CN105597101A - Innovative pharmaceutic adjuvant colloidal microcrystalline cellulose and preparation method thereof - Google Patents
Innovative pharmaceutic adjuvant colloidal microcrystalline cellulose and preparation method thereof Download PDFInfo
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- CN105597101A CN105597101A CN201510633947.0A CN201510633947A CN105597101A CN 105597101 A CN105597101 A CN 105597101A CN 201510633947 A CN201510633947 A CN 201510633947A CN 105597101 A CN105597101 A CN 105597101A
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Abstract
The invention relates to an innovative pharmaceutic adjuvant colloidal microcrystalline cellulose and a preparation method thereof. The method includes: taking 70%-99% of microcrystalline cellulose and 1%-30% of sodium carboxymethyl cellulose as raw materials, subjecting the microcrystalline cellulose and sodium carboxymethyl cellulose to extrusion and high pressure homogenization so as to obtain the colloidal microcrystalline cellulose. The colloidal microcrystalline cellulose provided by the invention has a good sedimentation volume ratio, and can effectively improve the dispersibility, dissolution rate and other preparation performance of pharmaceutical preparations.
Description
Technical field
The present invention relates to a kind of innovation pharmaceutic adjuvant colloidal microcrystalline cellulose, i.e. colloidal microcrystalline cellulose and preparation side thereofMethod.
Background technology
Microcrystalline cellulose (MCC) is through low concentration mineral acid hydrolysis the superfine micro-of the degree of polymerization that reach capacity by native celluloseWhite corynebacterium or imperfect crystal formation powder, odorless, tasteless. Granular size is generally at 20-80 micron, levelling off degree of polymerization(LODP) 15～375; Do not have a fibroid and more liquid. Water insoluble, diluted acid, organic solvent and grease, molten at diluted alkalineIn liquid, be partly dissolved, swollen, in carboxy methylation, acetylation, esterification process, there is higher reactivity worth. Lower owing to havingThe special natures such as the degree of polymerization and larger specific area, microcrystalline cellulose is widely used in medicine, food, cosmetics and lightChemical industry.
Although at present general fibre element has been carried out to some improvement, but still cannot meet asking of existing in dry mixed suspension preparationTopic, the particularly requirement of quality index to auxiliary material in insoluble drug.
Summary of the invention
The object of the invention is to overcome domestic existing microcrystalline cellulose can not meet existing dry mixed suspension preparation system completely and askShortcoming. A kind of colloidal microcrystalline cellulose and preparation method thereof is provided, there is good settling volume ratio, can make slightly solubility medicineThing preparation Fast Stripping.
One is innovated pharmaceutic adjuvant colloidal microcrystalline cellulose, it is characterized in that the settling volume of described colloidal microcrystalline celluloseThan being 0.945～0.998, comprise following component:
Microcrystalline cellulose 70%～99%
Sodium carboxymethylcellulose 1%～30%.
One is innovated pharmaceutic adjuvant colloidal microcrystalline cellulose, it is characterized in that the settling volume of described colloidal microcrystalline celluloseThan being 0.945～0.998, comprise following component:
Microcrystalline cellulose 76%～89%
Sodium carboxymethylcellulose 11%～24%.
A kind of innovation pharmaceutic adjuvant colloidal microcrystalline cellulose, is characterized in that, preparation method comprises the following steps:
(1) take microcrystalline cellulose 70%～99% and the sodium carboxymethylcellulose 1%～30% of recipe quantity, for subsequent use;
(2) by the sodium carboxymethylcellulose of 1/10 recipe quantity, add in purified water, stir, be mixed with solid content0.05%～1.2% solution, for subsequent use;
(3) microcrystalline cellulose of the sodium carboxymethylcellulose of 9/10 recipe quantity and recipe quantity is crossed to 80 mesh sieve 3 times, added0.2～0.4 times of amount 10% ethanolic solution, stirs, for subsequent use;
(4) material in above-mentioned (3) is placed in to rubber mixing machine, roller bearing spacing 2～5mm is set, push 1～3 time, for subsequent use;
(5) material in above-mentioned (4) is placed in to (2) solution, soaks 2～8h, add purified water, be mixed with solid content1.5%～4.2% solution, for subsequent use;
(6) material in above-mentioned (5) is placed in to high pressure homogenizer, controlled pressure is 85～96Mpa, and homogenous disperse is for subsequent use;
(7) by dry materials in above-mentioned (6), obtain colloidal microcrystalline cellulose of the present invention.
