JPS6344521A - Method for preventing adsorption of bromhexine hydrochloride - Google Patents
Method for preventing adsorption of bromhexine hydrochlorideInfo
- Publication number
- JPS6344521A JPS6344521A JP61187395A JP18739586A JPS6344521A JP S6344521 A JPS6344521 A JP S6344521A JP 61187395 A JP61187395 A JP 61187395A JP 18739586 A JP18739586 A JP 18739586A JP S6344521 A JPS6344521 A JP S6344521A
- Authority
- JP
- Japan
- Prior art keywords
- bromhexine hydrochloride
- packaging material
- granules
- adsorption
- polymer packaging
- 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 29
- 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 29
- 238000000034 method Methods 0.000 title claims description 7
- 238000001179 sorption measurement Methods 0.000 title abstract description 8
- 239000005022 packaging material Substances 0.000 claims abstract description 29
- 239000008187 granular material Substances 0.000 claims abstract description 26
- 229920000642 polymer Polymers 0.000 claims abstract description 17
- 150000002016 disaccharides Chemical class 0.000 claims abstract description 6
- 150000002772 monosaccharides Chemical class 0.000 claims abstract description 6
- 235000000346 sugar Nutrition 0.000 claims abstract description 6
- 238000002156 mixing Methods 0.000 claims description 6
- 150000008163 sugars Chemical class 0.000 claims description 4
- 239000000203 mixture Substances 0.000 abstract description 17
- 239000003795 chemical substances by application Substances 0.000 abstract description 8
- 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 abstract description 7
- 229930195725 Mannitol Natural products 0.000 abstract description 7
- 239000000594 mannitol Substances 0.000 abstract description 7
- 235000010355 mannitol Nutrition 0.000 abstract description 7
- 238000004806 packaging method and process Methods 0.000 abstract description 7
- 239000011230 binding agent Substances 0.000 abstract description 5
- 229920002153 Hydroxypropyl cellulose Polymers 0.000 abstract description 4
- 238000007796 conventional method Methods 0.000 abstract description 4
- 239000001863 hydroxypropyl cellulose Substances 0.000 abstract description 4
- 235000010977 hydroxypropyl cellulose Nutrition 0.000 abstract description 4
- 239000000463 material Substances 0.000 abstract 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 abstract description 2
- 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 abstract description 2
- WQZGKKKJIJFFOK-GASJEMHNSA-N Glucose Natural products OC[C@H]1OC(O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-GASJEMHNSA-N 0.000 abstract description 2
- WQZGKKKJIJFFOK-VFUOTHLCSA-N beta-D-glucose Chemical compound OC[C@H]1O[C@@H](O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-VFUOTHLCSA-N 0.000 abstract description 2
- 239000003172 expectorant agent Substances 0.000 abstract description 2
- 230000003419 expectorant effect Effects 0.000 abstract description 2
- 239000008103 glucose Substances 0.000 abstract description 2
- 239000000600 sorbitol Substances 0.000 abstract description 2
- -1 polyethylene Polymers 0.000 description 14
- 238000009472 formulation Methods 0.000 description 11
- 238000012360 testing method Methods 0.000 description 10
- 239000004698 Polyethylene Substances 0.000 description 8
- 229920000573 polyethylene Polymers 0.000 description 8
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 description 4
- 239000004743 Polypropylene Substances 0.000 description 4
- 239000004570 mortar (masonry) Substances 0.000 description 4
- 229920001155 polypropylene Polymers 0.000 description 4
- 238000002360 preparation method Methods 0.000 description 4
- 229920002472 Starch Polymers 0.000 description 3
- BZHJMEDXRYGGRV-UHFFFAOYSA-N Vinyl chloride Chemical compound ClC=C BZHJMEDXRYGGRV-UHFFFAOYSA-N 0.000 description 3
- AZDRQVAHHNSJOQ-UHFFFAOYSA-N alumane Chemical class [AlH3] AZDRQVAHHNSJOQ-UHFFFAOYSA-N 0.000 description 3
- XAGFODPZIPBFFR-UHFFFAOYSA-N aluminium Chemical compound [Al] XAGFODPZIPBFFR-UHFFFAOYSA-N 0.000 description 3
- 229910052782 aluminium Inorganic materials 0.000 description 3
- 239000001913 cellulose Substances 0.000 description 3
- 229920002678 cellulose Polymers 0.000 description 3
- 230000007423 decrease Effects 0.000 description 3
