JP2011098908A - Composition comprising active ingredient and modified starch - Google Patents
Composition comprising active ingredient and modified starch Download PDFInfo
- Publication number
- JP2011098908A JP2011098908A JP2009254599A JP2009254599A JP2011098908A JP 2011098908 A JP2011098908 A JP 2011098908A JP 2009254599 A JP2009254599 A JP 2009254599A JP 2009254599 A JP2009254599 A JP 2009254599A JP 2011098908 A JP2011098908 A JP 2011098908A
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- JP
- Japan
- Prior art keywords
- starch
- weight
- active ingredient
- tablet
- elution
- 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.)
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- 239000000203 mixture Substances 0.000 title claims description 19
- 229920000881 Modified starch Polymers 0.000 title claims description 7
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- 235000019426 modified starch Nutrition 0.000 title claims description 4
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Abstract
Description
本発明は、湿式顆粒圧縮法から直接打錠法に変更した場合であっても、元の湿式顆粒圧縮法により調製した錠剤と同等な溶出特性を維持するための技術である。 The present invention is a technique for maintaining dissolution characteristics equivalent to those of tablets prepared by the original wet granule compression method even when the wet granule compression method is changed to the direct tableting method.
薬物の溶出特性は、薬の投与量や投与間隔を決めるための重要な要素である。近年、新しい薬効又は副作用の軽減された新薬が開発されている。しかし、よい医薬品を多くの患者が購入できる社会とするためには、治療上の評価が確立された医薬品について、特許が切れた後に、ジェネリック医薬品としてより安くより良く提供できるようにすることが期待されている。 Drug elution characteristics are an important factor in determining the dose and interval of a drug. In recent years, new drugs with reduced efficacy or side effects have been developed. However, in order to create a society where many patients can purchase good medicines, it is hoped that medicines for which therapeutic evaluation has been established can be offered cheaper and better as generic medicines after the patent expires. Has been.
錠剤をより安価に供給するには、造粒・乾燥工程のある湿式顆粒圧縮法より、粉体を混合してすぐに打錠できる直接打錠法が好ましい。 In order to supply tablets more inexpensively, a direct tableting method in which powders are mixed and compressed immediately is preferable to a wet granule compression method having a granulation / drying process.
医薬品の製剤化において、湿式顆粒圧縮法から直接打錠法に変更した場合に変更前の溶出特性が維持できず、湿式顆粒圧縮法により調製した錠剤と比較して、直接打錠法で調製した錠剤のほうが速やかな薬物溶出を示す場合があった。そのような場合には、少量添加で、直接打錠法により調製した錠剤の薬物溶出を、湿式顆粒圧縮法により調製した錠剤と同程度に制御できる添加剤があれば有用である。特許文献1、特許文献2、特許文献3には、1種以上の活性成分と溶出制御基剤とを含有する徐放性固形製剤が記載されているが、湿式顆粒圧縮法を直接打錠法へ変更する際の薬物の溶出性を、元の湿式顆粒圧縮法により調製した錠剤と同程度に制御することについては記載されておらず、この課題に対する認識がなかった。 In the formulation of pharmaceuticals, when changing from the wet granule compression method to the direct tableting method, the dissolution characteristics before the change could not be maintained, and compared with the tablet prepared by the wet granule compression method, it was prepared by the direct tableting method In some cases, tablets showed faster drug dissolution. In such a case, it is useful to have an additive that can control the drug dissolution of a tablet prepared by a direct tableting method to the same extent as a tablet prepared by a wet granule compression method by adding a small amount. Patent Document 1, Patent Document 2, and Patent Document 3 describe sustained release solid preparations containing one or more active ingredients and an elution control base. There was no description about controlling the drug dissolution property when changing to the same level as the tablet prepared by the original wet granule compression method, and there was no recognition of this problem.
また、先行技術における薬物の溶出を制御する技術の適用は、活性成分が90%溶出するまでに3時間以上かかる徐放性製剤が対象であり、本願のように活性成分の90%溶出が3時間未満となる製剤は対象ではなかった。 In addition, the application of the technology for controlling drug elution in the prior art is for a sustained-release preparation that takes 3 hours or more until 90% of the active ingredient is eluted. Formulations that were less than time were not included.
本発明者らは、活性成分を含む固形製剤の溶液中でのゲル形成機構及び活性成分溶出機構について鋭意検討を重ねた。その結果、特定の加工澱粉を溶出調整剤として用いることで、直接打錠法により調製した錠剤の薬物溶出を湿式顆粒圧縮法により調製した錠剤の薬物溶出と同程度に調整できることを見出し、この知見に基づき本発明を完成した。すなわち、本発明は以下の通りである。 The present inventors have intensively studied the gel formation mechanism and the active ingredient elution mechanism in a solution of a solid preparation containing the active ingredient. As a result, it was found that by using a specific processed starch as an elution regulator, drug elution of tablets prepared by direct tableting can be adjusted to the same extent as drug elution of tablets prepared by wet granule compression. The present invention was completed based on the above. That is, the present invention is as follows.
(1) 活性成分を1〜95質量%、膨潤度が0.5〜2.0の加工澱粉を1〜10質量%、賦形剤を1〜98質量%含み、活性成分の90%以上が溶出する時間が3時間未満であることを特徴とする錠剤。
(2) 加工澱粉の量が1質量%以上、5質量%未満であることを特徴とする(1)に記載の錠剤。
(3) 直接打錠法により得られることを特徴とする、(1)又は(2)に記載の錠剤。
(4) 活性成分を1〜95質量%、膨潤度が0.5〜2.0の加工澱粉を1〜10質量%、賦形剤を1〜98質量%含有する組成物を直接打錠して錠剤を製造する方法。
(5) 活性成分の平均溶出率が、平均溶出率30%、50%、80%の各時点において、主薬含量が同一量の組成物を用いて湿式顆粒圧縮法により得られた錠剤の平均溶出率に対し、±15%以内であることを特徴とする(1)又は(2)の錠剤。
(1) 1 to 95% by weight of active ingredient, 1 to 10% by weight of processed starch having a swelling degree of 0.5 to 2.0, 1 to 98% by weight of excipient, and 90% or more of the active ingredient A tablet having a dissolution time of less than 3 hours.
(2) The tablet according to (1), wherein the amount of the modified starch is 1% by mass or more and less than 5% by mass.
(3) The tablet according to (1) or (2), which is obtained by a direct tableting method.
(4) Direct compression of a composition containing 1 to 95% by weight of active ingredient, 1 to 10% by weight of processed starch having a degree of swelling of 0.5 to 2.0, and 1 to 98% by weight of excipient To produce tablets.
(5) The average dissolution rate of tablets obtained by the wet granule compression method using the same amount of the active ingredient at each time point when the average dissolution rate of the active ingredient is 30%, 50%, and 80%. The tablet according to (1) or (2), which is within ± 15% of the rate.
本発明によれば、少量の溶出調整剤を添加することにより、湿式顆粒圧縮法を直接打錠法にすると変化してしまう薬物の溶出を、湿式顆粒圧縮法により調製した錠剤と同程度の薬物溶出にすることができる。 According to the present invention, by adding a small amount of dissolution regulator, the dissolution of a drug that changes when the wet granule compression method is changed to a direct tableting method is equivalent to that of a tablet prepared by the wet granule compression method. Elution can be achieved.
本発明について、以下具体的に説明する。本発明の溶出調整剤に用いられる澱粉は、膨潤度が0.5〜2.0である必要がある。好ましくは1.0〜2.0であることが望ましい。さらに好ましくは1.5〜2.0の範囲であることが望ましい。0.5以下であって
も問題ないが、一般的な錠剤は水を吸って膨らむため、低くてもせいぜい0.5程度は膨潤度を有することとなる。また、膨潤度が2.0を超えると膨潤粒子により錠剤が崩壊する等して溶出を調整する事ができないため、2.0以下が好ましい。
The present invention will be specifically described below. The starch used for the elution regulator of the present invention needs to have a degree of swelling of 0.5 to 2.0. Preferably it is 1.0-2.0. More preferably, it is in the range of 1.5 to 2.0. Even if it is 0.5 or less, there is no problem, but since a general tablet swells by sucking water, it has a degree of swelling of at most about 0.5 even if it is low. Further, when the degree of swelling exceeds 2.0, elution cannot be adjusted because the tablet is disintegrated by the swollen particles, so 2.0 or less is preferable.
本発明でいう膨潤度は、以下の方法で測定する。 The degree of swelling referred to in the present invention is measured by the following method.
澱粉を静圧プレス(MODEL−1321DW CREEP/アイコーエンジニアリング株式会社製)を用いて120MPaの圧力で圧縮し、直径1.13cm、重量0.5gの圧縮成型体を得、その厚みを測定する。次に、得られた圧縮成型体を37℃の純水に4時間浸漬させた後の圧縮成型体の厚みを測定する。圧縮成型体は、ビーカー壁等に着かないよう崩壊試験器のバスケットに入れて、37℃の純水に浸漬させる。また、圧縮成型体の厚みは中心部の厚みを測定する。 The starch is compressed at a pressure of 120 MPa using a static pressure press (MODEL-1321DW CREP / manufactured by Aiko Engineering Co., Ltd.) to obtain a compression molded body having a diameter of 1.13 cm and a weight of 0.5 g, and the thickness thereof is measured. Next, the thickness of the compression-molded body after the obtained compression-molded body is immersed in pure water at 37 ° C. for 4 hours is measured. The compression molded body is put in a basket of a disintegration tester so as not to reach a beaker wall or the like and immersed in pure water at 37 ° C. Further, the thickness of the compression molded body is measured at the center.
本発明の膨潤度とは、打錠直後と37℃の純水に浸漬後の厚みの比であり、下式(1)により求めた値で定義する。
膨潤度=4時間37℃浸漬後の圧縮成型体厚み(mm)÷打錠直後の圧縮成型体厚み(mm)・・・(1)
The degree of swelling of the present invention is the ratio of the thickness immediately after tableting to the thickness after immersion in 37 ° C. pure water, and is defined by the value obtained by the following formula (1).
