JPS63297321A - Prevention of adsorption of bromhexine hydrochloride - Google Patents
Prevention of adsorption of bromhexine hydrochlorideInfo
- Publication number
- JPS63297321A JPS63297321A JP62131791A JP13179187A JPS63297321A JP S63297321 A JPS63297321 A JP S63297321A JP 62131791 A JP62131791 A JP 62131791A JP 13179187 A JP13179187 A JP 13179187A JP S63297321 A JPS63297321 A JP S63297321A
- Authority
- JP
- Japan
- Prior art keywords
- bromhexine hydrochloride
- granules
- hydrochloride
- plastic
- laminated aluminum
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Granted
Links
- 229960002335 bromhexine hydrochloride Drugs 0.000 title claims abstract description 28
- YRSGDLIATOURQO-UHFFFAOYSA-N ethyl 4-acetyl-5-oxohexanoate Chemical compound CCOC(=O)CCC(C(C)=O)C(C)=O YRSGDLIATOURQO-UHFFFAOYSA-N 0.000 title claims abstract description 28
- 238000001179 sorption measurement Methods 0.000 title abstract description 5
- 230000002265 prevention Effects 0.000 title 1
- 229920003023 plastic Polymers 0.000 claims abstract description 24
- 239000004033 plastic Substances 0.000 claims abstract description 24
- 239000008187 granular material Substances 0.000 claims abstract description 22
- 239000000843 powder Substances 0.000 claims abstract description 17
- AZDRQVAHHNSJOQ-UHFFFAOYSA-N alumane Chemical class [AlH3] AZDRQVAHHNSJOQ-UHFFFAOYSA-N 0.000 claims abstract description 14
- 239000003814 drug Substances 0.000 claims abstract description 10
- 238000002156 mixing Methods 0.000 claims abstract description 3
- 239000005022 packaging material Substances 0.000 claims description 16
- RZVAJINKPMORJF-UHFFFAOYSA-N Acetaminophen Chemical compound CC(=O)NC1=CC=C(O)C=C1 RZVAJINKPMORJF-UHFFFAOYSA-N 0.000 abstract description 10
- 229960005489 paracetamol Drugs 0.000 abstract description 5
- SBNKFTQSBPKMBZ-UHFFFAOYSA-N ethenzamide Chemical compound CCOC1=CC=CC=C1C(N)=O SBNKFTQSBPKMBZ-UHFFFAOYSA-N 0.000 abstract description 4
- 229960000514 ethenzamide Drugs 0.000 abstract description 4
- CIVCELMLGDGMKZ-UHFFFAOYSA-N 2,4-dichloro-6-methylpyridine-3-carboxylic acid Chemical compound CC1=CC(Cl)=C(C(O)=O)C(Cl)=N1 CIVCELMLGDGMKZ-UHFFFAOYSA-N 0.000 abstract description 2
- SKZKKFZAGNVIMN-UHFFFAOYSA-N Salicilamide Chemical compound NC(=O)C1=CC=CC=C1O SKZKKFZAGNVIMN-UHFFFAOYSA-N 0.000 abstract description 2
- 229960000525 diphenhydramine hydrochloride Drugs 0.000 abstract description 2
- 229960000581 salicylamide Drugs 0.000 abstract description 2
- 239000000463 material Substances 0.000 abstract 4
- 238000012856 packing Methods 0.000 abstract 3
- 239000000203 mixture Substances 0.000 description 9
- 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 8
- 238000009472 formulation Methods 0.000 description 8
- 239000008101 lactose Substances 0.000 description 8
- 238000002360 preparation method Methods 0.000 description 6
- 229920002153 Hydroxypropyl cellulose Polymers 0.000 description 5
- 239000001863 hydroxypropyl cellulose Substances 0.000 description 5
- 235000010977 hydroxypropyl cellulose Nutrition 0.000 description 5
