JP3704531B2 - sampler - Google Patents

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JP3704531B2
JP3704531B2 JP2003101539A JP2003101539A JP3704531B2 JP 3704531 B2 JP3704531 B2 JP 3704531B2 JP 2003101539 A JP2003101539 A JP 2003101539A JP 2003101539 A JP2003101539 A JP 2003101539A JP 3704531 B2 JP3704531 B2 JP 3704531B2
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sampler
collar
eyelid
granular material
sample
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JP2004309253A (en
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哲夫 山下
豊彦 伊藤
裕士 那須
優史 土肥
芝  隆司
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Astellas Pharma Inc
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Astellas Pharma Inc
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Description

【0001】
【発明の属する技術分野】
本発明は、大型の容器等に収容された粉粒体の一部を採取する技術に関する。より詳細には、大型の容器等に収容された粉粒体の一部を静的に(採取の過程で再混合せずに)採取する技術に関する。
【0002】
【従来の技術】
従来から、固形製剤(錠剤、カプセル剤、顆粒剤等)における混合工程(打錠工程やカプセル充填工程等、固形製剤を構成する粉粒体を最終剤形に加工する直前に行われる工程であって、複数の異なる粉体同士、粒体同士または粉体と粒体を均一に混合する工程)は、最終製品である固形製剤の均一性を確保するための重要なプロセスである。
このような混合工程においては、混合均一性の適格性を検証するため、混合工程において用いられる混合器内の数点から十数点をサンプリング箇所(検体採取箇所)として予め設定しておき、混合作業終了後の粉粒体から検体を採取する。そして、個々の検体を分析して特定成分の分析値のばらつきを指標として混合均一性を評価する。
このとき、採取される検体の量が最終剤形の投与単位量と比較して多すぎると、混合均一性を検証することが困難な場合があるため、投与単位量の1〜3倍量の検体を採取することが望ましい。そして、このような数十mgから数百mgほどの微量な検体を採取するために用いられるサンプラーの技術は公知となっている。例えば、特許文献1に記載の如くである。
特許文献1に記載のサンプラー(以後、「従来のサンプラーの第一実施例」と呼ぶ)は、図11に示す如くサンプラー101の内管102が外管103に対して摺動可能な二重管構造であり、外管103の外周面には孔104が穿設され、内管102の外周面には検体を受容する窪みである受容部105が設けられている。該サンプラー101を検体採取作業に用いるときには、まず外管103に設けられた孔104と内管102に設けられた受容部105とを一致させた状態に保持して、内管102の一端に設けられた略円錐形状の部材である先端部材106を先端として粉粒体に挿入する。次に、外管103を摺動させて外管103の内周面で受容部105を閉塞し、受容部105に検体となる微量の粉粒体を封入した後、サンプラー101を粉粒体から引き抜いて検体を回収する。
また、特許文献1に記載の他にも、図12に示す「従来のサンプラーの第二実施例」の如きサンプラー111が公知となっている。サンプラー111は内管112が外管113に対して旋回可能な二重管構造であり、外管113の外周面には孔114が穿設されるとともに、粉粒体を孔114の内部に導入するための突起物である掻き取り部材117が該孔114の側方に設けられ、内管112の外周面には検体を受容する窪みである受容部115が設けられている。該サンプラー111を検体採取作業に用いるときには、まず外管113に設けられた孔114と内管112に設けられた受容部115とを一致させた状態に保持して、内管112の一端に設けられた略円錐形状の部材である先端部材116を先端として粉粒体に挿入する。次に、外管113を旋回させて外管113の内周面で受容部115を閉塞し、受容部115に検体となる微量の粉粒体を封入した後、サンプラー111を粉粒体から引き抜いて検体を回収する。
【0003】
【特許文献1】
米国特許第5440941号明細書
【0004】
【発明が解決しようとする課題】
しかし、図11および図12に示す従来のサンプラーにおいては、検体を封入する窪み(受容部)の開口方向がサンプラーの粉粒体への挿入方向(サンプラーの長手方向)に対して略垂直方向となるため、検体となる微量の粉粒体を検体採取作業の過程で再混合せずに窪みに封入することが困難であるという問題があった。
特に、混合工程終了後の粉粒体に占める主薬の比率が小さく、かつ主薬が分離偏析を起こしやすい粉粒体から検体を採取する場合、検体採取作業の過程で検体となる部分の粉粒体が再混合され、分離偏析を起こしている可能性がある。従って、該検体を分析して特定成分の分析値のばらつきを評価すると、検体の分析結果と混合工程終了後の粉粒体の実際の状態との間に乖離が生じる可能性がある(実際の粉粒体は十分に混合均一性が確保されているにもかかわらず、検体の分析結果からは混合均一性が十分でないという結論が導き出される可能性がある)。
本発明は以上の如き状況に鑑み、検体採取部位を再混合することなく微量な検体を採取することが可能なサンプラーを提供するものである。
【0005】
【課題を解決するための手段】
本発明の解決しようとする課題は以上の如くであり、次にこの課題を解決するための手段を説明する。
【0006】
即ち、請求項1においては、粉粒体を採取するサンプラーであって、
胴体と、該胴体の外周面に設けられる上杵と、該上杵に当接する位置と離間する位置との間を胴体の長手方向に摺動する下杵とを備え、上杵と下杵とが当接する部位には粉粒体を受容する受容部が上杵と下杵のいずれか一方、または上杵と下杵の両方に設けられるものである。
【0007】
請求項2においては、上杵と下杵のいずれか一方、または上杵と下杵の両方を胴体に対して着脱可能に取り付けたものである。
【0008】
請求項3においては、前記上杵に設けられる受容部の開口方向と、サンプラーの粉粒体への挿入方向とが略一致するものである。
【0009】
請求項4においては、前記胴体は側面に上杵が取り付けられる筒状体と、該筒状体に摺動可能に貫装されるとともに下杵が取り付けられる摺動体とを備えるものである。
【0010】
請求項5においては、前記下杵は、上杵から離間した位置において胴体の周方向に旋回するものである。
【0011】
請求項6においては、下杵4と上杵3とが当接した状態で固定可能に構成したものである。
【0012】
請求項7においては、前記胴体に目盛を設けたものである。
【0013】
【発明の実施の形態】
次に、発明の実施の形態を説明する。
図1は本発明の実施の一形態であるサンプラーの側面図、図2は本発明の実施の一形態であるサンプラーの先端部の側面断面図、図3は本発明の実施の一形態であるサンプラーの根元部の側面断面図、図4はハンドル支持部材の斜視図、図5は準備状態における本発明の実施の一形態であるサンプラーを長手方向から見た図、図6は準備状態における本発明の実施の一形態であるサンプラーの先端部の側面図、図7は帯状体を備えた本発明の実施の一形態であるサンプラーの根元部の側面図、図8は検体採取作業における検体採取位置の一例を示す平面図、図9は検体採取作業における検体採取位置の一例を示す側面断面図、図10は従来のサンプラーと本発明のサンプラーとを用いた検体採取実験の結果を示す図、図11は従来のサンプラーの第一実施例の先端部を示す側面断面図、図12は従来のサンプラーの第二実施例の先端部を示す側面断面図、図13は本発明の実施の一形態であるサンプラーの別実施例における根元部の側面図である。
【0014】
以下では、図1から図6を用いて本発明のサンプラーにおける実施の一形態であるサンプラー1について説明する。
なお、本発明のサンプラーは固形製剤を構成する粉粒体に限らず、容器等に収容された粉粒体から検体を採取する場合において広く適用可能である。また、「粉粒体」とは粉体、粒体、または粉体と粒体とが混合したもの、の総称とする。