Swelling degree = compression molded body thickness after immersion for 4 hours at 37 ° C. (mm) ÷ compression molded body thickness immediately after tableting (mm) (1)
本発明でいう溶出調整とは、同一の薬物を製剤化する場合において、湿式顆粒圧縮法により調整した錠剤と直接打錠法により調整した錠剤の薬物の平均溶出が30%,50%,80%附近の適当な3時点における平均溶出率が±15%の範囲に合わせることをいう。 The dissolution adjustment as used in the present invention means that when the same drug is formulated, the average dissolution of the drug between the tablet adjusted by the wet granule compression method and the tablet adjusted by the direct tableting method is 30%, 50%, 80%. This means that the average dissolution rate at the appropriate 3 time points is within the range of ± 15%.
本発明の錠剤は、加工澱粉を1〜10重量%含有する錠剤であることが好ましい。 The tablet of the present invention is preferably a tablet containing 1 to 10% by weight of processed starch.
本発明で用いられる澱粉は、安息角が45°以下であることが好ましい。好ましくは安息角が43°以下である。ここでいう安息角とは、杉原式安息角測定器(薬剤学27、p.260、1965年)を使用して求める値である。安息角が45°以下の澱粉は、活性成分との混合性・分散性に優れるため、本発明の溶出調整剤として用いると、溶出時の液性等の条件の変更に関わらず、同一の溶出特性を示し、安定としやすいので好ましい。 The starch used in the present invention preferably has an angle of repose of 45 ° or less. The angle of repose is preferably 43 ° or less. The angle of repose here is a value obtained using a Sugihara-type angle of repose measuring instrument (Pharmacology 27, p. 260, 1965). Starches with an angle of repose of 45 ° or less are excellent in mixing and dispersibility with active ingredients, so when used as an elution regulator of the present invention, the same elution occurs regardless of changes in conditions such as liquidity during elution. It is preferable because it shows characteristics and is easily stabilized.
また、本発明で用いられる澱粉は嵩密度が0.2g/cm3以上0.4g/cm3以下であることが好ましい。ここでいう嵩密度とは、スコットボリュームメーター(筒井理化学機器株式会社)を用いて測定する。粉体試料を、定量フィーダーを用いて2〜3分かけて測定容器内に粉体があふれるまで流下させる。次いで容器の上部に堆積した過剰量の粉体をすり落とし、また、容器の側面に付着した試料を除去する。その後、容器に疎充填された粉体重量を量る。測定容器の容器に疎充填された粉体重量を容積で除した値を嵩密度とする。嵩密度が0.2〜0.4g/cm3の範囲にある澱粉は、活性成分との混合性・分散性に優れるため、本発明の溶出調整剤として好ましい。薬物の溶出を安定としやすいので好ましい。 The starch used in the present invention preferably has a bulk density of 0.2 g / cm 3 or more and 0.4 g / cm 3 or less. The bulk density referred to here is measured using a Scott volume meter (Tsutsui Rikenki Co., Ltd.). The powder sample is allowed to flow using a quantitative feeder until the powder overflows in the measurement container over 2 to 3 minutes. Next, an excessive amount of powder deposited on the top of the container is scraped off, and the sample adhering to the side surface of the container is removed. Thereafter, the weight of the powder loosely filled in the container is measured. A value obtained by dividing the weight of the powder loosely packed in the container of the measurement container by the volume is defined as a bulk density. Starch having a bulk density in the range of 0.2 to 0.4 g / cm 3 is preferable as an elution regulator of the present invention because of excellent mixing and dispersibility with the active ingredient. This is preferable because it facilitates stable drug elution.
本発明で用いられる澱粉は、保水量が400%以上であることが好ましい。より好ましくは500%以上、特に好ましくは700%以上である。ここで保水量とは、乾燥した澱粉1gを20℃±5℃の純水に分散し遠心分離(2000G、10分)した後に澱粉が保持する純水量で定義する。保水量が400%以上で澱粉が水和してゲルを形成するため錠剤が崩壊しにくくなり、かつ活性成分の拡散速度が保たれて適度な状態で維持され、活性成分の溶出を制御しやすくなる。保水量が高いほどゲル形成能が高くなり、高いイオン強度下でもゲルが破壊されないので好ましいが、最大値は澱粉原料の特性に依存し、せいぜい3000%までである。 The starch used in the present invention preferably has a water retention amount of 400% or more. More preferably, it is 500% or more, and particularly preferably 700% or more. The amount of water retained herein is defined as the amount of pure water retained by starch after 1 g of dried starch is dispersed in pure water at 20 ° C. ± 5 ° C. and centrifuged (2000 G, 10 minutes). When the water retention amount is 400% or more, the starch hydrates to form a gel, so that the tablet is difficult to disintegrate, and the diffusion rate of the active ingredient is maintained and maintained in an appropriate state, so that the elution of the active ingredient is easy to control. Become. The higher the water retention amount, the higher the gel-forming ability, and the gel is not broken even under high ionic strength, which is preferable. However, the maximum value depends on the characteristics of the starch raw material and is at most 3000%.
また、本発明で用いられる澱粉はゲル押込み荷重値が200g以上であることが好ましい。ゲル押込み荷重値とは、加工澱粉0.5gを50MPaで圧縮して得られる直径1.13cmの円柱状成形体を20℃±5℃の純水中に4時間浸漬しゲル化させた後、0.1mm/secの速度で3mm直径の円柱状アダプターを押込んだ時の最大荷重で定義する。ここで、最大荷重とはゲル層の破断がある場合は破断時の荷重値、破断がない場合はアダプターがゲル化した円柱状成形体に5mm進入するまでに示した最大の荷重値とする。ゲル押込み荷重値が200g以上で、加工澱粉が形成するゲル層内での活性成分の拡散が適度な状態で維持され、活性成分の溶出を制御しやすくなる。ゲル押込み荷重値が高いほど制御能が高くなり好ましいが、せいぜい3000g程度である。 The starch used in the present invention preferably has a gel indentation load value of 200 g or more. The gel indentation load value is obtained by gelling a cylindrical molded body having a diameter of 1.13 cm obtained by compressing 0.5 g of processed starch at 50 MPa for 4 hours in pure water at 20 ° C. ± 5 ° C. This is defined as the maximum load when a 3 mm diameter cylindrical adapter is pushed in at a speed of 0.1 mm / sec. Here, the maximum load is the load value at the time of rupture when the gel layer is broken, and the maximum load value before the adapter enters 5 mm into the gelled cylindrical molded body when there is no rupture. When the gel indentation load value is 200 g or more, the diffusion of the active ingredient in the gel layer formed by the processed starch is maintained in an appropriate state, and the elution of the active ingredient is easily controlled. The higher the gel indentation load value, the higher the controllability and the better, but it is about 3000 g at most.
また、本発明で用いられる澱粉は水溶性成分量が30〜95重量%の範囲にあることが好ましい。水溶性成分量は、以下の計算によって得られる値として定義される。すなわち、澱粉1gに20℃±5℃の純水99gを加えてマグネチックスターラーで2時間攪拌して分散させ、得られた分散液の40gを50cm3の遠沈管に移し、5000Gで15分間遠心分離し、この上澄液30gを秤量瓶に入れ、110℃で一定重量になるまで乾燥して水溶性成分の乾燥重量(g)を求める。また、加工澱粉1gを110℃で一定重量になるまで乾燥して加工澱粉の絶乾重量(g)を求める。これらの値と下式(2)により求めた値で定義する。
水溶性成分量(重量%)=(乾燥重量(g)×100÷30)÷澱粉1gの絶乾重量(g)×100・・・(2)
Moreover, it is preferable that the starch used by this invention exists in the range whose water-soluble component amount is 30 to 95 weight%. The amount of the water-soluble component is defined as a value obtained by the following calculation. That is, 99 g of pure water at 20 ° C. ± 5 ° C. was added to 1 g of starch and dispersed by stirring for 2 hours with a magnetic stirrer, and 40 g of the resulting dispersion was transferred to a 50 cm 3 centrifuge tube and centrifuged at 5000 G for 15 minutes. Separate and put 30 g of this supernatant into a weighing bottle and dry at 110 ° C. to a constant weight to determine the dry weight (g) of the water-soluble component. Also, 1 g of the processed starch is dried at 110 ° C. until a constant weight is obtained, and the absolute dry weight (g) of the processed starch is determined. These values are defined by the values obtained by the following formula (2).
Water-soluble component amount (% by weight) = (dry weight (g) × 100 ÷ 30) ÷ absolute dry weight of 1 g of starch (g) × 100 (2)
水溶性成分量は、加工澱粉が糊化し水溶性となった糊成分の量を表す値である。水溶性成分量が30重量%以上で、水和速度が確保されて活性成分の溶出が遅くなりすぎることがなく、また、錠剤が溶媒と接した後、すぐに多量の活性成分が溶出してしまうような現象も生じにくい。水溶性成分量が95重量%以下で、固形製剤の強度が確保され、十分な溶出調整がしやすくなる。また、胃腸管の機械的運動による負荷に耐えうるため過度に侵食されることなく溶出速度が一定範囲に確保される。 The amount of the water-soluble component is a value representing the amount of the paste component that has been processed into starch and becomes water-soluble. When the amount of water-soluble component is 30% by weight or more, the hydration rate is secured and the elution of the active ingredient is not too slow. Also, a large amount of the active ingredient is eluted immediately after the tablet comes into contact with the solvent. It is difficult to cause such a phenomenon. When the amount of the water-soluble component is 95% by weight or less, the strength of the solid preparation is secured, and sufficient elution adjustment is facilitated. Further, since it can withstand the load caused by the mechanical movement of the gastrointestinal tract, the dissolution rate is ensured within a certain range without excessive erosion.