- 238000004806 packaging method and process Methods 0.000 description 5
- -1 polyethylene Polymers 0.000 description 5
- 239000004698 Polyethylene Substances 0.000 description 4
- 229920000573 polyethylene Polymers 0.000 description 4
- WEVYAHXRMPXWCK-UHFFFAOYSA-N Acetonitrile Chemical compound CC#N WEVYAHXRMPXWCK-UHFFFAOYSA-N 0.000 description 3
- FBPFZTCFMRRESA-FSIIMWSLSA-N D-Glucitol Natural products OC[C@H](O)[C@H](O)[C@@H](O)[C@H](O)CO FBPFZTCFMRRESA-FSIIMWSLSA-N 0.000 description 3
- 229940079593 drug Drugs 0.000 description 3
- VZCYOOQTPOCHFL-UPHRSURJSA-N maleic acid Chemical compound OC(=O)\C=C/C(O)=O VZCYOOQTPOCHFL-UPHRSURJSA-N 0.000 description 3
- 238000000034 method Methods 0.000 description 3
- 239000000600 sorbitol Substances 0.000 description 3
- VZCYOOQTPOCHFL-UHFFFAOYSA-N trans-butenedioic acid Natural products OC(=O)C=CC(O)=O VZCYOOQTPOCHFL-UHFFFAOYSA-N 0.000 description 3
- AKNNEGZIBPJZJG-MSOLQXFVSA-N (-)-noscapine Chemical compound CN1CCC2=CC=3OCOC=3C(OC)=C2[C@@H]1[C@@H]1C2=CC=C(OC)C(OC)=C2C(=O)O1 AKNNEGZIBPJZJG-MSOLQXFVSA-N 0.000 description 2
- PMGQWSIVQFOFOQ-BDUVBVHRSA-N (e)-but-2-enedioic acid;(2r)-2-[2-[1-(4-chlorophenyl)-1-phenylethoxy]ethyl]-1-methylpyrrolidine Chemical compound OC(=O)\C=C\C(O)=O.CN1CCC[C@@H]1CCOC(C)(C=1C=CC(Cl)=CC=1)C1=CC=CC=C1 PMGQWSIVQFOFOQ-BDUVBVHRSA-N 0.000 description 2
- GUBGYTABKSRVRQ-XLOQQCSPSA-N Alpha-Lactose Chemical compound O[C@@H]1[C@@H](O)[C@@H](O)[C@@H](CO)O[C@H]1O[C@@H]1[C@@H](CO)O[C@H](O)[C@H](O)[C@H]1O GUBGYTABKSRVRQ-XLOQQCSPSA-N 0.000 description 2
- VEXZGXHMUGYJMC-UHFFFAOYSA-M Chloride anion Chemical compound [Cl-] VEXZGXHMUGYJMC-UHFFFAOYSA-M 0.000 description 2
- HEDRZPFGACZZDS-UHFFFAOYSA-N Chloroform Chemical compound ClC(Cl)Cl HEDRZPFGACZZDS-UHFFFAOYSA-N 0.000 description 2
- FBPFZTCFMRRESA-KVTDHHQDSA-N D-Mannitol Chemical compound OC[C@@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-KVTDHHQDSA-N 0.000 description 2
- 229930195725 Mannitol Natural products 0.000 description 2
- 102000016943 Muramidase Human genes 0.000 description 2
- 108010014251 Muramidase Proteins 0.000 description 2
- 108010062010 N-Acetylmuramoyl-L-alanine Amidase Proteins 0.000 description 2
- 229910019142 PO4 Inorganic materials 0.000 description 2
- XAGFODPZIPBFFR-UHFFFAOYSA-N aluminium Chemical compound [Al] XAGFODPZIPBFFR-UHFFFAOYSA-N 0.000 description 2
- 229910052782 aluminium Inorganic materials 0.000 description 2
- 229940035676 analgesics Drugs 0.000 description 2
- 230000000954 anitussive effect Effects 0.000 description 2
- 239000000730 antalgic agent Substances 0.000 description 2
- 230000001754 anti-pyretic effect Effects 0.000 description 2
- 229940125715 antihistaminic agent Drugs 0.000 description 2
- 239000000739 antihistaminic agent Substances 0.000 description 2
- 239000002221 antipyretic Substances 0.000 description 2
- 239000003434 antitussive agent Substances 0.000 description 2
- 229940124584 antitussives Drugs 0.000 description 2
- 229960002689 clemastine fumarate Drugs 0.000 description 2
- 230000007423 decrease Effects 0.000 description 2
