CN105708832A - Medicine composition for improving docetaxel oral bioavailability - Google Patents
Medicine composition for improving docetaxel oral bioavailability Download PDFInfo
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- CN105708832A CN105708832A CN201610135877.0A CN201610135877A CN105708832A CN 105708832 A CN105708832 A CN 105708832A CN 201610135877 A CN201610135877 A CN 201610135877A CN 105708832 A CN105708832 A CN 105708832A
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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
- A61K31/33—Heterocyclic compounds
- A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
- A61K31/337—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having four-membered rings, e.g. taxol
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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
- A61K31/33—Heterocyclic compounds
- A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
- A61K31/35—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having six-membered rings with one oxygen as the only ring hetero atom
- A61K31/352—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having six-membered rings with one oxygen as the only ring hetero atom condensed with carbocyclic rings, e.g. methantheline
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
- A61K9/0056—Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
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Abstract
The invention provides a medicine composition for improving docetaxel oral bioavailability and belongs to the technical field of medicine. Flavone compounds comprising quercetin, myricetin and baicalein are combined with docetaxel according to a certain proportion, so that oral bioavailability of docetaxel is improved.
Description
Technical field
The present invention relates to a kind of pharmaceutical composition improving Docetaxel oral administration biaavailability, belong to technical field of pharmaceuticals.
Background technology
Docetaxel is a kind of compound with notable active anticancer, belongs to mitotic inhibitor, by promoting that micro-pipe is formed, and suppresses the depolymerization of micro-pipe to make microtubule stabilization, and blocks cellular is in G2 and M phase, the mitosis of final anticancer and propagation.Docetaxel all has good result for ovarian cancer, carcinoma of prostate, hepatocarcinoma, advanced breast cancer and gastric cancer etc..
Docetaxel is insoluble in water, and under room temperature, the dissolubility in water is only 0.5 μ g/mL, and the commercial preparation of current Docetaxel is injection, and preparation is contained within the Tween 80 of high concentration.Owing to Tween 80 has hemolytic, serious anaphylaxis, the severe allergy symptom such as including hypotension, angioedema, dyspnea and rubella can be caused after injection, bring painful and serious discomfort to others, directly affect the use of this medicine.Therefore, changing the administering mode of Docetaxel, slowing down or eliminating the injection side effect of Tween 80 is research and develop focus and difficult point.
Owing to Docetaxel is the substrate of outer row's property transporter P-gp and Cytochrome P450 isozyme CYP3A4, its oral absorption is limited by outer row's property transporter P-gp and is difficult to oral absorption, strong liver sausage first pass effect also leads to its relatively low blood drug level simultaneously, so that Docetaxel oral administration biaavailability is low.We find through lot of experiments research, are used with Docetaxel Combined with Oral by Chinese medicine flavone compound, can improve the oral absorption of Docetaxel.Also do not find that Docetaxel and chromocor compound are used in combination to improve the relevant report of the body absorption of Docetaxel at present.
Summary of the invention
The technical scheme is that and provide a kind of pharmaceutical composition improving Docetaxel oral administration biaavailability.
Pharmaceutical composition of the present invention contains chromocor compound and Docetaxel, and chromocor compound therein comprises ampelopsin, Quercetin and baicalin.In compositions, Docetaxel and chromocor compound weight ratio are 40: 2.5-40: 40, and the weight ratio of optimization is 40: 5-40: 20.
Heretofore described compositions adopts oral administration, reduces the toxic and side effects of drug administration by injection, significantly improves the oral absorption of Docetaxel.
