CN104027307A - Medicine composition and preparing method thereof - Google Patents
Medicine composition and preparing method thereof Download PDFInfo
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- CN104027307A CN104027307A CN201410314407.1A CN201410314407A CN104027307A CN 104027307 A CN104027307 A CN 104027307A CN 201410314407 A CN201410314407 A CN 201410314407A CN 104027307 A CN104027307 A CN 104027307A
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- polysaccharide
- acylate
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Abstract
The invention discloses a medicine composition. The medicine composition is composed of indissolvable medicine, injection emulgator, polysaccharide acyl chloride and solvent and comprises, by weight, 0.01-10% of indissolvable medicine, 0.5-50% of injection emulgator, 0.1-10% of polysaccharide acyl chloride and 10-99% of solvent, and the weight percentage sum of all the components is 100%. A preparing method of the medicine composition comprises the steps such as mixing, dissolving and stirring of all the components. The lipid solubility of the polysaccharide acyl chloride is enhanced due to introduction of hydrophobicity perssad dicyclohexyl urea, the polysaccharide acyl chloride can be mixed with the injection emulgator with any proportion and can serve as auxiliary emulgator, and the solubilization effect is obvious especially for glycoconjugate of the indissolvable medicine. The common solvent, the injection emulgator and the polysaccharide acyl chloride are used for preparing the indissolvable medicine into the clear medicine composition, the serious irritability, hemolysis and other hidden danger of the indissolvable medicine are eliminated from the formula, the polysaccharide acyl chloride has various pharmacological actions, and the curative effect of the medicine composition can be enhanced.
Description
Technical field
The invention belongs to field of pharmaceutical preparations, be specifically related to a kind of pharmaceutical composition and preparation method thereof, for insoluble drug, relate to the technology that increases insoluble drug dissolubility; For soluble agents, relate to the technology that strengthens multiple pharmacological effect.
Background technology
Anti-tumor botanical, antitumor antibiotics are widely used in clinical with its unique effect mechanism, but because of its poorly water-soluble, the cosolvent that need to be situated between, emulsifying agent could be applied to as injection clinical.And pharmacopeia allows the emulsifying agent Pluronic F-127 Oleum Ricini, the POLYSORBATE 80 that use to bring serious untoward reaction to patient, before needing, take a large amount of antiallergic agent Polyglucan reactions, bring very big misery to patient.In new drug development, approximately 40% medicine is restricted because water solubility problem makes exploitation, and some medicines are even insoluble in some conventional organic solvents.The solubilising of poorly water soluble drugs is one of important topic of pharmaceutics research.
Surfactant increases the dissolubility of nonpolar medicine in water by forming micelle.When a lot of insoluble anti-tumor medicament clinical injection are used, all must adopt surfactant to carry out solubilising.At present both at home and abroad approval can injection surfactant to have Polysorbate (be mainly polyoxyethylene sorbitan monoleate, be POLYSORBATE 80), polyoxyethylene castor oil class (being mainly Cremoph or EL), in order to reduce the side effect of emulsifying agent (being surfactant), can add the consumption that co-emulsifier reduces surfactant, reduce the incidence rate of untoward reaction.
Based on above-mentioned background; we have carried out a series of research; unexpected discovery; polysaccharide acylate (patent No.: 201210574597.1 the disclosed polysaccharide acylate of Chinese invention patent) is owing to introducing hydrophobic group 1,3-Dicyclohexylurea; its fat-soluble enhancing, can be miscible with arbitrary proportion with emulsifying agent, and can be used as co-emulsifier use; especially for the glycoconjugate of insoluble drug, its solubilizing effect is obvious.Can insoluble drug be prepared into by common solvent, emulsifying agent and this polysaccharide acylate to the pharmaceutical composition of clarification.And said composition afterwards just can intravenous drip by its (as 5% glucose solution, water for injection) dilution with injection solution.Good, the easy storage of composition stable, preparation method are simple, are suitable for suitability for industrialized production, and meanwhile, this polysaccharide acylate has multiple pharmacological effect, can mix with certain proportion with clinical conventional water soluble drug, increase curative effect.
