JPH04261118A - Composition for sugar coating of solid pharmaceutical preparation - Google Patents
Composition for sugar coating of solid pharmaceutical preparationInfo
- Publication number
- JPH04261118A JPH04261118A JP4056391A JP4056391A JPH04261118A JP H04261118 A JPH04261118 A JP H04261118A JP 4056391 A JP4056391 A JP 4056391A JP 4056391 A JP4056391 A JP 4056391A JP H04261118 A JPH04261118 A JP H04261118A
- Authority
- JP
- Japan
- Prior art keywords
- sugar
- pullulan
- coating
- sucrose
- composition
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Pending
Links
- 238000009495 sugar coating Methods 0.000 title claims abstract description 41
- 239000000203 mixture Substances 0.000 title claims abstract description 9
- 239000007787 solid Substances 0.000 title claims abstract description 9
- 239000000825 pharmaceutical preparation Substances 0.000 title abstract 3
- 229920001218 Pullulan Polymers 0.000 claims abstract description 29
- 235000019423 pullulan Nutrition 0.000 claims abstract description 29
- 239000004373 Pullulan Substances 0.000 claims abstract description 28
- 229930006000 Sucrose Natural products 0.000 claims abstract description 18
- CZMRCDWAGMRECN-UGDNZRGBSA-N Sucrose Chemical compound O[C@H]1[C@H](O)[C@@H](CO)O[C@@]1(CO)O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 CZMRCDWAGMRECN-UGDNZRGBSA-N 0.000 claims abstract description 18
- 239000005720 sucrose Substances 0.000 claims abstract description 18
- MKJXYGKVIBWPFZ-UHFFFAOYSA-L calcium lactate Chemical compound [Ca+2].CC(O)C([O-])=O.CC(O)C([O-])=O MKJXYGKVIBWPFZ-UHFFFAOYSA-L 0.000 claims abstract description 14
- 239000001527 calcium lactate Substances 0.000 claims abstract description 14
- 229960002401 calcium lactate Drugs 0.000 claims abstract description 14
- 235000011086 calcium lactate Nutrition 0.000 claims abstract description 14
- 238000002360 preparation method Methods 0.000 claims description 6
- 239000008298 dragée Substances 0.000 abstract description 20
- 239000007940 sugar coated tablet Substances 0.000 abstract description 20
- 239000000243 solution Substances 0.000 abstract description 10
- 239000007864 aqueous solution Substances 0.000 abstract description 6
- 230000015572 biosynthetic process Effects 0.000 abstract description 3
- 108010010803 Gelatin Proteins 0.000 description 7
- 230000000052 comparative effect Effects 0.000 description 7
- 229920000159 gelatin Polymers 0.000 description 7
- 239000008273 gelatin Substances 0.000 description 7
- 235000019322 gelatine Nutrition 0.000 description 7
- 235000011852 gelatine desserts Nutrition 0.000 description 7
- 238000000034 method Methods 0.000 description 7
- 239000003826 tablet Substances 0.000 description 7
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 7
- VTYYLEPIZMXCLO-UHFFFAOYSA-L Calcium carbonate Chemical compound [Ca+2].[O-]C([O-])=O VTYYLEPIZMXCLO-UHFFFAOYSA-L 0.000 description 6
- GWEVSGVZZGPLCZ-UHFFFAOYSA-N Titan oxide Chemical compound O=[Ti]=O GWEVSGVZZGPLCZ-UHFFFAOYSA-N 0.000 description 6
- 239000008199 coating composition Substances 0.000 description 6
- 238000000576 coating method Methods 0.000 description 6
- 239000007788 liquid Substances 0.000 description 6
- 239000008213 purified water Substances 0.000 description 6
- OGIDPMRJRNCKJF-UHFFFAOYSA-N titanium oxide Inorganic materials [Ti]=O OGIDPMRJRNCKJF-UHFFFAOYSA-N 0.000 description 6
- 239000011230 binding agent Substances 0.000 description 5
- 239000011248 coating agent Substances 0.000 description 5
- 229920000084 Gum arabic Polymers 0.000 description 4
- 241000978776 Senegalia senegal Species 0.000 description 4
- 239000000205 acacia gum Substances 0.000 description 4
