, Hardy dwarfing, can alleviate the toxic and side effects of platinum-like compounds; The most important thing is, adding of reduced glutathion has blood circulation promoting and blood stasis dispelling, strengthening liver's microcirculation and normal liver cell regeneration, itself and platinum-like compounds, especially after Miboplatin interacts, the platinum-like compounds especially drug effect of Miboplatin in antitumor drug can be strengthened further, especially for Hepatoma therapy, it has better curative effect.
Detailed description of the invention
Technical scheme of the present invention is further illustrated below by detailed description of the invention.
Those skilled in the art should understand, described embodiment is only help to understand the present invention, should not be considered as concrete restriction of the present invention.
Embodiment 1
1.1 formula
Note: [1], [2] preparation finished product do not occur, remove during lyophilization.
1.2 preparation technology
(1) weigh: take the Miboplatin of formula ratio, reduced glutathion, the tert-butyl alcohol and isopropyl alcohol;
(2) prepare: join in the tert-butyl alcohol by formula ratio Miboplatin, reduced glutathion, after at 30 ~ 40 DEG C of temperature, ultrasonic agitation makes to dissolve completely, the isopropyl alcohol adding formula ratio stirs;
(3) filter: with 0.22 μm of filter membrane aseptic filtration;
(4) fill: after intermediate detection is qualified, liquid medicine filling, in 40mL cillin bottle, is partly jumped a queue;
(5) lyophilization: freeze drying box empty van is cooled to less than-40 DEG C, puts sample in freeze drying box ,-40 DEG C of pre-freezes, keeps 3-4h; In the sublimation drying stage, shelf temperature is warming up to-25 DEG C with 5 DEG C/h, and-25 DEG C keep 12h; In the parsing-desiccation stage, shelf temperature is warming up to-1 DEG C with 10 DEG C/h, keeps 6h, is warming up to 25 DEG C with 10 DEG C/h, keeps 24h;
(6) roll lid: tamponade outlet, roll lid;
(7) lamp inspection.
Embodiment 2
1.1 formula
Note: [1], [2] preparation finished product do not occur, remove during lyophilization.
1.2 preparation technology
With embodiment 1.
Embodiment 3
1.1 formula
Note: [1], [2] preparation finished product do not occur, remove during lyophilization.
1.2 preparation technology
With embodiment 1.
Embodiment 4
1.1 formula
Note: [1], [2] preparation finished product do not occur, remove during lyophilization.
1.2 preparation technology
With embodiment 1.
Embodiment 5
1.1 formula
Note: [1], [2] preparation finished product do not occur, remove during lyophilization.
1.2 preparation technology
With embodiment 1.
Pharmacodynamics demonstration test:
To the body outer cell proliferation inhibitory action (soft agarose method) of hepatoma cell strain.
With reference to iodized poppy fatty acid oil ethyl ester suspension (hereinafter referred to as suspension) not directly and the evaluation methodology of cells contacting, by medicine being added in soft agar the soft agarose method that cell is cultivated, with HepG2 cell lines and rat hepatoma cell strain AH109A for object, the body outer cell proliferation inhibitory action of research Miboplatin suspension, cisplatin suspension and zinostatin suspension.
Inoculating cell on soft agar medium, covers the suspension of medicine subsequently, deposits in case at medicine, cultivates AH109A strain 7 days, cultivates HepG2 strain 14 days, calculates IC50 value (forming inhibition concentration during 50% colony).Miboplatin suspension is suitable with cisplatin suspension to the inhibitory action of Colony forming, higher than zinostatin suspension.
Table 1 is the body outer cell proliferation inhibitory action (soft agar culture method) to HepG2 cell lines and rat hepatoma cell strain AH109A.
Table 1
Mean+SD (n=3)
*) with the IC of Miboplatin suspension
50value is compared, with Tukey-Krammer identification method comparing difference remarkable (p < 0.01)
Ns) with the IC of Miboplatin suspension
50value is compared, and does not show with Tukey-Krammer identification method comparing difference.