【0015】
図1に示す如く、本実施例のサンプラー1は主に胴体2、上杵3、下杵4等で構成される。
【0016】
以下では、胴体2の詳細構成について説明する。
図2に示す如く、胴体2はサンプラー1の胴体部を形成する部材であり、本実施例においては該胴体2の先端側(検体採取の際に粉粒体に挿入される側)に上杵3および下杵4が配置される。胴体2は主に筒状体であるパイプ5、摺動体であるロッドシャフト6、先端側ガイド部材7、根元側ガイド部材8、ハンドル9、操作レバー10、ハンドル支持部材11等で構成される。
【0017】
パイプ5は略円筒形状の部材であり、サンプラー1の胴体外周面を構成する部材である。パイプ5の先端には先端側ガイド部材7が着脱可能に螺設される。先端側ガイド部材7には貫通孔(摺動孔)7aが穿設され、ロッドシャフト6の外周面が該摺動孔7aに摺動可能かつ旋回可能に当接している。また、パイプ5の外周面には上杵3の先端部を原点とし、サンプラー1の先端部から根元部に向かって目盛が形成される。
このように、サンプラー1は、胴体2に目盛が設けられており、後述する上杵3および下杵4を検体採取位置に精度良く移動させることが可能であり、作業性に優れる。
ロッドシャフト6はパイプ5内に配置された略円柱形状の部材であり、その先端部は先端側ガイド部材7の摺動孔7aを貫通し、パイプ5の先端側に向けて突出している。先端側ガイド部材7はロッドシャフト6が突出する方向に向かってやや先細りした形状となっており、サンプラー1を粉粒体に挿入する際の抵抗を極力小さくしている。
一方、図3に示す如く、パイプ5の根元側にはハンドル支持部材11の前端部が着脱可能に螺設される。ハンドル支持部材11は略円筒形状の部材であり、その外周面にはハンドル支持部11の長手方向(パイプ5の長手方向と略一致)に沿って摺動溝12が穿設される。
図4に示す如く、摺動溝12の後端はハンドル支持部材11の後端まで連通しており、レバー嵌入口12aが形成される。また、摺動溝12の前端はハンドル支持部材11の周方向に穿設された旋回溝13と連通し、摺動溝12と旋回溝13とで略T字型の溝が形成されている。
【0018】
図3に示す如く、ハンドル9はサンプラー1を用いて検体採取作業を行う際に作業者が手で握って支持する部位であり、主に係止部9aとグリップ部9bとで構成される。
係止部9aは、一方に底面を有する略円筒形状の部材である。係止部9aはハンドル支持部材11の後端部に遊嵌され、ハンドル支持部材11の外周面に穿設されたネジ孔11aに係止部9aの外周面に穿設された貫通孔14を貫通してボルト15を締結することにより、ハンドル9をハンドル支持部材11に固定する。このとき、係止部9aの底面により、摺動溝12のレバー嵌入口12aは閉塞される。
また、係止部9aの底面にはネジ孔16が穿設され、該ネジ孔16に根元側ガイド部材8が螺設される。根元側ガイド部材8は樹脂やプラスチック、あるいはゴム等の弾力のある材料で構成され、摺動孔8aが穿設される。そして、ロッドシャフト6の外周面が該摺動孔8aに摺動可能かつ旋回可能に当接し、ロッドシャフト6の後端がハンドル支持部材11の後端側に根元側ガイド部材8を貫通して突出している。
以上の如く構成することにより、ロッドシャフト6はガタつき音等を発生せずにパイプ5に対して滑らかに摺動および旋回することが可能である。
グリップ部9bは係止部9aの外周面より半径方向に突設される。なお、本実施例においては係止部9aがハンドル支持部材11に固定されたときに、ロッドシャフト6の長手方向(摺動方向)から見て、ハンドル9のグリップ部9bと摺動溝12に嵌合しているときの操作レバー10のグリップ部10bとが略一致する(重なる)位置に配置されるが、これに限定されず、ロッドシャフト6の長手方向(摺動方向)から見て、ハンドル9のグリップ部9bが摺動溝12に嵌合しているときの操作レバー10のグリップ部10bに対して回転した(重ならない)位置となるように構成してもよい。
【0019】
操作レバー10は主にロッド係止部10aとグリップ部10bで構成される。ロッド係止部10aは略円柱形状の部材であり、ハンドル支持部材11内においてロッドシャフト6にネジ17により外嵌固定される。また、ロッド係止部10aの外周面がハンドル支持部11の内周面と干渉しないようにロッド係止部10aの外径が定められる。
グリップ部10bはロッド係止部10aの外周面に突設され、摺動溝12または旋回溝13からハンドル支持部材11の外部に突出している。
【0020】
以上の如く、胴体2は側面に上杵3が取り付けられる筒状体(パイプ5)と、筒状体(パイプ5)に摺動可能に貫装されるとともに下杵4が取り付けられる摺動体(ロッドシャフト6)とを備えるので、十分な強度を有し、かつ簡便な構造でサンプラー1の先端部に設けられた下杵4の操作を行うことが可能である。また、簡便な構造であることから、検体採取作業終了後の洗浄も容易である。
【0021】
以下では、上杵3の詳細構成について説明する。
図2に示す如く、上杵3は主に略円柱形状の杵部3aと根元部3bとで構成され、先端側ガイド部材7の側面部に配置される。取付ボルト18は、上杵3の根元部3bに穿設された貫通孔3cを貫通して先端側ガイド部材7の外周面に穿設されたネジ孔7bに締結され、上杵3は先端側ガイド部材7に着脱可能に螺設される。
上杵3が先端側ガイド部材7に固定されたときに、上杵3の杵部3aの軸方向はロッドシャフト6の軸方向と略平行となり、かつ杵部3aの先端部には受容部19が形成される。受容部19は杵部3aの先端部に形成された窪みである。
このように構成することにより、検体採取作業が検体の混合均一性に影響を及ぼすことを防止し、検体の分析結果の信頼性を向上することが可能である。
【0022】
以下では、下杵4の詳細構成について説明する。
図2に示す如く、下杵4は略円柱形状の部材を中途部にて略直角に屈曲させた形状を有しており、主に杵部4aと取付部4bとで構成される。取付部4bはロッドシャフト6の先端側ガイド部材7から突出している方の先端部側面に穿設された取付孔6aに貫装される。また、ロッドシャフト6の先端側ガイド部材7から突出している方の先端面から取付孔6aまで貫通する貫通孔6bが穿設され、取付部4bの側面にはネジ孔20が穿設される。ネジ21は貫通孔6bを貫通してネジ孔20に締結され、下杵4はロッドシャフト6に着脱可能に螺設される。このとき、下杵4の杵部4aの軸方向はロッドシャフト6の軸方向と略平行となり、かつ、下杵4の先端部と上杵3の先端部とが対向する向きとなる。
下杵4の杵部4aの先端部には受容部22が形成される。受容部22は杵部4aの先端部に形成された窪みである。
【0023】
上記上杵3および下杵4は、胴体2に対して着脱可能に構成されている。そのため、上杵3および下杵4を複数個用意し、それぞれ異なる容積を有する受容部を形成することにより、取り扱う粉粒体の種類や分析条件等に応じて採取する検体の量を容易に変更することが可能である。
【0024】
以上の如きサンプラー1は、胴体2と、胴体2の外周面に設けられる上杵3と、上杵3に当接する位置と離間する位置との間を胴体2の長手方向に摺動する下杵4とを備え、上杵3と下杵4とが当接する部位には粉粒体を受容する受容部が上杵と下杵のいずれか一方,または上杵と下杵の両方に設けられる(本実施例では上杵3には受容部19、下杵4には受容部22がそれぞれ設けられる)ので、検体採取作業の過程で粉粒体を再混合せずに微量の検体を採取可能であり検体採取作業の信頼性が向上する。
【0025】
以下では、サンプラー1を用いた検体採取作業方法の一例を示す。
図1および図2に示す如く、「初期状態」では、サンプラー1の上杵3の先端部と下杵4の先端部とが当接し、受容部19と受容部22とが対向して、受容部19と受容部22とで構成される空間は粉粒体が流入しない程度に外部から閉じられた状態となっている。この受容部19と受容部22とで構成される空間に検体採取作業時に検体となる粉粒体が封入される。
このとき、操作レバー10のグリップ部10bは、摺動溝12の後端部(ハンドル9のグリップ部9bに近い側の端部)に位置している。
【0026】
サンプラー1の先端部(上杵3および下杵4が取り付けられている側)を粉粒体に挿入する前に、操作レバー10のグリップ部10bが、摺動溝12の後端部から旋回溝13の端部13aまたは端部13bに移動するように操作レバー10を操作する。このとき、ロッドシャフト6は先端側ガイド部材7から突出する方向に摺動するとともに周方向に旋回し、下杵4は上杵3から離間し、かつ図5に示す如くロッドシャフト6の軸線方向(図2の矢印Bの方向)から見て受容部19と受容部22とがロッドシャフト6の旋回方向にずれた位置となる(以下の記述ではこの状態を「準備状態」と呼ぶ)。
【0027】