- 235000010489 acacia gum Nutrition 0.000 description 4
- 239000011247 coating layer Substances 0.000 description 4
- 239000000454 talc Substances 0.000 description 4
- 229910052623 talc Inorganic materials 0.000 description 4
- 229910000019 calcium carbonate Inorganic materials 0.000 description 3
- 238000002845 discoloration Methods 0.000 description 3
- 239000008187 granular material Substances 0.000 description 3
- 238000002156 mixing Methods 0.000 description 3
- 238000005303 weighing Methods 0.000 description 3
- 239000002202 Polyethylene glycol Substances 0.000 description 2
- 229920002472 Starch Polymers 0.000 description 2
- 239000001913 cellulose Substances 0.000 description 2
- 229920002678 cellulose Polymers 0.000 description 2
- 230000003111 delayed effect Effects 0.000 description 2
- 239000002552 dosage form Substances 0.000 description 2
- 239000011521 glass Substances 0.000 description 2
- 239000010410 layer Substances 0.000 description 2
- 239000006187 pill Substances 0.000 description 2
- 229920001223 polyethylene glycol Polymers 0.000 description 2
- 229920000036 polyvinylpyrrolidone Polymers 0.000 description 2
- 239000001267 polyvinylpyrrolidone Substances 0.000 description 2
- 235000013855 polyvinylpyrrolidone Nutrition 0.000 description 2
- 239000008107 starch Substances 0.000 description 2
- 238000003860 storage Methods 0.000 description 2
- 229920000858 Cyclodextrin Polymers 0.000 description 1
- 229920002153 Hydroxypropyl cellulose Polymers 0.000 description 1
- GUBGYTABKSRVRQ-QKKXKWKRSA-N Lactose Natural products OC[C@H]1O[C@@H](O[C@H]2[C@H](O)[C@@H](O)C(O)O[C@@H]2CO)[C@H](O)[C@@H](O)[C@H]1O GUBGYTABKSRVRQ-QKKXKWKRSA-N 0.000 description 1
- 229920000715 Mucilage Polymers 0.000 description 1
- 239000004372 Polyvinyl alcohol Substances 0.000 description 1
- DPXJVFZANSGRMM-UHFFFAOYSA-N acetic acid;2,3,4,5,6-pentahydroxyhexanal;sodium Chemical compound [Na].CC(O)=O.OCC(O)C(O)C(O)C(O)C=O DPXJVFZANSGRMM-UHFFFAOYSA-N 0.000 description 1
- 239000000654 additive Substances 0.000 description 1
- 239000000853 adhesive Substances 0.000 description 1
- 229920003123 carboxymethyl cellulose sodium Polymers 0.000 description 1
- 229940063834 carboxymethylcellulose sodium Drugs 0.000 description 1
- 238000007796 conventional method Methods 0.000 description 1
- 238000012258 culturing Methods 0.000 description 1
- 238000004925 denaturation Methods 0.000 description 1
- 230000036425 denaturation Effects 0.000 description 1
- 230000000694 effects Effects 0.000 description 1
- 239000010419 fine particle Substances 0.000 description 1
- 235000013305 food Nutrition 0.000 description 1
- 239000001863 hydroxypropyl cellulose Substances 0.000 description 1
- 235000010977 hydroxypropyl cellulose Nutrition 0.000 description 1
- 239000001866 hydroxypropyl methyl cellulose Substances 0.000 description 1
- 229920003088 hydroxypropyl methyl cellulose Polymers 0.000 description 1
- 235000010979 hydroxypropyl methyl cellulose Nutrition 0.000 description 1
- UFVKGYZPFZQRLF-UHFFFAOYSA-N hydroxypropyl methyl cellulose Chemical compound OC1C(O)C(OC)OC(CO)C1OC1C(O)C(O)C(OC2C(C(O)C(OC3C(C(O)C(O)C(CO)O3)O)C(CO)O2)O)C(CO)O1 UFVKGYZPFZQRLF-UHFFFAOYSA-N 0.000 description 1
- 238000002347 injection Methods 0.000 description 1
- 239000007924 injection Substances 0.000 description 1
- 239000008101 lactose Substances 0.000 description 1
- 238000004519 manufacturing process Methods 0.000 description 1
- 238000004806 packaging method and process Methods 0.000 description 1
- 230000000704 physical effect Effects 0.000 description 1
- 239000000049 pigment Substances 0.000 description 1
- 229940093429 polyethylene glycol 6000 Drugs 0.000 description 1
- 229920000642 polymer Polymers 0.000 description 1