Summary of the invention
Technical problem to be solved by this invention is to provide a kind of pharmaceutical composition and preparation method thereof; in this pharmaceutical composition, contain insoluble drug and polysaccharide acylate; when but the amount ratio of its injection emulsifying agent uses separately injection emulsifying agent, consumption is few; the consumption of injection emulsifying agent can drop to below 50%; alleviate the side reaction that Pluronic F-127 Oleum Ricini, POLYSORBATE 80 cause, and its good effect.
In order to solve the problems of the technologies described above, the present invention adopts following technical scheme: pharmaceutical composition, and said composition is by insoluble drug, injection emulsifying agent, polysaccharide acylate and solvent composition, and each weight percentages of components is as follows:
Each weight percentages of components sum is 100% above;
Wherein said insoluble drug is selected from: Docetaxel, paclitaxel, capecitabine, cisplatin, oxaliplatin, gefitinib, doxorubicin, irinotecan, gemcitabine, pemetrexed, temozolomide, replace Buddhist nun's cloth according to wheat, vinorelbine, letrozole, teniposide, etoposide, podophyllotoxin, camptothecine, 10-hydroxycamptothecine, 9-hydroxy camptothecin, SN38 SN-38, topotecan, irinotecan, vinblastine, vincristine, vindesine, vinflunine, vinpocetine, cantharidin, silibinin, propofol, florfenicol, Mitiglinide, arteannuin, dihydroartemisinine, Artemether, artesunate, sirolimus, gliclazide, cisapride, glibenclamide, oleanolic acid, breviscapine, ferulic acid, to acetyl-amino phenol, palmityl rhizomycin, Ben Kemaiding, vitamin A, tamoxifen, nvelbine, valproic acid, tacrolimus, ciclosporin A, amphotericin B, ketoconazole, sulpiride, fenofibrate, bezafibrate, itraconazole, miconazole, propofol, brimonidine, latanoprost, silibinin, rifaxidin, diclofenac, indomethacin, teldane, meter Li Nong, valsartan, theophylline, ketoprofen, FRUSEMIDE, spironolactone, dipyridamole, piroxicam, mefenamic acid, trichlormethiazide, pindolol, lovastatin, fluvastatin, geldanamycin, their glycoconjugate or their mixture,
Described injection emulsifying agent is selected from: Pluronic F-127 Oleum Ricini, POLYSORBATE 80;
Described solvent is selected from: dehydrated alcohol.
The disclosed polysaccharide acylate of Chinese invention patent that polysaccharide acylate of the present invention is the patent No. 201210574597.1; it is under low Drug level; there is the performance of significant antiinflammatory, anti-tumour cell proliferative invasion and attack, transfer; under high concentration medicining condition, can resist dvt to form; there is self emulsifying, emulsification simultaneously; be beneficial to drug injection, enter blood circulation system, and hemorrhagic risk is low.Significantly inhibition tumor cell propagation, invasion and attack and transfer, does not have obvious toxic and side effects simultaneously.
" insoluble drug " of the present invention refer to known in field of medicaments adaptable medicine, and with respect to its effective dosage, the medicine lower to the dissolubility of water.In the dissolubility of recording in concrete indication Chinese Pharmacopoeia " note on the use ", use the medicine of " slightly soluble ", " atomic molten " or " almost insoluble or insoluble " term.In other words, refer to dissolve 1g or the needed quantity of solvent of 1mL solute (amount of water) more than 100mL (concentration is 1% below) medicine, preferred 1000mL (concentration is below 0.1%), be more preferably the medicine of 10000mL (concentration is below 0.01%).