Accompanying drawing explanation
Fig. 1: Docetaxel (40mg/kg) group and ampelopsin (2.5mg/kg)+Docetaxel (40mg/kg) organize blood concentration-time curve
Fig. 2: Docetaxel (40mg/kg) group and ampelopsin (10mg/kg)+Docetaxel (40mg/kg) organize blood concentration-time curve
Fig. 3: Docetaxel (40mg/kg) group and ampelopsin (40mg/kg)+Docetaxel (40mg/kg) organize blood concentration-time curve
Fig. 4: Docetaxel (40mg/kg) group and baicalin (2.5mg/kg)+Docetaxel (40mg/kg) organize blood concentration-time curve
Fig. 5: Docetaxel (40mg/kg) group and baicalin (10mg/kg)+Docetaxel (40mg/kg) organize blood concentration-time curve
Fig. 6: Docetaxel (40mg/kg) group and baicalin (40mg/kg)+Docetaxel (40mg/kg) organize blood concentration-time curve
Fig. 7: Docetaxel (40mg/kg) group and Quercetin (2.5mg/kg)+Docetaxel (40mg/kg) organize blood concentration-time curve
Fig. 8: Docetaxel (40mg/kg) group and Quercetin (10mg/kg)+Docetaxel (40mg/kg) organize blood concentration-time curve
Fig. 9: Docetaxel (40mg/kg) group and Quercetin (40mg/kg)+Docetaxel (40mg/kg) organize blood concentration-time curve
Detailed description of the invention
Below by way of detailed description of the invention, the foregoing of the present invention is described in further detail, it is not intended that embodiment limitation of the present invention, and the beneficial effect of of the present invention medicine is expanded on further by tests below.
The pharmacokinetic studies of the short Docetaxel oral absorption of embodiment 1 ampelopsin
Experimental program: SD rat, 250-300 gram, male, it is randomly divided into Docetaxel group and ampelopsin+Docetaxel group, often group 6, two groups of rat oral gavage administering modes are as follows:
Docetaxel group: Docetaxel (40mg/kg) is individually dosed.
Ampelopsin+Docetaxel group: ampelopsin (2.5mg/kg) and Docetaxel (40mg/kg) administering drug combinations.
After oral administration, take blood 0.4ml, centrifuging and taking upper plasma respectively at 5min, 15min, 30min, 45min, 60min, 90min, 2h, 3h, 4h, 6h, 8h, detect Docetaxel blood drug level, calculate area and relative bioavailability under its pharmaceutical concentration-time curve.
Experimental result:
Fig. 1 is seen according to the short Docetaxel plasma drug level-time graph of the ampelopsin that pharmacokinetic studies result is corresponding.
The Docetaxel group pharmacokinetic parameters corresponding with ampelopsin+Docetaxel group is as follows:
t1/2: biological half-life: Tmax: peak time;Cmax: maximum plasma concentration;AUC: area under drug-time curve;RB%: relative bioavailability.
Visible ampelopsin and Docetaxel Combined with Oral are remarkably improved the oral absorption of Docetaxel, and the oral relative bioavailability of Docetaxel improves 1.94 times.
The pharmacokinetic studies of the short Docetaxel oral absorption of embodiment 2 ampelopsin
Experimental program: SD rat, 250-300 gram, male, it is randomly divided into Docetaxel group and ampelopsin+Docetaxel group, often group 6, two groups of rat oral gavage administering modes are as follows:
Docetaxel group: Docetaxel (40mg/kg) is individually dosed.
Ampelopsin+Docetaxel group: ampelopsin (10mg/kg) and Docetaxel (40mg/kg) administering drug combinations.
After oral administration, take blood 0.4ml, centrifuging and taking upper plasma respectively at 5min, 15min, 30min, 45min, 60min, 90min, 2h, 3h, 4h, 6h, 8h, detect Docetaxel blood drug level, calculate area and relative bioavailability under its pharmaceutical concentration-time curve.
Experimental result:
Fig. 2 is seen according to the short Docetaxel plasma drug level-time graph of the ampelopsin that pharmacokinetic studies result is corresponding.
The Docetaxel group pharmacokinetic parameters corresponding with ampelopsin+Docetaxel group is as follows:
t1/2: biological half-life;Tmax: peak time;Cmax: maximum plasma concentration;AUC: area under drug-time curve;RB%: relative bioavailability.
Visible ampelopsin and Docetaxel Combined with Oral are remarkably improved the oral absorption of Docetaxel, and the oral relative bioavailability of Docetaxel improves 2.14 times.
