JP3845149B2 - Agar for tablets and method for producing tablets - Google Patents
Agar for tablets and method for producing tablets Download PDFInfo
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- JP3845149B2 JP3845149B2 JP20855396A JP20855396A JP3845149B2 JP 3845149 B2 JP3845149 B2 JP 3845149B2 JP 20855396 A JP20855396 A JP 20855396A JP 20855396 A JP20855396 A JP 20855396A JP 3845149 B2 JP3845149 B2 JP 3845149B2
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Description
【０００１】
【発明の属する技術分野】
この発明は、薬品と混合して一定形状の錠剤を作るための基剤または補助剤となる寒天の製造方法、及びその方法により作られる寒天を用いた錠剤の製造方法に関する。
【０００２】
【従来の技術】
錠剤は、薬品を一定の形状に成型したものであり、薬品をそのまま、または多くの場合他の添加剤を混合して成型される。錠剤は、その製造方法によって、薬品その他の混合物を軟塊として単に型に入れて乾燥させる湿製錠剤と、上記混合物を圧縮成型する圧縮錠剤とに分けられる。圧縮錠剤は更に、原料薬品を直接圧縮するもの（直接法）と、原料薬品を直接打錠せず一旦顆粒を作ってこれを圧縮するもの（間接法）とがある。
【０００３】
従来より、錠剤用基剤として種々のものが用いられているが、固形寒天や寒天粉末もその一つである。寒天は、錠剤用基剤として用いられる他、主薬が少ない場合に重量や大きさを稼ぐための賦形剤、粉末の結合を強化するための結合剤、水中や胃液中での崩壊を速めるための崩壊剤等の補助剤としても用いられている。
【０００４】
錠剤は、一定の錠剤強度を有すると同時に、崩壊性に優れていることが要求される。特に圧縮錠剤の場合、一般に湿製錠剤に比べて、錠剤強度が強いが崩壊が悪いという性質を有するため、崩壊性に優れたものとするべく、結晶セルロースや合成ケイ酸塩等を添加することが行われる。
【０００５】
【発明が解決しようとする課題】
錠剤用基剤としては、成型したときに十分な錠剤強度が得られると同時に、優れた崩壊性も得られるという性質を併せ持つことが望ましい。この様な性質を併せ持つ基剤であれば、他に結合剤や崩壊剤といった多くの補助剤を組み合わせることなく、錠剤を作ることができるからである。従来の寒天は、この観点からすると、崩壊用基剤として利用可能ではあるが、崩壊性、特に崩壊速度においてまだ十分な機能を持つとはいえなかった。
【０００６】
この発明は、優れた崩壊性を示す錠剤を得ることを可能とした錠剤用基剤または補助剤としての寒天の製造方法を提供することを目的とする。
この発明はまた、寒天を錠剤用基剤または補助剤とした優れた崩壊性を示す錠剤の製造方法を提供することを目的とする。
【０００７】
【課題を解決するための手段】
この発明は、第１に、薬品と混合して一定形状の錠剤を作るための錠剤用基剤または補助剤としての寒天の製造方法であって、固形または粉末の寒天を加水して吸水膨潤させる工程と、この工程で吸水膨潤させた寒天を再度脱水乾燥させる工程とを備えたことを特徴としている。
この発明は、第２に、薬品と混合して一定形状の錠剤を作るための錠剤用基剤または補助剤としての寒天の製造方法であって、海藻から抽出，濾過工程を経て得られ、あるいは固形または粉末の寒天を加水し加熱溶解して得られた寒天ゾルを冷却して寒天ゲルを形成する工程と、この工程で得られた寒天ゲルを凍結乾燥した後粉砕する工程とを備えたことを特徴としている。
この発明は、第３に、薬品と混合して一定形状の錠剤を作るための錠剤用基剤または補助剤としての寒天の製造方法であって、海藻から抽出，濾過工程を経て得られ、あるいは固形または粉末の寒天を加水し加熱溶解して得られた寒天ゾルを冷却して寒天ゲルを形成する工程と、この工程で得られた寒天ゲルを微粒子化する工程と、この工程で微粒子化された寒天ゲルを凍結乾燥した後粉砕する工程とを備えたことを特徴としている。
【０００８】
この発明はまた、錠剤の製造方法であって、上記第１〜第３のいずれかの方法で得られた錠剤用寒天を錠剤用基剤または補助剤として薬品と混合して錠剤を成型することを特徴としている。
この発明は更に、固形または粉末の寒天を錠剤用基剤または補助剤とする錠剤の製造方法であって、固形または粉末の寒天の他に賦形剤，結合剤，崩壊剤，滑沢剤の少なくとも一種を加えた一次原料を加水して吸水膨潤させる工程と、この工程で吸水膨潤させた一次原料を再度脱水乾燥させて固形または粉末の二次原料を得る工程と、この工程で得られた二次原料を薬品と混合して錠剤を成型する工程とを備えたことを特徴としている。