Table 2 is the body outer cell proliferation inhibitory action (soft agar culture method) to HepG2 cell lines and rat hepatoma cell strain AH109A.
Table 2
Mean+SD (n=3)
*) with the IC of Miboplatin suspension
50value is compared, with Tukey-Krammer identification method comparing difference remarkable (p < 0.01)
Ns) with the IC of Miboplatin suspension
50value is compared, not remarkable with Tukey-Krammer identification method comparing difference.
Table 3 is the body outer cell proliferation inhibitory action (soft agar culture method) to HepG2 cell lines and rat hepatoma cell strain AH109A.
Table 3
*) with the IC of Miboplatin suspension
50value is compared, with Tukey-Krammer identification method comparing difference remarkable (p < 0.01)
Ns) with the IC of Miboplatin suspension
50value is compared, not remarkable with Tukey-Krammer identification method comparing difference.
Table 4 is the body outer cell proliferation inhibitory action (soft agar culture method) to HepG2 cell lines and rat hepatoma cell strain AH109A.
Table 4
Mean+SD (n=3)
*) with the IC of Miboplatin suspension
50value is compared, with Tukey-Krammer identification method comparing difference remarkable (p < 0.01)
Ns) with the IC of Miboplatin suspension
50value is compared, not remarkable with Tukey-Krammer identification method comparing difference.
Table 5 is the body outer cell proliferation inhibitory action (soft agar culture method) to HepG2 cell lines and rat hepatoma cell strain AH109A.
Table 5
Mean+SD (n=3)
*) with the IC of Miboplatin suspension
50value is compared, with Tukey-Krammer identification method comparing difference remarkable (p < 0.01)
Ns) with the IC of Miboplatin suspension
50value is compared, not remarkable with Tukey-Krammer identification method comparing difference.
Applicant states, the present invention illustrates process of the present invention by above-described embodiment, but the present invention is not limited to above-mentioned processing step, does not namely mean that the present invention must rely on above-mentioned processing step and could implement.Person of ordinary skill in the field should understand, any improvement in the present invention, to equivalence replacement and the interpolation of auxiliary element, the concrete way choice etc. of raw material selected by the present invention, all drops within protection scope of the present invention and open scope.
Claims (9)
1. a platinum medicine combination preparation, is characterized in that, described preparation comprises following active ingredient by weight:
(1) platinum-like compounds 65-85 part;
(2) reduced glutathion 50-200 part.
2. platinum medicine combination preparation according to claim 1, it is characterized in that, described platinum-like compounds is the mixture of any one or at least two kinds in Eptaplatin, DNA-2114, enloplatin, sulfatodiamino cyclohexane platinum, Spiroplatin, dexormaplatin, iproplatin, lobaplatin, Miboplatin, nedaplatin, ormaplatin, oxaliplatin or sebriplatin, be preferably the mixture of any one or at least two kinds in oxaliplatin, lobaplatin or Miboplatin, more preferably Miboplatin.
3. platinum medicine combination preparation according to claim 1 and 2, is characterized in that, described preparation comprises following active ingredient by weight:
(1) Miboplatin, with C
34h
68n
2o
4pt counts, 65-85 part;
(2) reduced glutathion 50-200 part.
4. the platinum medicine combination preparation according to any one of claim 1-3, is characterized in that, described preparation is also containing pharmaceutic adjuvant;
Preferably, described pharmaceutic adjuvant is that a) molecular weight is the polylactic acid of 5000-15000,10000-20000,25000-35000 or 30000-50000; B) molecular weight is the polyglycolic acid of 5000-15000,10000-20000,25000-35000 or 30000-50000 and the copolymer of hydroxyacetic acid; C) ethylene vinyl acetate copolymer; Or d) to the copolymer of carboxy phenyl propane and SA, be wherein 10:90,20:80,30:70,40:60,50:50 or 60:40 to the weight ratio of carboxy phenyl propane and SA.