- 238000002347 injection Methods 0.000 description 2
- 239000007924 injection Substances 0.000 description 2
- 239000004325 lysozyme Substances 0.000 description 2
- 229960000274 lysozyme Drugs 0.000 description 2
- 235000010335 lysozyme Nutrition 0.000 description 2
- 239000011976 maleic acid Substances 0.000 description 2
- 239000000594 mannitol Substances 0.000 description 2
- 235000010355 mannitol Nutrition 0.000 description 2
- 229960004708 noscapine Drugs 0.000 description 2
- 239000000546 pharmaceutical excipient Substances 0.000 description 2
- NBIIXXVUZAFLBC-UHFFFAOYSA-K phosphate Chemical compound [O-]P([O-])([O-])=O NBIIXXVUZAFLBC-UHFFFAOYSA-K 0.000 description 2
- 239000010452 phosphate Substances 0.000 description 2
- 229920000728 polyester Polymers 0.000 description 2
- 229920002451 polyvinyl alcohol 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
- 239000007787 solid Substances 0.000 description 2
- FLNXBVJLPJNOSI-UHFFFAOYSA-N 1-[2-[(4-chlorophenyl)-phenylmethoxy]ethyl]piperidine Chemical compound C1=CC(Cl)=CC=C1C(C=1C=CC=CC=1)OCCN1CCCCC1 FLNXBVJLPJNOSI-UHFFFAOYSA-N 0.000 description 1
- NLHHRLWOUZZQLW-UHFFFAOYSA-N Acrylonitrile Chemical compound C=CC#N NLHHRLWOUZZQLW-UHFFFAOYSA-N 0.000 description 1
- 229920001824 Barex® Polymers 0.000 description 1
- FBPFZTCFMRRESA-JGWLITMVSA-N D-glucitol Chemical compound OC[C@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-JGWLITMVSA-N 0.000 description 1
- IMROMDMJAWUWLK-UHFFFAOYSA-N Ethenol Chemical compound OC=C IMROMDMJAWUWLK-UHFFFAOYSA-N 0.000 description 1
- VEXZGXHMUGYJMC-UHFFFAOYSA-N Hydrochloric acid Chemical compound Cl VEXZGXHMUGYJMC-UHFFFAOYSA-N 0.000 description 1
- 239000004743 Polypropylene Substances 0.000 description 1
- 239000004372 Polyvinyl alcohol Substances 0.000 description 1
- OFOBLEOULBTSOW-UHFFFAOYSA-N Propanedioic acid Natural products OC(=O)CC(O)=O OFOBLEOULBTSOW-UHFFFAOYSA-N 0.000 description 1
- DBMJMQXJHONAFJ-UHFFFAOYSA-M Sodium laurylsulphate Chemical compound [Na+].CCCCCCCCCCCCOS([O-])(=O)=O DBMJMQXJHONAFJ-UHFFFAOYSA-M 0.000 description 1
- 229920002472 Starch Polymers 0.000 description 1
- 238000002835 absorbance Methods 0.000 description 1
- QGZKDVFQNNGYKY-UHFFFAOYSA-O ammonium group Chemical group [NH4+] QGZKDVFQNNGYKY-UHFFFAOYSA-O 0.000 description 1
- 239000001913 cellulose Substances 0.000 description 1
- 229920002678 cellulose Polymers 0.000 description 1
- 229940046978 chlorpheniramine maleate Drugs 0.000 description 1
- 229960002544 cloperastine Drugs 0.000 description 1
- 150000002016 disaccharides Chemical class 0.000 description 1
- 230000000694 effects Effects 0.000 description 1
- 239000003172 expectorant agent Substances 0.000 description 1
- 230000003419 expectorant effect Effects 0.000 description 1
- 239000000945 filler Substances 0.000 description 1
- 150000004676 glycans Chemical class 0.000 description 1
- 239000004615 ingredient Substances 0.000 description 1
- 238000005259 measurement Methods 0.000 description 1
- 239000012528 membrane Substances 0.000 description 1