- 229920000728 polyester Polymers 0.000 description 3
- 239000000843 powder Substances 0.000 description 3
- 239000000243 solution Substances 0.000 description 3
- 239000008107 starch Substances 0.000 description 3
- 235000019698 starch Nutrition 0.000 description 3
- 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
- HEDRZPFGACZZDS-UHFFFAOYSA-N Chloroform Chemical compound ClC(Cl)Cl HEDRZPFGACZZDS-UHFFFAOYSA-N 0.000 description 2
- VEXZGXHMUGYJMC-UHFFFAOYSA-N Hydrochloric acid Chemical compound Cl VEXZGXHMUGYJMC-UHFFFAOYSA-N 0.000 description 2
- 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 2
- 230000000694 effects Effects 0.000 description 2
- 238000004898 kneading Methods 0.000 description 2
- 239000008101 lactose Substances 0.000 description 2
- 229920001592 potato starch Polymers 0.000 description 2
- 238000012113 quantitative test Methods 0.000 description 2
- 229910001220 stainless steel Inorganic materials 0.000 description 2
- 239000010935 stainless steel Substances 0.000 description 2
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-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
- 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 description 1
- 229930006000 Sucrose Natural products 0.000 description 1
- 238000010521 absorption reaction Methods 0.000 description 1
- 230000000052 comparative effect Effects 0.000 description 1
- 229940079593 drug Drugs 0.000 description 1
- 239000003814 drug Substances 0.000 description 1
- 239000011521 glass Substances 0.000 description 1
- 238000010438 heat treatment Methods 0.000 description 1
- 238000004128 high performance liquid chromatography Methods 0.000 description 1
- 238000002347 injection Methods 0.000 description 1
- 239000007924 injection Substances 0.000 description 1
- 238000004519 manufacturing process Methods 0.000 description 1
- 238000005259 measurement Methods 0.000 description 1
- 235000013336 milk Nutrition 0.000 description 1
- 239000008267 milk Substances 0.000 description 1
- 210000004080 milk Anatomy 0.000 description 1
- 229910000402 monopotassium phosphate Inorganic materials 0.000 description 1
- 235000019796 monopotassium phosphate Nutrition 0.000 description 1
- 238000012856 packing Methods 0.000 description 1
- PJNZPQUBCPKICU-UHFFFAOYSA-N phosphoric acid;potassium Chemical compound [K].OP(O)(O)=O PJNZPQUBCPKICU-UHFFFAOYSA-N 0.000 description 1
- 229920000036 polyvinylpyrrolidone Polymers 0.000 description 1
- 239000001267 polyvinylpyrrolidone Substances 0.000 description 1
- 235000013855 polyvinylpyrrolidone Nutrition 0.000 description 1
- 238000010992 reflux Methods 0.000 description 1
- 238000011160 research Methods 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
- 238000006884 silylation reaction Methods 0.000 description 1
- 235000019333 sodium laurylsulphate Nutrition 0.000 description 1
- 125000004079 stearyl group Chemical group [H]C([*])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])[H] 0.000 description 1
- 238000003860 storage Methods 0.000 description 1
- 239000000126 substance Substances 0.000 description 1
- 239000005720 sucrose Substances 0.000 description 1
- 238000005303 weighing Methods 0.000 description 1
Landscapes
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Medicinal Preparation (AREA)
Abstract
Description
【発明の詳細な説明】
［産業上の利用分野］
本発明は、粒剤中の塩酸ブロムヘキシンの高分子包材へ
の吸着防止方法に関する。DETAILED DESCRIPTION OF THE INVENTION [Field of Industrial Application] The present invention relates to a method for preventing adsorption of bromhexine hydrochloride in granules to a polymer packaging material.
［従来の技術］
従来、塩酸ブロムヘキシンにデンプン、結晶セルロース
等を配合し、常法により粒剤とし、これをガラスピンま
たはステンレス製容器で包装し、用時秤量し小１分けし
ていた。[Prior Art] In the past, starch, crystalline cellulose, etc. were blended with bromhexine hydrochloride, granules were made by a conventional method, the granules were packaged with glass pins or stainless steel containers, and the granules were weighed and divided into small portions at the time of use.
［発明が解決しようとする問題点コ
しかしながら、使用の都度これを秤量し小分けするのは
多忙時には煩瑣であるので、予め高分子包材に分包して
保存しておくのが実務上便利である。[Problems to be Solved by the Invention]However, weighing and dividing the product each time it is used is a hassle when you are busy, so it is practical to store it in advance by packaging it in polymeric packaging material. be.
