JP2759802B2 - Drug coating materials - Google Patents
Drug coating materialsInfo
- Publication number
- JP2759802B2 JP2759802B2 JP63218928A JP21892888A JP2759802B2 JP 2759802 B2 JP2759802 B2 JP 2759802B2 JP 63218928 A JP63218928 A JP 63218928A JP 21892888 A JP21892888 A JP 21892888A JP 2759802 B2 JP2759802 B2 JP 2759802B2
- Authority
- JP
- Japan
- Prior art keywords
- coating
- sugar
- syrup
- calcium lactate
- drug
- 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.)
- Expired - Lifetime
Links
Landscapes
- Medicinal Preparation (AREA)
Description
【発明の詳細な説明】 産業上の利用分野 本発明は、薬剤被覆用組成物、それを用いた被覆薬剤
及び被覆方法に関する。Description: TECHNICAL FIELD The present invention relates to a drug coating composition, a coating drug using the same, and a coating method.
従来の技術 従来、糖衣錠の製造に関しては、シロップ中にゼラチ
ン、アラビアゴム末等の結合剤を配合し、糖衣錠の強度
を保持することが、一般的方法として用いられてきた。
しかしながら、この方法ではゼラチン等の変質により、
糖衣錠の崩壊時間が経時的に遅延する等の問題があり、
ゼラチン等に代わる結合剤の探索が種々なされてきた
（特公昭56−10287号公報、特開昭59−219220号公報な
ど） 一方、古くからの糖衣技術では、シロップと散布剤と
を交互に振り掛けたり、また糖衣錠表面を美麗に仕上げ
るため、数種類の異なった組成のシロップを用意し、こ
れらを適宜組合せてコーティングするなど、複雑且つ熟
練を要する操作が必要であった。これに鑑み、乳酸カル
シウムを配合した単一のシロップにより、極めて簡単な
操作で美麗な糖衣錠を製作する方法（一液糖衣法）が開
発され（特公昭48−37815号公報）、糖衣技術は一大転
機を迎えることになった。2. Description of the Related Art Conventionally, in the production of sugar-coated tablets, it has been used as a general method to maintain the strength of sugar-coated tablets by blending a binder such as gelatin and gum arabic powder into a syrup.
However, in this method, due to deterioration of gelatin and the like,
There are problems such as the disintegration time of sugar-coated tablets being delayed with time,
Various binders have been searched for in place of gelatin and the like (Japanese Patent Publication No. 56-10287, Japanese Patent Application Laid-Open No. 59-219220, etc.) On the other hand, in the old sugar coating technique, syrup and dusting agent are alternately sprinkled. In addition, complicated and skillful operations such as preparing several types of syrups having different compositions and coating them in an appropriate combination were required to finish the surface of the sugar-coated tablet beautifully. In view of this, a method for producing a beautiful sugar-coated tablet (single-pack sugar coating method) by a very simple operation using a single syrup containing calcium lactate has been developed (Japanese Patent Publication No. 48-37815). The turning point has come.
発明が解決しようとする課題 しかしながら、この方法によっても経時的な変質を完
全に防止するには至らず、またこの方法では、コーティ
ング条件によっては糖衣錠表面に微細な亀裂を発生させ
る危険があった。Problems to be Solved by the Invention However, even with this method, deterioration over time has not been completely prevented, and with this method, depending on the coating conditions, there is a risk of generating fine cracks on the dragee surface.
そこで発明者らは、これらの欠点を補うべく鋭意研究
し、本発明を完成した。Thus, the inventors have conducted intensive studies to compensate for these drawbacks and completed the present invention.
本発明の目的は、強度に優れ、且つ経時的変質をおこ
しにくい糖衣錠となる薬剤被覆組成物、それを極めて簡
単な操作により製造する製造法、前記組成物を用いて被
覆した薬剤及びその被覆方法を抵抗することにある。SUMMARY OF THE INVENTION An object of the present invention is to provide a drug-coated composition which is a sugar-coated tablet which is excellent in strength and hardly causes deterioration over time, a production method for producing the same by an extremely simple operation, a drug coated using the composition and a method for coating the same. Is to resist.
