JP2000256215A - Lubricant and solid preparation using the same - Google Patents
Lubricant and solid preparation using the sameInfo
- Publication number
- JP2000256215A JP2000256215A JP11061024A JP6102499A JP2000256215A JP 2000256215 A JP2000256215 A JP 2000256215A JP 11061024 A JP11061024 A JP 11061024A JP 6102499 A JP6102499 A JP 6102499A JP 2000256215 A JP2000256215 A JP 2000256215A
- Authority
- JP
- Japan
- Prior art keywords
- particle size
- fatty acid
- metal salt
- acid metal
- lubricant
- 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.)
- Granted
Links
Landscapes
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
Description
【０００１】[0001]
【発明の属する技術分野】本発明は、滑沢剤およびそれ
を用いた固形製剤に関するものであり、詳しくは微細で
かつ粒径分布が狭い脂肪酸金属塩微粒子である滑沢剤お
よびそれを用いて薬物を圧縮成型した固形製剤に関する
ものである。BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a lubricant and a solid preparation using the same, and more particularly, to a lubricant which is fine particles of a metal salt of a fatty acid which is fine and has a narrow particle size distribution. The present invention relates to a solid preparation obtained by compression-molding a drug.
【０００２】[0002]
【従来の技術】固形製剤は、賦形剤、結合剤、崩壊剤、
界面活性剤、滑沢剤、流動性促進剤、矯味剤、着色剤、
香料等の各種添加剤とともに薬物を圧縮成型することに
より得られ、滑沢剤は固形製剤を圧縮する際、重量偏差
を少なくし、かつ固形製剤の表面を美しくする目的で添
加される。現在滑沢剤には、脂肪酸金属塩が汎用されて
いるが、従来より用いられている脂肪酸金属塩は、平均
粒径が、７μｍより大きく、かつ１０μｍ以上の粒径を
有する脂肪酸金属塩の全体に対する含有量が２０重量％
よりも大きいものである。このような脂肪酸金属塩を滑
沢剤に用いて圧縮成型した固形製剤では、薬物含有量の
均一性が低下することがあり、それに伴い薬物の溶出速
度や崩壊性が変動する場合がある。特に少量で強い作用
を示す薬物を用いる固形製剤では、その薬物含有量の変
動をいかに小さくするかが、製造上の重要な課題であ
る。2. Description of the Related Art Solid preparations include excipients, binders, disintegrants,
Surfactants, lubricants, fluidity promoters, flavoring agents, coloring agents,
It is obtained by compression-molding a drug together with various additives such as fragrances, and a lubricant is added for compressing a solid preparation to reduce the weight deviation and to make the surface of the solid preparation beautiful. At present, fatty acid metal salts are widely used as lubricants, but fatty acid metal salts conventionally used have an average particle size of more than 7 μm and a total of fatty acid metal salts having a particle size of 10 μm or more. 20% by weight
Is larger than In a solid preparation obtained by compression-molding using such a fatty acid metal salt as a lubricant, the uniformity of the drug content may be reduced, and the dissolution rate or disintegration of the drug may fluctuate accordingly. In particular, in a solid preparation using a drug having a strong action even in a small amount, how to reduce the fluctuation of the drug content is an important issue in production.
【０００３】[0003]
【発明が解決しようとする課題】本発明の目的は、固形
製剤間の薬物含有量の均一性が著しく改善できる滑沢剤
およびそれを用いた固形製剤を提供することである。SUMMARY OF THE INVENTION An object of the present invention is to provide a lubricant capable of significantly improving the uniformity of the drug content between solid preparations and a solid preparation using the same.
【０００４】[0004]
【課題を解決するための手段】本発明者らは、特定の粒
径および粒度分布を有する脂肪酸金属塩微粒子からなる
滑沢剤を用いれば、上記の目的が達成されることを見出
し、この発明を完成した。すなわち、本発明は、平均粒
径４μｍ以下であり、かつ粒径が１０μｍよりも大きな
粒子の全体に対する含有量が４重量％以下である脂肪酸
金属塩微粒子からなる滑沢剤およびそれを用いた固形製
剤である。Means for Solving the Problems The present inventors have found that the above object can be achieved by using a lubricant comprising fatty acid metal salt fine particles having a specific particle size and particle size distribution. Was completed. That is, the present invention relates to a lubricant comprising fatty acid metal salt fine particles having an average particle size of 4 μm or less and a total content of particles having a particle size of more than 10 μm of 4% by weight or less, and a solid using the same. It is a preparation.