ところが、本発明者らの研究の結果、塩酸ブロムヘキシ
ンは、配合する物質の種類（例えばデンプン、結晶セル
ロース等）により高分子包材に吸着し分包剤中の含量が
減少するという問題が生じることが明らかとなった。However, as a result of research conducted by the present inventors, it has been found that bromhexine hydrochloride may be adsorbed to polymer packaging materials depending on the type of substance to be blended (e.g., starch, crystalline cellulose, etc.), resulting in a problem in which the content in the packaging agent decreases. became clear.
塩酸ブロムヘキシンは優れた去挟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４ｍｇ程度の
少量にすぎない。Bromhexine hydrochloride is a drug that is widely used as an excellent expectorant, but its dosage is only a small amount of about 4 mg at a time.
従って、保存の間に粒剤中の塩酸ブロムヘキシンが高分
子包材に吸着して微量といえどもその含量を減すること
はその薬効に重大な影響を与える。Therefore, if the bromhexine hydrochloride in the granules is adsorbed to the polymeric packaging material during storage and its content is reduced, even if only by a small amount, this has a significant effect on its medicinal efficacy.
本発明の目的は、高分子包材により分包した粒剤中の塩
酸ブロムヘキシンが高分子包材に吸着するのを防止する
方法を提供することにある。An object of the present invention is to provide a method for preventing bromhexine hydrochloride contained in granules packaged with a polymeric packaging material from adsorbing to the polymeric packaging material.
［問題点を解決するための手段］
本発明の方法は、塩酸ブロムヘキシンを含有する粒剤に
おいて、単糖類および二糖類からなる群より選ばれる一
または二以上の糖を配合し、常法により粒剤にすること
により、この製剤を常用の高分子包材、例えばポリエチ
レン、ポリプロピレン、ポリエステル、塩化ビニル等で
包装して保存しても、粒剤中の塩酸ブロムヘキシンが高
分子包材へ吸着せず、粒剤中の塩酸ブロムヘキシン含量
を長期にわたって保持することを可能にするものである
。[Means for Solving the Problems] The method of the present invention involves blending one or more sugars selected from the group consisting of monosaccharides and disaccharides in granules containing bromhexine hydrochloride, and granulating them by a conventional method. By making this into a granule, the bromhexine hydrochloride in the granules will not be adsorbed to the polymer packaging material even if this preparation is packaged and stored in commonly used polymer packaging materials such as polyethylene, polypropylene, polyester, vinyl chloride, etc. This makes it possible to maintain the bromhexine hydrochloride content in the granules for a long period of time.
以下、本発明を詳細に述べる。The present invention will be described in detail below.
本発明における粒剤は、第１１改正日本薬局方に規定す
る顆粒剤および散剤を意味し、塩酸ブロムヘキシンを単
糖類および二糖類からなる群より選ばれる一または二以
上の糖とよく混合し、結合剤を用いて常法により製造す
る。The granules used in the present invention refer to granules and powders defined in the 11th edition of the Japanese Pharmacopoeia, in which bromhexine hydrochloride is thoroughly mixed with one or more sugars selected from the group consisting of monosaccharides and disaccharides, and then combined. It is manufactured by a conventional method using an agent.
前記単糖類、二糖類として、マンニトール、ソルビトー
ル、ブドウ糖、乳糖、白糖等を用いる。As the monosaccharides and disaccharides, mannitol, sorbitol, glucose, lactose, sucrose, etc. are used.
前記結合剤として、常用の結合剤、例えばヒドロキシプ
ロピルセルロース、ポリビニルピロリドン等を用いる。As the binder, a commonly used binder such as hydroxypropylcellulose, polyvinylpyrrolidone, etc. is used.
この粒剤をポリエチレン、ポリプロピレン、ポリエステ
ル、塩化ビニル等の高分子包材（例えば積層アルミニウ
ム包材、容器等）で包装した場合は塩酸ブロムヘキシン
含量が経時的に低下することがない。When this granule is packaged in a polymer packaging material such as polyethylene, polypropylene, polyester, or vinyl chloride (for example, a laminated aluminum packaging material, a container, etc.), the content of bromhexine hydrochloride does not decrease over time.
これに対し、デンプン、結晶セルロース［例えば商品名
アビセル、旭化成工業（株）製コ等を配合し、上記と同
様な製法で製造した粒剤は、同じ包材に包装した場合、
粒剤中の塩酸ブロムヘキシン含量が経時的に減少してし
まう。On the other hand, when granules containing starch and crystalline cellulose (for example, Avicel (trade name), produced by Asahi Kasei Industries, Ltd.) and manufactured using the same manufacturing method as above, are packaged in the same packaging material,
The bromhexine hydrochloride content in the granules decreases over time.