The pharmacokinetic studies of the short Docetaxel oral absorption of embodiment 3 ampelopsin
Experimental program: SD rat, 250-300 gram, male, it is randomly divided into Docetaxel group and ampelopsin+Docetaxel group, often group 6, two groups of rat oral gavage administering modes are as follows:
Docetaxel group: Docetaxel (40mg/kg) is individually dosed.
Ampelopsin+Docetaxel group: ampelopsin (40mg/kg) and Docetaxel (40mg/kg) administering drug combinations.
After oral administration, take blood 0.4ml, centrifuging and taking upper plasma respectively at 5min, 15min, 30min, 45min, 60min, 90min, 2h, 3h, 4h, 6h, 8h, detect Docetaxel blood drug level, calculate area and relative bioavailability under its pharmaceutical concentration-time curve.
Experimental result:
Fig. 3 is seen according to the short Docetaxel plasma drug level-time graph of the ampelopsin that pharmacokinetic studies result is corresponding.
The Docetaxel group pharmacokinetic parameters corresponding with ampelopsin+Docetaxel group is as follows:
t1/2: biological half-life;Tmax: peak time;Cmax: maximum plasma concentration;AUC: area under drug-time curve;RB%: relative bioavailability.
Visible ampelopsin and Docetaxel Combined with Oral are remarkably improved the oral absorption of Docetaxel, and the oral relative bioavailability of Docetaxel improves 2.17 times.
The pharmacokinetic studies of the short Docetaxel oral absorption of embodiment 4 baicalin
Experimental program: SD rat, 250-300 gram, male, it is randomly divided into Docetaxel group and baicalin+Docetaxel group, often group 6, two groups of rat oral gavage administering modes are as follows:
Docetaxel group: Docetaxel (40mg/kg) is individually dosed.
Baicalin+Docetaxel group: baicalin (2.5mg/kg) and Docetaxel (40mg/kg) administering drug combinations.
After oral administration, take blood 0.4ml, centrifuging and taking upper plasma respectively at 5min, 15min, 30min, 45min, 60min, 90min, 2h, 3h, 4h, 6h, 8h, detect Docetaxel blood drug level, calculate area and relative bioavailability under its pharmaceutical concentration-time curve.
Experimental result:
Fig. 4 is seen according to the short Docetaxel plasma drug level-time graph of the baicalin that pharmacokinetic studies result is corresponding.
The Docetaxel group pharmacokinetic parameters corresponding with baicalin+Docetaxel group is as follows:
t1/2: biological half-life;Tmax: peak time;Cmax: maximum plasma concentration;AUC: area under drug-time curve: RB%: relative bioavailability.
Visible baicalin and Docetaxel Combined with Oral are remarkably improved the oral absorption of Docetaxel, and the oral relative bioavailability of Docetaxel improves 1.63 times.
The pharmacokinetic studies of the short Docetaxel oral absorption of embodiment 5 baicalin
Experimental program: SD rat, 250-300 gram, male, it is randomly divided into Docetaxel group and baicalin+Docetaxel group, often group 6, two groups of rat oral gavage administering modes are as follows:
Docetaxel group: Docetaxel (40mg/kg) is individually dosed.
Baicalin+Docetaxel group: baicalin (10mg/kg) and Docetaxel (40mg/kg) administering drug combinations.
After oral administration, take blood 0.4ml, centrifuging and taking upper plasma respectively at 5min, 15min, 30min, 45min, 60min, 90min, 2h, 3h, 4h, 6h, 8h, detect Docetaxel blood drug level, calculate area and relative bioavailability under its pharmaceutical concentration-time curve.
Experimental result:
Fig. 5 is seen according to the short Docetaxel plasma drug level-time graph of the baicalin that pharmacokinetic studies result is corresponding.
The Docetaxel group pharmacokinetic parameters corresponding with baicalin+Docetaxel group is as follows:
t1/2: biological half-life: Tmax: peak time;Cmax: maximum plasma concentration;AUC: area under drug-time curve;RB%: relative bioavailability.