Drying means of the present invention is that spraying is dry, microwave drying, infrared drying, drum-type are dry, in belt dryingA kind of.
Specific embodiment
Embodiment 1
Component:
| Name of material | Ratio (%) | Weight (g) |
| Microcrystalline cellulose | 99 | 9900 |
| Sodium carboxymethylcellulose | 1 | 100 |
Preparation method:
(1) take microcrystalline cellulose 9900g and the sodium carboxymethylcellulose 100g of recipe quantity, for subsequent use;
(2) by the sodium carboxymethylcellulose of 1/10 recipe quantity, add in purified water, stir, be mixed with solid content1.2% solution, for subsequent use;
(3) microcrystalline cellulose of the sodium carboxymethylcellulose of 9/10 recipe quantity and recipe quantity is crossed to 80 mesh sieve 3 times, added0.4 times of amount 10% ethanolic solution, stirs, for subsequent use;
(4) material in above-mentioned (3) is placed in to rubber mixing machine, roller bearing spacing 2mm is set, push 2 times, for subsequent use;
(5) material in above-mentioned (4) is placed in to (2) solution, soaks 8h, add purified water, be mixed with solid content 4.2%Solution, for subsequent use;
(6) material in above-mentioned (5) is placed in to high pressure homogenizer, controlled pressure is 85Mpa, and homogenous disperse is for subsequent use;
(7) material in above-mentioned (6) is adopted to microwave drying, obtain colloidal microcrystalline cellulose of the present invention.
Embodiment 2
Component:
| Name of material | Ratio (%) | Weight (g) |
| Microcrystalline cellulose | 70 | 7000 |
| Sodium carboxymethylcellulose | 30 | 3000 |
Preparation method:
(1) take microcrystalline cellulose 7000g and the sodium carboxymethylcellulose 3000g of recipe quantity, for subsequent use;
(2) by the sodium carboxymethylcellulose of 1/10 recipe quantity, add in purified water, stir, be mixed with solid content0.5% solution, for subsequent use;
(3) microcrystalline cellulose of the sodium carboxymethylcellulose of 9/10 recipe quantity and recipe quantity is crossed to 80 mesh sieve 3 times, added0.3 times of amount 10% ethanolic solution, stirs, for subsequent use;
(4) material in above-mentioned (3) is placed in to rubber mixing machine, roller bearing spacing 5mm is set, push 3 times, for subsequent use;
(5) material in above-mentioned (4) is placed in to (2) solution, soaks 4h, add purified water, be mixed with solid content 1.5%Solution, for subsequent use;
(6) material in above-mentioned (5) is placed in to high pressure homogenizer, controlled pressure is 96Mpa, and homogenous disperse is for subsequent use;
(7) material in above-mentioned (6) is adopted to infrared drying, obtain colloidal microcrystalline cellulose of the present invention.
Embodiment 3
Component:
| Name of material | Ratio (%) | Weight (g) |
| Microcrystalline cellulose | 82 | 8200 |
| Sodium carboxymethylcellulose | 18 | 1800 |
Preparation method:
(1) take microcrystalline cellulose 8200g and the sodium carboxymethylcellulose 1800g of recipe quantity, for subsequent use;
(2) by the sodium carboxymethylcellulose of 1/10 recipe quantity, add in purified water, stir, be mixed with solid content0.05% solution, for subsequent use;
(3) microcrystalline cellulose of the sodium carboxymethylcellulose of 9/10 recipe quantity and recipe quantity is crossed to 80 mesh sieve 3 times, added0.2 times of amount 10% ethanolic solution, stirs, for subsequent use;
(4) material in above-mentioned (3) is placed in to rubber mixing machine, roller bearing spacing 4mm is set, push 1 time, for subsequent use;
(5) material in above-mentioned (4) is placed in to (2) solution, soaks 2h, add purified water, be mixed with solid content 3.5%Solution, for subsequent use;
(6) material in above-mentioned (5) is placed in to high pressure homogenizer, controlled pressure is 89Mpa, and homogenous disperse is for subsequent use;
(7) material in above-mentioned (6) is adopted to microwave drying, obtain colloidal microcrystalline cellulose of the present invention.