- 229920002451 polyvinyl alcohol Polymers 0.000 description 1
- 235000019422 polyvinyl alcohol Nutrition 0.000 description 1
- 239000000843 powder Substances 0.000 description 1
- 108090000623 proteins and genes Proteins 0.000 description 1
- 102000004169 proteins and genes Human genes 0.000 description 1
- HFHDHCJBZVLPGP-UHFFFAOYSA-N schardinger α-dextrin Chemical compound O1C(C(C2O)O)C(CO)OC2OC(C(C2O)O)C(CO)OC2OC(C(C2O)O)C(CO)OC2OC(C(O)C2O)C(CO)OC2OC(C(C2O)O)C(CO)OC2OC2C(O)C(O)C1OC2CO HFHDHCJBZVLPGP-UHFFFAOYSA-N 0.000 description 1
- 238000007789 sealing Methods 0.000 description 1
- 238000005507 spraying Methods 0.000 description 1
- 235000019698 starch Nutrition 0.000 description 1
Landscapes
- Medicinal Preparation (AREA)
Abstract
Description
【０００１】0001
【産業上の利用分野】本発明は医薬品の剤型として汎用
される細粒、顆粒、丸剤及び錠剤等の固形製剤に糖衣を
施すための糖衣被覆用組成物に関する。BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a sugar-coating composition for coating solid preparations such as fine particles, granules, pills and tablets, which are commonly used as pharmaceutical dosage forms.
【０００２】0002
【従来技術】従来より、糖衣錠の製造には、その強度を
高めるために結合剤としてゼラチン、アラビアガムが使
用されてきた。しかしながら、これら公知の結合剤であ
るゼラチン、アラビアガムは経時的な変色、不溶化によ
る崩壊時間の遅延等の変化が生じ易いことが知られてい
る。BACKGROUND OF THE INVENTION Conventionally, gelatin and gum arabic have been used as binders to increase the strength of sugar-coated tablets. However, gelatin and gum arabic, which are known binders, are known to easily undergo changes such as discoloration over time and a delay in disintegration time due to insolubilization.
【０００３】これらの欠点を補う目的で従来より種々の
結合剤が報告されてきた。例えば、カルボキシメチルセ
ルロースナトリウム、ポリエチレングリコール、ポリビ
ニルアルコール、ポリビニルピロリドン、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、α−デンプン等がゼラチン、アラビアガムの代用と
しての結合剤として報告されているが、いずれも充分な
ものではなかった。[0003] Various binders have been reported for the purpose of compensating for these drawbacks. For example, carboxymethylcellulose sodium, polyethylene glycol, polyvinyl alcohol, polyvinylpyrrolidone, hydroxypropylcellulose, hydroxypropylmethylcellulose, α-starch, etc. have been reported as binders as substitutes for gelatin and gum arabic, but none of them are sufficient. It wasn't.
【０００４】特開昭６２−１７８５２５号公報にはプル
ラン及びポリビニルピロリドンの配合による糖衣皮膜方
法が知られているが、本方法では皮膜が均一に形成しに
くいという問題がある。特開昭６３−１２６８２１号公
報にはプルラン、ゼラチン及び低分子ゼラチンを配合す
る糖衣用組成物について報告されているが、経時的な変
色、崩壊時間の遅延等の問題がある。特開平１−１３５
７１６号公報にはプルランと結晶セルロースを配合した
糖衣用組成物が報告されており、糖衣錠の耐衝撃性は改
善されるが、皮膜の均一性、崩壊性に問題がある。特開
平１−１９７４３２号公報にはプルランとシクロデキス
トリンを配合する糖衣用組成物について報告されている
が、糖衣錠の耐衝撃性に問題がある。特公昭４８−３７
８１５号公報にはショ糖水溶液に乳酸カルシウムを配合
することにより、単一の皮覆液で糖衣の自動化が可能で
ある糖衣法の報告がなされているが、経時的な変色、崩
壊遅延等の問題がある。[0004] JP-A-62-178525 discloses a sugar-coated coating method by blending pullulan and polyvinylpyrrolidone, but this method has the problem that it is difficult to form a uniform coating. JP-A-63-126821 reports a sugar-coating composition containing pullulan, gelatin, and low-molecular-weight gelatin, but it has problems such as discoloration over time and delayed disintegration time. Japanese Patent Publication No. 1-135
No. 716 reports a sugar-coating composition containing pullulan and crystalline cellulose, which improves the impact resistance of sugar-coated tablets, but has problems with film uniformity and disintegration. JP-A-1-197432 reports a sugar-coated composition containing pullulan and cyclodextrin, but there is a problem with the impact resistance of the sugar-coated tablet. Special Public Service 1977
Publication No. 815 reports a sugar coating method in which sugar coating can be automated with a single coating liquid by blending calcium lactate into a sucrose aqueous solution, but there are problems such as discoloration over time and delayed disintegration. There's a problem.