【０００９】
この発明により処理した寒天を用いた錠剤の崩壊性が向上する理由は、次の通りである。
通常の粉末寒天は、圧搾法または冷凍法により脱水した寒天を乾燥した後、粉砕機により物理的に粉砕して粉末化しているが、粉末化しても各粒子は寒天の硬い層になっているものと思われる。
これに対して、この発明の第１の方法では、寒天粒子を吸水膨潤させることによって粒子を軟質化し、この状態で脱水乾燥して粉砕することによって、得られる錠剤用寒天の粒子には微細な空隙が作られる。この場合脱水乾燥の方法には、熱風乾燥、凍結乾燥（フリーズドライ）、真空乾燥等が用いられる。熱風乾燥の場合、寒天粒子表面が熱により一部溶融して皮膜が形成され、この皮膜形成は打錠による結合性を若干低下させるものの、この第１の方法によると、寒天粒子の微細な空隙が吸水性を高め、従って得られる寒天を用いた錠剤は崩壊速度が速いものとなる。
【００１０】
また、第２の方法で吸水膨潤させることなくゲル化した寒天を凍結乾燥して粉砕すると、空隙の多いポーラス構造の寒天粒子が得られる。更に第３の方法でゲル化した寒天を微粒子化して凍結乾燥すると、より均質でかつポーラスな寒天粒子構造が得られる。これらの方法で得られる粉末化した錠剤用寒天は、錠剤を成型したときに、各粒子のポーラス性の結果として優れた崩壊性を示すのみならず、錠剤強度も大きいものとなる。
またこの発明によると、固形または粉末の寒天の他に賦形剤，結合剤，崩壊剤，滑沢剤の少なくとも一種を加えた一次原料を加水して吸水膨潤させ、これを脱水乾燥させて固形または粉末の二次原料を得て、この二次原料を薬品と混合して錠剤を成型することにより、優れた崩壊性を示す錠剤が得られる。
特にこの発明により得られる錠剤用寒天を錠剤用基剤として用いたとき、他に崩壊剤を添加しなくても、優れた崩壊性を示すという利点が得られる。
【００１１】
【発明の実施の形態】
以下、この発明の実施例を説明する。
一次原料としての粉末寒天１００部に水１００部を混練して、寒天を吸水膨潤させた後、熱風乾燥させた。乾燥させた寒天を粉砕して二次原料としての粉末寒天とした（試料１）。
一次原料としての粉末寒天１００部に水１００部を混練して、寒天を吸水膨潤させた後、凍結乾燥させた。乾燥させた寒天を粉砕して二次原料としての粉末寒天とした（試料２）。
一次原料としての粉末寒天５部を水１００部に加熱溶解した寒天ゾルを冷却凝固させて寒天ゲルを作り、これを凍結乾燥し粉砕して二次原料としての粉末寒天とした（試料３）。
一次原料としての粉末寒天５部を水１００部に加熱溶解した寒天ゾルを冷却凝固させた寒天ゲルを作り、この寒天ゲルをホモジナイザー（高圧式：マントンゴーリー社製）により微粒子化した後、凍結乾燥し粉砕して二次原料としての粉末寒天とした（試料４）。
【００１２】
上述の方法で得られた二次原料としての粉末寒天を基剤として、薬品や他の補助剤を加えることなく圧縮成型して、碁石型の疑似錠剤（φ１２−１６Ｒ）を作った。比較例として、一次原料を基剤として同様の条件で圧縮成型した疑似錠剤を作り、両者の特性比較試験を行った。その比較試験データを下表にまとめた。崩壊時間は、疑似錠剤を水に漬けたときの崩壊までの時間である。
【００１３】
【表１】
表１から明らかなように、一次原料の粉末寒天を用いた疑似錠剤の崩壊時間に比べて、一次原料に一定の処理を加えた二次原料である試料１〜４の寒天粉末を用いた疑似錠剤の崩壊時間は大きく短縮されている。また、試料３，４を用いたものは、一次原料を用いたものに比べて崩壊時間が短いだけでなく、硬度も大きくなっている。
【００１５】
また固形または粉末の寒天の他に賦形剤，結合剤，崩壊剤，滑沢剤の少なくとも一種を加えて一次原料とし、これを加水して吸水膨潤させ、脱水乾燥させて固形または粉末の二次原料を得て、この二次原料により疑似錠剤を成型することにより、崩壊性に優れた錠剤特性が得られることも確認された。
【００１６】
【発明の効果】
以上述べたようにこの発明によれば、（１）固形または粉末の寒天を加水して吸水膨潤させ、これを脱水乾燥させる、（２）寒天を加水し加熱溶解して得られた寒天ゾルを冷却して寒天ゲルを形成し、これを凍結乾燥した後粉砕する、（３）寒天を加水し加熱溶解して得られた寒天ゾルを冷却して寒天ゲルを形成し、これを微粒子化した後凍結乾燥して粉砕する、といった方法により優れた崩壊性を示す錠剤用寒天を得ることができる。[0001]
BACKGROUND OF THE INVENTION
The present invention relates to a method for producing agar as a base or an auxiliary agent for making a tablet having a fixed shape by mixing with a medicine, and a method for producing a tablet using agar produced by the method.
[0002]
[Prior art]