In aforementioned pharmaceutical compositions, can also in this prescription, further add as required other pharmaceutically acceptable adjuvant or the ratio of each component be carried out to minor alteration, as water, stabilizing agent, pH value regulator, antioxidant etc.But these improvement and variation it will be apparent to those skilled in the art that, and there is no difference with conventional use amount, therefore, these improvement do not depart from spirit of the present invention, drop in the protection domain of description of the present invention and claims yet.
Preferably, pharmaceutical composition, each weight percentages of components is as follows:
Each weight percentages of components sum is 100% above.
Preferably, pharmaceutical composition, consists of the following composition: paclitaxel 0.03g, Pluronic F-127 Oleum Ricini 2.7g, polysaccharide acylate 0.083g, dehydrated alcohol 3g.
Preferably, pharmaceutical composition, consists of the following composition: Docetaxel 0.08g, POLYSORBATE 80 2.0g, polysaccharide acylate 0.08g, dehydrated alcohol 3g.
The preparation method of aforementioned pharmaceutical compositions is: insoluble drug is dissolved in solvent or injection emulsifying agent or their mixed liquor; add again polysaccharide acylate; stirring makes can form transparent pharmaceutical composition after mix homogeneously, or by insoluble drug and prescription in other components dissolved in the mixture of solvent, injection emulsifying agent and polysaccharide acylate.
Aforementioned pharmaceutical compositions, glucose solution, normal saline, the water for injection of clinical use available 5% are diluted, injection.Also can, by the conventional method of pharmaceutics, aforementioned pharmaceutical compositions be prepared into capsule, oral liquid or external preparation etc.
Polysaccharide acylate is owing to introducing hydrophobic group 1,3-Dicyclohexylurea, and its fat-soluble enhancing, can be miscible with arbitrary proportion with injection emulsifying agent, and can be used as co-emulsifier use, and especially, for the glycoconjugate of insoluble drug, its solubilizing effect is obvious.The present invention is prepared into insoluble drug by common solvent, injection emulsifying agent and polysaccharide acylate the pharmaceutical composition of clarification.And for said composition, injection solution (as 5% glucose solution, water for injection) just can intravenous drip after being diluted.To sum up, aforementioned pharmaceutical compositions has the following advantages:
1. replaced the injection emulsifying agent in the commercially available ejection preparation of more existing insoluble drugs with polysaccharide acylate, the part of good biocompatibility; as Pluronic F-127 Oleum Ricini or POLYSORBATE 80, eliminate the hidden danger of insoluble drug preparation severe allergy and hemolytic etc. from filling a prescription.
2. in the present invention, insoluble drug is dissolved in solvent or injection emulsifying agent or their mixture, can be under lucifuge condition, and 4 DEG C of following storages.
3. the preparation technology of this pharmaceutical composition is simple, is convenient to suitability for industrialized production.
4. almost consistent with the compound method of existing preparation while application clinically, can not increase the difficulty of use, be conducive to improve the compliance of medication.
5. this polysaccharide acylate has multiple pharmacological effect, can increase curative effect.
Another technical problem to be solved by this invention is to provide a kind of pharmaceutical composition and preparation method thereof, contains soluble agents and polysaccharide acylate in this pharmaceutical composition, and the curative effect of this pharmaceutical composition is better.
In order to solve the problems of the technologies described above, the present invention adopts following technical scheme: pharmaceutical composition, and said composition is made up of soluble agents and polysaccharide acylate, and each weight percentages of components is as follows:
Soluble agents 0.1-70%
Polysaccharide acylate surplus
Wherein said soluble agents is selected from: hydroxycamptothecin, cyclophosphamide, ifosfamide, carmustine, Tespamin, methotrexate, fluorouracil, cytosine arabinoside, actinomycin D, mitomycin, amycin, aklavine, mitoxantrone, daunorubicin, epirubicin, vindesine, homoharringtonine, teniposide, gemcitabine hydrochloride, carboplatin, dacarbazine, asparaginase, pamidronate disodium, ribavirin, zidovudine, acyclovir, artesunate etc., spectinomycin hydrochloride, losartan, nitroglycerin, chlorine pyrroles thunder, phentolamine or their mixture.