- 229910000402 monopotassium phosphate Inorganic materials 0.000 description 1
- 235000019796 monopotassium phosphate Nutrition 0.000 description 1
- 150000002772 monosaccharides Chemical class 0.000 description 1
- PJNZPQUBCPKICU-UHFFFAOYSA-N phosphoric acid;potassium Chemical compound [K].OP(O)(O)=O PJNZPQUBCPKICU-UHFFFAOYSA-N 0.000 description 1
- 229920001155 polypropylene Polymers 0.000 description 1
- 229920001282 polysaccharide Polymers 0.000 description 1
- 239000005017 polysaccharide Substances 0.000 description 1
- 239000011347 resin Substances 0.000 description 1
- 229920005989 resin Polymers 0.000 description 1
- 230000035945 sensitivity Effects 0.000 description 1
- 239000000741 silica gel Substances 0.000 description 1
- 229910002027 silica gel Inorganic materials 0.000 description 1
- 235000019333 sodium laurylsulphate Nutrition 0.000 description 1
- 239000000243 solution Substances 0.000 description 1
- 229910001220 stainless steel Inorganic materials 0.000 description 1
- 239000010935 stainless steel Substances 0.000 description 1
- 239000008107 starch Substances 0.000 description 1
- 235000019698 starch Nutrition 0.000 description 1
Landscapes
- Medicinal Preparation (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
Abstract
Description
【発明の詳細な説明】
［産業上の利用分野］
本発明は、塩酸ブロムヘキシンの吸着防止方法に関し、
更に詳しくは、塩酸ブロムヘキシンがプラスチック積層
アルミニウム包材またはプラスチック包材に吸着される
ことを防止する方法に関する。[Detailed Description of the Invention] [Industrial Application Field] The present invention relates to a method for preventing the adsorption of bromhexine hydrochloride,
More specifically, the present invention relates to a method for preventing bromhexine hydrochloride from being adsorbed to plastic laminated aluminum packaging or plastic packaging.
［従来の技術］
塩酸ブロムヘキシンがプラスチック積層アルミニウム包
材またはプラスチック包材に吸着されること、あるいは
その防止する方法については知られていない。[Prior Art] It is not known that bromhexine hydrochloride is adsorbed to plastic laminated aluminum packaging or plastic packaging, or how to prevent this.
［発明が解決しようとする問題点］
塩酸ブロムヘキシン含有固形医薬品を結晶セルロース、
澱粉などの多糖類を賦形剤とした場合、塩酸ブロムヘキ
シンがポリエチレンなどのプラスチック積層アルミニウ
ム包材またはプラスチック包材に吸着されて含量が低下
する。この現象は、マンニット、ソルビット、乳糖など
の単糖類、二糖類を用いることによりある程度防止でき
るが、解熱鎮痛薬、抗ヒスタミン薬、鎮咳薬などの多成
分が配合されている場合そこに含有されている塩基性薬
によって、塩酸ブロムヘキシンのプラスチック積層アル
ミニウム包材またはプラスチック包材への吸着がきらに
促進されてしまうという問題が生じる。[Problems to be solved by the invention] Solid pharmaceuticals containing bromhexine hydrochloride are made of crystalline cellulose,
When a polysaccharide such as starch is used as an excipient, bromhexine hydrochloride is adsorbed to a plastic laminated aluminum packaging material or a plastic packaging material such as polyethylene, and the content decreases. This phenomenon can be prevented to some extent by using monosaccharides and disaccharides such as mannitol, sorbitol, and lactose, but if multiple ingredients such as antipyretic analgesics, antihistamines, and antitussives are combined, A problem arises in that the adsorption of bromhexine hydrochloride to the plastic laminated aluminum packaging material or plastic packaging material is greatly accelerated by the basic drug used.