【０００５】[0005]
【発明の実施の形態】本発明の滑沢剤に用いる脂肪酸金
属塩は、脂肪酸の多価金属塩であり、脂肪酸としては、
例えばラウリン酸、ミリスチン酸、パルミチン酸、ステ
アリン酸、べヘニン酸等が挙げられ、好ましくはステア
リン酸である。多価金属原子としてはマグネシウム、亜
鉛、アルミニウム、鉄等が挙げられ、好ましくはマグネ
シウムおよびカルシウムである。これらの１種または２
種以上を用いることができる。BEST MODE FOR CARRYING OUT THE INVENTION The fatty acid metal salt used in the lubricant of the present invention is a polyvalent metal salt of a fatty acid.
For example, lauric acid, myristic acid, palmitic acid, stearic acid, behenic acid and the like can be mentioned, and preferred is stearic acid. Examples of the polyvalent metal atom include magnesium, zinc, aluminum, iron and the like, and preferably magnesium and calcium. One or two of these
More than one species can be used.
【０００６】脂肪酸金属塩微粒子は、平均粒径が４μｍ
以下であり、かつ粒径が１０μｍよりも大きな粒子の全
体に対する含有量が４重量％以下である。好ましくは平
均粒径が３．５μｍ以下であるか、１０μｍよりも大き
な粒子の全体に対する含有量が３．５重量％以下であ
る。平均粒径が４μｍより大きいか、もしくは粒径が１
０μｍよりも大きな粒子の全体に対する含有量が４重量
％を超えると、固形製剤間の薬物含有量の均一性の低下
および固形製剤中の脂肪酸金属塩の偏在などの原因とな
る。脂肪酸金属塩微粒子の粒径の測定方法としては、例
えば、顕微鏡法、光走査法、レーザー回折散乱法などが
挙げられる。その中でも、本発明においては、より微細
な粒子に対して精度よく測定可能である光走査法、レー
ザー回折散乱法などが好適に使用される。The fatty acid metal salt fine particles have an average particle size of 4 μm.
Or less, and the content of the particles having a particle size larger than 10 μm to the whole is 4% by weight or less. Preferably, the average particle size is 3.5 μm or less, or the content of the particles larger than 10 μm to the whole is 3.5% by weight or less. Average particle size is larger than 4 μm or particle size is 1
If the content of the particles larger than 0 μm with respect to the whole exceeds 4% by weight, the uniformity of the drug content among the solid preparations is reduced, and the fatty acid metal salt is unevenly distributed in the solid preparations. Examples of the method for measuring the particle size of the fatty acid metal salt fine particles include a microscopic method, an optical scanning method, and a laser diffraction scattering method. Among them, in the present invention, an optical scanning method, a laser diffraction scattering method, and the like, which can accurately measure finer particles, are preferably used.
【０００７】本発明の滑沢剤に用いる脂肪酸金属塩微粒
子は、３０％粒径ＲAと７０％粒径ＲCとの差ＲC−ＲAが
３μｍ以下または５０％粒径ＲBと９５％粒径ＲDとの差
ＲD−ＲBが６μｍ以下であるものが好ましい。ここで３
０％粒径ＲAとは、脂肪酸金属塩微粒子の全重量に対す
る３０％がその粒径以下であることを示し、下記のよう
に定義される。すなわち、図１は、本発明で用いるステ
アリン酸カルシウム塩微粒子の粒度分布および粒度累積
曲線の一例を示すグラフであり、この粒度累積曲線にお
いて、累積３０％（重量基準）での粒径（μｍ）を、３
０％粒径ＲAと定義する。５０％粒径ＲB、７０％粒径Ｒ
C、９５％粒径ＲDも、上記３０％粒径ＲAと同様に定義
される。図１の場合、３０％粒径ＲA、５０％粒径ＲB、
７０％粒径ＲC、９５％粒径ＲDはそれぞれ、１．１μ
ｍ、１．７μｍ、２．５μｍおよび４．６μｍである。
したがって、ＲC−ＲAおよびＲD−ＲBはそれぞれ１．４
μｍおよび２．９μｍとなる。ＲC−ＲAおよびＲD−ＲB
のそれぞれの値が低いほど、脂肪酸金属塩微粒子の粒度
分布の範囲が狭いことを意味する。The fatty acid metal salt fine particles used in the lubricant of the present invention have a difference R C -R A between 30% particle size R A and 70% particle size R C of 3 μm or less or 50% particle size R B and 95%. % particle diameter as the difference R D -R B and R D is 6μm or less. Where 3
The 0% particle size RA indicates that 30% of the total weight of the fatty acid metal salt fine particles is not more than the particle size, and is defined as follows. That is, FIG. 1 is a graph showing an example of the particle size distribution and the particle size cumulative curve of the calcium stearate fine particles used in the present invention. In this particle size cumulative curve, the particle size (μm) at a cumulative 30% (weight basis) is shown. , 3
Defined as 0% particle size RA . 50% particle size R B , 70% particle size R
C and the 95% particle size RD are also defined in the same manner as the 30% particle size RA . For Figure 1, 30% particle size R A, 50% particle diameter R B,
The 70% particle size R C and the 95% particle size R D are each 1.1 μm.
m, 1.7 μm, 2.5 μm and 4.6 μm.