Described polysaccharide acylate is the disclosed polysaccharide acylate of the Chinese invention patent of the patent No. 201210574597.1.
Preferably, pharmaceutical composition, consists of the following composition: artesunate 0.06g, polysaccharide acylate 0.25g.
Preferably, pharmaceutical composition, consists of the following composition: ribavirin 0.25g, polysaccharide acylate 0.125g.
For the second pharmaceutical composition, in the time of clinical practice, can be by soluble in water to soluble agents and polysaccharide acylate, after filtration, sterilizing, lyophilization, make lyophilized powder.Can also make other dosage forms such as suspension, injectable powder, ointment, slow releasing agent, aerosol.
Described polysaccharide acylate has multiple pharmacological effect; under low Drug level, there is the performance of significant antiinflammatory, anti-tumour cell proliferative invasion and attack, transfer, under high concentration, there is anticoagulation, self emulsifying function; and hemorrhagic risk is low, there is no obvious toxic and side effects.This polysaccharide acylate can mix with certain proportion with clinical conventional water soluble drug, increases curative effect.
Detailed description of the invention
Below in conjunction with embodiment, the invention will be further described:
Embodiment 1
Pharmaceutical composition
Prescription:
Paclitaxel 0.03g
Pluronic F-127 Oleum Ricini 2.7g
Polysaccharide acylate 0.083g
Dehydrated alcohol 3g
Preparation method:
Paclitaxel is joined in dehydrated alcohol, until completely dissolved, then add the polysaccharide acylate of Pluronic F-127 Oleum Ricini and sterilizing, stir and be this pharmaceutical composition.
Embodiment 2
Pharmaceutical composition
Prescription:
Docetaxel 0.08g
POLYSORBATE 80 3g
Polysaccharide acylate 0.08g
Dehydrated alcohol 3g
Preparation method:
Docetaxel is joined in dehydrated alcohol, until completely dissolved, then add the polysaccharide acylate of POLYSORBATE 80 and sterilizing, stir and be this pharmaceutical composition.
Embodiment 3
Pharmaceutical composition
Prescription:
Paclitaxel 0.08g
Pluronic F-127 Oleum Ricini 2.6g
Polysaccharide acylate 0.08g
Dehydrated alcohol 3g
Preparation method:
Paclitaxel is joined in dehydrated alcohol, until completely dissolved, then add the polysaccharide acylate of Pluronic F-127 Oleum Ricini and sterilizing, stir and make their mix homogeneously be this drug composition.
Embodiment 4
Pharmaceutical composition
Etoposide 0.1g
POLYSORBATE 80 2g
Polysaccharide acylate 0.08g
Dehydrated alcohol 5g
Preparation method:
Etoposide is joined in the mixed liquor of POLYSORBATE 80 and dehydrated alcohol, until completely dissolved, then add the polysaccharide acylate of sterilizing, stir and make their mix homogeneously be this drug composition.
Embodiment 5
Pharmaceutical composition
Prescription:
Paclitaxel glycoconjugate 0.15g
Polymerization epoxy ethylene castor oil 10.0g
Polysaccharide acylate 0.42g
Dehydrated alcohol 10g
Preparation method:
Paclitaxel glycoconjugate is joined in dehydrated alcohol, until completely dissolved, then add the polysaccharide acylate of Pluronic F-127 Oleum Ricini and sterilizing, stir and make their mix homogeneously be this drug composition.
Embodiment 6
Pharmaceutical composition
Prescription:
Docetaxel 0.08g
POLYSORBATE 80 3g
Polysaccharide acylate 0.08g
Dehydrated alcohol 5g
Preparation method:
Docetaxel is joined in POLYSORBATE 80, until completely dissolved, then add polysaccharide acylate and the dehydrated alcohol of sterilizing, stirring and making their mix homogeneously had been both this drug composition.