課題を解決するための手段 本発明を概説すれば、本発明の第１の発明は、薬剤被
覆用組成物に関する発明であって、糖衣全工程を少なく
とも糖類及び乳酸カルシウムを含む単一のシロップで被
覆するための薬剤被覆用組成物において、糖類と乳酸カ
ルシウムと懸濁性粉末としての結晶セルロースを必須成
分として含み、実質的に結合剤を含まないシロップであ
る薬剤被覆用組成物に関する。本発明の第２の発明は、
糖衣全工程を少なくとも糖類及び乳酸カルシウムを含む
単一のシロップからなる被覆用組成物で被覆されている
被覆薬剤において、糖類と乳酸カルシウムと懸濁性粉末
として結晶セルロースを必須成分として含み、実質的に
結合剤を含まないシロップである薬剤被覆用組成物のみ
で被覆されている被覆薬剤であり、本発明の第３の発明
は糖衣全工程を少なくとも糖類及び乳酸カルシウムを含
む単一のシロップからなる被覆用組成物で被覆する薬剤
被覆方法において、糖類と乳酸カルシウムと懸濁性粉末
としての結晶セルロースを必須成分として含み、実質的
に結合剤を含まないシロップである薬剤被覆用組成物の
みで被覆する薬剤被覆方法である。Means for Solving the Problems To summarize the present invention, a first invention of the present invention relates to a composition for drug coating, wherein the entire sugar-coating step is carried out with a single syrup containing at least sugar and calcium lactate. The present invention relates to a drug coating composition which is a syrup that contains sugars, calcium lactate, and crystalline cellulose as a suspending powder as essential components, and is substantially free of a binder. According to a second aspect of the present invention,
In a coating agent in which the entire sugar coating process is coated with a coating composition comprising a single syrup containing at least a sugar and calcium lactate, the coating agent comprises crystalline sugar as essential components as sugars, calcium lactate and a suspendable powder, A coating agent coated only with a drug coating composition that is a syrup containing no binder, and the third invention of the present invention comprises a single syrup containing at least sugar and calcium lactate in the entire sugar coating process. In a drug coating method of coating with a coating composition, the drug is coated with only a drug coating composition which is a syrup substantially containing no saccharide, calcium lactate, and crystalline cellulose as a suspendable powder as essential components, and is substantially free of a binder. This is a chemical coating method.
本発明の各発明が共通する点は、糖衣全工程を少なく
とも糖類及び乳酸カルシウムを含む単一のシロップから
なる被覆用組成物において、糖類と乳酸カルシウムと懸
濁性粉末としての結晶セルロースを必須成分として含
み、実質的に結合剤を含まないシロップである薬剤被覆
用組成物にあります。本願の各発明がこの構成を採用し
たことにより、従来では考えもつかなかった作用効果を
もたらしたものであります。The common feature of each invention of the present invention is that in the coating composition consisting of a single syrup containing at least sugar and calcium lactate in the entire sugar coating process, sugar, calcium lactate and crystalline cellulose as a suspendable powder are essential components. As a syrup that is substantially free of binders. The adoption of this configuration in each of the inventions of the present application has brought effects and effects that could not be thought of before.
すなわち、本発明の第一の要点は、乳酸カルシウムを
配合したシロップを用いる糖衣法において、いわゆる結
合剤を配合しない時、糖衣表面に発生する微細な亀裂の
発生率が極めて小さくなることを見出したことにある。
この時、シロップ中に水不溶性成分が多いほど、更にこ
の傾向が強くなることを併せて発見した。That is, the first essential point of the present invention is that, in a sugar coating method using a syrup containing calcium lactate, when a so-called binder is not added, it has been found that the incidence of fine cracks generated on the sugar coating surface is extremely small. It is in.
At this time, it was also discovered that the more water-insoluble components in the syrup, the stronger this tendency.