次に、「準備状態」のサンプラー1の先端部を、容器等に収容された粉粒体に挿入する。
また、図5に示す如く、「準備状態」においてはロッドシャフト6の軸線方向から見て受容部19と受容部22とがロッドシャフト6の旋回方向にずれた位置となるので、上杵3が検体採取位置に来たときの受容部19内に位置する粉粒体は、サンプラー1を粉粒体に挿入する作業により再混合されることがなく、混合器での混合工程終了時の状態を保持している。
言い換えれば、サンプラー1の下杵4は、上杵3から離間した位置において胴体2の周方向に旋回するので、サンプラーを粉粒体に挿入する過程で、上杵3の挿入方向の前方で粉粒体を再混合することがなく、検体の混合均一性に影響をおよぼすことを防止し、検体の分析結果の信頼性を向上することが可能である。
【0028】
続いて、操作レバー10のグリップ部10bが、旋回溝13の端部13aまたは端部13bから摺動溝12の後端部に移動するように操作レバー10を操作する。このとき、ロッドシャフト6は周方向に旋回するとともに下杵4が上杵3に近づく方向に摺動して下杵4と上杵3とが当接し、受容部19と受容部22とが対向して、受容部19と受容部22とで構成される空間には検体採取位置の粉粒体が封入された状態となっている(以下の記述ではこの状態を「採取状態」と呼ぶ)。
このとき、下杵4は上杵3から離間した位置にて旋回し、その後、摺動して受容部19と受容部22が対向した状態で接近して検体を採取する。これは、ちょうど検体をピンセットにて掴み取った如き状態であり、受容部19と受容部22とで構成される空間に封入された粉粒体(検体)は、サンプラー1の挿入、下杵4の旋回および摺動により再混合されることがない。
【0029】
次に、「採取状態」のサンプラー1を粉粒体の外まで引き抜き、サンプラー1を「準備状態」にして、受容部19と受容部22で構成された空間(収容部)に収容されていた検体を回収する。
このとき、図7に示す如く、ハンドル9の先端部にゴム等の弾性材料からなる帯状体23を設け、操作レバー10がハンドル9側に引き寄せられているとき(すなわち、下杵4が上杵3に当接したとき)に、該帯状体23を操作レバー10の先端部に係止し、操作レバー10をハンドル8側に引き寄せる方向に付勢可能に構成してもよい。
このように構成することにより、サンプラー1を粉粒体から引き抜く際に、誤って下杵4を操作して受容部19・22からなる空間内に封入された検体(微量な粉粒体)が検体採取位置と異なる位置にある粉粒体と混ざることが無く、検体採取作業を確実に行うことが可能である。
なお、上記帯状体23に限定されず、下杵4と上杵3とが当接した状態で固定可能であれば他の構成であっても同様の効果を奏する。
【0030】
以上の作業を繰り返して、容器等に収容された粉粒体の所定の検体採取位置から検体を採取する。
【0031】
なお、本実施例のサンプラー1においては、筒状体であるパイプ5内に摺動体であるロッドシャフト6を摺動・旋回可能に貫装したが、これに限定されず、摺動体の軸受けを筒状体の外部に設けてもよい。
また、下杵の操作手段はロッドシャフトと操作レバーとの組み合わせに限定されず、バネ等の付勢手段で一方向(例えば、下杵が上杵から離間する方向)に付勢されたワイヤを筒状体の内部に設け、筒状体に摺動可能に係合した下杵にワイヤの一端を取り付け、筒状体の根元側から該ワイヤの他端を操作して下杵を上杵に対して摺動させてもよい。また、下杵の先端部および上杵の先端部を別部材として、該先端部のみを交換して検体の採取量を変更する構成としてもよい。
さらに、上杵および下杵の胴体への取付位置は、胴体の先端部に限定されず、胴体の中途部に取り付けてもよい。また、上杵と下杵の組を一つの胴体に複数組設けてもよい。
【0032】
また、図13に示すサンプラー1の別実施例の如く、ハンドル支持部材11を省略し、筒状体5に直接摺動溝212を穿設してもよい。このように構成することにより、部品点数の削減が可能である。
【0033】
さらに、図13に示すサンプラー1の別実施例の如く、摺動溝212の前端には旋回溝を設けず、下杵4は上杵3に対してロッドシャフト6の摺動方向にのみ移動して、下杵4と上杵3とが当接および離間する構成とすることも可能である。
旋回溝を設けない構成のサンプラー1の別実施例を用いて検体採取作業を行う場合には、下杵4が上杵3に当接した状態(初期状態)でサンプラー1の別実施例を粉粒体の所定の深さまで挿入し、次に下杵4を下方に摺動させて下杵4と上杵3とが離間した状態とし、続いてサンプラー1の別実施例自体を所定の角度(例えば、90度)旋回させ、下杵4を上方に摺動させて上杵3と当接させることにより、受容体19・22に検体となる粉粒体を封入する。このような方法でも検体となる部分の粉粒体の再混合をせずに検体を採取することが可能である。
【0034】
さらにまた、図1に示すサンプラー1の実施例において、ハンドル支持部材11は残し、旋回溝13を設けず、下杵4は上杵3に対してロッドシャフト6の摺動方向にのみ移動して、下杵4と上杵3とが当接および離間する構成とすることも可能である。
このような旋回溝を設けない構成のサンプラー1を用いての検体採取作業は、前記図13に示す旋回溝を設けない構成のサンプラー1の別実施例を用いての検体採取作業と同様に行うことが可能である。
【0035】
以下では、図8、図9および図10を用いて、検体採取作業が混合均一性におよぼす影響に関する実験の一例について説明する。
本実験に使用された粉粒体は、混合により分離偏析を起こしやすく、かつ主薬含量の低い製剤Aである。該製剤Aの投与単位は65[mg]であり、投与単位中の主薬含有量は0.5[mg]である。
【0036】
図8および図9に示す如く、本実験に用いた粉粒体は略円筒形状のコンテナ30に収容されている。コンテナ30に収容された製剤Aから従来のサンプラーの第二実施例であるサンプラー111、および本発明の実施の一形態であるサンプラー1を用いて検体採取した。
検体採取位置の決定方法は、まず平面視でコンテナ30の略中心となる第二挿入地点32と、第二挿入地点32およびコンテナ30の壁面から略等距離にある第一挿入地点31と、第一挿入地点31と第二挿入地点32との間の距離と略等距離かつ第二挿入地点32を挟んで第一挿入地点31の反対側となる第三挿入地点33をコンテナ30に収容された粉粒体の表面に定める。該挿入地点からサンプラー1またはサンプラー111を下方に挿入する。
【0037】
第一挿入地点31の場合、コンテナ30に収容された粉粒体の表面からの深さの異なる3つの採取地点である底部第一採取地点41a、中央部第一採取地点41b、表層部第一採取地点41cを定め、該採取地点にて検体を採取した。これらの採取地点の深さはコンテナ30の粉粒体深さをLとして、底部第一採取地点41aはコンテナ30の底面から(1/4)×Lの位置、中央部第一採取地点41bはコンテナ30の底面から(2/4)×Lの位置、表層部第一採取地点41cはコンテナ30の底面から(3/4)×Lの位置とした。
なお、第二挿入地点32および第三挿入地点33についても第一挿入地点31と同様に検体採取地点(底部第二採取地点42a、中央部第二採取地点42b、表層部第二採取地点42cおよび底部第三採取地点43a、中央部第三採取地点43b、表層部第三採取地点43c)を定めた。
また、粉粒体への検体採取作業の影響を考慮して、同一の挿入地点から採取する場合、粉粒体の表面からの深さが浅い地点から順に(第一挿入地点31の場合、表層部第一採取地点41c→中央部第一採取地点41b→底部第一採取地点41aの順に)採取した。
【0038】
上記の方法で従来のサンプラーの第二実施例であるサンプラー111、および本発明の実施の一形態であるサンプラー1について、それぞれ計9個の検体を採取し、各検体の採取重量を測定し、採取重量の平均値[mg]、最大値[mg]、最小値[mg]、および採取重量の相対標準偏差であるRSD(Relative Standard Deviation)[%]を求めた。これらの測定結果を図10に示す。
検体採取時の目標重量は、製剤Aの投与単位である65[mg]の3倍量である195[mg]とし、採取後の検体から製剤Aの投与単位である65[mg]を秤取し、これを混合均一性を求めるための試料に供した。
【0039】
図10に示す混合均一性の平均値[%]は、製剤Aの投与単位において含有されるべき主薬の含量[mg](本実験の場合0.5[mg])、に対する、分析により求められた主薬の含量(投与単位に換算した値)の平均値[mg]、の割合を百分率で表したものである。
【0040】
図10に示す混合均一性の最大値[%]は、製剤Aの投与単位において含有されるべき主薬の含量[mg](本実験の場合0.5[mg])、に対する、分析により求められた計9個の検体における主薬の含量(投与単位に換算した値)のうち最大のもの[mg]、の割合を百分率で表したものである。