［発明の効果コ
本発明の、単糖類および二糖類からなる群より選ばれる
一または二以上の糖を配合する方法により作られる塩酸
ブロムヘキシン含有粒剤は、ポリエチレン、ポリプロピ
レン、ポリエステル、塩化ビニル等の常用の高分子包材
で包装して保存しても、塩酸ブロムヘキシンがその高分
子包材に吸着することなく、粒剤中の塩酸ブロムヘキシ
ン含量を長期にわたって保持することができる。[Effects of the Invention] The bromhexine hydrochloride-containing granules of the present invention, which are produced by the method of blending one or more sugars selected from the group consisting of monosaccharides and disaccharides, are made of polyethylene, polypropylene, polyester, vinyl chloride, etc. Even if the granules are packaged and stored using a commonly used polymer packaging material, the bromhexine hydrochloride content in the granules can be maintained for a long period of time without adsorption of bromhexine hydrochloride to the polymer packaging material.
［実施例コ
以下、本発明の実施例および試験例を示し、本発明をき
らに具体的に説明する。[Example] Hereinafter, the present invention will be specifically explained by showing examples and test examples of the present invention.
（実施例１）
塩酸フロムヘキシン４ｇ１マンニトール７００ｇの混合
物を乳鉢に入れ、これにヒドロキシプロピルセルロース
１４ｇをエタノール９０ｇに溶解したものを結合剤とし
て加え、乳鉢中で練合した。練合後、１２号のふるいを
通し、循環式乾燥器［ＤＨ−６１、ヤマト科学（株）製
コにより６０°Ｃで２時間乾燥した。(Example 1) A mixture of 4 g of fromhexine hydrochloride and 700 g of mannitol was placed in a mortar, and a solution of 14 g of hydroxypropyl cellulose dissolved in 90 g of ethanol was added as a binder and kneaded in the mortar. After kneading, the mixture was passed through a No. 12 sieve and dried at 60°C for 2 hours in a circulating dryer [DH-61, manufactured by Yamato Scientific Co., Ltd.].
このうち、１２号のふるいをとおり、１４号のふるいに
残るものを選定し、顆粒剤６８０ｇを得た。Of these, those that passed through a No. 12 sieve and remained on a No. 14 sieve were selected to obtain 680 g of granules.
これを製剤１とし、その７２０ｍｇずつをポリエチレン
￥Ｉ！アルミニウム包材で分包、包装し、５０°Ｃで４
週間保存したが、塩酸ブロムヘキシンの高分子包材への
吸着はほとんど起こらなかった。This is Formulation 1, and each 720mg of polyethylene ￥I! Separate and wrap in aluminum packaging material and store at 50°C for 4 days.
Although it was stored for a week, there was almost no adsorption of bromhexine hydrochloride to the polymer packaging material.
（実施例２）
マンニトール７００ｇのかわりに乳＠ ７００ｇを使用
する他は、前記実施例１に準じて顆粒剤６８０ｇを得た
。(Example 2) 680 g of granules were obtained in the same manner as in Example 1, except that 700 g of milk was used instead of 700 g of mannitol.
これを製剤２とし、その７２０ｍｇずつを塩化ビニル積
層アルミニウム包材で分包、包装し、実施例１と同一条
件で保存したが、塩酸ブロムヘキシンの高分子包材への
吸着はほとんど起こらなかった。This was designated as Formulation 2, and 720 mg of each was divided and packaged in vinyl chloride laminated aluminum packaging and stored under the same conditions as Example 1, but almost no adsorption of bromhexine hydrochloride to the polymer packaging material occurred.
（実施例３）
塩酸フロムヘキシン４ｇ１マンニトール７００乙の混合
物を乳鉢に入れ、これにヒドロキシプロピルセルロース
１４ｇをエタノール９０ｇに溶解したものを結合剤とし
て加え、乳鉢中で練合した。練合後、３０号のふるいを
通し、循環式乾燥器［ＤＮ−６１、ヤマト科学（株）製
コにより６０°Ｃで２時間乾燥した。(Example 3) A mixture of 4 g of fromhexine hydrochloride and 700 g of mannitol was placed in a mortar, and a solution of 14 g of hydroxypropyl cellulose dissolved in 90 g of ethanol was added as a binder and kneaded in the mortar. After kneading, the mixture was passed through a No. 30 sieve and dried at 60°C for 2 hours in a circulating dryer [DN-61, manufactured by Yamato Scientific Co., Ltd.].
