CN103976955A - Human albumin nano-particle and preparation method thereof - Google Patents
Human albumin nano-particle and preparation method thereof Download PDFInfo
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- CN103976955A CN103976955A CN201410159700.5A CN201410159700A CN103976955A CN 103976955 A CN103976955 A CN 103976955A CN 201410159700 A CN201410159700 A CN 201410159700A CN 103976955 A CN103976955 A CN 103976955A
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Abstract
The invention discloses a nano-particle utilizing human albumin as a carrier material. The nano-particle comprises 50g of a drug, 30-80g of lecithin, 2-16g of cholesterol, anhydrous ethanol, 20-120g of disodium hydrogen phosphate, 20-120g of sodium dihydrogen phosphate, 100-200g of human albumin (calculated based on its solution), 50-150g of Arabic gum and 1-100ml of hydrochloric acid.
Description
Technical field
The present invention relates to a kind of process of preparing of human albumin's Nano microsphere, for the preparation of medicament nano microsphere provides new quick process program.
Background technology
The research of Nano microsphere is one of more popular technology.There is the research of the preparation method of a large amount of Nano microspheres both at home and abroad, be also no lack of and have the listing of the drug products of Nano microsphere.
The material of preparing microsphere, microcapsule has a variety of.For the material of protide, be exactly mainly albumin (as human albumin, bSA), zein, egg albumen, New-born calf brain protein etc., biodegradable.Without obvious antigenicity.Conventional different temperatures heat cross-linking solidifies or chemical cross-linking agent (as formaldehyde, glutaraldehyde, butadiene) solidifies.
In above-mentioned preparation method, use chemical cross-linking agent, residual being not easy in medicine controlled, and preparation flow is comparatively complicated, and the difficulty that microspheres quality is controlled is larger.
The feature that conjugated protein both sexes of the present invention are dissociated, utilizes the localized hyperthermia of high-speed homogenization machine, processes in short-term, by medicine emulsifying and be fixed in microsphere.Preparation technology is simple, and quality control is convenient.
Summary of the invention
The present invention is subject to Lu Bin chief editor's novel pharmaceutical formulation and the enlightenment of new technique (the 2nd edition, Beijing people's health publishing house, in July, 2005).Three the characteristic steps such as solidification to protein microsphere that the both sexes of protein are dissociated, the emulsifying of high-speed homogenization process, local temperature improve are in short-term integrated, simplified the preparation section of human albumin's microsphere.Be convenient to the quality control of product.
Formula of the present invention is composed as follows:
| Sequence number | Supplementary material title | Consumption |
| 1 | Medicine | 50 grams |
| 2 | Lecithin | 30-80 gram |
| 3 | Cholesterol | 2-16 gram |
| 4 | Dehydrated alcohol | 50-100ml |
| 5 | Sodium hydrogen phosphate | 20-120 gram |
| 6 | Sodium dihydrogen phosphate | 20-120 gram |
| 7 | Human albumin | 100-200 gram (solution conversion) |
| 8 | Arabic gum | 50-150 gram |
| 9 | Hydrochloric acid | 1-100ml |
The preparation process of human albumin's of the present invention nanoparticle is:
1) prepare the solution phase of medicine; Take medicine, phospholipid, the cholesterol of recipe quantity, with anhydrous alcohol solution, make transparent solution;
2) prepare protein solution; With sodium hydrogen phosphate, sodium dihydrogen phosphate mediator blood albumin solution, make its pH between 6.2-7.0; Add arabic gum that it is dissolved thoroughly;
3) high-speed homogenization processing and microsphere solidify;
1. emulsifying and regulate pH.The frequency that regulates high-speed homogenization machine, makes in stirring, and drug solution is slowly transferred in protein solution, after transfer, drips hydrochloric acid, and the pH that makes solution is 3.6-4.5;
2. microsphere solidifies.After regulating pH, high-speed homogenization machine is adjusted to maximum (top) speed, as 20000-35000, high-speed homogenization is processed 20 minutes at twice, and Nano microsphere forms and solidify complete in the process of high-speed homogenization.The phosphate buffer that is 6.2-7.0 with pH washing.