A tablet is formed by molding a medicine into a certain shape, and is formed by mixing the medicine as it is or in many cases with other additives. Tablets can be divided into wet tablets that are simply put into a mold as a soft mass and dried, and compressed tablets that compress the mixture, depending on the manufacturing method. Compressed tablets are further classified into those in which the raw chemical is directly compressed (direct method), and those in which the raw chemical is not compressed directly but granulated and then compressed (indirect method).
[0003]
Conventionally, various bases for tablets have been used, and solid agar and agar powder are one of them. Agar is used as a base for tablets, excipients to gain weight and size when there are few active ingredients, binders to strengthen the binding of powders, to accelerate disintegration in water and gastric juice It is also used as an adjuvant such as a disintegrant.
[0004]
Tablets are required to have a certain tablet strength and at the same time have excellent disintegration properties. In particular, in the case of compressed tablets, it has the property that tablet strength is strong but disintegration is poor compared to wet tablets, so to add crystalline cellulose, synthetic silicate, etc. to have excellent disintegration Is done.
[0005]
[Problems to be solved by the invention]
As a tablet base, it is desirable to have a property that, when molded, sufficient tablet strength can be obtained, and at the same time, excellent disintegration can be obtained. This is because a base having such properties can produce a tablet without combining many other adjuvants such as a binder and a disintegrant. From this point of view, conventional agar can be used as a base for disintegration, but it has not yet been able to function sufficiently in disintegration, particularly disintegration speed.
[0006]
An object of the present invention is to provide a method for producing agar as a tablet base or an auxiliary agent, which makes it possible to obtain tablets exhibiting excellent disintegration properties.
Another object of the present invention is to provide a method for producing a tablet exhibiting excellent disintegration using agar as a tablet base or adjuvant.
