CN105982874A - Pitavastatin calcium composition - Google Patents
Pitavastatin calcium composition Download PDFInfo
- Publication number
- CN105982874A CN105982874A CN201510674766.2A CN201510674766A CN105982874A CN 105982874 A CN105982874 A CN 105982874A CN 201510674766 A CN201510674766 A CN 201510674766A CN 105982874 A CN105982874 A CN 105982874A
- Authority
- CN
- China
- Prior art keywords
- pitavastatin calcium
- lecithin
- microcrystalline cellulose
- carboxymethyl starch
- starch sodium
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Pending
Links
Abstract
The invention relates to a pharmaceutical composition comprising pitavastatin calcium tablets and belongs to the technical field of medicine. A stable pitavastatin calcium tablet composition is characterized in that 1-2 g of pitavastatin calcium 25 Mum in D90, 80-100 g of microcrystalline cellulose, 1-3 g of lecithin and 3-5 g of sodium carboxymethyl starch are contained per 1000 tablets. The composition is prepared by dry-process tableting technical scheme; the pre-cracking problem in dry tableting is solved using the technical scheme of the invention is solved; the problem that tablets are non-uniform in content is solved.
Description
Technical field
Invention relates to a kind of preparation compositions containing pitavastatin calcium tablet, belongs to pharmaceutical technology field.
Background technology
Pitavastatin calcium tablet is by the third generation statins of Japanese Nissan chemical industry Co., Ltd. with Kowa company Ltd's joint development, in
1999
Year
11
Month at Japan registration, and in
2003
Year
7
Month
17
Day is first in Japan's approval listing.It is primarily adapted for use in the treatment of hyperlipidemia and familial hypercholesterolemia.
Pitavastatin Calcium is the most readily biodegradable, and the preparation of existing tablet typically uses wet granulation, and regulates the acid-base value of tablet, to reduce the degraded of active substance.Owing to Pitavastatin Calcium self is to the control of process conditions and strict, in industrialized production, slightly technology controlling and process fluctuation, easily have related substance higher, and cause deposit during have the situation that related substance exceeds standard.
Dry method direct compression, compared with traditional wet granule compression tablet technique, has the advantages that product stability is good, production technology simple, and production efficiency is high, therefore since
20
Century
70
Since age is born, it is widely applied, there are about America and Europe now
50%
The tablet kind of left and right has used this production technology.But at home, limited by adjuvant, equipment and production technology, applied limited.During dry process pitavastatin calcium tablet, capping situation easily occurs, affect the application of compressing dry granulation technology.
Summary of the invention
It is an object of the invention to provide a kind of pitavastatin calcium tablet prepared through dry process, improve yield rate.
The technical scheme is that
A kind of stable Pitavastatin Calcium tablet composition, it is characterised in that every
1000
Sheet contains
D90
For
25um
Pitavastatin Calcium
1-2g
, microcrystalline Cellulose
80-100 g
, lecithin
1-3g
, carboxymethyl starch sodium
3-5g
, use compressing dry granulation technology to prepare.
Currently preferred technical scheme, it is characterised in that every
1000
Sheet contains
D90
For
25um
Pitavastatin Calcium
1g
, microcrystalline Cellulose
85 g
, lecithin
2g
, carboxymethyl starch sodium
4g
, use compressing dry granulation technology to prepare.
Currently preferred technical scheme, it is characterised in that every
1000
Sheet contains
D90
For
25um
Pitavastatin Calcium
1g
, microcrystalline Cellulose
90 g
, lecithin
2g
, carboxymethyl starch sodium
3.5g
, use compressing dry granulation technology to prepare.
Currently preferred technical scheme, it is characterised in that every
1000
Sheet contains
D90
For
25um
Pitavastatin Calcium
1g
, microcrystalline Cellulose
95 g
, lecithin
2.5g
, carboxymethyl starch sodium
4.5g
, use compressing dry granulation technology to prepare.