Medicine can be dissolved in alcoholic solution or in protein solution according to its solubility property.If the dissolving of medicine in two solution is all undesirable, can the form with powder add in emulsion in the emulsifying later stage.
The applicable medicine of human albumin's nanoparticle of the present invention includes: pyrimidine and derivant thereof, amycin doxorubicin, amphotericin, paclitaxel, docetaxel.
The specific embodiment
embodiment 1: the preparation of human albumin's Nano microsphere of 5-fluorouracil
1 prepares the solution phase of medicine
Take 0 gram of phosphatidase 13,8 grams, cholesterol, with dehydrated alcohol 60ml, dissolve, make transparent solution;
2 prepare protein solution
2.1 use sodium hydrogen phosphates, sodium dihydrogen phosphate mediator blood albumin solution 500ml, amounting to human albumin's consumption is 100 grams, making its pH is 6.2-7.0;
2.2 add 60 grams of arabic gums, and it is dissolved thoroughly;
2.3 add 10 grams of 5-fluorouracil, and it is dissolved thoroughly;
3 high-speed homogenizations are processed and microsphere solidifies
3.1 emulsifyings and adjusting pH.Regulating the frequency of high-speed homogenization machine is 3000-8000rpm, makes in stirring, and drug solution is slowly transferred in protein solution, after transfer, drips hydrochloric acid, and the pH that makes solution is 3.6-4.5;
3.2 microspheres solidify.After regulating pH, high-speed homogenization machine is adjusted to maximum (top) speed, as 20000-35000, high-speed homogenization is processed 20 minutes at twice, and Nano microsphere forms and solidify complete in the process of high-speed homogenization.The phosphate buffer that is 6.2-7.0 with pH washing.
embodiment 2: the preparation of human albumin's Nano microsphere of doxorubicin
1 prepares the solution phase of medicine
Take 0 gram of phosphatidase 14,8 grams, cholesterol, with dehydrated alcohol 60ml, dissolve, make transparent solution;
2 prepare protein solution
2.1 use sodium hydrogen phosphates, sodium dihydrogen phosphate mediator blood albumin solution 500ml, amounting to human albumin's consumption is 100 grams, makes its pH between 6.2-7.0;
2.2 add 80 grams of arabic gums, and it is dissolved thoroughly;
2.3 add 10 grams of doxorubicins, and it is dissolved thoroughly;
3 high-speed homogenizations are processed and microsphere solidifies
3.1 emulsifyings and adjusting pH.Regulating the frequency of high-speed homogenization machine is 3000-8000rpm, makes in stirring, and drug solution is slowly transferred in protein solution, after transfer, drips hydrochloric acid, and the pH that makes solution is 3.6-4.5;
3.2 microspheres solidify.After regulating pH, high-speed homogenization machine is adjusted to maximum (top) speed, as 20000-35000, high-speed homogenization is processed 20 minutes at twice, and Nano microsphere forms and solidify complete in the process of high-speed homogenization.The phosphate buffer that is 6.2-7.0 with pH washing.
embodiment 3: the preparation of human albumin's Nano microsphere of doxorubicin hydrochloride
1 prepares the solution phase of medicine
Take 0 gram of phosphatidase 14,6 grams, cholesterol, with dehydrated alcohol 60ml, dissolve, make transparent solution;
2 prepare protein solution
2.1 use sodium hydrogen phosphates, sodium dihydrogen phosphate mediator blood albumin solution 500ml, amounting to human albumin's consumption is 100 grams, makes its pH between 6.2-7.0;
2.2 add 80 grams of arabic gums, and it is dissolved thoroughly;
2.3 add 10 grams of doxorubicin hydrochloride, and it is dissolved thoroughly;
3 high-speed homogenizations are processed and microsphere solidifies
3.1 emulsifyings and adjusting pH.Regulating the frequency of high-speed homogenization machine is 3000-8000rpm, makes in stirring, and drug solution is slowly transferred in protein solution, after transfer, drips hydrochloric acid, and the pH that makes solution is 3.6-4.5;
3.2 microspheres solidify.After regulating pH, high-speed homogenization machine is adjusted to maximum (top) speed, as 20000-35000, high-speed homogenization is processed 20 minutes at twice, and Nano microsphere forms and solidify complete in the process of high-speed homogenization.The phosphate buffer that is 6.2-7.0 with pH washing.