【0041】
図10に示す混合均一性の最小値[%]は、製剤Aの投与単位において含有されるべき主薬の含量[mg](本実験の場合0.5[mg])、に対する、分析により求められた計9個の検体における主薬の含量(投与単位に換算した値)のうち最小のもの[mg]、の割合を百分率で表したものである。
【0042】
図10に示す混合均一性のRSD[%]は、混合均一性の平均値の相対標準偏差である。
【0043】
図10に示す如く、既存のサンプラー(従来のサンプラーの第二実施例であるサンプラー111)で検体を採取した場合、採取重量のRSD(%)が本発明のサンプラー1で検体を採取した場合と比較して大きく、採取される計9検体の採取重量のばらつきは既存のサンプラーの方が大きいことが分かる。
【0044】
このことは、サンプラー1とサンプラー111とで、検体を封入する部分の構造が異なることが大きな要因となっていると考えられる。
すなわち、サンプラー111の場合、検体を封入する受容部(窪み)115の開口方向がサンプラー111の粉粒体への挿入方向に対して略直角となっている(サンプラーの胴体側面に開口している)ため、サンプラー111が検体採取位置まで挿入されても、受容部115に粉粒体が密に充填されていない場合があることが推察される。従って、受容部115に粉粒体を密に充填してから封入するためには、外管113を左右に複数回旋回させて、掻き取り部材117で粉粒体を受容部115内に掻き入れる必要がある。
【0045】
一方、本発明のサンプラー1の場合、上杵3の受容部19の開口方向はサンプラー1の粉粒体への挿入方向と略平行となっているため、サンプラー1が検体採取位置まで挿入されたときに受容部19内に粉粒体が密に充填されている。また、下杵4の受容部22の開口方向は、下杵4が上杵3に当接するときの摺動方向と略一致していることから、下杵4が上杵3に当接したときに受容部22内に粉粒体が密に充填されている。従って、本発明のサンプラー1の場合、検体の採取重量にばらつきが小さく、確実に所望の重量のサンプルを採取することが可能である。
【0046】
また、図10に示す如く、既存のサンプラー(従来のサンプラーの第二実施例であるサンプラー111)で検体を採取した場合、混合均一性のRSD(%)も本発明のサンプラー1で検体を採取した場合と比較して大きく、採取される計9検体の混合均一性のばらつきも既存のサンプラーの方が大きいことが分かる。
【0047】
このことは、前記同一ロットで採取される計9検体の採取重量のばらつきが既存のサンプラーの方が大きいことと同様に、サンプラー1とサンプラー111とで、検体を封入する部分の構造が異なることが大きな要因となっていると考えられる。
すなわち、サンプラー111の場合、受容部115内に粉粒体を充填する過程で外管113を旋回させて掻き入れるので、受容部115に封入される粉粒体は再混合が起こりやすい。また、上述の如く、受容部115内に確実に粉粒体を充填するためには外管113を左右に複数回旋回させるが、この場合検体採取地点における再混合がさらに進行してしまう。
【0048】
一方、本発明のサンプラー1の場合、一度下杵4を上杵3に向かって摺動・当接させれば確実に受容部19・22内に粉粒体が保持されるとともに、下杵4の摺動動作では検体採取位置の粉粒体が再混合されることがないので、検体採取作業に起因する混合均一性のばらつきが小さく、実際の粉粒体の混合状況を反映した検体を採取することが可能である。
本発明においては、下杵4と上杵3とにより構成される粉粒体採取部位は、胴体2の長手方向から見て胴体2の外周面よりも外側にオフセットしており、サンプラー1の挿入により影響を受け難い部位の粉粒体を採取することが可能である。
さらに、受容部19・22における粉粒体の保持面を下杵4の摺動方向に対して略垂直とし、下杵4の摺動方向をサンプラー1の取出し方向と一致させるので、サンプラー1の引き抜き時に、採取した粉粒が他の部位の粉粒の流入等による影響を受け難い。従って、下杵4と上杵3との間に一定の間隙を設けながら(上杵3と下杵4とが当接せずに)粉粒体を保持して検体を採取することも出来る。このため、小さな外力により検体を採取することが可能であり、採取時に検体にかかる外力を小さくし、採取前と採取後とにおける検体(微量の粉粒体)の状態変化を小さくすることが可能である。すなわち、より実際の混合状態に近い状態で検体を採取することができる。
【0049】
【発明の効果】
本発明は、以上のように構成したので、以下に示すような効果を奏する。
【0050】
即ち、請求項1に示す如く、粉粒体を採取するサンプラーであって、
胴体と、該胴体の外周面に設けられる上杵と、該上杵に当接する位置と離間する位置との間を胴体の長手方向に摺動する下杵とを備え、上杵と下杵とが当接する部位には粉粒体を受容する受容部が上杵と下杵のいずれか一方、または上杵と下杵の両方に設けられるので、検体採取作業の過程で粉粒体を再混合せずに微量の検体を採取可能であり検体採取作業の信頼性が向上する。
【0051】
請求項2に示す如く、上杵と下杵のいずれか一方、または上杵と下杵の両方を胴体に対して着脱可能に取り付けたので、取り扱う粉粒体の種類や分析条件等に応じて採取する検体の量を容易に変更することが可能である。
【0052】
請求項3に示す如く、前記上杵に設けられる受容部の開口方向と、サンプラーの粉粒体への挿入方向とが略一致するので、サンプラーを検体採取位置まで挿入したときに受容部内に位置する粉粒体は再混合されず、検体採取作業が検体の混合均一性に影響を及ぼすことを防止し、検体の分析結果の信頼性を向上することが可能である。
【0053】
請求項4に示す如く、前記胴体は側面に上杵が取り付けられる筒状体と、該筒状体に摺動可能に貫装されるとともに下杵が取り付けられる摺動体とを備えるので、十分な強度を有し、かつ簡便な構造でサンプラーの先端部に設けられた下杵の操作を行うことが可能である。また、簡便な構造であることから、検体採取作業終了後の洗浄も容易である。
【0054】
請求項5に示す如く、前記下杵は、上杵から離間した位置において胴体の周方向に旋回するので、サンプラーを粉粒体に挿入する過程で、下杵が上杵の挿入方向の前方で粉粒体を再混合することがなく、検体の混合均一性に影響をおよぼすことを防止し、検体の分析結果の信頼性を向上することが可能である。
【0055】
請求項6に示す如く、下杵4と上杵3とが当接した状態で固定可能に構成したので、サンプラーを粉粒体から引き抜く際に、誤って下杵を操作して受容部に封入された検体(微量な粉粒体)が検体採取位置と異なる位置にある粉粒体と混ざることが無く、検体採取作業を確実に行うことが可能である。
【0056】
請求項7に示す如く、前記胴体に目盛を設けたので、上杵および下杵を検体採取位置に精度良く移動させることが可能であり、作業性に優れる。
【図面の簡単な説明】
【図1】本発明の実施の一形態であるサンプラーの側面図。
【図2】本発明の実施の一形態であるサンプラーの先端部の側面断面図。
【図3】本発明の実施の一形態であるサンプラーの根元部の側面断面図。
【図4】ハンドル支持部材の斜視図。
【図5】準備状態における本発明の実施の一形態であるサンプラーを長手方向から見た図。
【図6】準備状態における本発明の実施の一形態であるサンプラーの先端部の側面図。
【図7】帯状体を備えた本発明の実施の一形態であるサンプラーの根元部の側面図。
【図8】検体採取作業における検体採取位置の一例を示す平面図。
【図9】検体採取作業における検体採取位置の一例を示す側面断面図。
【図10】従来のサンプラーと本発明のサンプラーとを用いた検体採取実験の結果を示す図。
【図11】従来のサンプラーの第一実施例の先端部を示す側面断面図。
【図12】従来のサンプラーの第二実施例の先端部を示す側面断面図。
【図13】本発明の実施の一形態であるサンプラーの別実施例における根元部の側面図。
【符号の説明】
1 サンプラー
2 胴体
3 上杵
4 下杵
5 パイプ(筒状体)
6 ロッドシャフト(摺動体)
19 受容部(上杵側)
22 受容部(下杵側)
23 帯状体
[0001]
BACKGROUND OF THE INVENTION
The present invention relates to a technique for collecting a part of a granular material housed in a large container or the like. More specifically, the present invention relates to a technique for collecting a part of a granular material contained in a large container or the like statically (without remixing in the collection process).