5. the preparation method of the platinum medicine combination preparation according to any one of claim 1-4, is characterized in that, comprise the following steps:
(1) platinum-like compounds, reduced glutathion are joined in the tert-butyl alcohol, stir at 30-40 DEG C of temperature after making to dissolve completely, then add isopropyl alcohol and stir;
(2) after filtration, fill, dry, to obtain final product.
6. method according to claim 5, is characterized in that, in step (1), the addition of the described tert-butyl alcohol is 13900-16500g; The addition of described isopropyl alcohol is 450-550g;
Preferably, described stirring is ultrasonic agitation.
7. the method according to claim 5 or 6, is characterized in that, in step (2), and described filtration 0.22 μm of filter membrane aseptic filtration;
Preferably, described fill is for after intermediate detection is qualified, and liquid medicine filling, in 40mL cillin bottle, is partly jumped a queue;
Preferably, described drying comprises: a) lyophilization: freeze drying box empty van is cooled to less than-40 DEG C, is put by sample in freeze drying box ,-40 DEG C of pre-freezes, keeps 3-4h; B) sublimation drying: shelf temperature is warming up to-25 DEG C with 5 DEG C/h ,-25 DEG C keep 12h; C) parsing-desiccation: shelf temperature is warming up to-1 DEG C with 10 DEG C/h, keeps 6h, is warming up to 25 DEG C with 10 DEG C/h, keeps 24h.
8. the method according to any one of claim 5-7, is characterized in that, comprises the following steps:
(1) weigh: take Miboplatin, reduced glutathion, the tert-butyl alcohol and isopropyl alcohol;
(2) prepare: Miboplatin, reduced glutathion are joined in the tert-butyl alcohol, after ultrasonic agitation makes to dissolve completely at 30-40 DEG C of temperature, then add isopropyl alcohol and stir;
(3) filter: with 0.22 μm of filter membrane aseptic filtration;
(4) fill: after intermediate detection is qualified, liquid medicine filling, in 40mL cillin bottle, is partly jumped a queue;
(5) dry: a) lyophilization: freeze drying box empty van is cooled to less than-40 DEG C, sample is put in freeze drying box ,-40 DEG C of pre-freezes, keep 3-4h; B) sublimation drying: shelf temperature is warming up to-25 DEG C with 5 DEG C/h ,-25 DEG C keep 12h; C) parsing-desiccation: shelf temperature is warming up to-1 DEG C with 10 DEG C/h, keeps 6h, is warming up to 25 DEG C with 10 DEG C/h, keeps 24h, to obtain final product.
9. the platinum medicine combination preparation according to any one of claim 1-4 is for the preparation of the application in antitumor especially Hepatoma therapy medicine.
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Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1596111A (en) * | 2001-11-29 | 2005-03-16 | 桑得医药品公司 | Methods and compositions for ameliorating the undesirable effects of chemotherapy |
| CN1634017A (en) * | 2004-11-22 | 2005-07-06 | 山东蓝金生物工程有限公司 | Pharmaceutical composition for solid tumour |
-
2015
- 2015-12-01 CN CN201510862573.XA patent/CN105327352A/en active Pending
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1596111A (en) * | 2001-11-29 | 2005-03-16 | 桑得医药品公司 | Methods and compositions for ameliorating the undesirable effects of chemotherapy |
| CN1634017A (en) * | 2004-11-22 | 2005-07-06 | 山东蓝金生物工程有限公司 | Pharmaceutical composition for solid tumour |
Non-Patent Citations (2)
| Title |
|---|
| 徐艳岩等: "谷胱甘肽与铂类药物联用对人胃癌细胞株的影响", 《山东大学学报》 * |
| 徐艳岩等: "谷胱甘肽与顺铂合用对肝癌细胞HepG2增殖及凋亡的影响", 《中国老年学杂志》 * |
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