塩酸ブロムヘキシンは優れた去痰薬として広く利用きれ
ている薬物であるが、その投与量は１回に４■程度の少
量にすぎない。従って、保存中のプラスチック積層アル
ミニウム包材またはプラスチック包材への吸着による含
有量の低下は、微量とは言えども薬効に影響を与える。Bromhexine hydrochloride is a drug that has been widely used as an excellent expectorant, but its dosage is only as small as 4 ml at a time. Therefore, a decrease in the content due to adsorption to the plastic laminated aluminum packaging material or plastic packaging material during storage affects the medicinal efficacy, albeit in a small amount.
［問題点を解決するための手段］
本発明者らは、前記問題点を解決すべく種々研究の結果
、塩酸ブロムヘキシンと塩基性薬含有固形製剤において
、塩酸ブロムヘキシンと塩基性薬とを各々顆粒剤または
散剤とし、これらの顆粒剤または散剤を更に混合して、
顆粒剤または散剤とすることにより、塩酸ブロムヘキシ
ンがプラスチック積層アルミニウム包材またはプラスチ
ック包材に吸着されることを肪止できることを見出し、
さらにその知見により本発明を完成した。[Means for Solving the Problems] As a result of various studies to solve the above-mentioned problems, the present inventors have developed a solid preparation containing bromhexine hydrochloride and a basic drug, in which bromhexine hydrochloride and a basic drug are each contained in granules. Or as a powder, and further mix these granules or powders,
We have discovered that bromhexine hydrochloride can be prevented from being adsorbed to plastic laminated aluminum packaging materials or plastic packaging materials by forming them into granules or powders,
Furthermore, based on this knowledge, the present invention was completed.
本発明において、塩基性薬とは２級または３級アンモニ
ウムをもつものであり、解熱鎮痛薬、鎮咳薬あるいは抗
ヒスタミン薬などでいえば、アセトアミノフェン、エテ
ンザミド、サリチルアミド、塩酸ジフェンヒドラミン、
リン酸コディン、塩酸ノスカピン、ｄ！−マレイン酸ク
ロルフェニラミン、マレイン酸カルピノキサミン、リン
酸ジヒトロフデイン、ノスカ番ピンなどが挙（デられる
。In the present invention, basic drugs are those containing secondary or tertiary ammonium, such as antipyretic analgesics, antitussives, and antihistamines such as acetaminophen, ethenzamide, salicylamide, diphenhydramine hydrochloride,
Codine phosphate, noscapine hydrochloride, d! - Chlorpheniramine maleate, carpinoxamine maleate, dihydrofdeine phosphate, Noskabanpin, etc. are listed.
また、プラスチック積層アルミニウム包材またはプラス
チック包材に用いられるプラスチック類とはアクリロニ
トリル系樹脂、エチレン−ビニルフルー１−ル共ｆ１合
体、ポリビニルアルコール、ポリエチレン、ポリエステ
ル、ポリプロピレンなどのものである０例えば、バレッ
クス２１０［商品名；三井東圧化学（株）製］、エバー
ル［商品名；（株）クラレ製］、ポバール［商品名；（
株）クラレ製］などがある。In addition, the plastics used for plastic laminated aluminum packaging materials or plastic packaging materials include acrylonitrile resin, ethylene-vinylfluor co-f1 combination, polyvinyl alcohol, polyethylene, polyester, polypropylene, etc.0 For example, Valex 210 [Product name; manufactured by Mitsui Toatsu Chemical Co., Ltd.], Eval [Product name; manufactured by Kuraray Co., Ltd.], Poval [Product name;
manufactured by Kuraray Co., Ltd.].
本発明の製剤は、例えば、次の方法により製造すること
ができる。The formulation of the present invention can be produced, for example, by the following method.