【０００５】また、本発明者らはすでにプルラン及び／
又は水溶性プルラン誘導体を用いる固形製剤の糖衣皮膜
方法（特開昭５９−２１９２２０号）について特許出願
したが、プルラン濃度を高くした場合展延性が不十分と
なり、プルラン濃度を制限せざるをえなかった。[0005] Furthermore, the present inventors have already discovered that pullulan and/or
Or, a patent application was filed for a sugar-coating method for solid preparations using water-soluble pullulan derivatives (Japanese Patent Laid-Open No. 59-219220), but when the pullulan concentration was increased, the spreadability became insufficient, so the pullulan concentration had to be limited. Ta.
【０００６】[0006]
【発明が解決しようとする課題】耐衝撃性に優れ、経時
的に変色せず、しかもプルラン濃度を高くしても、錠剤
等の固形製剤の均一な糖衣層の形成が可能な組成物が望
まれていた。[Problems to be Solved by the Invention] It is desirable to have a composition that has excellent impact resistance, does not discolor over time, and is capable of forming a uniform sugar-coated layer of solid preparations such as tablets even when the concentration of pullulan is increased. It was rare.
【０００７】[0007]
【課題を解決するための手段】前記課題を解決する方法
について鋭意研究を行った結果、プルランを配合するシ
ョ糖水溶液に乳酸カルシウムを配合することにより明ら
かに改良されることを見いだした。[Means for Solving the Problems] As a result of intensive research into methods for solving the above-mentioned problems, it has been found that a clear improvement can be achieved by incorporating calcium lactate into the sucrose aqueous solution containing pullulan.
【０００８】プルランは水に対して良好な溶解性を有し
、ゼラチンのようなタンパク変性による経時変化を示さ
ず、強力な皮膜を形成する。これらの特性は糖衣用結合
剤として好ましい。しかし、高濃度のショ糖水溶液にプ
ルランを溶解した場合、プルラン濃度を高くすると曳糸
性を示し、これが均一な糖衣層の形成を妨げる要因とな
っていた。ところが、プルラン配合のショ糖水溶液に乳
酸カルシウムを配合することにより展延性が著しく改良
され、均一な糖衣層の形成が可能であることを見出し本
発明を完成した。更にプルランと乳酸カルシウムの配合
による本発明の糖衣用組成物は、糖衣皮覆時の重量増加
率が大きいため糖衣回数及び時間が短縮され、糖衣層が
強いため従来の糖衣に比較して皮覆量を少なくすること
ができるという利点がある。[0008] Pullulan has good solubility in water, does not show changes over time due to protein denaturation like gelatin, and forms a strong film. These properties are preferable as a binder for sugar coating. However, when pullulan is dissolved in a high-concentration sucrose aqueous solution, it exhibits stringiness when the pullulan concentration is increased, which is a factor that prevents the formation of a uniform sugar coating layer. However, the present invention was completed by discovering that by incorporating calcium lactate into a sucrose aqueous solution containing pullulan, the spreadability was significantly improved and a uniform sugar coating layer could be formed. Furthermore, the sugar-coating composition of the present invention, which is a combination of pullulan and calcium lactate, has a high weight increase rate during sugar-coating, so the number of times and time for sugar-coating is shortened, and the sugar-coating layer is strong, so coating is easier than with conventional sugar-coating. It has the advantage that the amount can be reduced.
【０００９】本発明において用いられるプルランは、プ
ルラリア・プルランスの培養により得られる菌体外粘質
物として得られた天然高分子線状重合体である。プルラ
ンは菌株の種類や培養条件によって物性が若干異なるが
、本発明に於いてはいずれの場合も用いることができる
。その分子量に特に制限はないが、好ましくは１０，０
００以上５，０００，０００以下が適している。[0009] Pullulan used in the present invention is a natural linear polymer obtained as an extracellular mucilage obtained by culturing Pluralia pullulans. Although the physical properties of pullulan differ slightly depending on the type of strain and culture conditions, it can be used in any case in the present invention. There is no particular restriction on its molecular weight, but it is preferably 10,0
A value of 00 or more and 5,000,000 or less is suitable.