Embodiment 7
Pharmaceutical composition
Prescription:
Arteannuin 0.15mg
Tween 80 0.2g
Polysaccharide acylate 0.08mg
Dehydrated alcohol 2g
Preparation method:
Arteannuin is joined in POLYSORBATE 80, until completely dissolved, then add polysaccharide acylate and the dehydrated alcohol of sterilizing, stirring and making their mix homogeneously had been both this drug composition.Add again 2g water and can be made into suspension.
Embodiment 8
Prescription:
Hydroxycamptothecin 0.02g
Aminoacid 0.5g
Polysaccharide acylate 0.5g
Sodium hydroxide 2g
Water for injection 5g
Preparation method:
Hydroxycamptothecin, aminoacid, polysaccharide acylate, sodium hydroxide and water for injection are stirred and makes their mix homogeneously, filter, injectable powder is made in lyophilization.
Embodiment 9
Prescription:
Artesunate 0.06g
Polysaccharide acylate 0.25g
Water for injection 5g
Preparation method:
Artesunate and polysaccharide acylate are dissolved in to water for injection, after filtration, sterilizing, lyophilization, make injectable powder.
Embodiment 10
Prescription:
Ribavirin 0.25g
Polysaccharide acylate 0.125g
Water for injection 2g
Preparation method:
Ribavirin and polysaccharide acylate are dissolved in to water for injection, after filtration, sterilizing, lyophilization, make lyophilized powder.
Be to be understood that example as herein described and embodiment are only in order to illustrate, those skilled in the art can make various amendments or variation according to it, in the situation that not departing from spirit of the present invention, all belong to protection scope of the present invention.
Claims (8)
1. pharmaceutical composition, is characterized in that, said composition is by insoluble drug, injection emulsifying agent, polysaccharide acylate and solvent composition, and each weight percentages of components is as follows:
Each weight percentages of components sum is 100% above;
Wherein said insoluble drug is selected from: Docetaxel, paclitaxel, capecitabine, cisplatin, oxaliplatin, gefitinib, doxorubicin, irinotecan, gemcitabine, pemetrexed, temozolomide, replace Buddhist nun's cloth according to wheat, vinorelbine, letrozole, teniposide, etoposide, podophyllotoxin, camptothecine, 10-hydroxycamptothecine, 9-hydroxy camptothecin, SN38 SN-38, topotecan, irinotecan, vinblastine, vincristine, vindesine, vinflunine, vinpocetine, cantharidin, silibinin, propofol, florfenicol, Mitiglinide, arteannuin, dihydroartemisinine, Artemether, artesunate, sirolimus, gliclazide, cisapride, glibenclamide, oleanolic acid, breviscapine, ferulic acid, to acetyl-amino phenol, palmityl rhizomycin, Ben Kemaiding, vitamin A, tamoxifen, nvelbine, valproic acid, tacrolimus, ciclosporin A, amphotericin B, ketoconazole, sulpiride, fenofibrate, bezafibrate, itraconazole, miconazole, propofol, brimonidine, latanoprost, silibinin, rifaxidin, diclofenac, indomethacin, teldane, meter Li Nong, valsartan, theophylline, ketoprofen, FRUSEMIDE, spironolactone, dipyridamole, piroxicam, mefenamic acid, trichlormethiazide, pindolol, lovastatin, fluvastatin, geldanamycin, their glycoconjugate or their mixture,
Described injection emulsifying agent is selected from: Pluronic F-127 Oleum Ricini, POLYSORBATE 80;
Described solvent is selected from: dehydrated alcohol.
2. pharmaceutical composition as claimed in claim 1, is characterized in that: each weight percentages of components is as follows:
Each weight percentages of components sum is 100% above.
3. pharmaceutical composition as claimed in claim 1, is characterized in that, consists of the following composition: paclitaxel 0.03g, Pluronic F-127 Oleum Ricini 2.7g, polysaccharide acylate 0.083g, dehydrated alcohol 3g.