Visible baicalin and Docetaxel Combined with Oral are remarkably improved the oral absorption of Docetaxel, and the oral relative bioavailability of Docetaxel improves 1.77 times.
The pharmacokinetic studies of the short Docetaxel oral absorption of embodiment 6 baicalin
Experimental program: SD rat, 250-300 gram, male, it is randomly divided into Docetaxel group and baicalin+Docetaxel group, often group 6, two groups of rat oral gavage administering modes are as follows:
Docetaxel group: Docetaxel (40mg/kg) is individually dosed.
Baicalin+Docetaxel group: baicalin (40mg/kg) and Docetaxel (40mg/kg) administering drug combinations.
After oral administration, take blood 0.4ml, centrifuging and taking upper plasma respectively at 5min, 15min, 30min, 45min, 60min, 90min, 2h, 3h, 4h, 6h, 8h, detect Docetaxel blood drug level, calculate area and relative bioavailability under its pharmaceutical concentration-time curve.
Experimental result:
Fig. 6 is seen according to the short Docetaxel plasma drug level-time graph of the baicalin that pharmacokinetic studies result is corresponding.
The Docetaxel group pharmacokinetic parameters corresponding with baicalin+Docetaxel group is as follows:
t1/2: biological half-life;Tmax: peak time;Cmax: maximum plasma concentration;AUC: area under drug-time curve;RB%: relative bioavailability.
Visible baicalin and Docetaxel Combined with Oral are remarkably improved the oral absorption of Docetaxel, and the oral relative bioavailability of Docetaxel improves 1.67 times.
The pharmacokinetic studies of the short Docetaxel oral absorption of embodiment 7 Quercetin
Experimental program: SD rat, 250-300 gram, male, it is randomly divided into Docetaxel group and Quercetin+Docetaxel group, often group 6, two groups of rat oral gavage administering modes are as follows:
Docetaxel group: Docetaxel (40mg/kg) is individually dosed.
Quercetin+Docetaxel group: Quercetin (2.5mg/kg) and Docetaxel (40mg/kg) administering drug combinations.
After oral administration, take blood 0.4ml, centrifuging and taking upper plasma respectively at 5min, 15min, 30min, 45min, 60min, 90min, 2h, 3h, 4h, 6h, 8h, detect Docetaxel blood drug level, calculate area and relative bioavailability under its pharmaceutical concentration-time curve.
Experimental result:
Fig. 7 is seen according to the short Docetaxel plasma drug level-time graph of the Quercetin that pharmacokinetic studies result is corresponding.
The Docetaxel group pharmacokinetic parameters corresponding with Quercetin+Docetaxel group is as follows:
t1/2: biological half-life;Tmax: peak time;Cmax: maximum plasma concentration;AUC: area under drug-time curve: RB%: relative bioavailability.
Visible Quercetin and Docetaxel Combined with Oral are remarkably improved the oral absorption of Docetaxel, and the oral relative bioavailability of Docetaxel improves 1.9 times.
The pharmacokinetic studies of the short Docetaxel oral absorption of embodiment 8 Quercetin
Experimental program: SD rat, 250-300 gram, male, it is randomly divided into Docetaxel group and Quercetin+Docetaxel group, often group 6, two groups of rat oral gavage administering modes are as follows:
Docetaxel group: Docetaxel (40mg/kg) is individually dosed.
Quercetin+Docetaxel group: Quercetin (10mg/kg) and Docetaxel (40mg/kg) administering drug combinations.
After oral administration, take blood 0.4ml, centrifuging and taking upper plasma respectively at 5min, 15min, 30min, 45min, 60min, 90min, 2h, 3h, 4h, 6h, 8h, detect Docetaxel blood drug level, calculate area and relative bioavailability under its pharmaceutical concentration-time curve.
Experimental result:
Fig. 8 is seen according to the short Docetaxel plasma drug level-time graph of the Quercetin that pharmacokinetic studies result is corresponding.