次に、本発明の第二の要点はシロップ中に結合剤を全
く配合しないで糖衣錠の強度を補強した点にある。一般
にシロップ中に結合剤を全く配合しない場合、糖衣錠の
強度が不足する。しかし、発明者らはシロップ中にタル
ク等の懸濁性粉末を多く配合すると、錠剤の落下衝撃に
対する強度が著しく増大することを発見した。また、さ
らに適度の結晶セルロースを配合すると、小さな衝撃が
積み重なった場合に発生する糖衣錠表面の剥離に対して
も強くなることを発見し、本発明を完成したのである。Next, the second essential point of the present invention is that the strength of the sugar-coated tablet is reinforced without incorporating any binder in the syrup. In general, when no binder is incorporated in a syrup, the strength of a sugar-coated tablet is insufficient. However, the present inventors have found that when a large amount of suspending powder such as talc is incorporated into a syrup, the strength of the tablet against drop impact is significantly increased. Further, they have found that the addition of an appropriate amount of crystalline cellulose increases the resistance to the peeling of the sugar-coated tablet surface which occurs when small impacts are accumulated, and thus completed the present invention.
本願発明の薬剤被覆組成物に関し要約すれば、次の通
りである。本願の被覆組成物中の必須構成要件として
は、被覆液中に乳酸カルシウムを0.5〜10％、望ましく
は２〜５％含有し、かつ懸濁性粉末として結晶セルロー
スを１〜８％、望ましくは２〜５％含有することであ
る。シロップ液となる糖類として代表的なものは、ショ
糖、グルコース、ソルビット、マンニット等が挙げられ
る。その使用量は被覆液中40〜70％、好ましくは50〜60
％である。The summary of the drug coating composition of the present invention is as follows. The essential constituents in the coating composition of the present invention are that the coating solution contains 0.5 to 10%, preferably 2 to 5% of calcium lactate, and 1 to 8%, preferably 1 to 8%, of crystalline cellulose as a suspension powder. 2 to 5%. Representative saccharides that can be used as a syrup include sucrose, glucose, sorbitol, mannitol, and the like. Its use amount is 40 to 70% in the coating liquid, preferably 50 to 60%.
%.
本願発明で不要としている結合剤とは、ゼラチン、ア
ラビアゴム末に代表される糖衣用接合剤、及びヒドロキ
シプロピルセルロース、ヒドロキシプロピルメチルセル
ロース、プルランなどの被膜形成能のある水溶性高分子
物質等を指し、シロップ組成中にはこれらの結合剤を実
質的に含まないことが特徴である。The binder unnecessary in the present invention refers to gelatin, a bonding agent for sugar coating represented by gum arabic powder, and a water-soluble polymer substance capable of forming a film such as hydroxypropylcellulose, hydroxypropylmethylcellulose, and pullulan. The syrup composition is characterized by being substantially free of these binders.
本発明において結合剤は本来一切不要であるが、実質
的に含まないとは結合剤として用をなさない微量の、例
えば0.1％以下の添加を包含するものである。In the present invention, the binder is not required at all, but it means that the addition of a very small amount, for example, 0.1% or less, which does not serve as a binder does not substantially include the binder.
また、シロップ中に防水基剤、可塑剤、光線遮断剤、
顔料、着色剤、安定化剤、矯味剤、矯臭剤等を配合する
ことについては必要に応じ行われることであって特にこ
れを制限するものではない。そして、前記組成物は、乳
酸カルシウム、結晶セルロース及び糖類を混合したもの
を溶剤に溶解分散して用いるか、シロップ中に乳酸カル
シウム、結晶セルロースを粉末を溶解分解して使用す
る。Also, in the syrup waterproof base, plasticizer, light blocking agent,
The addition of a pigment, a colorant, a stabilizer, a flavoring agent, a flavoring agent, and the like is performed as needed, and is not particularly limited. The composition is prepared by dissolving and dispersing a mixture of calcium lactate, crystalline cellulose and saccharide in a solvent, or dissolving and dissolving calcium lactate and crystalline cellulose in a syrup.