塩酸ブロムヘキシンと常用の賦形剤、例えば、乳糖、マ
ンニットなどを第１１改正日本薬局方製剤総則に従って
顆粒剤または散剤を製造し、塩基性薬も同様に第１１改
正日本薬局方製剤総則に従って顆粒剤または散剤とする
。しかるのちに、造する。これをプラスチック積層アル
ミニウム包材またはプラスチック容器で包装をし、製品
とすることができる。Bromhexine hydrochloride and commonly used excipients such as lactose and mannitol are made into granules or powders according to the 11th revised Japanese Pharmacopoeia General Rules for Preparations, and basic drugs are also granulated according to the 11th revised Japanese Pharmacopoeia General Rules for Preparations. formulation or powder. After that, I will build it. This can be packaged in a plastic laminated aluminum packaging material or a plastic container to produce a product.
［発明の効果］
本発明により、顆粒剤または散剤中の塩酸ブロムヘキシ
ンが包装中のプラスチック類に吸着移れることを肪止で
きるので、常用のプラスチック包材やプラスデック積層
アルミニウム包材を用いて塩酸ブロムヘキシン頼粒剤ま
たは散剤を包装し、製品とすることが可能となった。[Effects of the Invention] According to the present invention, it is possible to prevent bromhexine hydrochloride in granules or powders from being adsorbed and transferred to plastics in the packaging. It is now possible to package granules or powders and make them into products.
［実施例］
以下、実施例と試験例を挙げて本発明を具体的に説明す
る。[Example] Hereinafter, the present invention will be specifically explained with reference to Examples and Test Examples.
実施例１
処方
Ａ；塩酸ブロムヘキシン ４■
乳糖 ４９１■
ヒドロキシプロピルセルロース
５ 蒐Ｂ；アセトアミノフェン ３００■
ｄｉ −マレイン酸りロルフＸニラミン
２ 、５ ■塩酸グロペラスチン
１６ ■ヒドロキシプロピルセルロース
５ ■乳糖 １７
６．５■
上記処方で第１１改正日本薬局方製剤総則５に従い、顆
粒剤を得た。Example 1 Prescription A; Bromhexine hydrochloride 4■ Lactose 491■ Hydroxypropyl cellulose
5 蒐B; Acetaminophen 300■ di-maleic acid rolf x niramine
2, 5 ■ Groperastine hydrochloride
16 ■Hydroxypropylcellulose
5 ■Lactose 17
6.5■ Granules were obtained using the above formulation in accordance with the 11th revised Japanese Pharmacopoeia General Rules for Preparations 5.
各々のＡ、Ｂ顆粒を混合し、目的顆粒剤を得た。The A and B granules were mixed to obtain the desired granules.
この顆粒剤をポリエチレン積層アルミニウムバッりに充
填した。The granules were filled into polyethylene laminated aluminum bags.
実施例２
処方
Ａ：塩酸ブロムヘキシン ４蒐
ヒドロキシプロピルセルロース
５ ■ソルビトール ２９１＋ｔｇ
Ｂ；アセトアミノフェン ３００ｆｌｌ！マレイン酸
カルビノキフミン ２ 、５
■塩酸ノスカピン １６ｎｇ
ヒドロキシプロピルセルロース
５ ■ソルビトール ２７６．５■
上記処方で第１１改正日本薬局方製剤総則５に従い、顆
粒剤を得た。Example 2 Formulation A: Bromhexine hydrochloride 4 g Hydroxypropylcellulose
5 ■Sorbitol 291+tg B; Acetaminophen 300fll! Carbinokyhumine maleate 2, 5
■Noscapine hydrochloride 16ng hydroxypropyl cellulose
5 ■Sorbitol 276.5■ Granules were obtained according to the 11th revised Japanese Pharmacopoeia General Rules for Preparations 5 using the above formulation.
各々のＡ、Ｂ顆粒を混合し、目的顆粒剤を得た。The A and B granules were mixed to obtain the desired granules.
この顆粒剤をポリエステル積層アルミニウムパックに充
填した。This granule was filled into a polyester laminated aluminum pack.