[0002]
[Prior art]
Conventionally, it is a process that is performed immediately before processing the granule constituting the solid preparation into a final dosage form, such as a mixing process (tablet process, capsule filling process, etc.) in a solid preparation (tablet, capsule, granule, etc.). In addition, a step of uniformly mixing a plurality of different powders, particles or particles and particles is an important process for ensuring the uniformity of the solid preparation as the final product.
In such a mixing process, in order to verify the suitability of mixing uniformity, several to a dozen points in the mixer used in the mixing process are set in advance as sampling points (specimen sampling points) and mixed. Collect a sample from the powder after completion of the work. Then, each sample is analyzed, and the uniformity of the mixing is evaluated using the variation in the analysis value of the specific component as an index.
At this time, if the amount of the sample collected is too large compared to the dosage unit amount of the final dosage form, it may be difficult to verify mixing uniformity. It is desirable to collect samples. And the technique of the sampler used in order to extract | collect such a micro sample about several tens mg to several hundred mg is known. For example, as described in Patent Document 1.
A sampler described in Patent Document 1 (hereinafter referred to as “first example of a conventional sampler”) is a double tube in which an inner tube 102 of a sampler 101 can slide with respect to an outer tube 103 as shown in FIG. In the structure, a hole 104 is formed in the outer peripheral surface of the outer tube 103, and a receiving portion 105, which is a recess for receiving a specimen, is provided in the outer peripheral surface of the inner tube 102. When the sampler 101 is used for the sample collection operation, first, the hole 104 provided in the outer tube 103 and the receiving portion 105 provided in the inner tube 102 are held in alignment with each other and provided at one end of the inner tube 102. The tip member 106, which is a substantially conical member, is inserted into the granular material as a tip. Next, the outer tube 103 is slid to close the receiving portion 105 on the inner peripheral surface of the outer tube 103, and a small amount of granular material serving as a specimen is sealed in the receiving portion 105, and then the sampler 101 is removed from the granular material. Pull out and collect the specimen.
In addition to the description in Patent Document 1, a sampler 111 such as a “second example of a conventional sampler” shown in FIG. 12 is known. The sampler 111 has a double tube structure in which the inner tube 112 can pivot with respect to the outer tube 113. A hole 114 is formed in the outer peripheral surface of the outer tube 113, and powder particles are introduced into the hole 114. A scraping member 117, which is a projection for the purpose, is provided on the side of the hole 114, and an outer peripheral surface of the inner tube 112 is provided with a receiving portion 115 that is a recess for receiving a specimen. When the sampler 111 is used for a sample collection operation, first, the hole 114 provided in the outer tube 113 and the receiving portion 115 provided in the inner tube 112 are held in alignment and provided at one end of the inner tube 112. The tip member 116, which is a substantially conical member, is inserted into the granular material as a tip. Next, the outer tube 113 is turned to close the receiving portion 115 on the inner peripheral surface of the outer tube 113, and a small amount of granular material serving as a specimen is sealed in the receiving portion 115, and then the sampler 111 is pulled out from the granular material. Collect the sample.