また、本発明で用いられる澱粉は、目開き75μmの篩を通過する粒子が90重量%以上、目開き32μmの篩を通過する粒子が20重量%以上、且つ、平均粒径が20μm以上50μm未満である必要がある。好ましくは、目開き75μmの篩を通過する粒子が95重量%以上、目開き32μmの篩を通過する粒子が30重量%以上であり、特に好ましくは、目開き75μmの篩を通過する粒子が98重量%以上、目開き32μmの篩を通過する粒子が40重量%以上である。澱粉は、粒子が小さい方が膨潤性が小さく、ゲル強度も強い。そのため、目開き75μmの篩を通過する粒子が90重量%以上、目開き32μmの篩を通過する粒子が20重量%以上、且つ、平均粒径が50μm未満であれば、澱粉粒子、及び該澱粉粒子からなる固形製剤の膨潤性が比較的小さい範囲に留まる。そのため、固形製剤が膨潤して壊れることなく、固形製剤からの活性成分の溶出が圧縮成形圧により変動しにくくなる。 The starch used in the present invention is 90% by weight or more of particles passing through a sieve having an opening of 75 μm, 20% by weight or more of particles passing through a sieve having an opening of 32 μm, and an average particle size of 20 μm or more and less than 50 μm. Need to be. Preferably, the particles passing through the sieve having an opening of 75 μm are 95% by weight or more, the particles passing through the sieve having an opening of 32 μm are 30% by weight or more, and particularly preferably, the particles passing through the sieve having an opening of 75 μm are 98%. More than 40% by weight of particles passing through a sieve having a weight of 32% or more by weight. The smaller the particles, the smaller the swelling and the higher the gel strength. Therefore, if the particles passing through the sieve having an opening of 75 μm are 90% by weight or more, the particles passing through the sieve having an opening of 32 μm are 20% by weight or more, and the average particle size is less than 50 μm, the starch particles and the starch The swelling property of the solid preparation composed of particles remains within a relatively small range. Therefore, the elution of the active ingredient from the solid preparation is less likely to fluctuate due to the compression molding pressure without causing the solid preparation to swell and break.
本発明で用いられる澱粉は、水中での沈降体積が6cm3/g以上15cm3/g以下であることが好ましい。加工澱粉の水中での沈降体積は以下の方法で測定する。 The starch used in the present invention preferably has a sedimentation volume in water of 6 cm 3 / g or more and 15 cm 3 / g or less. The sedimentation volume of the modified starch in water is measured by the following method.
加工澱粉1.0gを20±5℃の純水に分散させて100cm3の沈降管に移し、全量を100cm3とし、16時間放置した後、上下に分かれた下層の容積V(cm3)と澱粉1.0gの乾燥重量(g)とを測定し、下式(3)より求めた値と定義する。
澱粉の沈降体積(cm3/g)=V(cm3)/澱粉の乾燥重量(g)・・・(3)
1.0 g of processed starch was dispersed in pure water at 20 ± 5 ° C. and transferred to a 100 cm 3 sedimentation tube. The total amount was 100 cm 3 and left for 16 hours, and then the volume V (cm 3 ) of the lower layer divided into upper and lower parts The dry weight (g) of 1.0 g of starch is measured and defined as the value obtained from the following formula (3).
Sedimentation volume of starch (cm 3 / g) = V (cm 3 ) / dry weight of starch (g) (3)
加工澱粉の水中での沈降体積が6cm3/g以上で、水和してゲルを形成するため活性成分の溶出を調整しやすくなる。また、加工澱粉の水中での沈降体積が15cm3/gより小さいと、該加工澱粉の膨潤に起因した固形製剤の膨潤を防ぐことができ、活性成分の溶出速度の遅延や、固形製剤の崩壊を防ぐことができるので好ましい。よって、澱粉の水中での沈降体積が6cm3/g以上15cm3/g以下の範囲で、活性成分が安定に溶出されやすくなるので、好ましい。 The settling volume of the processed starch in water is 6 cm 3 / g or more, and hydrates to form a gel, so that it becomes easy to adjust the elution of the active ingredient. Moreover, when the sedimentation volume in water of processed starch is smaller than 15 cm < 3 > / g, swelling of the solid formulation resulting from swelling of this processed starch can be prevented, and the elution rate of an active ingredient is delayed, or disintegration of solid formulation Is preferable. Therefore, it is preferable because the active ingredient is easily eluted stably when the sedimentation volume of starch in water is in the range of 6 cm 3 / g to 15 cm 3 / g.
以下に、溶出調整剤を1〜10重量%を含む組成物を直接打錠法により打錠して得られる本発明の錠剤の製造方法について記述する。 Below, the manufacturing method of the tablet of this invention obtained by tableting the composition containing 1-10 weight% of elution regulators by the direct tableting method is described.
膨潤度が0.5〜2.0の加工澱粉を1〜10質量%、活性成分を1〜95質量%、賦形剤を1〜98質量%含有した組成物を圧縮成形機(例えば、静圧プレス機、シングルパンチ打錠機、ロータリー打錠機、多層錠剤成形機、有核打錠等)を用いて硬度が6kgfとなる圧力で圧縮し、直径0.8cm、重量0.18gの錠剤を得る。 A composition containing 1 to 10% by weight of processed starch having a degree of swelling of 0.5 to 2.0, 1 to 95% by weight of active ingredient, and 1 to 98% by weight of excipient is compressed with a compression molding machine (for example, static A tablet with a diameter of 0.8 cm and a weight of 0.18 g using a pressure press, single punch tableting machine, rotary tableting machine, multilayer tableting machine, dry tableting machine, etc. Get.
本発明で用いられる膨潤度0.5〜2.0の澱粉の製造方法を以下に記述する。 A method for producing starch having a swelling degree of 0.5 to 2.0 used in the present invention will be described below.
澱粉は、澱粉質原料を水存在下60〜150℃で加熱し、澱粉質原料の澱粉粒子の一部又は全てを膨潤させる工程、及び、次いで乾燥させることにより、1箇所以上がくぼんだ構造である澱粉粒子と、その澱粉粒子の外部に存在するアミロースとアミロペクチンとを含有する混合物の粉末を得る工程により製造される。 The starch has a structure in which one or more portions are recessed by heating the starchy raw material at 60 to 150 ° C. in the presence of water to swell part or all of the starch particles of the starchy raw material, and then drying. It is produced by a step of obtaining a powder of a mixture containing certain starch particles and amylose and amylopectin existing outside the starch particles.
本発明でいう澱粉質原料とは、コメ、モチゴメ、トウモロコシ、モチトウモロコシ、アミロトウモロコシ、モロコシ、コムギ、オオムギ、サトイモ、リョクトウ、バレイショ、ユリ、カタクリ、チューリップ、カンナ、エンドウ、シワエンドウ、クリ、クズ、ヤマノイモ、カンショ、ソラマメ、インゲンマメ、サゴ、タピオカ(キャッサバ)、ワラビ、ハス、ヒシ等の天然澱粉、老化澱粉、架橋澱粉等が例示され、澱粉質物質を含有するものであれば特に制限されないが、粒子の膨潤性が高く保水量を高く制御しやすいという観点からバレイショが好ましい。 The starchy raw material referred to in the present invention is rice, glutinous rice, corn, waxy corn, amylo corn, sorghum, wheat, barley, taro, mung bean, potato, lily, corn chestnut, tulip, canna, pea, wrinkled pea, chestnut, kuzu Natural starch such as yam, sweet potato, broad bean, kidney bean, sago, tapioca (cassava), bracken, lotus, eagles, and the like are exemplified, and it is not particularly limited as long as it contains a starchy substance. From the viewpoint of high particle swellability and easy control of water retention, potato is preferred.
次に、本発明でいう活性成分とは、固形製剤が投与された体内等の周辺環境に対して、化学的又は生物学的に望ましい影響を与える成分を言い、例えば、医薬品薬効成分、農薬成分、肥料成分、飼料成分、食品成分、化粧品成分、色素、香料、金属、セラミックス、触媒、界面活性剤等をいう。活性成分は、粉体状、結晶状、油状、液状、半固形状等のいずれの性状でもよいし、粉末、細粒、顆粒等のいずれの形態でもよい。活性成分は、それ単独で使用しても、2種以上を併用してもよい。医薬品薬効成分としては、解熱鎮痛消炎薬、催眠鎮静薬、眠気防止薬、鎮暈薬、小児鎮痛薬、健胃薬、制酸薬、消化薬、強心薬、不整脈用薬、降圧薬、血管拡張薬、利尿薬、抗潰瘍薬、整腸薬、骨粗症治療薬、鎮咳去痰薬、抗喘息薬、抗菌剤、頻尿改善剤、滋養強壮剤、ビタミン剤など、経口で投与されるものなどが挙げられる。医薬品薬効成分は、それを単独で使用しても、2種以上を併用することもできる。 Next, the active ingredient as used in the present invention refers to an ingredient that has a desirable chemical or biological effect on the surrounding environment such as the body to which the solid preparation is administered. , Fertilizer ingredients, feed ingredients, food ingredients, cosmetic ingredients, pigments, fragrances, metals, ceramics, catalysts, surfactants and the like. The active ingredient may be in any form such as powder, crystal, oil, liquid, semi-solid, etc., and may be in any form such as powder, fine granules, granules and the like. An active ingredient may be used independently or may use 2 or more types together. Anti-pyretic analgesics, antihypnotics, drowsiness preventives, antipruritics, pediatric analgesics, stomachic drugs, antacids, digestives, cardiotonic drugs, arrhythmic drugs, antihypertensives, vasodilators, Examples include diuretics, anti-ulcer drugs, intestinal drugs, osteoporosis drugs, antitussive expectorants, anti-asthma drugs, antibacterial agents, frequent urination improvers, nourishing tonics, vitamins, etc. It is done. The medicinal medicinal ingredients can be used alone or in combination of two or more.
本発明で用いられる医薬品薬効成分の例を以下に列挙する。 Examples of pharmaceutical medicinal ingredients used in the present invention are listed below.