実施例３
処方
Ａ；塩酸ブロムヘキシン ４ｒ＋ｇポリビニルピ
ロリドン ５■
乳糖 １９１■
Ｂ；エテンザミド ５００■
フマル酸クレマスチン ０ 、１
２ ■塩化リゾチーム ２０■
ポリビニルピロリドン １５■
乳糖 ２６４．８８ＩＴｇ計
ＳＯＯ■上記処方で第１１改正
日本薬局方製剤総則１１に従い、散剤を得た。Example 3 Formulation A; Bromhexine hydrochloride 4r+g polyvinylpyrrolidone 5■ Lactose 191■ B; Ethenzamide 500■ Clemastine fumarate 0, 1
2 ■ Lysozyme chloride 20 ■ Polyvinylpyrrolidone 15 ■ Lactose 264.88 ITg total
SOO ■ A powder was obtained according to the above-mentioned prescription in accordance with the 11th edition of the Japanese Pharmacopoeia, General Rules for Preparations 11.
各々のＡ、Ｂ散粒を混合し、目的散剤を得た。The respective powders A and B were mixed to obtain the desired powder.
この散剤をポリエチレン積層アルミニウムパックに充填
した。This powder was filled into a polyethylene laminated aluminum pack.
試験例１
（検体）
実施例１，３で得られた顆粒剤をバレックス２１０［商
品名；三井東圧化学（株）製］を積層したアルミニウム
包材にそれぞれ塩酸ブロムヘキシン４■相当量をパック
したものを検体１．２とした。また、対照量として以下
の処方の顆粒剤をバレックス２１０を積層したアルミニ
ウム包材にそれぞれ塩酸ブロムヘキシン４■相当量をパ
ックしたものを対照量１．２とした。Test Example 1 (Sample) The granules obtained in Examples 1 and 3 were each packed in an aluminum packaging material laminated with Valex 210 [trade name; manufactured by Mitsui Toatsu Chemical Co., Ltd.] in an amount equivalent to 4 μm of bromhexine hydrochloride. This was designated as specimen 1.2. Further, as a control amount, granules having the following formulation were each packed in an aluminum packaging material laminated with Valex 210 in an amount equivalent to 4 μm of bromhexine hydrochloride, and the control amount was 1.2.
対照量１の処方；
塩酸ブロムヘキシン ４■
アセトアミノフエン ３００■
ｄｌ −マレイン酸りロルフＸニラミン
２ 、５ ■塩酸クロペラスチン １６■
ヒドロキシプロピルセルロース
１０ｎｇ乳糖 ６６７．５ｑ対照
品２の処方；
塩酸ブロムヘキシン ４ｗ。Prescription for control amount 1; Bromhexine hydrochloride 4 ■ Acetaminophen 300 ■ dl - Rolf X Niramine maleic acid
2, 5 ■ Cloperastine hydrochloride 16 ■ Hydroxypropyl cellulose
10ng lactose 667.5q Control product 2 formulation; Bromhexine hydrochloride 4w.
エテンザミド ５００■
フマル酸クレマスチン ０．１２■塩化リゾチーム
２０■
ポリゼニルビロリドン ２０■
乳糖 ２５５．８８ｇ
計 ５ｏｏＴｒｔ
：検体１，２および対照１，２を、５０℃で保存して、
１週間後、２週間後、３週間後、４週間後にそれぞれの
包材をクロロホルム中で５０℃、３０分間還流した抽出
液について、下記条件でバレックス膜中の塩酸ブロムヘ
キシンについて定量した。Ethenzamide 500 ■ Clemastine fumarate 0.12 ■ Lysozyme chloride 20 ■ Polyzenylpyrrolidone 20 ■ Lactose 255.88g Total 5ooTrt
: Samples 1 and 2 and Controls 1 and 2 were stored at 50°C,
After 1 week, 2 weeks, 3 weeks, and 4 weeks, each packaging material was refluxed in chloroform at 50° C. for 30 minutes, and the extract was quantified for bromhexine hydrochloride in the Barex membrane under the following conditions.