Accordingly, R C -R A and R D -R B, respectively 1.4
μm and 2.9 μm. R C -R A and R D -R B
It means that the lower the value of each is, the narrower the range of the particle size distribution of the fatty acid metal salt fine particles is.
【０００８】上記、ＲC−ＲAが３μｍを超えたり、ＲD
−ＲBが６μｍを超える脂肪酸金属塩は、粒径分布が広
く、かつ大粒径の粒子が多くなるため、それを用いて圧
縮成型して得られる固形製剤の薬物含有量均一性が低下
する可能性がある。したがって、このＲC−ＲAおよびＲ
D−ＲBは、それぞれ３μｍ以下および６μｍ以下である
ことが好ましい。[0008] When R C -R A exceeds 3 μm or R D
Fatty acid metal salts -R B exceeds 6μm has a wide particle size distribution, and since the particles of the large particle size increases, drug content uniformity of the solid preparation obtained by compression molding is lowered therewith there is a possibility. Therefore, this R C -R A and R
D -R B is preferably respectively at 3μm or less and 6μm or less.
【０００９】[0009]
【発明の効果】本発明の滑沢剤は、それを用いて圧縮成
型して得られる固形製剤の薬物含有量の均一性が顕著に
改善される。EFFECT OF THE INVENTION The lubricant of the present invention significantly improves the uniformity of the drug content of a solid preparation obtained by compression molding using the lubricant.
【００１０】[0010]
【実施例】本発明で用いるステアリン酸カルシウム塩微
粒子の粒度分布と累積を表１および図１に示す。EXAMPLES Table 1 and FIG. 1 show the particle size distribution and accumulation of calcium stearate fine particles used in the present invention.
【００１１】[0011]
【表１】 [Table 1]
【００１２】表１および図１より、本発明で用いるステ
アリン酸カルシウム塩微粒子の３０％粒径ＲA、５０％
粒径ＲB、７０％粒径ＲC、９５％粒径ＲDは、それぞれ
１．１μｍ、１．７μｍ、２．５μｍ、４．６μｍであ
り、ＲC−ＲAは１．４μｍ、Ｒ D−ＲBは２．９μｍとな
り、平均粒径は１．９５μｍであった。次に、ステアリ
ン酸カルシウム塩従来品の粒度分布と累積を表２および
図２に示す。From Table 1 and FIG. 1, the steps used in the present invention are shown.
30% particle size R of calcium arsenate fine particlesA, 50%
Particle size RB, 70% particle size RC, 95% particle size RDRespectively
1.1 μm, 1.7 μm, 2.5 μm, 4.6 μm
RC-RAIs 1.4 μm, R D-RBIs 2.9 μm
The average particle size was 1.95 μm. Next, Steari
Table 2 shows the particle size distribution and accumulation of the conventional calcium acid salt.
As shown in FIG.
【００１３】[0013]
【表２】 [Table 2]
【００１４】表２および図２より、ステアリン酸カルシ
ウム塩従来品における３０％粒径Ｒ A、５０％粒径ＲB、
７０％粒径ＲC、９５％粒径ＲDは、それぞれ３．２μ
ｍ、３．５μｍ、８．２μｍ、２２．１μｍであり、Ｒ
C−ＲAは５．０μｍ、ＲD−ＲBは１８．６μｍとなり、
平均粒径は７．１μｍであった。According to Table 2 and FIG.
30% particle size R in conventional um salt A, 50% particle size RB,
70% particle size RC, 95% particle size RDAre 3.2 μ each
m, 3.5 μm, 8.2 μm, 22.1 μm, R
C-RAIs 5.0 μm, RD-RBIs 18.6 μm,
The average particle size was 7.1 μm.