【００１０】本発明の糖衣被覆用組成物に使用されるプ
ルランの配合量はショ糖に対して０．１〜１０．０ｗ／
ｗ％が好ましい。乳酸カルシウムの配合量はショ糖に対
して２．０〜４０．０ｗ／ｗ％が好ましい。また、必要
に応じて公知の添加剤である炭酸カルシウム、タルク、
結晶セルロース、酸化チタン、ポリエチレングリコール
、色素等を加えてもよい。糖衣操作法は公知の方法であ
る手動による液注加法、あるいは自動噴霧法等により実
施される。固形製剤の剤型としては自由であるが、一般
に錠剤、丸剤、顆粒剤、細粒剤等の形態が採用される。[0010] The blending amount of pullulan used in the sugar coating composition of the present invention is 0.1 to 10.0 w/w/sucrose.
w% is preferred. The amount of calcium lactate to be blended is preferably 2.0 to 40.0 w/w% relative to sucrose. In addition, known additives such as calcium carbonate, talc,
Crystalline cellulose, titanium oxide, polyethylene glycol, pigments, etc. may also be added. The sugar-coating operation method is performed by a known method such as manual liquid injection method or automatic spraying method. Although the dosage form of the solid preparation is free, tablets, pills, granules, fine granules, etc. are generally adopted.
【００１１】[0011]
【実施例】以下具体的に実施例を挙げて説明するが、本
発明はなんらこれらに限定されるものではない。
実施例１
プルラン７．５ｇ、乳酸カルシウム４２．５ｇ、ショ糖
３００ｇを、加温した精製水１５０ｇに順次溶解して糖
衣液とした。この糖衣液を直径８．０ｍｍ、重量１８０
ｍｇの乳糖、デンプンからなる錠剤３，０００錠に、常
法により糖衣を施し、１錠３１０ｍｇの糖衣錠を得た。[Examples] The present invention will be specifically explained below with reference to Examples, but the present invention is not limited to these in any way. Example 1 7.5 g of pullulan, 42.5 g of calcium lactate, and 300 g of sucrose were sequentially dissolved in 150 g of heated purified water to obtain a sugar coating solution. This sugar-coated liquid was made into a powder with a diameter of 8.0 mm and a weight of 180 mm.
3,000 mg of lactose and starch tablets were coated with sugar by a conventional method to obtain sugar-coated tablets of 310 mg each.
【００１２】実施例２
プルラン１１ｇ、乳酸カルシウム５５ｇ、ショ糖２６４
ｇを、加温した精製水１６０ｇに順次溶解し、さらにタ
ルク５５ｇ、酸化チタン５．５ｇを分散して糖衣液とし
た。この糖衣液を用いて実施例１と同様に糖衣を施し、
１錠３３０ｍｇの糖衣錠を得た。Example 2 Pullulan 11g, calcium lactate 55g, sucrose 264g
g was sequentially dissolved in 160 g of heated purified water, and further dispersed with 55 g of talc and 5.5 g of titanium oxide to obtain a sugar coating solution. Using this sugar coating solution, sugar coating was applied in the same manner as in Example 1,
Sugar-coated tablets each weighing 330 mg were obtained.
【００１３】実施例３
プルラン１０ｇ、乳酸カルシウム２５ｇ、ショ糖２９０
ｇ、食用黄色５号色素微量を、加温した精製水１７５ｇ
に順次溶解して糖衣液とした。この糖衣液を用いて実施
例１と同様に糖衣を施し、１錠２９０ｍｇの糖衣錠を得
た。Example 3 Pullulan 10g, calcium lactate 25g, sucrose 290g
g, 175 g of purified water heated with a trace amount of food yellow color No. 5
The sugar coating solution was prepared by sequentially dissolving the sugar in the following. Sugar-coating was performed using this sugar-coating solution in the same manner as in Example 1 to obtain sugar-coated tablets weighing 290 mg each.