鎮痛及び抗炎症性薬剤(NSAID、フェンタニール、インドメタシン、イブプロフェン、ケトプロフェン、ナブメトン(nabumetone)、パラセタモール、ピロキシカム、トラマドール、セロコキシブ(celecoxib)及びロフェコキシブ(rofecoxib)のようなCOX-2インヒビター);抗不整脈剤(プロカインアミド、キニジン、ベラパミル);抗細菌及び抗原生動物剤(アモキシリン、アンピシリン、ベンザチン ペニシリン、ベンジルペニシリン、セファクロール、セファドロキシル、セフプロジル(cefprozil)、セフロキシム アキセチル(cefuroximeaxetil)、セファレキシン、クロラムフェニコール、クロロキン、シプロフロキサシン、クラリスロマイシン(clarithromycin)、クラブラン酸、クリンダマイシン、ドキシサイクリン(doxyxyclin)、エリスロマイシン、フルクロキサシリン(flucloxacillin)ナトリウム、ハロファントリン(halofantrine)、イソニアジド、硫酸カナマイシン、リンコマイシン、メフロキン、ミノサイクリン、ナフシリン ナトリウム、ナリジクス酸、ネオマイシン、ノルフロキサシン、オフロキサシン(ofloxacin)、オキサシリン、フェノキシメチル−ペニシリン カリウム、ピリメタミン−スルファドキシム、ストレプトマイシン);抗凝固剤(ワルファリン);抗鬱剤(アミトリプチリン、アモキサピン、ブトリプチリン、クロミプラミン、デシプラミン、ドチエピン(dothiepin)、ドキセピン、フルオキセチン、レボキセチン(reboxetine)、アミネプチン(amineptine)、セレジリン、ジェピロン、イミプラミン、炭酸リチウム、ミアンセリン、ミルナシプラン(milnacipran)、ノルトリプチリン、パロキセチン(paroxetine)、セルトラリン(sertraline);3-[2-[3,4-ジヒドロベンゾフラン[3,2-c]ピリジン-2(1H)-イル]エチル]-2-メチル-4H-ピリド[1,2-a]ピリミジン-4-オン);抗糖尿病剤(グリベンクラミド(glibenclamide)、メトホルミン);抗癲癇剤(カルマバゼピン、クロナゼパム、エトスクシミド、ガバペンチン(gabapentin)、ラモトリジン、レベチラセタム(lavetiracetam)、フェノバルビトン(phenobarbitone)、フェニトイン、プリミドン、チアガビン(tiagabine)、トピラメート(topiramate)、バルプロミド(valpromide)、ビガバトリン);抗菌剤(アンホテリシン、クロトリマゾール、エコナゾール、フルコナゾール(fluconazole)、フルシトシン、グリセオフルビン、イトラコナゾール(itraconazole)、ケトコナゾール、硝酸ミコナゾール、ナイスタチン、テルビナフィン(terbinafine)、ボリコナゾール(voriconazole));抗ヒスタミン剤(アステミゾール、シンナリジン(cinnarizine)、シプロヘプタジン、デカルボエトキシロラタジン(decarboethoxyloratadine)、フェキソフェナジン(fexofenadine)、フルナリジン、レボカバスチン(levocabastine)、ロラタジン(loratadine)、ノルアステミゾール(norastemizole)、オキサトミド(oxatomide)、プロメタジン、テルフェナジン);抗高血圧剤(カプトプリルエナラプリル、ケンタセリン、リジノプリル、ミノキシジル、プラゾシン、ラミプリル(ramipril)、レセルピン、テラゾシン);抗ムスカリン作用剤(硫酸アトロピン、ヒオスシン);抗腫瘍剤及び代謝拮抗物質(シスプラチン、カルボプラチンのような白金化合物;パクリタキセル、ドセタキセル(docetaxel)のようなタキサン(taxane);カンプトテシン(camptothecin)、イリノテカン(irinotecan)、トポテカン(topotecan)のようなテカン(tecan);ビンブラスチン、ビンデシン、ビンクリスチン、ビノレルビン(vinorelbine)のようなビンカ アルカロイド;5-フルオロウラシル、カペシタビン(capecitabine)、ジェムシタビン(gemcitabine)、メルカプトプリン、チオグアニン、クラドリビン(cladribine)、メトトレキセートのようなヌクレオシド誘導体及び葉酸アンタゴニスト;ナイトロジェン マスタード、例えばシクロホスファミド、クロラムブシル(chlorambucil)、クロルメチン(chlormethine)、イホスファミド(iphosphamide)、メルファラン(melphalan)、あるいはニトロソウレア、例えばカルムスチン、ロムスチンのようなアルキル化剤、あるいは他のアルキル化剤、例えばブスルファン、ダルカルバジン、プロカルバジン、チオテパ;ダウノルビシン、ドキソルビシン、イダルビシン(idarubicin)、エピルビシン(epirubicin)、ブレオマイシン、ダクチノマイシン、マイトマイシンのような抗生物質;トラスツズマブ(trastuzumab)のようなHER2抗体;エトポシド、テニポシド(teniposide)のようなポドフィロトキシン誘導体;ファルネシル トランスフェラーゼ インヒビター;ミトザントロンのようなアントラキノン誘導体);抗偏頭痛剤(アルニジタン(alniditan)、ナラトリプタン(naratriptan)、スマトリプタン(sumatriptan));抗パーキンソン剤(ブロモクリプチン メシレート(bromocryptinemesylate)レボトバ、セレジリン);抗精神性、催眠性及び鎮静剤(アルプラゾラム、ブスピロン、クロルジアゼポキシド(chlordiazepoxide)、クロルプロマジン(chlorpromazine)クロザピン、ジアゼパム、フルペチキソール、フルフェナジン、フルラゼパム、9-ヒドロキシリスペリドン(hydroxyrisperidone)、ロラゼパム、マザペルチン(mazapertine)、オランザピン(olanzapine)、オキサゼパム、ピモジド、ピパンペロン、ピラセタム(piracetam)、プロマジン、リスペリドン(risperidone)、セルホテル(selfotel)、セロクエル(seroquel)、セルチンドール(sertindole)、スルピリド、テマゼパム、チオチキセン、トリアゾラム、トリフルペリドール、ジプラシドン(ziprasidone)、ゾルピデム);抗発作剤(ルベルゾール(lubeluzole)、ルベルゾール オキシド(lubeluzoleoxide)、リルゾール(riluzole)、アプチガネル(aptiganel)、エリプロジル(eliprodil)、レマセミド(remacemide));鎮咳剤(デキストロメトルファン、レボドロプロピジン(laevodropropizine));抗ウイルス剤(アシクロビル、ガンシクロビル、ロビリド(loviride)、チビラピン(tivirapine)、ジドブジン、ラミブジン(lamivudine)、ジドブジン+ラミブジン、ジダノシン(didanosine)、ザルシタビン(zalcitabine)、スタブジン(stavudine)、アバカビル(abacavir)、ロピナビル(lopinavir)、アンプレナビル(amprenavir)、ネビラピン(nevirapine)、エファビレンズ(efavirenz)、デラビルジン(delavirdine)、インジナビル(indinavir)、ネルフィナビル(nelfinavir)、リトナビル(ritonavir)、サキナビル(saquinavir)、アデホビル(adefovir)、ヒドロキシウレア);ベータ−アドレナリン作用性受容体剤(アテノロール、カルベディロール、メトプロロール、ネビボロール(nebivolol)、プロパノルオール);心変力性剤(アムリノン、ジギトキシン、ジゴキシン、ミルリノン);コルチコステロイド(ジプロピオン酸ベクロメタゾン、ベタメゾン、ブデソニド(budesonide)、デキサメタゾン、ヒドロコルチゾン、メチルプレドニゾロン、プレドニゾロン、プレドニゾン、トリアムシノロン);殺菌剤(クロルヘキシジン);利尿剤(アセタゾラミド、フルセミド(frusemide)、ヒドロクロロチアジド、イソソルビド);酵素;精油(アネトール、アニス油、キャラウェイ、カルダモン、カシア油、シネオール、シナモン油、クローブ油、コリアンダー油、脱メントール化(dementholised)ミント油、ディル油、ユーカリ油、オイゲノール、ジンジャー、レモン油、からし油、ネロリ油、ナツメグ油、オレンジ油、ペパーミント、セージ、スペアミント、テルピネオール、タイム);胃腸薬(シメチジン、シサプリド(cisapride)、クレボプリド(clebopride)、ジフェノキシラート、ドンペリドン、ファモチジン、ランソプラゾール(lansoprazole)、ロペルアミド(loperamide)、ロペルアミド オキシド(loperamideoxide)、メサラジン(mesalazine)、メトクロプラミド(metoclopramide)、モサプリド(mosapride)、ニザチジン、ノルシスアプリド(norcisapride)、オルサラジン(olsalazine)、オメプラゾール、パントプラゾール(pantoprazole)、ペルプラゾール(perprazole)、プルカロプリド(prucalopride)、ラベプラゾール(rabeprazole)、ラニチジン、リドグレル(ridogrel)、スルファサラジン(suphasalazine));止血剤(アミノカプロン酸);脂質調節剤(アトルバスチン(atorvastine)、セバスタチン、プラバスタチン、プロブコール、シンバスタチン);局所麻酔剤(ベンゾカイン、リグノカイン(lignocaine));オピオイド鎮痛剤(ブプレノルフィン、コデイン、デキストロモルアミド、ジヒドロコデイン、ヒドロコドン、オキシコドン、モルフィネ);副交感神経作用性及び抗痴呆剤(AIT-082、エプタスチグミン(eptastigmine)、ガランタミン、メトリホナート、ミラメリン(milameline)、ネオスチグミン、フィゾスチグミン、タクリン、ドネペジル(donepezil)、リバスチグミン(rivastigmine)、サブコメリン(sabcomeline)、タルサクリジン(talsaclidine)、キサノメリン(xanomeline)、メマンチン(memantine)、ラザベミド(lazabemide));ペプチド及びタンパク質(抗体、ベカルプレルミン(becaplermine)、シクロスポリン、エリスロポエチン、免疫グロブリン、インスリン);性ホルモン(卵胞ホルモン:抱合卵胞ホルモン、エチニルエストラジオール、メストラノール、エストラジオール、エストリオール、エストロン;プロゲステロン;酢酸クロマジン、酢酸シプロテン、17-デアセチル ノルゲスチメート(deacetylnorgestimate)、デソゲストレル(desogestrel)、ジエノゲスト(dienogest)、ジドロゲステロン、エチノジオール(ethynodiol)ジアセテート、ゲストデン(gestodene)、3-ケトデソゲストレル(ketodesogestrel)、レボノルゲストレル(levonorgestrel)、リネストレノール、酢酸メトキシプロゲステロン、メゲステロール、ノルエチンドロン、酢酸ノルエチンドロン、ノルエチステロン、酢酸ノルエチステロン、ノルエチノドレル、ノルゲスチメート(norgestimate)、ノルゲストレル、ノルゲストリエノン(norgestrienone)、プロゲステロン、酢酸キンゲスタノール);刺激剤(シルデナフィル(sildenafil));血管拡張剤(アムロジピン、ブフロメジル(buflomedil)、亜硝酸アミル、ジルチアゼム、ジピリダモール、三硝酸グリセリル、イソソルビドジニトレート、リドフラジン、モルシドミン(molsidomine)、ニサルジピン、ニフェジピン、オキシペンチフィリン(oxpentifylline)、三硝酸ペンタエリスリトール);上記の物質のN−オキシド、上記の物質の医薬的に許容され得る酸又は塩基付加塩、及び上記の物質の立体化学異性体等が挙げられる。 Analgesic and anti-inflammatory drugs (COX-2 inhibitors such as NSAID, fentanyl, indomethacin, ibuprofen, ketoprofen, nabumetone, paracetamol, piroxicam, tramadol, celecoxib and rofecoxib; antiarrhythmic agents ( Procainamide, quinidine, verapamil); antibacterial and antigenic animal agents (amoxiline, ampicillin, benzathine penicillin, benzylpenicillin, cefaclor, cefadroxyl, cefprozil, cefuroxime axetyl (cefuroximeaxetil), cephalexin, chloramphenicol, chloramphenicol , Ciprofloxacin, clarithromycin, clavulanic acid, clindamycin, doxyxyclin, erythromycin, Flucloxacillin sodium, halofantrine, isoniazid, kanamycin sulfate, lincomycin, mefloquine, minocycline, nafcillin sodium, nalidixic acid, neomycin, norfloxacin, ofloxacin, oxacillin, phenoxymethyl-penicillin potassium, pyrimethamine potassium Anti-coagulants (warfarin); antidepressants (amitriptyline, amoxapine, buttriptyline, clomipramine, desipramine, dothiepin, doxepin, fluoxetine, reboxetine, amineptine, diminepinemine, diminepinemine, cerine Lithium carbonate, mianserin, milnacipran, nortripty Phosphorous, paroxetine, sertraline; 3- [2- [3,4-dihydrobenzofuran [3,2-c] pyridin-2 (1H) -yl] ethyl] -2-methyl-4H-pyrido [1,2-a] pyrimidin-4-one); antidiabetics (glibenclamide, metformin); antiepileptics (carmabazepine, clonazepam, ethosuximide, gabapentin, lamotrigine, lavetiracetam, phenobarbi Tons (phenobarbitone), phenytoin, primidone, tiagabine, topiramate, valpromide, vigabatrin; antibacterial agents (amphotericin, clotrimazole, econazole, fluconazole, flucytosine, griseofulzol, itraconazole ), Ketoconazole, miconazole nitrate, nysta Terbinafine, voriconazole; antihistamines (astemizole, cinnarizine, cyproheptadine, decarboethoxyloratadine, fexofenadine, flunarizine, levocabastine, levocabastine, levocabastine , Norastemizole, oxatomide, promethazine, terfenadine; antihypertensive agents (captopril enalapril, centarine, lizinopril, minoxidil, prazosin, ramipril, reserpine, terazosin); antimuscarinic agent (atropine sulfate) Antitumor agents and antimetabolites (platinum compounds such as cisplatin and carboplatin; paclitaxel, docetaxel (doc taxanes such as etaxel; tecans such as camptothecin, irinotecan, topotecan; vinca alkaloids such as vinblastine, vindesine, vincristine, vinorelbine; 5- Nucleoside derivatives and folic acid antagonists such as fluorouracil, capecitabine, gemcitabine, mercaptopurine, thioguanine, cladribine, methotrexate; nitrogen mustard such as cyclophosphamide, chlorambucil, chlorine ), Ifosphamide, melphalan, or nitrosourea, eg alkylating agents such as carmustine, lomustine, or others Alkylating agents such as busulfan, dalbazine, procarbazine, thiotepa; daunorubicin, doxorubicin, idarubicin, epirubicin, antibiotics such as bleomycin, dactinomycin, mitomycin; HER2 antibodies such as trastuzumab; Podophyllotoxin derivatives such as etoposide, teniposide; farnesyl transferase inhibitors; anthraquinone derivatives such as mitozantrone; antimigraine agents (alniditan, naratriptan, sumatriptan); Antiparkinsonian (bromocryptinemesylate levotova, selegiline); antipsychotic, hypnotic and sedative (alprazolam, buspirone, black Diazepoxide (chlordiazepoxide), chlorpromazine (chlorpromazine) clozapine, diazepam, flupetixol, fluphenazine, flurazepam, 9-hydroxyrisperidone (hydroxyrisperidone), lorazepam, mazapertine, olanzapine (amanzapine), oxazepam, racazepam , Promazine, risperidone, selfotel, seroquel, sertindole, sulpiride, temazepam, thiothixene, triazolam, trifluperidol, ziprasidone, zolpidem; Lubeluzole, lubeluzoleoxide, riluzole, aptiganel, eliprodil, remasemide remacemide)); antitussives (dextromethorphan, leevodropropizine); antiviral agents (acyclovir, ganciclovir, lobiride, tivirapine, zidovudine, lamivudine, zidovudine plus lamivudine, didanosine didanosine, zalcitabine, stavudine, abacavir, lopinavir, amprenavir, nevirapine, efavirenz, delavirdine, indinavir (indinavir) Nelfinavir (nelfinavir), ritonavir, saquinavir, adefovir (adefovir, hydroxyurea); beta-adrenergic receptor agents (atenolol, carvedilol, metoprolol, nebi) Roll (nebivolol), propanolol; cardiac inotropic agent (amrinone, digitoxin, digoxin, milrinone); corticosteroid (beclomethasone dipropionate, betamethasone, budesonide, dexamethasone, hydrocortisone, methylprednisolone, prednisolone, Prednisone, triamcinolone); fungicides (chlorhexidine); diuretics (acetazolamide, frusemide, hydrochlorothiazide, isosorbide); enzymes; essential oils (anethole, anise oil, caraway, cardamom, cassia oil, cinnamon oil, cinnamon oil, clove oil) , Coriander oil, dementholised mint oil, dill oil, eucalyptus oil, eugenol, ginger, lemon oil, mustard oil, neroli oil, nutmeg oil, orange oil, Peppermint, sage, spearmint, terpineol, thyme; gastrointestinal drugs (cimetidine, cisapride, clebopride, diphenoxylate, domperidone, famotidine, lansoprazole, loperamide, loperamide oxide) , Mesalazine (mesalazine), metoclopramide (mosapride), mosapride, nizatidine, norcisapride, olsalazine, omeprazole, pantoprazole, perprazole, prucalopride, prrucalopride ), Ranitidine, ridogrel, suphasalazine); hemostatic agent (aminocaproic acid); lipid regulator (atorvast ine), sevastatin, pravastatin, probucol, simvastatin); local anesthetics (benzocaine, lignocaine); opioid analgesics (buprenorphine, codeine, dextromolamide, dihydrocodeine, hydrocodone, oxycodone, morphine); parasympathomimetic And anti-dementia drugs (AIT-082, eptastigmine, galastamine, metriphonate, mirameline, neostigmine, physostigmine, tacrine, donepezil, rivastigmine, sabcomeline, saclcomline, sabcomeline, sabcomeline) (Xanomeline), memantine, lazabemide); peptides and proteins (antibodies, becaplermine, cyclosporine, erythrocytes) Stropoetin, immunoglobulin, insulin); sex hormone (follicular hormone: conjugated follicular hormone, ethinyl estradiol, mestranol, estradiol, estriol, estrone; progesterone; chromadine acetate, cyproten acetate, 17-deacetylnorgestimate, desogestrel , Dienogest, diedrogesterone, etynodiol diacetate, gestodene, 3-ketosogestrel, levonorgestrel, linestrenol, methoxyprogesterone acetate, megesterol, norethindrone, acetic acid Norethindrone, Norethisterone, Norethisterone acetate, Norethinodrel, Norgestimate, Nor Strel, norgestrienone, progesterone, kingestanol acetate; stimulant (sildenafil); vasodilator (amlodipine, buflomedil, amyl nitrite, diltiazem, dipyridamole, glyceryl trinitrate, isosorbide Dinitrate, ridofuradine, molsidomine, nisardipine, nifedipine, oxpentifylline, pentaerythritol trinitrate); N-oxides of the above substances, pharmaceutically acceptable acid or base addition salts of the above substances And stereochemical isomers of the above substances.
本発明における錠剤には、活性成分の他に、必要に応じて崩壊剤、結合剤、流動化剤、滑沢剤、矯味剤、香料、着色剤、甘味剤等の他の成分を含有しても構わない。また他の成分は希釈剤として使用してもよい。 In addition to the active ingredient, the tablet in the present invention contains other components such as a disintegrant, a binder, a fluidizing agent, a lubricant, a corrigent, a fragrance, a colorant, and a sweetener as necessary. It doesn't matter. Moreover, you may use another component as a diluent.
結合剤としては、白糖、ブドウ糖、乳糖、果糖、トレハロース等の糖類、マンニトール、キシリトール、マルチトール、エリスリトール、ソルビトール等の糖アルコール類、ゼラチン、プルラン、カラギーナン、ローカストビーンガム、寒天、グルコナンナン、キサンタンガム、タマリンドガム、ペクチン、アルギン酸ナトリウム、アラビアガム等の水溶性多糖類、結晶セルロース(例えば、旭化成ケミカルズ株式会社製、「セオラス(登録商標、以下同じ)」PH−101、PH−101D、PH−101L、PH−102、PH−301、PH−301Z、PH−302、PH−F20、PH−M06、M15、M25、KG−801、KG−802、KG−1000、UF−702、UF−711等)、粉末セルロース、ヒドロキシプロピルセルロース、メチルセルロース等のセルロース類、アルファー化デンプン、デンプン糊等のデンプン類、ポリビニルピロリドン、カルボキシビニルポリマー、ポリビニルアルコール等の合成高分子類、リン酸水素カルシウム、炭酸カルシウム、合成ヒドロタルサイト、ケイ酸アルミン酸マグネシウム等の無機化合物類等が挙げられことができ、上記から選ばれる1種を単独で使用しても、2種以上を併用することもできる。 As binders, sugars such as sucrose, glucose, lactose, fructose, trehalose, sugar alcohols such as mannitol, xylitol, maltitol, erythritol, sorbitol, gelatin, pullulan, carrageenan, locust bean gum, agar, gluconannan, xanthan gum , Tamarind gum, pectin, sodium alginate, gum arabic, etc., water-soluble polysaccharides, crystalline cellulose (for example, “Theolas (registered trademark, the same shall apply hereinafter)” PH-101, PH-101D, PH-101L, manufactured by Asahi Kasei Chemicals Corporation PH-102, PH-301, PH-301Z, PH-302, PH-F20, PH-M06, M15, M25, KG-801, KG-802, KG-1000, UF-702, UF-711, etc.) , Powdered cellulose, hydroxyp Celluloses such as pill cellulose and methyl cellulose, starches such as pregelatinized starch and starch paste, synthetic polymers such as polyvinylpyrrolidone, carboxyvinyl polymer and polyvinyl alcohol, calcium hydrogen phosphate, calcium carbonate, synthetic hydrotalcite, silica Inorganic compounds such as magnesium aluminate can be used, and one kind selected from the above can be used alone, or two or more kinds can be used in combination.