The Docetaxel group pharmacokinetic parameters corresponding with Quercetin+Docetaxel group is as follows:
t1/2: biological half-life;Tmax: peak time;Cmax: maximum plasma concentration;AUC: area under drug-time curve;RB%: relative bioavailability.
Visible Quercetin and Docetaxel Combined with Oral are remarkably improved the oral absorption of Docetaxel, and the oral relative bioavailability of Docetaxel improves 2.04 times.
The pharmacokinetic studies of the short Docetaxel oral absorption of embodiment 9 Quercetin
Experimental program: SD rat, 250-300 gram, male, it is randomly divided into Docetaxel group and Quercetin+Docetaxel group, often group 6, two groups of rat oral gavage administering modes are as follows:
Docetaxel group: Docetaxel (40mg/kg) is individually dosed.
Quercetin+Docetaxel group: Quercetin (40mg/kg) and Docetaxel (40mg/kg) administering drug combinations.
After oral administration, take blood 0.4ml, centrifuging and taking upper plasma respectively at 5min, 15min, 30min, 45min, 60min, 90min, 2h, 3h, 4h, 6h, 8h, detect Docetaxel blood drug level, calculate area and relative bioavailability under its pharmaceutical concentration-time curve.
Experimental result:
Fig. 9 is seen according to the short Docetaxel plasma drug level-time graph of the Quercetin that pharmacokinetic studies result is corresponding.
The Docetaxel group pharmacokinetic parameters corresponding with Quercetin+Docetaxel group is as follows:
t1/2: biological half-life: Tmax: peak time;Cmax: maximum plasma concentration;AUC: area under drug-time curve;RB%: relative bioavailability.
Visible Quercetin and Docetaxel Combined with Oral are remarkably improved the oral absorption of Docetaxel, and the oral relative bioavailability of Docetaxel improves 2.08 times.
Claims (2)
1. the pharmaceutical composition improving Docetaxel oral administration biaavailability, it is by Docetaxel and chromocor compound Combined with Oral, thus increasing the oral administration biaavailability of Docetaxel, described chromocor compound is the one in ampelopsin, Quercetin and baicalin.
2. the pharmaceutical composition improving Docetaxel oral administration biaavailability as described in claims 1, it is characterized in that in compositions, the weight ratio of Docetaxel and chromocor compound is 40: 2.5-40: 40, after optimizing further, in compositions, the weight ratio of Docetaxel and chromocor compound is 40: 5-40: 20.
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Cited By (2)
Publication number | Priority date | Publication date | Assignee | Title |
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CN106309411A (en) * | 2016-09-23 | 2017-01-11 | 潍坊医学院 | Quercetin and paclitaxel co-transportation pulmonary inhaled nanometer targeted porous polymer particle and preparation method thereof |
CN107501211A (en) * | 2017-07-05 | 2017-12-22 | 中国药科大学 | The common amorphous substance of Docetaxel flavones |
Citations (1)
Publication number | Priority date | Publication date | Assignee | Title |
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CN101836958A (en) * | 2009-03-20 | 2010-09-22 | 北京大学 | Preparation of taxane pH sensitive nanoparticles composite for oral administration and application thereof |
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Publication number | Priority date | Publication date | Assignee | Title |
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CN101836958A (en) * | 2009-03-20 | 2010-09-22 | 北京大学 | Preparation of taxane pH sensitive nanoparticles composite for oral administration and application thereof |
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Cited By (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN106309411A (en) * | 2016-09-23 | 2017-01-11 | 潍坊医学院 | Quercetin and paclitaxel co-transportation pulmonary inhaled nanometer targeted porous polymer particle and preparation method thereof |
CN106309411B (en) * | 2016-09-23 | 2019-05-03 | 潍坊医学院 | A kind of Quercetin and taxol convey lung sucking nano target porous polymeric particle and preparation method thereof altogether |
CN107501211A (en) * | 2017-07-05 | 2017-12-22 | 中国药科大学 | The common amorphous substance of Docetaxel flavones |
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Application publication date: 20160629 |