【００１４】実施例４
プルラン９ｇ、乳酸カルシウム３６ｇ、ショ糖３００ｇ
、ポリエチレングリコール６０００ ３０ｇを、加温
した精製水１５６ｇに順次溶解し、炭酸カルシウム６０
ｇ、酸化チタン９ｇを分散して糖衣液とした。この糖衣
液を用いて実施例１と同様に糖衣を施し、１錠３３０ｍ
ｇの糖衣錠を得た。Example 4 Pullulan 9g, calcium lactate 36g, sucrose 300g
, 30g of polyethylene glycol 6000 was sequentially dissolved in 156g of heated purified water, and calcium carbonate 60g was dissolved in
g, and 9 g of titanium oxide were dispersed to prepare a sugar coating solution. Using this sugar coating solution, sugar coating was applied in the same manner as in Example 1, and one tablet was 330 m
g sugar-coated tablets were obtained.
【００１５】[0015]
【作用】本発明の糖衣錠の耐衝撃性及び保存安定性等に
関する試験を行った。比較検体は次の通り調製した。
比較例１
ゼラチン２．５ｇ、アラビアガム５．０ｇ、乳酸カルシ
ウム４０ｇ、ショ糖２５０ｇを、加温した精製水１４８
ｇに順次溶解し、タルク５０ｇ、酸化チタン５ｇを分散
して糖衣液とした。この糖衣液を用いて実施例１と同様
に糖衣を施し、１錠３１０ｍｇの糖衣錠とする。[Operation] Tests were conducted regarding the impact resistance, storage stability, etc. of the sugar-coated tablets of the present invention. Comparative samples were prepared as follows. Comparative Example 1 2.5 g of gelatin, 5.0 g of gum arabic, 40 g of calcium lactate, and 250 g of sucrose were mixed with 148 g of heated purified water.
50 g of talc and 5 g of titanium oxide were dispersed therein to obtain a sugar coating solution. Using this sugar-coating solution, sugar-coating is applied in the same manner as in Example 1 to obtain sugar-coated tablets each weighing 310 mg.
【００１６】比較例２
プルラン１０ｇ、ショ糖３６０ｇを、加温した精製水１
４５ｇに順次溶解し、炭酸カルシウム５０ｇ、タルク５
０ｇ、酸化チタン５ｇを分散して糖衣液とした。この糖
衣液を用いて実施例１と同様に糖衣を施し、１錠３３０
ｍｇの糖衣錠とする。Comparative Example 2 10 g of pullulan and 360 g of sucrose were added to heated purified water 1
45g of calcium carbonate, 50g of talc,
0g of titanium oxide and 5g of titanium oxide were dispersed to prepare a sugar coating liquid. Using this sugar coating liquid, sugar coating was applied in the same manner as in Example 1, and one tablet was 330 yen.
mg sugar-coated tablets.
【００１７】試験例１
耐衝撃性試験
実施例１及び比較例１の糖衣錠を、１５０ｃｍのガラス
管の上部からガラス瓶を受け器として１錠ずつ落下させ
て糖衣層の欠け発生錠数により試験した。その結果を表
１に示す。Test Example 1 Impact Resistance Test The sugar-coated tablets of Example 1 and Comparative Example 1 were dropped one by one from the top of a 150 cm glass tube using a glass bottle as a receiver, and tested to determine the number of tablets with chipping of the sugar coating layer. The results are shown in Table 1.
【００１８】[0018]
【表１】[Table 1]
【００１９】表１の結果より明かに本発明の糖衣錠の方
が耐衝撃性において優れていた。
試験例２
外観安定性
実施例１、実施例４及び比較例１の糖衣錠を５０℃で６
０日、及び６０℃で３０日間保存した後の外観変化を比
較した。その結果を表２に示す。From the results shown in Table 1, it was clear that the sugar-coated tablets of the present invention were superior in impact resistance. Test Example 2 Appearance Stability The sugar-coated tablets of Example 1, Example 4 and Comparative Example 1 were heated at 50°C.
Changes in appearance were compared after storage for 0 days and at 60°C for 30 days. The results are shown in Table 2.
【００２０】[0020]
【表２】[Table 2]
【００２１】表２により明かに本発明の糖衣錠は外観の
安定性に優れていた。
試験例３
崩壊性
試験例２で使用した保存検体（実施例１及び比較例１の
糖衣錠）の崩壊時間を、日局崩壊試験に準じて行った。
その結果を表３に示す。Table 2 clearly shows that the sugar-coated tablets of the present invention had excellent stability in appearance. Test Example 3 Disintegration The disintegration time of the preserved specimens (sugar-coated tablets of Example 1 and Comparative Example 1) used in Test Example 2 was determined according to the Japanese Pharmacopoeia disintegration test. The results are shown in Table 3.