結合剤として使用できる結晶セルロースとしては、圧縮成形性に優れるものが好ましい。圧縮成形性に優れる結晶セルロースを使用することにより、低打圧で打錠できるため打圧で失活する活性成分の活性維持が可能である。商業的に入手可能である圧縮成形性に優れる結晶セルロースとしては、「セオラス」KG−801、KG−802、KG−1000、UF−702、UF−711(旭化成ケミカルズ株式会社製)等が利用できる。 As the crystalline cellulose that can be used as the binder, those excellent in compression moldability are preferable. By using crystalline cellulose excellent in compression moldability, the tablet can be tableted with a low compression pressure, so that it is possible to maintain the activity of the active ingredient deactivated by the compression pressure. As commercially available crystalline cellulose having excellent compression moldability, “Theolas” KG-801, KG-802, KG-1000, UF-702, UF-711 (manufactured by Asahi Kasei Chemicals Corporation) and the like can be used. .
崩壊剤としては、クロスカルメロースナトリウム、カルメロース、カルメロースカルシウム、カルメロースナトリウム、低置換度ヒドロキシプロピルセルロース等のセルロース類、カルボキシメチルスターチナトリウム、ヒドロキシプロピルスターチ、コメデンプン、コムギデンプン、トウモロコシデンプン、バレイショデンプン、部分アルファー化デンプン等のデンプン類、結晶セルロース、粉末セルロース等のセルロース類、クロスポビドン、クロスポビドンコポリマー等の合成高分子等が挙げることができる。上記から選ばれる1種を単独で使用しても、2種以上を併用してもよい。 Disintegrants include croscarmellose sodium, carmellose, carmellose calcium, carmellose sodium, celluloses such as low-substituted hydroxypropyl cellulose, carboxymethyl starch sodium, hydroxypropyl starch, rice starch, wheat starch, corn starch, potato Examples thereof include starches such as starch and partially pregelatinized starch, celluloses such as crystalline cellulose and powdered cellulose, and synthetic polymers such as crospovidone and crospovidone copolymer. One kind selected from the above may be used alone, or two or more kinds may be used in combination.
流動化剤としては、含水二酸化ケイ素、軽質無水ケイ酸等のケイ素化合物類を挙げることができる。それを単独で使用しても、2種以上を併用してもよい。 Examples of the fluidizing agent include silicon compounds such as hydrous silicon dioxide and light anhydrous silicic acid. It may be used alone or in combination of two or more.
滑沢剤としては、ステアリン酸マグネシウム、ステアリン酸カルシウム、ステアリン酸、ショ糖脂肪酸エステル、タルク、メタケイ酸アルミン酸マグネシウム、含水二酸化ケイ素、軽質無水ケイ酸等が挙げることができる。上記から選ばれる1種を単独で使用しても、2種以上を併用してもよい。ここで、水への溶解度が0.0001〜100mg/cm3の範囲にある活性成分に対しては、溶出性への影響が少なく、打錠粉末の臼杵への付着を防止できる点で、ショ糖脂肪酸エステル、タルク、軽質無水ケイ酸から選ばれる1種以上を用いるのが好ましい。また、溶出性への影響が少なく、打錠粉末の流動性確保、及び圧縮成形物の破断荷重を増強できる点で、メタケイ酸アルミン酸マグネシウム、含水二酸化ケイ素、軽質無水ケイ酸から選ばれる1種以上を用いるのが好ましい。なかでも、ショ糖脂肪酸エステル、タルク、軽質無水ケイ酸から選択される1種以上と、メタケイ酸アルミン酸マグネシウムとの組み合わせを用いると、打錠粉末の臼杵への付着防止、打錠粉末の流動性確保、圧縮成形物の破断荷重の増強を同時に満たすことができるので好ましい。また、水への溶解度が100〜100000mg/cm3の範囲にある活性成分に対しては、溶出性への影響が少なく、打錠粉末の臼杵への付着を防止できる点で、ステアリン酸マグネシウム、ステアリン酸カルシウム、ステアリン酸、ショ糖脂肪酸エステル、タルク、軽質無水ケイ酸から選ばれる1種以上を用いるのが好ましい。また、溶出性への影響が少なく、打錠粉末の流動性確保、及び圧縮成形物の破断荷重を増強できる点で、メタケイ酸アルミン酸マグネシウム、含水二酸化ケイ素、軽質無水ケイ酸から選ばれる1種以上を用いるのが好ましい。なかでも、ステアリン酸マグネシウム、ステアリン酸カルシウム、ステアリン酸、ショ糖脂肪酸エステル、タルク、軽質無水ケイ酸から選択される1種以上と、メタケイ酸アルミン酸マグネシウムとの組み合わせを用いると、打錠粉末の臼杵への付着防止、打錠粉末の流動性確保、圧縮成形物の破断荷重の増強を同時に満たすことができるので好ましい。 Examples of the lubricant include magnesium stearate, calcium stearate, stearic acid, sucrose fatty acid ester, talc, magnesium aluminate metasilicate, hydrous silicon dioxide, light anhydrous silicic acid and the like. One kind selected from the above may be used alone, or two or more kinds may be used in combination. Here, the active ingredient having a solubility in water in the range of 0.0001 to 100 mg / cm 3 has little influence on the dissolution property, and can prevent the tableting powder from adhering to the mortar. It is preferable to use one or more selected from sugar fatty acid esters, talc and light anhydrous silicic acid. In addition, one kind selected from magnesium aluminate metasilicate, hydrous silicon dioxide, and light anhydrous silicic acid in that it has little influence on dissolution and can secure the fluidity of the tableting powder and enhance the breaking load of the compression molded product. It is preferable to use the above. In particular, when a combination of one or more selected from sucrose fatty acid ester, talc, and light anhydrous silicic acid and magnesium aluminate metasilicate is used, the tableting powder is prevented from adhering to the mortar and the flow of the tableting powder. It is preferable because it can satisfy both the securing of the property and the enhancement of the breaking load of the compression molded product. In addition, with respect to an active ingredient having a solubility in water in the range of 100 to 100,000 mg / cm 3 , magnesium stearate, which has little influence on dissolution and can prevent tableting powder from adhering to the mortar, It is preferable to use one or more selected from calcium stearate, stearic acid, sucrose fatty acid ester, talc, and light anhydrous silicic acid. In addition, one kind selected from magnesium aluminate metasilicate, hydrous silicon dioxide, and light anhydrous silicic acid in that it has little influence on dissolution and can secure the fluidity of the tableting powder and enhance the breaking load of the compression molded product. It is preferable to use the above. Among them, when using a combination of at least one selected from magnesium stearate, calcium stearate, stearic acid, sucrose fatty acid ester, talc, and light anhydrous silicic acid, and magnesium aluminate metasilicate, the mortar of a tableting powder This is preferable because it can simultaneously prevent adhesion to the tablet, ensure fluidity of the tableting powder, and increase the breaking load of the compression molded product.
矯味剤としては、グルタミン酸、フマル酸、コハク酸、クエン酸、クエン酸ナトリウム、酒石酸、リンゴ酸、アスコルビン酸、塩化ナトリウム、1−メントール等を挙げることができる。上記から選ばれる1種を単独で使用しても、2種以上を併用してもよい。 Examples of the corrigent include glutamic acid, fumaric acid, succinic acid, citric acid, sodium citrate, tartaric acid, malic acid, ascorbic acid, sodium chloride, 1-menthol and the like. One kind selected from the above may be used alone, or two or more kinds may be used in combination.
香料としては、オレンジ、バニラ、ストロベリー、ヨーグルト、メントール、ウイキョウ油、ケイヒ油、トウヒ油、ハッカ油等の油類、緑茶末等を挙げることができ、上記から選ばれる1種を単独で使用しても、2種以上を併用してもよい。 Examples of the fragrances include oils such as orange, vanilla, strawberry, yogurt, menthol, fennel oil, cinnamon oil, spruce oil, mint oil, green tea powder and the like, and one kind selected from the above is used alone. Or you may use 2 or more types together.
着色剤としては、食用赤色3号、食用黄色5号、食用青色1号等の食用色素、銅クロロフィンナトリウム、酸化チタン、リボフラビンなどを挙げることができる。上記から選ばれる1種を単独で使用しても、2種以上を併用してもよい。 Examples of the colorant include food colors such as food red No. 3, food yellow No. 5, and food blue No. 1, copper chlorofin sodium, titanium oxide, and riboflavin. One kind selected from the above may be used alone, or two or more kinds may be used in combination.
甘味剤としては、アスパルテーム、サッカリン、ギリチルリチン酸二カリウム、ステビア、マルトース、マルチトール、水飴、アマチャ末等を挙げることができる。上記から選ばれる1種を単独で使用しても、2種以上を併用してもよい。 Examples of the sweetening agent include aspartame, saccharin, dipotassium gilicyrrhizinate, stevia, maltose, maltitol, starch syrup, and amateur powder. One kind selected from the above may be used alone, or two or more kinds may be used in combination.