これを３０号のふるいにかけて通過したものを集め、散
剤７００ｇを得た。This was passed through a No. 30 sieve and the material that passed through was collected to obtain 700 g of powder.
これを製剤３とし、その７２０ｍｇずつをポリエチレン
積欝アルミニウム包材で分包、包装し５０°Ｃで４週間
保存したが、塩酸ブロムヘキシンの高分子包材への吸着
はほとんどなかった。This was designated as Formulation 3, and 720 mg of each was divided and packaged in polyethylene bulk aluminum packaging and stored at 50°C for 4 weeks, but there was almost no adsorption of bromhexine hydrochloride to the polymer packaging.
（試験例１〉
製剤１および製剤２をそれぞれ、内側にポリエチレンを
ＭＭしたアルミニウム包材に包装して加温条件下（５０
°Ｃ）で保存し、１週間後、２週間後、３週間後および
４週間後に於ける包材中の塩酸ブロムヘキシン含量を、
下記の条件により、高速液体クロマトグラフ法を用いて
定量した。包材中の塩酸ブロムヘキシンについては、包
材をクロロホルム中で５０℃、３０分間還流した抽出液
について定量した。(Test Example 1) Formulation 1 and Formulation 2 were each packaged in an aluminum packaging material with polyethylene MM inside and heated under heating conditions (50
°C), and the bromhexine hydrochloride content in the packaging material after 1 week, 2 weeks, 3 weeks, and 4 weeks,
It was quantified using high performance liquid chromatography under the following conditions. Bromhexine hydrochloride in the packaging material was quantified using an extract obtained by refluxing the packaging material in chloroform at 50°C for 30 minutes.
なお、マンニトールあるいは乳糖のかわりにそれぞれバ
レイショデンブンまたはアビセルを配合して実施例１に
準じて顆粒剤を製造し、これらをそれぞれ対照剤１、対
照剤２とし、製剤１および製剤２と同様にして定量した
。In addition, granules were prepared according to Example 1 by blending potato starch or Avicel instead of mannitol or lactose, respectively, and these were used as Control Agent 1 and Control Agent 2, respectively, and were prepared in the same manner as Formulation 1 and Formulation 2. It was quantified.
定量条件
１）ポンプ ； ＨＩＴＡＣＨＩ ６５５Ａ−１２［（
株）日立製作新製コ
２〉検出器 ； ＨＩＴＡＣ）ＩＩ ６５５Ａ［（株）
日立製作新製］
３）操作条件；
検出器 ：紫外吸光光度計
測定波長 ： ２１０ｎｍ
検出器感度： ０．０４ＡＵＦＳ
カラム ：内径４ ｍｍ 、長’；ａ 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５μｍのシリカゲルを充填する。Quantitative conditions 1) Pump; HITACHI 655A-12 [(
Hitachi Seisakusho Co., Ltd. New Ko2〉Detector; HITAC) II 655A
Newly manufactured by Hitachi] 3) Operating conditions; Detector: Ultraviolet absorption photometer Measurement wavelength: 210 nm Detector sensitivity: 0.04 AUFS Column: Internal diameter 4 mm, length: a 150 mm stainless steel tube, octadecyl silylation as a packing material Fill with 5 μm silica gel.
カラム温度：５０°Ｃ付近の一定温度
移動相 ニアセトニトリルと、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５２０：４８０）流量 ：毎分的１ｍｌの一定流
量
４）注入量 ；塩酸ブロムヘキシン濃度２０ｑ／ｍＱ程
度のものを１０μ注入
（試験例２）
顆粒剤を包装する高分子包材に、ポリエチレン積層アル
ミニウム包材のかわりに塩化ビニル積層アルミニウム包
材を使用して、製剤１と対照剤１について前記試験例１
と同様にして定量試験を行なった。Column temperature: Constant temperature mobile phase around 50°C Mixture of niacetonitrile and 1/15M potassium dihydrogen phosphate solution of sodium lauryl sulfate (mixing ratio 520:480) Flow rate: Constant flow rate of 1 ml per minute 4) Injection Amount: Inject 10 μ of bromhexine hydrochloride with a concentration of approximately 20 q/mQ (Test Example 2) A vinyl chloride laminated aluminum packaging material was used instead of a polyethylene laminated aluminum packaging material for the polymer packaging material used to package the granules. 1 and Comparative Agent 1 The above Test Example 1
A quantitative test was conducted in the same manner as above.