embodiment 4: the preparation of human albumin's Nano microsphere of amphotericin
1 prepares the solution phase of medicine
Take 0 gram of phosphatidase 13,8 grams, cholesterol, with dehydrated alcohol 60ml, dissolve, make transparent solution;
2 prepare protein solution
2.1 use sodium hydrogen phosphates, sodium dihydrogen phosphate mediator blood albumin solution 500ml, amounting to human albumin's consumption is 100 grams, makes its pH between 6.2-7.0;
2.2 add 100 grams of arabic gums, and it is dissolved thoroughly;
3 high-speed homogenizations are processed and microsphere solidifies
3.1 emulsifyings and adjusting pH.Regulating the frequency of high-speed homogenization machine is 3000-8000rpm, makes in stirring, and drug solution is slowly transferred in protein solution, after transfer, drips hydrochloric acid, and the pH that makes solution is 3.6-4.5;
3.2 slowly add 8 grams of amphotericin crude drug micropowders;
3.3 microspheres solidify.After regulating pH, high-speed homogenization machine is adjusted to maximum (top) speed, as 20000-35000, high-speed homogenization is processed 20 minutes at twice, and Nano microsphere forms and solidify complete in the process of high-speed homogenization.The phosphate buffer that is 6.2-7.0 with pH washing.
embodiment 5: the preparation of human albumin's Nano microsphere of paclitaxel
1 prepares the solution phase of medicine
Take 20 grams of paclitaxels, 0 gram of phosphatidase 14,8 grams, cholesterol, dissolve with dehydrated alcohol 80ml, makes transparent solution;
2 prepare protein solution
2.1 use sodium hydrogen phosphates, sodium dihydrogen phosphate mediator blood albumin solution 500ml, make its pH between 6.2-7.0;
2.2 add 60 grams of arabic gums, and it is dissolved thoroughly.
3 high-speed homogenizations are processed and microsphere solidifies
3.1 emulsifyings and adjusting pH.Regulating the frequency of high-speed homogenization machine is 3000-8000rpm, makes in stirring, and drug solution is slowly transferred in protein solution, after transfer, drips hydrochloric acid, and the pH that makes solution is 3.6-4.5;
3.2 microspheres solidify.After regulating pH, high-speed homogenization machine is adjusted to maximum (top) speed, as 20000-35000, high-speed homogenization is processed 20 minutes at twice, and Nano microsphere forms and solidify complete in the process of high-speed homogenization.The phosphate buffer that is 6.2-7.0 with pH washing.
embodiment 6: the preparation of human albumin's Nano microsphere of docetaxel
1 prepares the solution phase of medicine
Take 10 grams of docetaxels, 0 gram of phosphatidase 14,10 grams, cholesterol, dissolve with dehydrated alcohol 100ml, makes transparent solution;
2 prepare protein solution
2.1 use sodium hydrogen phosphates, sodium dihydrogen phosphate mediator blood albumin solution 500ml, make its pH between 6.2-7.0;
2.2 add 60 grams of arabic gums, and it is dissolved thoroughly;
3 high-speed homogenizations are processed and microsphere solidifies
3.1 emulsifyings and adjusting pH.Regulating the frequency of high-speed homogenization machine is 3000-8000rpm, makes in stirring, and drug solution is slowly transferred in protein solution, after transfer, drips hydrochloric acid, and the pH that makes solution is 3.6-4.5;
3.2 microspheres solidify.After regulating pH, high-speed homogenization machine is adjusted to maximum (top) speed, as 20000-35000, high-speed homogenization is processed 20 minutes at twice, and Nano microsphere forms and solidify complete in the process of high-speed homogenization.The phosphate buffer that is 6.2-7.0 with pH washing.