[0007]
[Means for Solving the Problems]
This invention is firstly a method for producing agar as a tablet base or auxiliary agent for mixing with a drug to form a tablet having a fixed shape, and swells solid or powdered agar to absorb water and swell. And a step of dehydrating and drying again the agar swollen by absorbing water in this step.
Secondly, the present invention is a method for producing agar as a tablet base or auxiliary agent for mixing with a drug to form a tablet having a fixed shape, which is obtained from a seaweed through an extraction and filtration process, or It was provided with a step of forming an agar gel by cooling an agar sol obtained by heating and dissolving solid or powdered agar, and a step of freeze-drying and then pulverizing the agar gel obtained in this step It is characterized by.
Thirdly, the present invention is a method for producing agar as a tablet base or an auxiliary agent for mixing with a drug to form a tablet having a fixed shape, which is obtained from a seaweed through an extraction and filtration process, or A process of forming an agar gel by cooling an agar sol obtained by adding solid or powdered agar to heat and dissolving it, a process of forming an agar gel obtained in this process, and a process of forming microparticles in this process And a step of pulverizing the agar gel after freeze-drying.
[0008]
The present invention is also a method for producing a tablet, wherein the tablet agar obtained by any one of the first to third methods is mixed with a medicine as a tablet base or an auxiliary agent to form a tablet. It is characterized by.
The present invention further relates to a method for producing a tablet using a solid or powder agar as a tablet base or an auxiliary agent, wherein the excipient, binder, disintegrant, lubricant is used in addition to the solid or powder agar. A step of hydrating the primary raw material to which at least one kind has been added to absorb water and swelling, a step of dehydrating and drying the primary raw material swollen by absorbing water in this step again to obtain a solid or powdery secondary raw material, and And a step of molding a tablet by mixing a secondary raw material with a chemical.
[0009]
The reason why the disintegration property of the tablet using the agar treated according to the present invention is improved is as follows.
Ordinary powdered agar is dried by pressing or freezing agar and then physically pulverized by a pulverizer. Even if powdered, each particle is a hard layer of agar. It seems to be.
On the other hand, in the first method of the present invention, the agar particles are softened by water absorption and swelling, and dehydrated, dried and pulverized in this state, the resulting agar particles for tablets are fine. A void is created. In this case, hot air drying, freeze drying (freeze drying), vacuum drying, or the like is used as the dehydration drying method. In the case of hot air drying, a part of the surface of the agar particles is melted by heat to form a film, and this film formation slightly reduces the binding property by tableting. However, the tablet using agar obtained has a high disintegration rate.
[0010]
In addition, when agar that has been gelled without swelled by water absorption by the second method is freeze-dried and pulverized, agar particles having a porous structure with many voids can be obtained. Further, when the agar gelled by the third method is microparticulated and freeze-dried, a more homogeneous and porous agar particle structure can be obtained. The powdered agar for tablets obtained by these methods not only exhibits an excellent disintegration property as a result of the porous property of each particle, but also has a high tablet strength.
According to the present invention, the primary raw material to which at least one of an excipient, a binder, a disintegrant, and a lubricant is added in addition to solid or powdered agar is added to swell and absorb water, which is dehydrated and dried to form a solid. Alternatively, by obtaining a powdery secondary material and mixing the secondary material with a chemical to form a tablet, a tablet exhibiting excellent disintegration can be obtained.
In particular, when the agar for tablets obtained according to the present invention is used as a tablet base, the advantage of exhibiting excellent disintegration can be obtained without adding any other disintegrant.
[0011]
DETAILED DESCRIPTION OF THE INVENTION
Examples of the present invention will be described below.
100 parts of water was kneaded with 100 parts of powder agar as a primary raw material, and the agar was swollen with water and then dried with hot air. The dried agar was pulverized into powder agar as a secondary material (Sample 1).
100 parts of water was kneaded with 100 parts of powder agar as a primary raw material to absorb and swell the agar, and then freeze-dried. The dried agar was pulverized into powder agar as a secondary material (Sample 2).