本願の薬剤被覆用組成物による被覆は通常の方法によ
って行われる。本願発明は一液糖衣法として使用される
ものである。また、製造方法においての溶剤は、通常蒸
留水を使用するが一部に有機溶剤を用いることも可能で
ある。Coating with the composition for drug coating of the present application is performed by a usual method. The present invention is used as a one-pack sugar coating method. In addition, distilled water is usually used as a solvent in the production method, but an organic solvent can be partially used.
以下に本願発明の実施例を示す。 Examples of the present invention will be described below.
実施例１ 蒸留水270gを60℃以上に加温し、撹拌しながら、ショ
糖530g、乳酸カルシウム40g、マクロゴール20,000 20g
を順次溶解し、次いでタルク100g、酸化チタン20g、結
晶セルロース20gを均一に分散し、シロップとする。Example 1 270 g of distilled water was heated to 60 ° C. or higher, and with stirring, 530 g of sucrose, 40 g of calcium lactate, and 20,000 20 g of macrogol
Are sequentially dissolved, and then 100 g of talc, 20 g of titanium oxide, and 20 g of crystalline cellulose are uniformly dispersed to obtain a syrup.
実施例２ コーティングパンに150mg/Tの裸錠を仕込み、実施例
１で得た上記シロップを用いて、5g/kgに調湿した空気
を送りながら、錠剤重量が230mgになるまでコーティン
グを施した。Example 2 A 150 mg / T naked tablet was charged into a coating pan, and coating was performed using the syrup obtained in Example 1 while sending air conditioned to 5 g / kg until the tablet weight reached 230 mg. .
対照として、ゼラチンを含む従来のシロップを用い
て、同様にコーティングを施したものを用意した。As a control, a conventional syrup containing gelatin and similarly coated was prepared.
これらの錠剤及びこれらを一晩減圧乾燥した錠剤の外
観を観察し、表面の微細な亀裂の有無を確認した。The appearance of these tablets and the tablets dried under reduced pressure overnight was observed, and the presence or absence of fine cracks on the surface was confirmed.
また、これらの錠剤を40℃、75％RH及び50℃に１ヶ月
放置し、崩壊時間を測定したところ以下の結果を得た。 In addition, these tablets were allowed to stand at 40 ° C., 75% RH and 50 ° C. for one month, and the disintegration time was measured. The following results were obtained.
なお、対照物のシロップの組成は次のものです。 The composition of the control syrup is as follows.
ショ糖 57.5％ ゼラチン 0.5％ アラビアゴム末 １ ％ 乳酸カルシウム ４ ％ マクロゴール20,000 ２ ％ タルク ５ ％ 酸化チタン ２ ％ 水 28 ％ 実施例３ 次の組成のシロップを調製し、150mg/Tの裸錠にコー
ティングを施し、錠剤重量が230mg/Tになるまで仕上げ
た。Sucrose 57.5% Gelatin 0.5% Gum arabic powder 1% Calcium lactate 4% Macrogol 20,000 2% Talc 5% Titanium oxide 2% Water 28% Example 3 A syrup having the following composition was prepared and used as a 150 mg / T naked tablet. It was coated and finished to a tablet weight of 230 mg / T.
これらの錠剤の強度を測定したところ、以下のような
結果を得た。 When the strength of these tablets was measured, the following results were obtained.
落下試験法：錠剤を1mの高さからＰタイルの床面に落下
させ、亀裂の有無を確認する。 Drop test method: A tablet is dropped from a height of 1 m onto the floor of a P tile to check for cracks.
摩損試験法：ロッシュ摩損試験機により、錠剤を3000回
転させた時、錠剤に破損が生じたか否かを確認する。Abrasion test method: It is checked whether or not the tablet is broken when the tablet is rotated 3000 times using a Roche attrition tester.
発明の効果 以上説明したように、本発明の薬剤被覆組成物は従来
の被覆薬剤より強度に優れ経時的に変化に耐えることが
できるものであって、しかも乳酸カルシウム、結晶セル
ロースを用いることにより、フィニシング層を必要とし
ない程の美麗な薬剤を得ることができる。また、製造方
法においても従来熟練にたよらなければならなかった糖
衣作業が極めて簡単な操作で行える等の効果を奏するこ
とができた。Effect of the Invention As described above, the drug coating composition of the present invention has higher strength than conventional coating drugs and can withstand changes over time, and furthermore, by using calcium lactate and crystalline cellulose, A beautiful medicine that does not require a finishing layer can be obtained. In addition, in the production method, the effect that the sugar coating work, which had to be conventionally performed by a skilled person, can be performed by an extremely simple operation, and the like can be obtained.