【００１５】実施例１ 本発明のステアリン酸カルシウム塩微粒子を滑沢剤とし
て用い、下記の処方に従って〜を均一に混合し、打
錠機にて圧縮成型して、一錠２００ｍｇの固形製剤を得
た。 これら固形製剤の成型される順に１０錠の群を作り、乱
数表を使用して１０錠の群より１錠を抽出して、２０錠
を採取した。これら２０錠の固形製剤の各々、１錠中に
含まれるスルピリド含有量を測定した。その結果を表３
に示す。Example 1 The calcium stearate fine particles of the present invention were used as a lubricant, and were uniformly mixed according to the following formulation, and were compression-molded with a tableting machine to obtain a solid preparation of 200 mg per tablet. . A group of 10 tablets was prepared in the order in which these solid preparations were molded. One tablet was extracted from the group of 10 tablets using a random number table, and 20 tablets were collected. The sulpiride content in one tablet of each of these 20 tablets was measured. Table 3 shows the results.
Shown in
【００１６】[0016]
【表３】 [Table 3]
【００１７】表３から、本発明のステアリン酸カルシウ
ム塩微粒子を滑沢剤として用いた固形製剤中のスルピリ
ドの平均含有量は２０．３７ｍｇ、含有量の分散度およ
び相対標準偏差はそれぞれ０．５１および３．５０％で
あった。From Table 3, it can be seen that the average content of sulpiride in a solid preparation using the calcium stearate microparticles of the present invention as a lubricant was 20.37 mg, the degree of dispersion of the content and the relative standard deviation were 0.51 and 0.5, respectively. It was 3.50%.
【００１８】比較例１ 平均粒径が７．１１μｍであり、かつ１０μｍ以上の粒
径を有するものの含有量が全体の３３重量％であるステ
アリン酸カルシウム塩従来品を滑沢剤として用い、実施
例１と同様にして、得られる固形製剤中のスルピリド含
有量を測定した。結果を表４に示す。Comparative Example 1 A conventional calcium stearate salt having an average particle size of 7.11 μm and having a particle size of 10 μm or more and having a content of 33% by weight was used as a lubricant. The sulpiride content in the obtained solid preparation was measured in the same manner as in. Table 4 shows the results.
【００１９】[0019]
【表４】 [Table 4]
【００２０】表４より、ステアリン酸カルシウム塩従来
品を滑沢剤として用いた固形製剤中のスルピリドの平均
含有量は１９．３２ｍｇ、含有量の分散度および相対標
準偏差は、それぞれ１．２２および５．７２％であっ
た。本発明の滑沢剤であるステアリン酸カルシウム塩微
粒子は分散度０．５１と薬物含有量の変動が小さく、均
一である。一方、本発明の範囲外であるステアリン酸カ
ルシウム塩従来品を用いた比較例は、分散度１．２２と
本発明品に比べ薬物含有量の変動が大きく均一性に劣っ
ている。From Table 4, it can be seen that the average content of sulpiride in a solid preparation using a conventional calcium stearate salt as a lubricant was 19.32 mg, the degree of dispersion of the content and the relative standard deviation were 1.22 and 5 respectively. 0.72%. The calcium stearate fine particles as the lubricant of the present invention have a dispersity of 0.51 and a small change in drug content, and are uniform. On the other hand, the comparative example using the calcium stearate salt, which is out of the range of the present invention, has a dispersion degree of 1.22 and a large variation in the drug content as compared with the product of the present invention, resulting in poor uniformity.
【図１】 実施例１で使用したステアリン酸カルシウム
塩微粒子の粒度分布と粒度累積を示す。1 shows the particle size distribution and the particle size accumulation of calcium stearate fine particles used in Example 1. FIG.
【図２】 比較例１で使用したステアリン酸カルシウム
塩従来品の粒度分布と粒度累積を示す。FIG. 2 shows the particle size distribution and the particle size accumulation of a conventional calcium stearate used in Comparative Example 1.
Claims (4)
が１０μｍよりも大きい粒子の脂肪酸金属塩微粒子全体
に対する含有量が４重量％以下である脂肪酸金属塩微粒
子を用いることを特徴とする滑沢剤。1. Use is made of fatty acid metal salt fine particles having an average particle size of 4 μm or less and a content of particles having a particle size of more than 10 μm with respect to the entire fatty acid metal salt fine particles of 4% by weight or less. lubricant.
と７０％粒径Ｒcとの差（Ｒc−ＲA）が３μｍ以下であ
る請求項１記載の滑沢剤。2. The method according to claim 1, wherein the fatty acid metal salt fine particles have a 30% particle size R A.
When lubricant according to claim 1, wherein the difference between the 70% particle diameter R c (R c -R A) is 3μm or less.