4. pharmaceutical composition as claimed in claim 1, is characterized in that, consists of the following composition: Docetaxel 0.08g, POLYSORBATE 80 2.0g, polysaccharide acylate 0.08g, dehydrated alcohol 3g.
5. the preparation method of pharmaceutical composition as claimed in claim 1; it is characterized in that: insoluble drug is dissolved in solvent or injection emulsifying agent or their mixed liquor; add again polysaccharide acylate; stirring makes can form transparent pharmaceutical composition after mix homogeneously, or by insoluble drug and prescription in other components dissolved in the mixture of solvent, injection emulsifying agent and polysaccharide acylate.
6. pharmaceutical composition, is characterized in that, said composition is made up of soluble agents and polysaccharide acylate, and each weight percentages of components is as follows:
Soluble agents 0.1-70%
Polysaccharide acylate surplus
Wherein said soluble agents is selected from: hydroxycamptothecin, cyclophosphamide, ifosfamide, carmustine, Tespamin, methotrexate, fluorouracil, cytosine arabinoside, actinomycin D, mitomycin, amycin, aklavine, mitoxantrone, daunorubicin, epirubicin, vindesine, homoharringtonine, teniposide, gemcitabine hydrochloride, carboplatin, dacarbazine, asparaginase, pamidronate disodium, ribavirin, zidovudine, acyclovir, artesunate etc., spectinomycin hydrochloride, losartan, nitroglycerin, chlorine pyrroles thunder, phentolamine or their mixture.
7. pharmaceutical composition as claimed in claim 6, is characterized in that, consists of the following composition: artesunate 0.06g, polysaccharide acylate 0.25g.
8. pharmaceutical composition as claimed in claim 6, is characterized in that, consists of the following composition: ribavirin 0.25g, polysaccharide acylate 0.125g.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201410314407.1A CN104027307A (en) | 2014-07-02 | 2014-07-02 | Medicine composition and preparing method thereof |
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| CN201410314407.1A CN104027307A (en) | 2014-07-02 | 2014-07-02 | Medicine composition and preparing method thereof |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105418804A (en) * | 2015-12-01 | 2016-03-23 | 蚌埠医学院 | Hydrophobic low-anticoagulation heparin as well as preparation method and application thereof |
Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1720900A (en) * | 2004-07-14 | 2006-01-18 | 无锡杰西医药科技有限公司 | Medicinal emulsion adapted for difficultly soluble medicine and method for preparing the same |
| CN101926757A (en) * | 2010-09-01 | 2010-12-29 | 北京大学 | Liquid composition of indissolvable medicines and preparation method thereof |
| CN103059165A (en) * | 2012-12-26 | 2013-04-24 | 蚌埠丰原涂山制药有限公司 | Polysaccharide acylate and preparation method thereof |
-
2014
- 2014-07-02 CN CN201410314407.1A patent/CN104027307A/en active Pending
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1720900A (en) * | 2004-07-14 | 2006-01-18 | 无锡杰西医药科技有限公司 | Medicinal emulsion adapted for difficultly soluble medicine and method for preparing the same |
| CN101926757A (en) * | 2010-09-01 | 2010-12-29 | 北京大学 | Liquid composition of indissolvable medicines and preparation method thereof |
| CN103059165A (en) * | 2012-12-26 | 2013-04-24 | 蚌埠丰原涂山制药有限公司 | Polysaccharide acylate and preparation method thereof |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105418804A (en) * | 2015-12-01 | 2016-03-23 | 蚌埠医学院 | Hydrophobic low-anticoagulation heparin as well as preparation method and application thereof |
| CN105418804B (en) * | 2015-12-01 | 2018-08-10 | 蚌埠医学院 | Low anticoagulant property heparin of a kind of hydrophobization and its preparation method and application |
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Application publication date: 20140910 |
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