錠剤とするための圧縮成形機としては、例えば、静圧プレス機、シングルパンチ打錠機、ロータリー打錠機、多層錠剤成形機、有核打錠等の圧縮機を使用でき、特に制限されない。 As a compression molding machine for making a tablet, for example, a compression machine such as a static pressure press machine, a single punch tableting machine, a rotary tableting machine, a multilayer tablet molding machine, and a dry tableting machine can be used, and there is no particular limitation.
また、本発明の効果を損なわない限り、錠剤それ自体に、活性成分の溶出性の制御や味のマスキングや防湿等の目的でコーティングが施されていてもよい。コーティング剤としては、例えばセルロース系コーティング剤(エチルセルロース、ヒドロキシプロピルメチルセルロースフタレート、カルボキシメチルエチルセルロース、ヒドロキシプロピルメチルセルロースアセテートサクシネート、セルロースアセテートサクシネート、セルロースアセテートフタレート、セルロースアセテート等)、アクリルポリマー系コーティング剤(オイドラギットRS、オイドラギットL、オイドラギットNE等)、シェラック、シリコン樹脂等から選択される1種以上を用いることができる。これらのコーティング剤の使用方法は公知の方法を用いることができる。コーティング剤は有機溶媒に溶解しても、水に懸濁させて用いてもよい。 Moreover, as long as the effect of the present invention is not impaired, the tablet itself may be coated for the purpose of controlling the dissolution of the active ingredient, masking the taste, preventing moisture, and the like. Examples of the coating agent include cellulose-based coating agents (ethylcellulose, hydroxypropylmethylcellulose phthalate, carboxymethylethylcellulose, hydroxypropylmethylcellulose acetate succinate, cellulose acetate succinate, cellulose acetate phthalate, cellulose acetate, etc.), acrylic polymer coating agents (eudragit) One or more selected from RS, Eudragit L, Eudragit NE, etc.), shellac, silicon resin and the like can be used. A known method can be used as a method of using these coating agents. The coating agent may be dissolved in an organic solvent or suspended in water.
以下、実施例により本発明を詳細に説明するが、これらは本発明の範囲を限定するものではない。なお、実施例、比較例における各試験法、及び物性の測定方法は以下の通りである。 EXAMPLES Hereinafter, although an Example demonstrates this invention in detail, these do not limit the scope of the present invention. In addition, each test method in an Example and a comparative example and the measuring method of a physical property are as follows.
(1)溶出試験
第14改正日本薬局方に記載の溶出試験法の第一法に準拠する方法で、試験液に日本薬局方記載の第1液(pH1.2、以下、「第1液」と略すことがある)を用い、試験液900cm3、パドル回転数50rpm、試験液温度37±0.5℃の条件で行う。
(1) Dissolution test The first solution described in the Japanese Pharmacopoeia (pH 1.2, hereinafter referred to as “first solution”) in accordance with the first method of the dissolution test method described in the 14th revised Japanese Pharmacopoeia. The test solution is 900 cm 3 , the paddle rotation speed is 50 rpm, and the test solution temperature is 37 ± 0.5 ° C.
(2)粒度分布32μmより小さい粒子数
JIS篩の目開き32μmを利用し、測定試料5gを5分間エアージェットシーブで篩分した時、篩を通過する測定試料の重量百分率より求める。
(2) Particle size distribution The number of particles smaller than 32 μm Using a JIS sieve opening of 32 μm, when 5 g of a measurement sample is sieved with an air jet sieve for 5 minutes, the particle size distribution is obtained from the weight percentage of the measurement sample passing through the sieve.
(3)粒度分布75μmより小さい粒子数
JIS篩の目開き75μmを利用し、測定試料10gを5分間エアージェットシーブで篩分した時、篩を通過する測定試料の重量百分率より求める。
(3) Number of particles smaller than 75 μm in particle size distribution Using 75 μm of JIS sieve mesh, when 10 g of a measurement sample is sieved with an air jet sieve for 5 minutes, it is determined from the weight percentage of the measurement sample passing through the sieve.
(4)粒度分布 平均粒径(μm)
JIS篩目開き500μm、300μm、250μm、212μm、150μm篩を用い、測定試料20gを15分間ロータップ式篩振盪機(平工作所製シーブシェーカーA型)で篩分する。次に、150μm篩を篩過した測定試料5gを、JIS篩目開き75μmを用い、5分間エアージェットシーブで篩分する。更に、150μm篩を篩過した測定試料5gを、JIS篩目開き32μmを用い、5分間エアージェットシーブで篩分する。各篩の篩上重量百分率[%]を求め、累積重量百分率が50%の時の粒子径として求める。
(4) Particle size distribution Average particle size (μm)
Using a JIS sieve opening of 500 μm, 300 μm, 250 μm, 212 μm, and 150 μm, 20 g of the measurement sample is sieved for 15 minutes with a low-tap type sieve shaker (Sieve Shaker A type manufactured by Hira Kogakusho). Next, 5 g of a measurement sample obtained by sieving a 150 μm sieve is sieved with an air jet sieve for 5 minutes using a JIS sieve opening of 75 μm. Further, 5 g of a measurement sample obtained by sieving a 150 μm sieve is sieved with an air jet sieve for 5 minutes using a JIS sieve opening of 32 μm. The weight percentage [%] on the sieve of each sieve is obtained, and the particle diameter is obtained when the cumulative weight percentage is 50%.
(5)安息角(°)
杉原式安息角測定器(薬剤学27、p.260、1965年)を使用して求める。
(5) Angle of repose (°)
Obtained using a Sugihara-type angle of repose measuring instrument (Pharmacology 27, p.260, 1965).
(6)嵩密度(g/cc)
スコットボリュームメーター(筒井理化学機器株式会社)を用いて測定する。粉体試料を定量フィーダーを用いて2−3分かけて測定容器内に粉体があふれるまで流下させる。次いで容器の上部に堆積した過剰量の粉体をすり落とし、また、容器の側面に付着した試料を除去する。その後、容器に疎充填された粉体重量を量る。
容器に疎充填された粉体重量を測定容器の容積で除した値を嵩密度とする。
(6) Bulk density (g / cc)
Measured using a Scott volume meter (Tsutsui Rikenki Co., Ltd.). The powder sample is allowed to flow down for 2-3 minutes using a quantitative feeder until the powder overflows into the measurement container. Next, an excessive amount of powder deposited on the top of the container is scraped off, and the sample adhering to the side surface of the container is removed. Thereafter, the weight of the powder loosely filled in the container is measured.
The value obtained by dividing the weight of the powder loosely packed in the container by the volume of the measurement container is defined as the bulk density.
(7)保水量(%)
乾燥した澱粉W0(g)(約1g)を、約15cm3の20℃±5℃の純水が入った50cm3遠沈管へ少しずつ入れ、かき混ぜながら透明〜半透明になるまで純水に分散させる。50cm3沈降管の7割程度になるよう20℃±5℃の純水を追加して遠心分離(2000G、10分)する。
遠心分離終了後すぐに分離した上層を切り捨てた後、下層に残る重量W(g)(澱粉+澱粉が保持する純水量)から下式(4)により保水量を求める。
保水量(%)=100×(W−W0)/W0・・・・(4)
(7) Water retention (%)
Dried starch W0 (g) (about 1 g) is gradually put into a 50 cm 3 centrifuge tube containing about 15 cm 3 of 20 ° C. ± 5 ° C. pure water, and dispersed in pure water while stirring until it becomes transparent to translucent. Let Add pure water at 20 ° C. ± 5 ° C. and centrifuge (2000 G, 10 minutes) so that it becomes about 70% of the 50 cm 3 sedimentation tube.
The upper layer separated immediately after the end of the centrifugation is discarded, and the water retention amount is determined by the following formula (4) from the weight W (g) remaining in the lower layer (starch + pure water amount retained by the starch).
Water retention amount (%) = 100 × (W−W0) / W0 (4)
(8)ゲル押込み荷重(g)
処方粉末0.5gを静圧プレス(MODEL−1321DW CREEP/アイコーエンジニアリング株式会社製)を用いて50MPaの圧縮力で成形して得られる直径1.13cmの円柱状成形体を20℃±5℃の純水中に4時間浸漬しゲル化させた後、レオメーター(RHEONER、RE−33005、YAMADEN製)を使用し、0.1mm/secの速度で3mm直径の円柱状アダプターを押込んだ時の最大荷重と定義する。最大荷重とはゲル層の破断があれば破断時の、破断がなければアダプターがゲル化した円柱状成形体に5mm侵入するまでに示した最大の荷重値とする。成形体5個の平均値を算出する。
(8) Gel indentation load (g)
Formulation powder 0.5g static pressure press (MODEL-1321DW CREEP / Aiko Engineering Co., Ltd.) forming a cylindrical shaped body having a diameter of 1.1 3 cm obtained by 20 ° C. ± the compression force of 50MPa using a 5 After gelling by immersion in pure water at 4 ° C. for 4 hours, a 3 mm diameter cylindrical adapter was pushed in at a rate of 0.1 mm / sec using a rheometer (RHEONER, RE-33005, manufactured by YAMADEN). It is defined as the maximum load at the time. The maximum load is the maximum load value at the time of breaking if the gel layer is broken, or the maximum load value until the adapter enters 5 mm into the gelled cylindrical molded body if there is no breaking. The average value of 5 molded bodies is calculated.
(9)水溶性成分量(%)
澱粉1gに20℃±5℃の純水99gを加えてマグネチックスターラーで2時間攪拌して分散させ、得られた分散液の40cm3を50cm3の遠沈管に移し、5000Gで15分間遠心分離し、この上澄液30cm3を秤量瓶に入れ、110℃で一定重量になるまで乾燥して乾燥重量(g)を測定する。
また、澱粉1gを110℃で一定重量になるまで乾燥して絶乾重量(g)を測定する。これらの測定値及び式(2)により求めた値を水溶性成分量と定義する。
(9) Amount of water-soluble component (%)
99 g of pure water at 20 ° C. ± 5 ° C. is added to 1 g of starch and dispersed by stirring for 2 hours with a magnetic stirrer. 40 cm 3 of the resulting dispersion is transferred to a 50 cm 3 centrifuge tube and centrifuged at 5000 G for 15 minutes. Then, 30 cm 3 of the supernatant is put into a weighing bottle, dried at 110 ° C. until a constant weight is obtained, and the dry weight (g) is measured.