An agar sol prepared by heating and dissolving 5 parts of powder agar as a primary material in 100 parts of water was cooled and solidified to form an agar gel, which was freeze-dried and pulverized to obtain powder agar as a secondary material (sample 3).
An agar gel was prepared by cooling and solidifying an agar sol in which 5 parts of powder agar as a primary raw material was dissolved in 100 parts of water. Then, it was pulverized to obtain powder agar as a secondary material (Sample 4).
[0012]
Using the powder agar as the secondary raw material obtained by the above-mentioned method as a base, compression molding was performed without adding chemicals or other adjuvants to make a meteorite-type pseudo tablet (φ12-16R). As a comparative example, a pseudo-tablet compression-molded under the same conditions using a primary raw material as a base was prepared, and a characteristic comparison test between the two was performed. The comparative test data is summarized in the table below. The disintegration time is the time until disintegration when the pseudo tablet is immersed in water.
[0013]
[Table 1]
As is apparent from Table 1, compared to the disintegration time of the pseudo tablet using the primary raw material powder agar, the pseudo raw material using the agar powder of Samples 1 to 4 which is a secondary raw material obtained by adding a certain treatment to the primary raw material. The disintegration time of tablets is greatly shortened. In addition, the samples using Samples 3 and 4 have not only a shorter disintegration time but also higher hardness than those using the primary raw material.
[0015]
In addition to solid or powdered agar, at least one of excipients, binders, disintegrants, and lubricants is added as a primary raw material, which is swelled by water absorption, dehydrated and dried to obtain solid or powdered agar. It was also confirmed that tablet characteristics excellent in disintegration can be obtained by obtaining a secondary raw material and molding a pseudo tablet from this secondary raw material.
[0016]
【The invention's effect】
As described above, according to the present invention, (1) a solid or powdered agar is swelled by water absorption and swelled and dehydrated and dried. (2) An agar sol obtained by adding agar to water and dissolving by heating is obtained. Cooling to form an agar gel, freeze-drying and then pulverizing. (3) After cooling the agar sol obtained by adding and heating and heating the agar to form an agar gel and making it into fine particles Agar for tablets exhibiting excellent disintegration can be obtained by a method such as freeze-drying and pulverization.
Claims (5)
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP20855396A JP3845149B2 (en) | 1996-08-07 | 1996-08-07 | Agar for tablets and method for producing tablets |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP20855396A JP3845149B2 (en) | 1996-08-07 | 1996-08-07 | Agar for tablets and method for producing tablets |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| JPH1045628A JPH1045628A (en) | 1998-02-17 |
| JP3845149B2 true JP3845149B2 (en) | 2006-11-15 |
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Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP20855396A Expired - Lifetime JP3845149B2 (en) | 1996-08-07 | 1996-08-07 | Agar for tablets and method for producing tablets |
Country Status (1)
| Country | Link |
|---|---|
| JP (1) | JP3845149B2 (en) |
Families Citing this family (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP4547161B2 (en) * | 2004-01-22 | 2010-09-22 | エスエス製薬株式会社 | Fast dissolving solid preparations |
| JP5046202B2 (en) * | 2006-10-25 | 2012-10-10 | 浜田食品工業株式会社 | Dragees and methods for producing the same |
| JP6045237B2 (en) * | 2012-07-27 | 2016-12-14 | 旭化成株式会社 | Tablet-type thickener |
| JP6045238B2 (en) * | 2012-07-27 | 2016-12-14 | 旭化成株式会社 | Tablet containing thickening polysaccharide |
| JP7371880B2 (en) * | 2019-02-20 | 2023-10-31 | 有限会社富山サプリメント | Water-soluble solid rehydration drinks and rehydration drinks |
| JP7366394B2 (en) * | 2019-06-19 | 2023-10-23 | 八幡物産株式会社 | Method for manufacturing tablets for oral intake |
-
1996
- 1996-08-07 JP JP20855396A patent/JP3845149B2/en not_active Expired - Lifetime
Also Published As
| Publication number | Publication date |
|---|---|
| JPH1045628A (en) | 1998-02-17 |
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