[0003]
[Patent Document 1]
US Pat. No. 5,440,941
[0004]
[Problems to be solved by the invention]
However, in the conventional sampler shown in FIG. 11 and FIG. 12, the opening direction of the recess (receiving portion) for enclosing the specimen is substantially perpendicular to the insertion direction of the sampler into the granular material (longitudinal direction of the sampler). Therefore, there has been a problem that it is difficult to enclose a minute amount of powder particles as a specimen in the depression without remixing in the course of the specimen collection operation.
In particular, when the sample is collected from a powder that has a small proportion of the active ingredient in the powder after completion of the mixing process and the active ingredient is likely to cause segregation and segregation, the granular material that becomes the sample in the course of the sample collection operation May be mixed again and cause segregation. Therefore, when analyzing the sample and evaluating the variation in the analysis value of the specific component, there is a possibility that a divergence occurs between the analysis result of the sample and the actual state of the powder after the mixing process (actual Despite the fact that mixing uniformity is sufficiently ensured for the granular material, the conclusion that mixing uniformity is not sufficient may be derived from the analysis result of the specimen).
In view of the circumstances as described above, the present invention provides a sampler capable of collecting a trace amount of sample without remixing the sample collection site.
[0005]
[Means for Solving the Problems]
The problem to be solved by the present invention is as described above. Next, means for solving the problem will be described.
[0006]
That is, in claim 1, a sampler for collecting powder particles,
A body, an upper collar provided on the outer peripheral surface of the trunk, and a lower collar that slides in a longitudinal direction of the trunk between a position that contacts the upper collar and a position that is separated from the upper collar, A receiving portion for receiving the granular material is provided in either the upper eyelid or the lower eyelid, or both the upper eyelid and the lower eyelid at the portion where the abutment comes into contact.
[0007]
In claim 2, either one of the upper and lower heels, or both the upper and lower heels are detachably attached to the trunk.
[0008]
According to a third aspect of the present invention, the opening direction of the receiving portion provided on the upper eyelid and the insertion direction of the sampler into the granular material substantially coincide with each other.
[0009]
According to a fourth aspect of the present invention, the body includes a cylindrical body with an upper collar attached to a side surface, and a sliding body that is slidably inserted into the cylindrical body and has a lower collar attached thereto.
[0010]
According to a fifth aspect of the present invention, the lower rod turns in the circumferential direction of the body at a position spaced from the upper rod.
[0011]
According to the sixth aspect of the present invention, the lower collar 4 and the upper collar 3 are configured to be fixable in contact with each other.
[0012]
According to a seventh aspect of the present invention, the body is provided with a scale.
[0013]
DETAILED DESCRIPTION OF THE INVENTION
Next, embodiments of the invention will be described.
FIG. 1 is a side view of a sampler according to an embodiment of the present invention, FIG. 2 is a side sectional view of a tip portion of the sampler according to an embodiment of the present invention, and FIG. 3 is an embodiment of the present invention. FIG. 4 is a perspective view of the handle support member, FIG. 5 is a view of a sampler as an embodiment of the present invention in the prepared state, as viewed from the longitudinal direction, and FIG. 6 is a book in the prepared state. FIG. 7 is a side view of a root portion of a sampler according to an embodiment of the present invention having a strip, and FIG. 8 is a sample collection in a sample collection operation. FIG. 9 is a side sectional view showing an example of a sample collection position in a sample collection operation, FIG. 10 is a view showing a result of a sample collection experiment using a conventional sampler and the sampler of the present invention, FIG. 11 shows a conventional sampler FIG. 12 is a side sectional view showing a tip portion of a second example of a conventional sampler, and FIG. 13 is another example of a sampler according to an embodiment of the present invention. It is a side view of the root part in an example.
[0014]
Below, the sampler 1 which is one Embodiment in the sampler of this invention is demonstrated using FIGS. 1-6.
Note that the sampler of the present invention is not limited to powders constituting a solid preparation, and can be widely applied in the case of collecting a specimen from powders contained in a container or the like. The “powder” is a generic term for powder, granules, or a mixture of powder and granules.
[0015]
As shown in FIG. 1, the sampler 1 of this embodiment is mainly composed of a body 2, an upper collar 3, a lower collar 4, and the like.
[0016]
Below, the detailed structure of the fuselage | body 2 is demonstrated.
As shown in FIG. 2, the body 2 is a member that forms the body of the sampler 1. In this embodiment, the upper body is placed on the distal end side (the side that is inserted into the granular material when the specimen is collected). 3 and the lower arm 4 are arranged. The body 2 is mainly composed of a pipe 5 that is a cylindrical body, a rod shaft 6 that is a sliding body, a tip side guide member 7, a root side guide member 8, a handle 9, an operation lever 10, a handle support member 11, and the like.
[0017]
The pipe 5 is a substantially cylindrical member and is a member constituting the outer peripheral surface of the body of the sampler 1. A distal end side guide member 7 is detachably screwed to the distal end of the pipe 5. A through hole (sliding hole) 7a is formed in the distal end side guide member 7, and the outer peripheral surface of the rod shaft 6 is slidably contacted with the sliding hole 7a. On the outer peripheral surface of the pipe 5, a scale is formed from the tip of the sampler 1 toward the root with the tip of the upper collar 3 as the origin.
As described above, the sampler 1 is provided with a scale on the body 2 and can move the upper eyelid 3 and the lower eyelid 4 described later to the specimen collection position with high accuracy, and is excellent in workability.
The rod shaft 6 is a substantially columnar member disposed in the pipe 5, and the tip portion of the rod shaft 6 passes through the sliding hole 7 a of the tip side guide member 7 and protrudes toward the tip side of the pipe 5. The distal end side guide member 7 has a shape that is slightly tapered in the direction in which the rod shaft 6 protrudes, and the resistance when the sampler 1 is inserted into the granular material is minimized.
On the other hand, as shown in FIG. 3, the front end portion of the handle support member 11 is detachably screwed to the base side of the pipe 5. The handle support member 11 is a substantially cylindrical member, and a sliding groove 12 is formed in the outer peripheral surface along the longitudinal direction of the handle support portion 11 (substantially coincident with the longitudinal direction of the pipe 5).
As shown in FIG. 4, the rear end of the sliding groove 12 communicates with the rear end of the handle support member 11, and a lever fitting inlet 12a is formed. Further, the front end of the sliding groove 12 communicates with a turning groove 13 formed in the circumferential direction of the handle support member 11, and the sliding groove 12 and the turning groove 13 form a substantially T-shaped groove.
[0018]
As shown in FIG. 3, the handle 9 is a portion that is held and supported by the operator when the sample collection operation is performed using the sampler 1, and mainly includes a locking portion 9 a and a grip portion 9 b.
The locking portion 9a is a substantially cylindrical member having a bottom surface on one side. The locking portion 9a is loosely fitted to the rear end portion of the handle support member 11, and a through hole 14 drilled in the outer peripheral surface of the locking portion 9a is formed in the screw hole 11a drilled in the outer peripheral surface of the handle support member 11. The handle 9 is fixed to the handle support member 11 by passing through and fastening the bolt 15. At this time, the lever insertion opening 12a of the sliding groove 12 is closed by the bottom surface of the locking portion 9a.