The preparation method of pitavastatin calcium tablet of the present invention, it is characterised in that comprise the following steps:
The first step uses jet mill by pitavastatin calcium raw material drug micronization processes, the particle diameter after micronization
D90
For
25um
。
Adjuvant mistake in second step prescription
120
Mesh sieve.
3rd step weighs the crude drug of recipe quantity and mixs homogeneously with microcrystalline Cellulose, lecithin, carboxymethyl starch sodium.
4th step tabletting, film-making pressure
60N
。
Beneficial effect: in technical solution of the present invention, the addition of lecithin solves the capping problem in dry compression, it is provided that a kind of dry compression technology, shortens film-making operation and time, improves production efficiency；Control active component
D90
For
25
Micron, solves the inhomogenous problem of content between tablet.
Embodiment
1
、
D90
For
25um
Pitavastatin Calcium
1g
, microcrystalline Cellulose
80 g
, lecithin
1g
, carboxymethyl starch sodium
3g
, as described in technical scheme prepared by preparation method
1000
Sheet.
Observe slice, thin piece outward appearance, occur without capping situation.
Embodiment
2
、
D90
For
25um
Pitavastatin Calcium
2g
, microcrystalline Cellulose
100 g
, lecithin
3g
, carboxymethyl starch sodium
5g
, as described in technical scheme prepared by preparation method
1000
Sheet.
Observe slice, thin piece outward appearance, occur without capping situation.
Embodiment
3
、
D90
For
25um
Pitavastatin Calcium
1g
, microcrystalline Cellulose
90 g
, lecithin
2g
, carboxymethyl starch sodium
3.5g
, as described in technical scheme prepared by preparation method
1000
Sheet.Observe slice, thin piece outward appearance, occur without capping situation.
Embodiment
4
、
D90
For
25um
Pitavastatin Calcium
1g
, microcrystalline Cellulose
85 g
, lecithin
2g
, carboxymethyl starch sodium
4g
, as described in technical scheme prepared by preparation method
1000
Sheet.
Observe slice, thin piece outward appearance, occur without capping situation.
Embodiment
5
、
D90
For
25um
Pitavastatin Calcium
1g
, microcrystalline Cellulose
95 g
, lecithin
2.5g
, carboxymethyl starch sodium
4.5g
, as described in technical scheme prepared by preparation method
1000
Sheet.
Observe slice, thin piece outward appearance, occur without capping situation.
Reference examples
1
、
D90
For
25um
Pitavastatin Calcium
1g
, microcrystalline Cellulose
90 g
, carboxymethyl starch sodium
3.5g
, as described in technical scheme prepared by preparation method
1000
Sheet.
Observe slice, thin piece outward appearance, about
10%
Slice, thin piece have capping situation to occur.
Reference examples
2
、
D90
For
40um
Pitavastatin Calcium
1 g
, microcrystalline Cellulose
90 g
, carboxymethyl starch sodium
3.5g
, as described in technical scheme prepared by preparation method
1000
Sheet.
Observe slice, thin piece outward appearance, about
2%
Slice, thin piece have capping situation to occur.
Test example
1
, Example
1-5
And reference examples
1-2
Sample respectively take
10
Sheet, by the homogeneity assay method of States Pharmacopoeia specifications, measures Pitavastatin calcium content therein respectively, and result is recorded in table
1
。
Table
1
Embodiment
1-5
And reference examples
1-2
The content of Pitavastatin Calcium in prepared tablet, labelled amount
%
Table
1
Data illustrate, the embodiment of the present invention
1-5
The content of sheet relatively reference examples
1-2
The uniform content of sheet.
Test example
2
, Example
1-5
And reference examples
1-2
Sample respectively take whole slice, thin piece
20
Sheet, official regulation, carry out friability measurement, respectively the weight loss before and after record test and the complete situation of sheet, data are recorded in table
2.
Table
2
Embodiment
1-5
And reference examples
1-2
Prepared tablet friability inspection
Table
2
Data illustrate, reference examples
1
With
2
Prepared tablet, fragment incidence rate is significantly larger than the embodiment of the present invention
1-5
Prepared tablet.Illustrate that the tablet hardness obtained by technical solution of the present invention is moderate, meet clinical application requirement.