Embodiment 4
Component:
| Name of material | Ratio (%) | Weight (g) |
| Microcrystalline cellulose | 76 | 7600 |
| Sodium carboxymethylcellulose | 24 | 2400 |
Preparation method:
(1) take microcrystalline cellulose 7600g and the sodium carboxymethylcellulose 2400g of recipe quantity, for subsequent use;
(2) by the sodium carboxymethylcellulose of 1/10 recipe quantity, add in purified water, stir, be mixed with solid content0.1% solution, for subsequent use;
(3) microcrystalline cellulose of the sodium carboxymethylcellulose of 9/10 recipe quantity and recipe quantity is crossed to 80 mesh sieve 3 times, added0.35 times of amount 10% ethanolic solution, stirs, for subsequent use;
(4) material in above-mentioned (3) is placed in to rubber mixing machine, roller bearing spacing 3mm is set, push 2 times, for subsequent use;
(5) material in above-mentioned (4) is placed in to (2) solution, soaks 6h, add purified water, be mixed with solid content 2.5%Solution, for subsequent use;
(6) material in above-mentioned (5) is placed in to high pressure homogenizer, controlled pressure is 88Mpa, and homogenous disperse is for subsequent use;
(7) material in above-mentioned (6) is adopted to infrared drying, obtain colloidal microcrystalline cellulose of the present invention.
Embodiment 5
Component:
| Name of material | Ratio (%) | Weight (g) |
| Microcrystalline cellulose | 89 | 8900 3 --> |
| Sodium carboxymethylcellulose | 11 | 1100 |
Preparation method:
(1) take microcrystalline cellulose 8900g and the sodium carboxymethylcellulose 1100g of recipe quantity, for subsequent use;
(2) by the sodium carboxymethylcellulose of 1/10 recipe quantity, add in purified water, stir, be mixed with solid content0.1% solution, for subsequent use;
(3) microcrystalline cellulose of the sodium carboxymethylcellulose of 9/10 recipe quantity and recipe quantity is crossed to 80 mesh sieve 3 times, added0.2 times of amount 10% ethanolic solution, stirs, for subsequent use;
(4) material in above-mentioned (3) is placed in to rubber mixing machine, roller bearing spacing 4mm is set, push 1 time, for subsequent use;
(5) material in above-mentioned (4) is placed in to (2) solution, soaks 5h, add purified water, be mixed with solid content 2.0%Solution, for subsequent use;
(6) material in above-mentioned (5) is placed in to high pressure homogenizer, controlled pressure is 85Mpa, and homogenous disperse is for subsequent use;
(7) adopt spraying dry material in above-mentioned (6), obtain colloidal microcrystalline cellulose of the present invention.
Embodiment 6
Component:
| Name of material | Ratio (%) | Weight (g) |
| Microcrystalline cellulose | 81 | 8100 |
| Sodium carboxymethylcellulose | 19 | 1900 |
Preparation method:
(1) take microcrystalline cellulose 8100g and the sodium carboxymethylcellulose 1900g of recipe quantity, for subsequent use;
(2) by the sodium carboxymethylcellulose of 1/10 recipe quantity, add in purified water, stir, be mixed with solid content0.1% solution, for subsequent use;
(3) microcrystalline cellulose of the sodium carboxymethylcellulose of 9/10 recipe quantity and recipe quantity is crossed to 80 mesh sieve 3 times, added0.4 times of amount 10% ethanolic solution, stirs, for subsequent use;
(4) material in above-mentioned (3) is placed in to rubber mixing machine, roller bearing spacing 4mm is set, push 1 time, for subsequent use;
(5) material in above-mentioned (4) is placed in to (2) solution, soaks 5h, add purified water, be mixed with solid content 2.0%Solution, for subsequent use;
(6) material in above-mentioned (5) is placed in to high pressure homogenizer, controlled pressure is 85Mpa, and homogenous disperse is for subsequent use;
(7) material in above-mentioned (6) is adopted to microwave drying, obtain colloidal microcrystalline cellulose of the present invention.