A screw hole 16 is formed in the bottom surface of the locking portion 9a, and the root side guide member 8 is screwed into the screw hole 16. The root side guide member 8 is made of an elastic material such as resin, plastic, or rubber, and has a sliding hole 8a. The outer peripheral surface of the rod shaft 6 abuts on the sliding hole 8 a so as to be slidable and pivotable, and the rear end of the rod shaft 6 penetrates the root side guide member 8 to the rear end side of the handle support member 11. It protrudes.
By configuring as described above, the rod shaft 6 can smoothly slide and turn with respect to the pipe 5 without generating a rattling sound or the like.
The grip portion 9b is projected in the radial direction from the outer peripheral surface of the locking portion 9a. In this embodiment, when the locking portion 9 a is fixed to the handle support member 11, the grip portion 9 b and the sliding groove 12 of the handle 9 are seen from the longitudinal direction (sliding direction) of the rod shaft 6. Although it is arranged at a position where the grip portion 10b of the operating lever 10 is substantially coincident (overlapped) when fitted, it is not limited to this, and when viewed from the longitudinal direction (sliding direction) of the rod shaft 6, You may comprise so that it may become a position rotated with respect to the grip part 10b of the operation lever 10 when the grip part 9b of the handle | steering-wheel 9 is fitted to the sliding groove | channel 12 (it does not overlap).
[0019]
The operation lever 10 is mainly composed of a rod locking portion 10a and a grip portion 10b. The rod locking portion 10 a is a substantially columnar member, and is externally fixed to the rod shaft 6 with a screw 17 in the handle support member 11. Further, the outer diameter of the rod locking portion 10a is determined so that the outer peripheral surface of the rod locking portion 10a does not interfere with the inner peripheral surface of the handle support portion 11.
The grip portion 10 b is projected from the outer peripheral surface of the rod locking portion 10 a and protrudes from the sliding groove 12 or the turning groove 13 to the outside of the handle support member 11.
[0020]
As described above, the body 2 has a cylindrical body (pipe 5) to which the upper collar 3 is attached to the side surface, and a sliding body (slidably inserted into the cylindrical body (pipe 5) and to which the lower collar 4 is attached ( Since the rod shaft 6) is provided, it is possible to operate the lower rod 4 provided at the front end portion of the sampler 1 with a sufficient strength and a simple structure. In addition, since the structure is simple, it is easy to clean after completion of the sample collection operation.
[0021]
Below, the detailed structure of the upper collar 3 is demonstrated.
As shown in FIG. 2, the upper collar 3 is mainly composed of a substantially cylindrical collar part 3 a and a root part 3 b, and is disposed on the side part of the distal end side guide member 7. The mounting bolt 18 passes through the through hole 3c drilled in the base portion 3b of the upper collar 3 and is fastened to the screw hole 7b drilled in the outer peripheral surface of the distal end side guide member 7. The guide member 7 is detachably screwed.
When the upper flange 3 is fixed to the distal end side guide member 7, the axial direction of the flange 3a of the upper flange 3 is substantially parallel to the axial direction of the rod shaft 6, and the receiving portion 19 is provided at the distal end of the flange 3a. Is formed. The receiving part 19 is a recess formed at the tip of the collar part 3a.
With this configuration, it is possible to prevent the sample collection operation from affecting the mixing uniformity of the sample and improve the reliability of the analysis result of the sample.
[0022]
Below, the detailed structure of the lower arm 4 is demonstrated.
As shown in FIG. 2, the lower rod 4 has a shape in which a substantially cylindrical member is bent at a substantially right angle in the middle portion, and is mainly composed of a flange portion 4a and an attachment portion 4b. The attachment portion 4b is inserted into an attachment hole 6a formed in the side surface of the distal end portion protruding from the distal end side guide member 7 of the rod shaft 6. Further, a through hole 6b penetrating from the distal end surface of the rod shaft 6 protruding from the distal end side guide member 7 to the mounting hole 6a is drilled, and a screw hole 20 is drilled on the side surface of the mounting portion 4b. The screw 21 passes through the through hole 6 b and is fastened to the screw hole 20, and the lower collar 4 is detachably screwed to the rod shaft 6. At this time, the axial direction of the flange portion 4a of the lower rod 4 is substantially parallel to the axial direction of the rod shaft 6, and the tip portion of the lower rod 4 and the tip portion of the upper rod 3 are opposed to each other.
A receiving portion 22 is formed at the tip of the collar portion 4a of the lower collar 4. The receiving part 22 is a recess formed at the tip of the collar part 4a.
[0023]
The upper and lower collars 3 and 4 are configured to be detachable from the body 2. Therefore, by preparing a plurality of upper and lower eyelids 3 and 4 and forming receiving portions each having different volumes, the amount of sample to be collected can be easily changed according to the type of granular material to be handled, analysis conditions, etc. Is possible.
[0024]
The sampler 1 as described above includes a trunk 2, an upper collar 3 provided on the outer peripheral surface of the trunk 2, and a lower collar that slides in the longitudinal direction of the trunk 2 between a position that contacts the upper collar 3 and a position that is separated from the upper collar 3. 4 and a receiving part for receiving the granular material is provided in either the upper eyelid or the lower eyelid or in both the upper eyelid and the lower eyelid at a portion where the upper eyelid 3 and the lower eyelid 4 abut ( In this embodiment, the upper eyelid 3 is provided with a receiving portion 19 and the lower eyelid 4 is provided with a receiving portion 22), so that it is possible to collect a small amount of sample without remixing the powder particles in the course of the sample collecting operation. Yes The reliability of sample collection work is improved.
[0025]
Below, an example of the sample collection operation method using the sampler 1 is shown.
As shown in FIGS. 1 and 2, in the “initial state”, the tip of the upper collar 3 of the sampler 1 and the tip of the lower collar 4 come into contact with each other, and the receiving portion 19 and the receiving portion 22 face each other. The space formed by the portion 19 and the receiving portion 22 is in a state closed from the outside to such an extent that the granular material does not flow. In the space constituted by the receiving part 19 and the receiving part 22, powder particles that become the specimen during the specimen collecting operation are enclosed.
At this time, the grip portion 10b of the operating lever 10 is located at the rear end portion of the sliding groove 12 (the end portion on the side close to the grip portion 9b of the handle 9).
[0026]
Before inserting the front end portion of the sampler 1 (the side to which the upper and lower eyelets 3 and 4 are attached) into the granular material, the grip portion 10b of the operating lever 10 is turned from the rear end portion of the sliding groove 12 to the turning groove. The operation lever 10 is operated so as to move to the end portion 13a or the end portion 13b. At this time, the rod shaft 6 slides in the direction protruding from the distal end guide member 7 and pivots in the circumferential direction, the lower rod 4 is separated from the upper rod 3, and the axial direction of the rod shaft 6 as shown in FIG. The receiving portion 19 and the receiving portion 22 are in a position shifted in the turning direction of the rod shaft 6 as viewed from (in the direction of arrow B in FIG. 2) (this state is referred to as “preparation state” in the following description).
[0027]
Next, the tip portion of the sampler 1 in the “prepared state” is inserted into the granular material housed in a container or the like.
Further, as shown in FIG. 5, in the “prepared state”, the receiving portion 19 and the receiving portion 22 are shifted in the turning direction of the rod shaft 6 when viewed from the axial direction of the rod shaft 6. The granular material located in the receiving portion 19 when it comes to the sample collection position is not remixed by the operation of inserting the sampler 1 into the granular material, and the state at the end of the mixing process in the mixer is not changed. keeping.