（定量条件）
１）ポンプ、ＨＩＴＡＣＨＩ ６５５Ａ−１２［（株
）日立製作新製］
２）検出器；ＨＩＴＡＣＨＩ ６５５Ａ［（株）日立
製作新製コ
３）操作条件；
検出器、ＵＶ吸光度計
測定波長；２１０ｎｍ
検出器感度；０．０４ＡＵＦＳ
カラム；内径４ ｍｌ、長＊；１５０ｍｍのステンレス
管に、充填剤としてオクタデシルシリル化した５−のシ
リカゲルを充填する。(Quantitative conditions) 1) Pump, HITACHI 655A-12 [Newly manufactured by Hitachi Seisakusho Co., Ltd.] 2) Detector; HITACHI 655A [Newly manufactured by Hitachi Seisakusho Co., Ltd.] 3) Operating conditions; Detector, UV absorbance meter measurement wavelength 210 nm Detector sensitivity: 0.04 AUFS Column: A stainless steel tube with an inner diameter of 4 ml and a length* of 150 mm is filled with octadecylsilylated 5-silica gel as a filler.
カラム温度；５０°Ｃ
移動相；アセトニトリルとラウリル硫酸ナトリウムの１
／１５Ｍリン酸二水素カリウム溶液の混液（混合比５２
０：４８０）
流量；毎分１ｍ１ｌ
注入量；塩酸ブロムヘキシン濃度２０ｑ／ｍＱのものを
１０Ｐ１１注入
（結果）
定量結果を、試験開始時の検体中の塩酸ブロムヘキシン
の量を１００とした百分率で第１表に示した。Column temperature: 50°C Mobile phase: 1 of acetonitrile and sodium lauryl sulfate
/15M potassium dihydrogen phosphate solution (mixing ratio 52
0:480) Flow rate: 1ml/min Injection volume: 10P11 injections of bromhexine hydrochloride with a concentration of 20q/mQ (results) The quantitative results are shown in Table 1 as a percentage with the amount of bromhexine hydrochloride in the sample at the start of the test as 100. It was shown to.
第１表Table 1
Claims (1)
剤とし、これらの顆粒剤または散剤を更に混合して顆粒
剤または散剤とすることにより、塩酸ブロムヘキシンが
プラスチック積層アルミニウム包材またはプラスチック
包材に吸着されることを防止する方法。By making bromhexine hydrochloride and a basic drug into granules or powders, and further mixing these granules or powders to make granules or powders, bromhexine hydrochloride is adsorbed to the plastic laminated aluminum packaging material or the plastic packaging material. How to prevent this from happening.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP13179187A JPH085783B2 (en) | 1987-05-29 | 1987-05-29 | Bromhexine hydrochloride adsorption prevention method |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP13179187A JPH085783B2 (en) | 1987-05-29 | 1987-05-29 | Bromhexine hydrochloride adsorption prevention method |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| JPS63297321A true JPS63297321A (en) | 1988-12-05 |
| JPH085783B2 JPH085783B2 (en) | 1996-01-24 |
Family
ID=15066216
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP13179187A Expired - Lifetime JPH085783B2 (en) | 1987-05-29 | 1987-05-29 | Bromhexine hydrochloride adsorption prevention method |
Country Status (1)
| Country | Link |
|---|---|
| JP (1) | JPH085783B2 (en) |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP2007119453A (en) * | 2005-09-29 | 2007-05-17 | Daiichi Sankyo Healthcare Co Ltd | Method for preventing lowering of bromhexine hydrochloride content |
| CN114831942A (en) * | 2022-05-19 | 2022-08-02 | 齐鲁动物保健品有限公司 | Veterinary medicine bromhexine hydrochloride soluble powder and preparation method thereof |
-
1987
- 1987-05-29 JP JP13179187A patent/JPH085783B2/en not_active Expired - Lifetime
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP2007119453A (en) * | 2005-09-29 | 2007-05-17 | Daiichi Sankyo Healthcare Co Ltd | Method for preventing lowering of bromhexine hydrochloride content |
| CN114831942A (en) * | 2022-05-19 | 2022-08-02 | 齐鲁动物保健品有限公司 | Veterinary medicine bromhexine hydrochloride soluble powder and preparation method thereof |
Also Published As
| Publication number | Publication date |
|---|---|
| JPH085783B2 (en) | 1996-01-24 |
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