Embodiment 7
Component:
| Name of material | Ratio (%) | Weight (g) |
| Microcrystalline cellulose | 72 | 7200 |
| Sodium carboxymethylcellulose | 28 | 2800 |
Preparation method:
(1) take microcrystalline cellulose 7200g and the sodium carboxymethylcellulose 2800g of recipe quantity, for subsequent use;
(2) by the sodium carboxymethylcellulose of 1/10 recipe quantity, add in purified water, stir, be mixed with solid content0.5% solution, for subsequent use;
(3) microcrystalline cellulose of the sodium carboxymethylcellulose of 9/10 recipe quantity and recipe quantity is crossed to 80 mesh sieve 3 times, added0.2 times of amount 10% ethanolic solution, stirs, for subsequent use;
(4) material in above-mentioned (3) is placed in to rubber mixing machine, roller bearing spacing 5mm is set, push 3 times, for subsequent use;
(5) material in above-mentioned (4) is placed in to (2) solution, soaks 4h, add purified water, be mixed with solid content 1.5%Solution, for subsequent use;
(6) material in above-mentioned (5) is placed in to high pressure homogenizer, controlled pressure is 96Mpa, and homogenous disperse is for subsequent use;
(7) material in above-mentioned (6) is adopted to belt drying, obtain colloidal microcrystalline cellulose of the present invention.
Embodiment 8
Component:
| Name of material | Ratio (%) | Weight (g) |
| Microcrystalline cellulose | 90 | 9000 |
| Sodium carboxymethylcellulose | 10 | 1000 |
Preparation method:
(1) take microcrystalline cellulose 9000g and the sodium carboxymethylcellulose 1000g of recipe quantity, for subsequent use;
(2) by the sodium carboxymethylcellulose of 1/10 recipe quantity, add in purified water, stir, be mixed with solid content1.2% solution, for subsequent use;
(3) microcrystalline cellulose of the sodium carboxymethylcellulose of 9/10 recipe quantity and recipe quantity is crossed to 80 mesh sieve 3 times, added0.4 times of amount 10% ethanolic solution, stirs, for subsequent use;
(4) material in above-mentioned (3) is placed in to rubber mixing machine, roller bearing spacing 3mm is set, push 2 times, for subsequent use;
(5) material in above-mentioned (4) is placed in to (2) solution, soaks 6h, add purified water, be mixed with solid content 3.2%Solution, for subsequent use;
(6) material in above-mentioned (5) is placed in to high pressure homogenizer, controlled pressure is 87Mpa, and homogenous disperse is for subsequent use;
(7) adopt drum-type dry material in above-mentioned (6), obtain colloidal microcrystalline cellulose of the present invention.
Embodiment 9 (comparative example)
Component:
| Name of material | Ratio (%) | Weight (g) |
| Microcrystalline cellulose | 80 | 8000 |
| Sodium carboxymethylcellulose | 20 | 2000 |
Preparation method:
(1) take microcrystalline cellulose 8000g and the sodium carboxymethylcellulose 2000g of recipe quantity, mix, for subsequent use.
Embodiment 10 (comparative example)
Component:
| Name of material | Ratio (%) | Weight (g) |
| Microcrystalline cellulose | 80 | 8000 |
| Sodium carboxymethylcellulose | 20 | 2000 |
Preparation method:
(1) take microcrystalline cellulose 8000g and the sodium carboxymethylcellulose 2000g of recipe quantity, mix, for subsequent use;
(2) material in above-mentioned (1) is added to purified water, be mixed with the solution of solid content 3.2%, for subsequent use;
(3) material in above-mentioned (2) is placed in to high pressure homogenizer, controlled pressure is 87Mpa, and homogenous disperse is for subsequent use;
(4) material in above-mentioned (3) is adopted to microwave drying, for subsequent use.
Test example 1
Apparatus plug graduated cylinder is got purified water 50ml, adds test sample appropriate, and firmly jolting 1 minute, writes down the beginning of suspended matterHeight H0, leave standstill 3 hours, write down the height H of suspended matter, calculated settlement volume ratio (settling volume ratio=H/H0)。
Sample source: sample of sample one: embodiment; Sample two: embodiment binomial sample; Sample three: embodiment tri-Item sample; Tetra-samples of sample four: embodiment; Five samples of sample five: embodiment; Six samples of sample six: embodiment; SampleSeven: seven samples of embodiment; Eight samples of sample eight: embodiment; Nine samples of sample nine: embodiment; Sample ten: embodiment tenItem sample; Sample 11: microcrystalline cellulose; Sample 12: AVICEL; Sample 13: sodium carboxymethylcellulose; Sample 14:Commercially available import sample. Experimental result is in table 1, and result shows that settling volume of the present invention is than large, and formulation application has advantage.