Further, 1 g of starch is dried at 110 ° C. to a constant weight, and the absolute dry weight (g) is measured. These measured values and the value obtained by the equation (2) are defined as the amount of water-soluble component.
(10)澱粉の水中での沈降体積(cm3/g)
澱粉1.0gを20±5℃の純水に分散させて100cm3の沈降管に移し、全量を100cm3とし、16時間放置した後、上下に分かれた下層の容積V(cm3)と澱粉1.0gの乾燥重量(g)を測定し、下式(5)より算出する。
澱粉の水中での沈降体積(cm3/g)=V/加工澱粉の乾燥重量・・・・(5)
(10) Precipitation volume of starch in water (cm 3 / g)
1.0 g of starch is dispersed in pure water at 20 ± 5 ° C. and transferred to a 100 cm 3 sedimentation tube. The total amount is 100 cm 3 and left for 16 hours, and then the volume V (cm 3 ) of the lower layer divided into upper and lower and starch A dry weight (g) of 1.0 g is measured and calculated from the following formula (5).
Sedimentation volume of starch in water (cm 3 / g) = V / dry weight of processed starch (5)
澱粉粉末A
澱粉質原料を水存在下60〜150℃で加熱し、澱粉質原料の澱粉粒子の一部又は全てを膨潤させる工程、及び、次いで乾燥させることにより、1箇所以上がくぼんだ構造である澱粉粒子と、その澱粉粒子の外部に存在するアミロースとアミロペクチンとを含有する澱粉粉末Aを得た。
Starch powder A
Starch particles having a structure in which one or more portions are recessed by heating a starch raw material at 60 to 150 ° C. in the presence of water to swell part or all of the starch particles of the starch raw material, and then drying. And starch powder A containing amylose and amylopectin existing outside the starch particles.
[実施例1]
膨潤度が1.7の澱粉粉末Aとサリチル酸ナトリウム(エーピーアイコーポレーション社製)、結晶セルロース(「セオラス」UF−711、旭化成ケミカルズ株式会社製)、スーパータブ(旭化成ケミカルズ社製)、軽質無水ケイ酸(アエロジル200、日本アエロジル社製)とを5/70/20/5/0.5の重量比になるように均一に混合した。この混合物を、ロータリー打錠(クリーンプレス・コレクト12HUK)を用いて硬度6kgfとなる圧力で圧縮し、直径0.8cm、重量0.18gの錠剤を得た。圧縮成形で得られた錠剤と、日本薬局方記載の第1液(pH1.2)の試験液を用いて溶出試験を行い、サリチル酸ナトリウムの薬物溶出パターンを測定した。溶出試験の結果を図1に示した。得られた錠剤は湿式顆粒圧縮法により調製した錠剤と同程度の溶出特性を示した。
[Example 1]
Starch powder A having a swelling degree of 1.7, sodium salicylate (manufactured by API Corporation), crystalline cellulose (“Theorus” UF-711, manufactured by Asahi Kasei Chemicals Corporation), super tab (manufactured by Asahi Kasei Chemicals Corporation), light anhydrous silica Acid (Aerosil 200, manufactured by Nippon Aerosil Co., Ltd.) was uniformly mixed so as to have a weight ratio of 5/70/20/5 / 0.5. This mixture was compressed using a rotary tableting (clean press collect 12HUK) at a pressure of 6 kgf to obtain a tablet having a diameter of 0.8 cm and a weight of 0.18 g. A dissolution test was performed using tablets obtained by compression molding and a test solution of the first solution (pH 1.2) described in the Japanese Pharmacopoeia, and the drug dissolution pattern of sodium salicylate was measured. The results of the dissolution test are shown in FIG. The obtained tablets exhibited dissolution characteristics comparable to those of tablets prepared by the wet granule compression method.
湿式顆粒圧縮法により得られた錠剤の処方
処方成分及びその混合比を、サリチル酸ナトリウム(エーピーアイコーポレーション社製)、ファーマトース200メッシュ(DMV社製)、コーンスターチ(日澱化学社製)、結晶セルロース(「セオラス」PH−101、旭化成ケミカルズ株式会社製)、ヒドロキシプロピルセルロースLタイプ(日本曹達社製)=70/15/5/10/0.75とし、湿式顆粒打錠法により、錠剤を調製した。本錠剤の溶出試験の結果は、図1及び図2に示されている。
Formulation of tablets obtained by the wet granule compression method The formulation components and the mixing ratio thereof are sodium salicylate (manufactured by API Corporation), pharmatose 200 mesh (manufactured by DMV), corn starch (manufactured by Nissho Chemical Co., Ltd.), crystalline cellulose ("Seolus" PH-101, manufactured by Asahi Kasei Chemicals Corporation), hydroxypropylcellulose L type (manufactured by Nippon Soda Co., Ltd.) = 70/15/5/10 / 0.75 did. The results of the dissolution test of this tablet are shown in FIG. 1 and FIG.
直接打錠法により得られた錠剤の処方
処方成分及びその混合比を、サリチル酸ナトリウム(エーピーアイコーポレーション社製)、結晶セルロース(「セオラス」UF−711、旭化成ケミカルズ株式会社製)、スーパータブ(旭化成ケミカルズ社製)、アエロジル200(日本アエロジル社製)=70/20/10/0.5とし、直接打錠法により、錠剤を調製した。本錠剤の溶出試験の結果は、図1及び図2に示されている。
Formulation of Tablets Obtained by Direct Tableting Method The prescription ingredients and the mixing ratio thereof are as follows: sodium salicylate (manufactured by API Corporation), crystalline cellulose ("Seolas" UF-711, manufactured by Asahi Kasei Chemicals Corporation), super tab (Asahi Kasei) Chemicals), Aerosil 200 (Nihon Aerosil Co., Ltd.) = 70/20/10 / 0.5, and tablets were prepared by direct compression. The results of the dissolution test of this tablet are shown in FIG. 1 and FIG.
[比較例1]
膨潤度が約1.0のヒドロキシプロピルセルロースLタイプの微粉グレード(日本曹達社製)とサリチル酸ナトリウム(エーピーアイコーポレーション社製)、結晶セルロース(「セオラス」UF−711、旭化成ケミカルズ株式会社製)、軽質無水ケイ酸(アエロジル200、日本アエロジル社製)とを12/70/18/0.5の重量比になるように均一に混合した。この混合物を実施例1と同様に操作して、圧縮成形で得られた錠剤の溶出試験を行った。溶出試験の結果を図2に示した。得られた錠剤は薬物の溶出を少しは制御できるものの、湿式顆粒圧縮法により調製した錠剤と同程度の溶出特性は示さなかった。
[Comparative Example 1]
Hydroxypropyl cellulose L type fine powder grade (Nippon Soda Co., Ltd.) and sodium salicylate (manufactured by API Corporation), crystalline cellulose ("Seolus" UF-711, Asahi Kasei Chemicals Corporation) Light anhydrous silicic acid (Aerosil 200, manufactured by Nippon Aerosil Co., Ltd.) was uniformly mixed so as to have a weight ratio of 12/70/18 / 0.5. This mixture was operated in the same manner as in Example 1, and a tablet obtained by compression molding was subjected to a dissolution test. The results of the dissolution test are shown in FIG. Although the obtained tablets could slightly control the dissolution of the drug, they did not exhibit the same dissolution characteristics as tablets prepared by the wet granule compression method.
[比較例2]
膨潤度が約1.9のヒドロキシプロピルメチルセルロース(METOLOSE 90SH−100SR、信越化学工業社製)とサリチル酸ナトリウム(エーピーアイコーポレーション社製)、結晶セルロース(「セオラス」UF−711、旭化成ケミカルズ株式会社製)、軽質無水ケイ酸(アエロジル200、日本アエロジル社製)とを12/70/18/0.5の重量比になるように均一に混合した。この混合物を実施例1と同様に操作して、圧縮成形で得られた錠剤の溶出試験を行った。得られた錠剤は薬物の溶出を制御できず、湿式顆粒圧縮法により調製した錠剤と同程度の溶出特性は示さなかった。
[Comparative Example 2]
Hydroxypropyl methylcellulose (METOLOSE 90SH-100SR, manufactured by Shin-Etsu Chemical Co., Ltd.) and sodium salicylate (manufactured by API Corporation), crystalline cellulose ("Theorus" UF-711, manufactured by Asahi Kasei Chemicals Corporation) having a swelling degree of about 1.9 Then, light anhydrous silicic acid (Aerosil 200, manufactured by Nippon Aerosil Co., Ltd.) was uniformly mixed so as to have a weight ratio of 12/70/18 / 0.5. This mixture was operated in the same manner as in Example 1, and a tablet obtained by compression molding was subjected to a dissolution test. The obtained tablets could not control the dissolution of the drug, and did not exhibit the same dissolution characteristics as tablets prepared by the wet granule compression method.
[比較例3]
膨潤度が約2.1の部分アルファー化澱粉(PCS PC−10、旭化成ケミカルズ社製)とサリチル酸ナトリウム(エーピーアイコーポレーション社製)、結晶セルロース(「セオラス」UF−711、旭化成ケミカルズ株式会社製)、軽質無水ケイ酸(アエロジル200、日本アエロジル社製)とを12/70/18/0.5の重量比になるように均一に混合した。この混合物を実施例1と同様に操作して、圧縮成形で得られた錠剤の溶出試験を行った。得られた錠剤は薬物の溶出を制御できず、逆に促進させる結果となり、湿式顆粒圧縮法により調製した錠剤と同程度の溶出特性は示さなかった。
Partially pregelatinized starch having a degree of swelling of about 2.1 (PCS PC-10, manufactured by Asahi Kasei Chemicals), sodium salicylate (manufactured by API Corporation), crystalline cellulose ("Theorus" UF-711, manufactured by Asahi Kasei Chemicals) Then, light anhydrous silicic acid (Aerosil 200, manufactured by Nippon Aerosil Co., Ltd.) was uniformly mixed so as to have a weight ratio of 12/70/18 / 0.5. This mixture was operated in the same manner as in Example 1, and a tablet obtained by compression molding was subjected to a dissolution test. The obtained tablet could not control the dissolution of the drug, and on the contrary, it resulted in acceleration, and did not show the same dissolution characteristics as the tablet prepared by the wet granule compression method.
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