Claims (3)
1. human albumin's nanoparticle, is characterized in that its prescription consists of: 50 grams of medicines, lecithin 30-80 gram, cholesterol 2-16 gram, dehydrated alcohol, sodium hydrogen phosphate 20-120 gram, sodium dihydrogen phosphate 20-120 gram, human albumin 100-200 gram (solution conversion), arabic gum 50-150 gram, hydrochloric acid 1-100ml.
2. a preparation method for human albumin's nanoparticle, is characterized in that preparation process is:
1) prepare the solution phase of medicine: take medicine, phospholipid, the cholesterol of recipe quantity, with anhydrous alcohol solution, make transparent solution;
2) prepare protein solution: with sodium hydrogen phosphate, sodium dihydrogen phosphate mediator blood albumin solution, making its pH is 6.2-7.0; Add arabic gum that it is dissolved thoroughly;
3) high-speed homogenization processing and microsphere solidify:
1. emulsifying and regulate pH: regulate the frequency of high-speed homogenization machine, make in stirring, drug solution is slowly transferred in protein solution, after transfer, drip hydrochloric acid, the pH that makes solution is 3.6-4.5;
2. microsphere solidifies: after regulating pH, high-speed homogenization machine is adjusted to maximum (top) speed, as 20000-35000rpm, high-speed homogenization is processed 20 minutes at twice, and Nano microsphere forms and solidify complete in the process of high-speed homogenization; The phosphate buffer that is 6.2-7.0 with pH washing.
3. a kind of human albumin's nano-particle according to claim 1, is characterized in that the applicable medicine of human albumin's nanoparticle includes: pyrimidine and derivant thereof, amycin doxorubicin, amphotericin, paclitaxel, docetaxel.
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN107753435A (en) * | 2017-10-31 | 2018-03-06 | 聊城大学 | A kind of medicine phosphatide/albumin compound nano-particle and preparation technology |
| CN110075073A (en) * | 2019-06-03 | 2019-08-02 | 深圳市健开医药有限公司 | A kind of Cabazitaxel protein nano injection and preparation method thereof |
| CN111449055A (en) * | 2020-05-23 | 2020-07-28 | 河北康腾生物科技有限公司 | Adipose tissue cryopreservation liquid, preparation method and adipose tissue storage method |
-
2014
- 2014-04-21 CN CN201410159700.5A patent/CN103976955A/en active Pending
Cited By (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN107753435A (en) * | 2017-10-31 | 2018-03-06 | 聊城大学 | A kind of medicine phosphatide/albumin compound nano-particle and preparation technology |
| CN107753435B (en) * | 2017-10-31 | 2020-06-05 | 聊城大学 | Medicine-phospholipid/albumin composite nanoparticles and preparation process thereof |
| CN110075073A (en) * | 2019-06-03 | 2019-08-02 | 深圳市健开医药有限公司 | A kind of Cabazitaxel protein nano injection and preparation method thereof |
| CN110075073B (en) * | 2019-06-03 | 2021-09-07 | 深圳市健开医药有限公司 | Cabazitaxel protein nano injection and preparation method thereof |
| CN111449055A (en) * | 2020-05-23 | 2020-07-28 | 河北康腾生物科技有限公司 | Adipose tissue cryopreservation liquid, preparation method and adipose tissue storage method |
| CN111449055B (en) * | 2020-05-23 | 2021-07-23 | 河北康腾生物科技有限公司 | Adipose tissue cryopreservation liquid, preparation method and adipose tissue storage method |
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Application publication date: 20140813 |
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