と９５％粒径ＲDとの差（ＲD−ＲB）が６μｍ以下であ
る請求項１記載の滑沢剤。3. The method according to claim 1, wherein the fatty acid metal salt fine particles have a 50% particle size R B.
When the difference between the 95% particle diameter R D (R D -R B) is a lubricant according to claim 1 is 6μm or less.
を滑沢剤に用いて薬物を圧縮成型した固形製剤。4. A solid preparation obtained by compression-molding a drug using the fatty acid metal salt fine particles according to claim 1 as a lubricant.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP06102499A JP4538858B2 (en) | 1999-03-09 | 1999-03-09 | Lubricant and solid preparation using the same |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP06102499A JP4538858B2 (en) | 1999-03-09 | 1999-03-09 | Lubricant and solid preparation using the same |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| JP2000256215A true JP2000256215A (en) | 2000-09-19 |
| JP4538858B2 JP4538858B2 (en) | 2010-09-08 |
Family
ID=13159334
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP06102499A Expired - Lifetime JP4538858B2 (en) | 1999-03-09 | 1999-03-09 | Lubricant and solid preparation using the same |
Country Status (1)
| Country | Link |
|---|---|
| JP (1) | JP4538858B2 (en) |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP2007502303A (en) * | 2003-08-13 | 2007-02-08 | バイオコン・リミテッド | Microparticulate fatty acid salt solid formulation for therapeutics |
Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JPH10139688A (en) * | 1996-11-05 | 1998-05-26 | Dai Ichi Kogyo Seiyaku Co Ltd | Lubricant for tablet and tableted cake |
-
1999
- 1999-03-09 JP JP06102499A patent/JP4538858B2/en not_active Expired - Lifetime
Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JPH10139688A (en) * | 1996-11-05 | 1998-05-26 | Dai Ichi Kogyo Seiyaku Co Ltd | Lubricant for tablet and tableted cake |
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|---|
| JPN6009043652, ＬＥＩＮＯＮＥＮ，Ｕ．Ｉ． ｅｔ ａｌ, "Ｐｈｙｓｉｃａｌ ａｎｄ ｌｕｂｒｉｃａｔｉｏｎ ｐｒｏｐｅｒｔｉｅｓ ｏｆ ｍａｇｎｅｓｉｕｍ ｓｔｅａｒａｔｅ", Ｊ Ｐｈａｒｍ Ｓｃｉ, 1992, Ｖｏｌ．８１， Ｎｏ．１２, ｐ．１１９４−１１９８ * |
| JPN6009043653, ＢＡＲＲＡ， Ｊ． ｅｔ ａｌ．, "Ｉｎｆｌｕｅｎｃｅ ｏｆ ｔｈｅ Ｐｈｙｓｉｃｏｃｈｅｍｉｃａｌ Ｖａｒｉａｂｉｌｉｔｙ ｏｆ Ｍａｇｎｅｓｉｕｍ Ｓｔｅａｒａｔｅ ｏｎ Ｉｔｓ Ｌｕｂｒｉｃａｎｔ Ｐｒｏｐｅｒｔｉｅｓ： Ｐｏｓｓ", Ｄｒｕｇ Ｄｅｖ Ｉｎｄ Ｐｈａｒｍ, 1996, Ｖｏｌ．２２， Ｎｏ．１１, ｐ．１１０５−１１２０ * |
| JPN6009043654, ＤＡＮＳＥＲＥＡＵ，Ｒ． ｅｔ ａｌ．, "Ｔｈｅ ｅｆｆｅｃｔ ｏｆ ｔｈｅ ｖａｒｉａｂｉｌｉｔｙ ｉｎ ｔｈｅ ｐｈｙｓｉｃａｌ ａｎｄ ｃｈｅｍｉｃａｌ ｐｒｏｐｅｒｔｉｅｓ ｏｆ ｍａｇｎｅｓｉｕｍ ｓｔｅａｒａｔｅ ｏｎ ｔｈｅ ｐ", Ｄｒｕｇ Ｄｅｖ Ｉｎｄ Ｐｈａｒｍ, 1987, Ｖｏｌ．１３， Ｎｏ．６, ｐ．９７５−９９９ * |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP2007502303A (en) * | 2003-08-13 | 2007-02-08 | バイオコン・リミテッド | Microparticulate fatty acid salt solid formulation for therapeutics |
| JP4880461B2 (en) * | 2003-08-13 | 2012-02-22 | バイオコン・リミテッド | Microparticulate fatty acid salt solid formulation for therapeutics |
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|---|---|
| JP4538858B2 (en) | 2010-09-08 |
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