【００２２】[0022]
【表３】[Table 3]
【００２３】表３により明らかに本発明の糖衣錠は崩壊
性に優れていた。
試験例４
重量均一性試験
実施例２及び比較例２の糖衣錠１錠ずつの重量を、各々
６０錠測定し、その重量ばらつきを比較した。その結果
を表４に示す。Table 3 clearly shows that the sugar-coated tablets of the present invention had excellent disintegration properties. Test Example 4 Weight Uniformity Test The weight of 60 sugar-coated tablets of Example 2 and Comparative Example 2 was measured, and the weight variations were compared. The results are shown in Table 4.
【００２４】[0024]
【表４】[Table 4]
【００２５】表４より本発明の糖衣錠は、展延性が改良
されたことによる均一な皮膜の形成が可能であったこと
から、重量偏差がきわめて少なく、その大きさが均一で
あるため、ヒートシール包装の場合に不適合率が低く、
大量生産に有利である。Table 4 shows that the sugar-coated tablets of the present invention were able to form a uniform film due to improved spreadability, had extremely small weight deviations, and were uniform in size, making them suitable for heat sealing. In the case of packaging, the nonconformity rate is low,
It is advantageous for mass production.
【００２６】[0026]
【発明の効果】本発明により得られる糖衣被覆液組成物
を用いて得られる糖衣錠は耐衝撃性、外観安定性及び崩
壊性が改良され、更に展延性に優れるため均一な糖衣層
の形成が可能であり、固形剤の糖衣被覆用組成物として
有用である。[Effects of the Invention] Sugar-coated tablets obtained using the sugar-coated coating liquid composition obtained according to the present invention have improved impact resistance, appearance stability, and disintegration properties, and are also excellent in spreadability, making it possible to form a uniform sugar-coated layer. It is useful as a sugar-coating composition for solid preparations.
Claims (1)
ムを添加して得られる固形製剤の糖衣被覆用組成物．【
請求項２】プルランがショ糖に対して０．１〜１０．０
ｗ／ｗ％である請求項（１）記載の糖衣被覆用組成物。 【請求項３】乳酸カルシウムがショ糖に対して２．０〜
４０．０ｗ／ｗ％である請求項（１）記載の糖衣被覆用
組成物。Scope of the Claims: [Claim 1] A composition for sugar-coating a solid preparation obtained by adding pullulan and calcium lactate to an aqueous sucrose solution. [
Claim 2: Pullulan is 0.1 to 10.0 relative to sucrose.
The composition for sugar coating according to claim (1), which is w/w%. Claim 3: Calcium lactate is 2.0 to 2.0 to sucrose.
The composition for sugar coating according to claim (1), which has a content of 40.0 w/w%.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP4056391A JPH04261118A (en) | 1991-02-13 | 1991-02-13 | Composition for sugar coating of solid pharmaceutical preparation |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP4056391A JPH04261118A (en) | 1991-02-13 | 1991-02-13 | Composition for sugar coating of solid pharmaceutical preparation |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| JPH04261118A true JPH04261118A (en) | 1992-09-17 |
Family
ID=12583936
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP4056391A Pending JPH04261118A (en) | 1991-02-13 | 1991-02-13 | Composition for sugar coating of solid pharmaceutical preparation |
Country Status (1)
| Country | Link |
|---|---|
| JP (1) | JPH04261118A (en) |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP2009073814A (en) * | 2007-08-31 | 2009-04-09 | Taisho Pharmaceutical Co Ltd | Erythritol-formulated coating liquid |
| EP3372245A4 (en) * | 2015-11-02 | 2019-07-10 | Mitsubishi Shoji Foodtech Co., Ltd. | Method for accelerating sugar coating formation for forming sugar coating composed of sugar alcohol with calcium lactate |
-
1991
- 1991-02-13 JP JP4056391A patent/JPH04261118A/en active Pending
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP2009073814A (en) * | 2007-08-31 | 2009-04-09 | Taisho Pharmaceutical Co Ltd | Erythritol-formulated coating liquid |
| EP3372245A4 (en) * | 2015-11-02 | 2019-07-10 | Mitsubishi Shoji Foodtech Co., Ltd. | Method for accelerating sugar coating formation for forming sugar coating composed of sugar alcohol with calcium lactate |
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