（試験例３）
顆粒剤を包装する高分子包材に、ポリエチレン積層アル
ミニウム包材のかわりにポリプロピレン類の気密容器を
使用して、製剤１と゛対照剤１について前記試験例１と
同様にして定量試験を行なった。(Test Example 3) Preparation 1 and Control Agent 1 were quantitatively determined in the same manner as in Test Example 1, using a polypropylene airtight container instead of polyethylene laminated aluminum packaging as the polymer packaging material for the granules. I conducted a test.
（試験例４）
製剤１および製剤２のかわりに製剤３を用いる他は前記
試験例１と同様にして定量試験を行なった。(Test Example 4) A quantitative test was conducted in the same manner as in Test Example 1 except that Formulation 3 was used instead of Formulation 1 and Formulation 2.
なお、マンニトールのかわりにバレイショデンブンを配
合して実施例３に準じて散剤を製造し、これを対照剤３
とし、製剤３と同様にして定量した。In addition, a powder was prepared according to Example 3 by blending potato starch instead of mannitol, and this was mixed with Control Agent 3.
and quantified in the same manner as Formulation 3.
以上の試験例１〜３の結果を、製剤の製造直後に於ける
塩酸ブロムヘキシン含量に基づいて百分率で表示し、第
１表にまとめた。The results of Test Examples 1 to 3 above are expressed in percentages based on the bromhexine hydrochloride content immediately after preparation of the preparations, and are summarized in Table 1.
Claims (1)
糖類および二糖類からなる群より選ばれる一または二以
上の糖を配合することにより、高分子包材を用いて前記
粒剤を分包、保存する間に塩酸ブロムヘキシンが前記高
分子包材に吸着することを防止する方法。(1) In the granules containing bromhexine hydrochloride, by blending one or more sugars selected from the group consisting of monosaccharides and disaccharides, the granules are packaged and stored using a polymer packaging material. A method for preventing bromhexine hydrochloride from being adsorbed to the polymer packaging material during the process.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP61187395A JPH0739341B2 (en) | 1986-08-09 | 1986-08-09 | Bromhexine hydrochloride anti-adsorption formulation |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP61187395A JPH0739341B2 (en) | 1986-08-09 | 1986-08-09 | Bromhexine hydrochloride anti-adsorption formulation |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| JPS6344521A true JPS6344521A (en) | 1988-02-25 |
| JPH0739341B2 JPH0739341B2 (en) | 1995-05-01 |
Family
ID=16205277
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP61187395A Expired - Lifetime JPH0739341B2 (en) | 1986-08-09 | 1986-08-09 | Bromhexine hydrochloride anti-adsorption formulation |
Country Status (1)
| Country | Link |
|---|---|
| JP (1) | JPH0739341B2 (en) |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US5552730A (en) * | 1993-07-05 | 1996-09-03 | Nec Corporation | Mos differential voltage-to-current converter circuit with improved linearity |
| JP2007119453A (en) * | 2005-09-29 | 2007-05-17 | Daiichi Sankyo Healthcare Co Ltd | Method for preventing lowering of bromhexine hydrochloride content |
Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JPS54163820A (en) * | 1978-05-26 | 1979-12-26 | Thomae Gmbh Dr K | Hyperglycemic kidney inflammation treating agent |
-
1986
- 1986-08-09 JP JP61187395A patent/JPH0739341B2/en not_active Expired - Lifetime
Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JPS54163820A (en) * | 1978-05-26 | 1979-12-26 | Thomae Gmbh Dr K | Hyperglycemic kidney inflammation treating agent |
Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US5552730A (en) * | 1993-07-05 | 1996-09-03 | Nec Corporation | Mos differential voltage-to-current converter circuit with improved linearity |
| US5552729A (en) * | 1993-07-05 | 1996-09-03 | Nec Corporation | MOS differential voltage-to-current converter circuit with improved linearity |
| US5598117A (en) * | 1993-07-05 | 1997-01-28 | Nec Corporation | MOS differential voltage-to-current converter circuit with improved linearity |
| JP2007119453A (en) * | 2005-09-29 | 2007-05-17 | Daiichi Sankyo Healthcare Co Ltd | Method for preventing lowering of bromhexine hydrochloride content |
Also Published As
| Publication number | Publication date |
|---|---|
| JPH0739341B2 (en) | 1995-05-01 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| EXPY | Cancellation because of completion of term |