Claims (3)
シウムを含む単一のシロップで被覆するための薬剤被覆
用組成物において、糖類と乳酸カルシウムと懸濁性粉末
としての結晶セルロースを必須成分として含み、実質的
に結合剤を含まないシロップである薬剤被覆用組成物。1. A pharmaceutical coating composition for coating the entire sugar coating process with a single syrup containing at least sugar and calcium lactate, comprising sugar, calcium lactate and crystalline cellulose as a suspendable powder as essential components. , A pharmaceutical coating composition which is a syrup substantially free of binders.
シウムを含む単一のシロップからなる被覆用組成物で被
覆されている被覆薬剤において、糖類と乳酸カルシウム
と懸濁性粉末としての結晶セルロースを必須成分として
含み、実質的に結合剤を含まないシロップである薬剤被
覆用組成物のみで被覆されている被覆薬剤。2. A coating agent coated in a coating composition comprising a single syrup containing at least sugar and calcium lactate in the entire sugar coating process, wherein the sugar, calcium lactate and crystalline cellulose as a suspendable powder are essential. A coated drug that is coated with only a drug coating composition that is a syrup that contains as an ingredient and is substantially free of a binder.
シウムを含む単一のシロップからなる被覆用組成物で被
覆する薬剤被覆方法において、糖類と乳酸カルシウムと
懸濁性粉末としての結晶セルロースを必須成分として含
み、実質的に結合剤を含まないシロップである薬剤被覆
用組成物のみで被覆する薬剤被覆方法。3. A drug coating method in which the entire sugar coating process is coated with a coating composition comprising a single syrup containing at least sugar and calcium lactate, wherein the sugar, calcium lactate and crystalline cellulose as a suspendable powder are essential components. A drug coating method comprising coating only with a drug coating composition which is a syrup substantially free of a binder.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP63218928A JP2759802B2 (en) | 1988-08-31 | 1988-08-31 | Drug coating materials |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP63218928A JP2759802B2 (en) | 1988-08-31 | 1988-08-31 | Drug coating materials |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| JPH0267214A JPH0267214A (en) | 1990-03-07 |
| JP2759802B2 true JP2759802B2 (en) | 1998-05-28 |
Family
ID=16727516
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP63218928A Expired - Lifetime JP2759802B2 (en) | 1988-08-31 | 1988-08-31 | Drug coating materials |
Country Status (1)
| Country | Link |
|---|---|
| JP (1) | JP2759802B2 (en) |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2017078024A1 (en) * | 2015-11-02 | 2017-05-11 | 三菱商事フードテック株式会社 | Method for accelerating sugar coating formation for forming sugar coating composed of sugar alcohol with calcium lactate |
Families Citing this family (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP4969747B2 (en) * | 2001-01-19 | 2012-07-04 | 武田薬品工業株式会社 | Tablet film coating composition |
| WO2004054619A1 (en) * | 2002-12-17 | 2004-07-01 | Wakunaga Pharmaceutical Co., Ltd. | Light-blocking agent and film-forming composition |
| CN112641746B (en) * | 2020-12-31 | 2023-04-18 | 重庆市药研院制药有限公司 | Coating method of sugar-coated tablets |
Family Cites Families (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JPS5332128B2 (en) * | 1971-09-18 | 1978-09-06 |
-
1988
- 1988-08-31 JP JP63218928A patent/JP2759802B2/en not_active Expired - Lifetime
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2017078024A1 (en) * | 2015-11-02 | 2017-05-11 | 三菱商事フードテック株式会社 | Method for accelerating sugar coating formation for forming sugar coating composed of sugar alcohol with calcium lactate |
Also Published As
| Publication number | Publication date |
|---|---|
| JPH0267214A (en) | 1990-03-07 |
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