Table 1 settling volume compares measurement result
| Sample | Settling volume is than (H/H0) |
| Sample one | 0.976 |
| Sample two | 0.965 |
| Sample three | 0.971 |
| Sample four | 0.998 |
| Sample five | 0.954 |
| Sample six | 0.950 |
| Sample seven | 0.948 |
| Sample eight | 0.945 |
| Sample nine | 0.894 |
| Sample ten | 0.876 |
| Sample 11 | 0.802 |
| Sample 12 | 0.891 |
| Sample 13 | 0 |
| Sample 14 | 0.907 |
Test example 2
Get Cefpodoxime Proxetil raw material appropriate, add in test example 1 sample appropriate, and add appropriate silica, mix, systemBecome dry suspensoid agent, measure settling volume ratio according to method in test example 1, and according to " Chinese pharmacopoeia version in 2010 " two Cefpodoxime ProxetilsIn Quality Standards of Drugs for Suspension, method is measured dissolution rate. Experimental result is in table 1, and result shows that the dry suspensoid agent that the present invention makes sinksFall volume ratio large, stripping is fast, and formulation application has advantage.
Claims (6)
1. innovate a pharmaceutic adjuvant colloidal microcrystalline cellulose, it is characterized in that the settling volume ratio of described colloidal microcrystalline celluloseBe 0.945～0.998, comprise following component:
Microcrystalline cellulose 70%～99%
Sodium carboxymethylcellulose 1%～30%.
2. a kind of innovation pharmaceutic adjuvant colloidal microcrystalline cellulose as claimed in claim 1, is characterized in that described colloidal state crystalliteCellulosic settling volume ratio is 0.945～0.998, comprises following component:
Microcrystalline cellulose 76%～89%
Sodium carboxymethylcellulose 11%～24%.
3. the innovation of the one as described in claim 1-2 pharmaceutic adjuvant colloidal microcrystalline cellulose, is characterized in that preparation method's bagDraw together following steps:
(1) take microcrystalline cellulose 70%～99% and the sodium carboxymethylcellulose 1%～30% of recipe quantity, for subsequent use;
(2) by the sodium carboxymethylcellulose of 1/10 recipe quantity, add in purified water, stir, be mixed with solid content 0.05%～1.2% solution, for subsequent use;
(3) microcrystalline cellulose of the sodium carboxymethylcellulose of 9/10 recipe quantity and recipe quantity is crossed to 80 mesh sieve 3 times, add 0.2～0.4 times of amount 10% ethanolic solution, stirs, for subsequent use;
(4) material in above-mentioned (3) is placed in to rubber mixing machine, roller bearing spacing 2～5mm is set, push 1～3 time, for subsequent use;
(5) material in above-mentioned (4) is placed in to (2) solution, soaks 2～8h, add purified water, be mixed with solid content 1.5%～4.2% solution, for subsequent use;
(6) material in above-mentioned (5) is placed in to high pressure homogenizer, controlled pressure is 85～96Mpa, and homogenous disperse is for subsequent use;
(7) by dry materials in above-mentioned (6), obtain colloidal microcrystalline cellulose of the present invention.
4. the innovation of the one as described in claim 1-3 pharmaceutic adjuvant colloidal microcrystalline cellulose, is characterized in that prepared glueThe settling volume ratio of state microcrystalline cellulose is 0.945～0.998.
As claimed in claim 3 drying means for spraying is dry, dry, the belt drying of microwave drying, infrared drying, drum-typeIn one or both.
6. drying means is microwave drying, infrared drying as claimed in claim 3.
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| CN106692068A (en) * | 2017-01-16 | 2017-05-24 | 中国药科大学 | Dry suspension for improving dissolution |
| CN112022830A (en) * | 2020-08-04 | 2020-12-04 | 华北制药河北华民药业有限责任公司 | Preparation method of cefalexin capsules |
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| CN112022830A (en) * | 2020-08-04 | 2020-12-04 | 华北制药河北华民药业有限责任公司 | Preparation method of cefalexin capsules |
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Application publication date: 20160525 |