Claims (5)
1. a stable Pitavastatin Calcium tablet composition, it is characterised in that containing the Pitavastatin Calcium 1-2g that D90 is 25um, microcrystalline Cellulose 80-100 g, lecithin 1-3g, carboxymethyl starch sodium 3-5g in every 1000, uses compressing dry granulation technology to prepare.
2. compositions described in claim 1, it is characterised in that containing the Pitavastatin Calcium 1g that D90 is 25um, microcrystalline Cellulose 85 g, lecithin 2g, carboxymethyl starch sodium 4g in every 1000, uses compressing dry granulation technology to prepare.
3. compositions described in claim 1, it is characterised in that containing the Pitavastatin Calcium 1g that D90 is 25um, microcrystalline Cellulose 90 g, lecithin 2g, carboxymethyl starch sodium 3.5g in every 1000, uses compressing dry granulation technology to prepare.
4. compositions described in claim 1, it is characterised in that containing the Pitavastatin Calcium 1g that D90 is 25um, microcrystalline Cellulose 95 g, lecithin 2.5g, carboxymethyl starch sodium 4.5g in every 1000, uses compressing dry granulation technology to prepare.
5. the preparation method of compositions described in claim 1, it is characterised in that comprise the following steps:
The first step uses jet mill to be 25um by pitavastatin calcium raw material drug micronization processes, the particle diameter D90 after micronization；
120 mesh sieves crossed by adjuvant in second step prescription；
3rd step weighs the crude drug of recipe quantity and mixs homogeneously with microcrystalline Cellulose, lecithin, carboxymethyl starch sodium；
4th step tabletting, film-making pressure 60N.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201510674766.2A CN105982874A (en) | 2015-10-19 | 2015-10-19 | Pitavastatin calcium composition |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201510674766.2A CN105982874A (en) | 2015-10-19 | 2015-10-19 | Pitavastatin calcium composition |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN105982874A true CN105982874A (en) | 2016-10-05 |
Family
ID=57039962
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201510674766.2A Pending CN105982874A (en) | 2015-10-19 | 2015-10-19 | Pitavastatin calcium composition |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN105982874A (en) |
Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4374082A (en) * | 1981-08-18 | 1983-02-15 | Richard Hochschild | Method for making a pharmaceutical and/or nutritional dosage form |
| CN1698609A (en) * | 2005-04-29 | 2005-11-23 | 邢为藩 | Pitavastatin soluble tablet composition and preparation method thereof |
| CN1969849A (en) * | 2005-11-24 | 2007-05-30 | 上海药明康德新药开发有限公司 | Stable pharmaceutical composition containing pitavastatin calcium and preparation process thereof |
| CN104644586A (en) * | 2015-03-20 | 2015-05-27 | 王雪雁 | Medicinal composition for treating cardiovascular disease |
-
2015
- 2015-10-19 CN CN201510674766.2A patent/CN105982874A/en active Pending
Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4374082A (en) * | 1981-08-18 | 1983-02-15 | Richard Hochschild | Method for making a pharmaceutical and/or nutritional dosage form |
| CN1698609A (en) * | 2005-04-29 | 2005-11-23 | 邢为藩 | Pitavastatin soluble tablet composition and preparation method thereof |
| CN1969849A (en) * | 2005-11-24 | 2007-05-30 | 上海药明康德新药开发有限公司 | Stable pharmaceutical composition containing pitavastatin calcium and preparation process thereof |
| CN104644586A (en) * | 2015-03-20 | 2015-05-27 | 王雪雁 | Medicinal composition for treating cardiovascular disease |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| C06 | Publication | ||
| PB01 | Publication | ||
| SE01 | Entry into force of request for substantive examination | ||
| SE01 | Entry into force of request for substantive examination | ||
| RJ01 | Rejection of invention patent application after publication |
Application publication date: 20161005 |
|
| RJ01 | Rejection of invention patent application after publication |