In other words, the lower rod 4 of the sampler 1 pivots in the circumferential direction of the body 2 at a position away from the upper rod 3, so that in the process of inserting the sampler into the granular material, the powder is moved forward in the insertion direction of the upper rod 3. It is possible to prevent the influence of the mixing uniformity of the sample without re-mixing the particles and improve the reliability of the analysis result of the sample.
[0028]
Subsequently, the operating lever 10 is operated so that the grip portion 10 b of the operating lever 10 moves from the end portion 13 a or the end portion 13 b of the turning groove 13 to the rear end portion of the sliding groove 12. At this time, the rod shaft 6 turns in the circumferential direction and the lower rod 4 slides in a direction approaching the upper rod 3 so that the lower rod 4 and the upper rod 3 come into contact with each other, and the receiving portion 19 and the receiving portion 22 face each other. Thus, the space formed by the receiving part 19 and the receiving part 22 is in a state in which the granular material at the specimen collecting position is enclosed (this state is referred to as “collecting state” in the following description).
At this time, the lower eyelid 4 turns at a position away from the upper eyelid 3, and then slides and approaches in a state where the receiving portion 19 and the receiving portion 22 face each other, and collects the specimen. This is a state in which the specimen is just grasped with tweezers, and the granular material (specimen) enclosed in the space constituted by the receiving portion 19 and the receiving portion 22 is inserted into the sampler 1 and the lower eyelid 4 Is not remixed by swiveling and sliding.
[0029]
Next, the sampler 1 in the “collected state” was pulled out of the powder and the sampler 1 was set in the “prepared state” and was accommodated in a space (accommodating part) composed of the receiving part 19 and the receiving part 22. Collect the specimen.
At this time, as shown in FIG. 7, a band-like body 23 made of an elastic material such as rubber is provided at the tip of the handle 9, and the operating lever 10 is pulled toward the handle 9 (that is, the lower eyelid 4 is the upper eyelid). 3), the belt-like body 23 may be locked to the distal end portion of the operation lever 10 so that the operation lever 10 can be biased in the direction of pulling it toward the handle 8 side.
By configuring in this way, when the sampler 1 is pulled out from the granular material, the sample (a small amount of granular material) enclosed in the space formed by the receiving portions 19 and 22 by operating the lower eyelid 4 by mistake. The sample collection operation can be reliably performed without being mixed with the powder particles at a position different from the sample collection position.
In addition, it is not limited to the said strip | belt-shaped body 23, If it can fix in the state which the lower collar 4 and the upper collar 3 contact | abutted, there will exist the same effect even if it is another structure.
[0030]
By repeating the above operation, a sample is collected from a predetermined sample collection position of the granular material accommodated in a container or the like.
[0031]
In the sampler 1 of the present embodiment, the rod shaft 6 that is a sliding body is slidably and slidably inserted in the pipe 5 that is a cylindrical body. However, the present invention is not limited to this, and the bearing of the sliding body is used. You may provide in the exterior of a cylindrical body.
In addition, the operating means for the lower eyelid is not limited to the combination of the rod shaft and the operating lever, but a wire urged in one direction (for example, the direction in which the lower eyelid is separated from the upper eyelid) by the urging means such as a spring. One end of the wire is attached to the lower arm provided inside the cylindrical body and slidably engaged with the cylindrical body, and the other end of the wire is operated from the base side of the cylindrical body so that the lower arm becomes the upper arm. You may make it slide with respect. Alternatively, the tip of the lower eyelid and the tip of the upper eyelid may be separate members, and only the tip may be replaced to change the sample collection amount.
Furthermore, the attachment position of the upper and lower collars to the trunk is not limited to the tip of the trunk, but may be attached to the middle part of the trunk. A plurality of sets of upper and lower heels may be provided on one body.
[0032]
Further, as in another embodiment of the sampler 1 shown in FIG. 13, the handle support member 11 may be omitted, and the sliding groove 212 may be directly drilled in the cylindrical body 5. By configuring in this way, the number of parts can be reduced.
[0033]
Further, as in another embodiment of the sampler 1 shown in FIG. 13, there is no turning groove at the front end of the sliding groove 212, and the lower rod 4 moves only in the sliding direction of the rod shaft 6 relative to the upper rod 3. Thus, the lower collar 4 and the upper collar 3 may be in contact with and separated from each other.
When the sample collection operation is performed using another embodiment of the sampler 1 having a configuration in which the swivel groove is not provided, another embodiment of the sampler 1 is powdered with the lower eyelid 4 in contact with the upper eyelid 3 (initial state). Insert the granule to a predetermined depth, and then slide the lower eyelid 4 downward so that the lower eyelid 4 and the upper eyelet 3 are separated from each other. Then, another embodiment of the sampler 1 itself is set at a predetermined angle ( For example, by rotating 90 degrees), the lower rod 4 is slid upward and brought into contact with the upper rod 3 to enclose the granular material as a specimen in the receptors 19 and 22. Even with such a method, it is possible to collect the specimen without remixing the granular material in the part to be the specimen.
[0034]
Furthermore, in the embodiment of the sampler 1 shown in FIG. 1, the handle support member 11 is left, the turning groove 13 is not provided, and the lower rod 4 moves only in the sliding direction of the rod shaft 6 with respect to the upper rod 3. It is also possible to adopt a configuration in which the lower collar 4 and the upper collar 3 are brought into contact with and separated from each other.
The sample collection operation using the sampler 1 having no configuration of the swivel groove is performed in the same manner as the sample collection operation using another embodiment of the sampler 1 having no configuration of the swivel groove shown in FIG. It is possible.
[0035]
Hereinafter, an example of an experiment relating to the influence of the sample collection operation on the mixing uniformity will be described with reference to FIGS. 8, 9, and 10.
The granular material used in this experiment is a preparation A which tends to cause segregation due to mixing and has a low main ingredient content. The dosage unit of the preparation A is 65 [mg], and the content of the active ingredient in the dosage unit is 0.5 [mg].
[0036]
As shown in FIGS. 8 and 9, the granular material used in this experiment is accommodated in a substantially cylindrical container 30. Samples were collected from the preparation A contained in the container 30 by using a sampler 111 which is a second example of a conventional sampler and a sampler 1 which is an embodiment of the present invention.
The specimen collection position determination method includes a second insertion point 32 that is substantially the center of the container 30 in plan view, a first insertion point 31 that is substantially equidistant from the second insertion point 32 and the wall surface of the container 30, A third insertion point 33, which is substantially the same distance as the distance between the one insertion point 31 and the second insertion point 32 and is opposite to the first insertion point 31 across the second insertion point 32, is accommodated in the container 30. Determined on the surface of the powder. Sampler 1 or sampler 111 is inserted downward from the insertion point.
[0037]
In the case of the first insertion point 31, the bottom first collection point 41a, the center first collection point 41b, and the surface layer part first, which are three collection points having different depths from the surface of the granular material accommodated in the container 30. A collection point 41c was determined, and a sample was collected at the collection point. The depth of these sampling points is the depth of the granular material of the container 30 as L, the bottom first sampling point 41a is (1/4) × L from the bottom of the container 30, and the central first sampling point 41b is The position of (2/4) × L from the bottom of the container 30 and the surface layer first sampling point 41c were set to a position of (3/4) × L from the bottom of the container 30.
As with the first insertion point 31, the second insertion point 32 and the third insertion point 33 are similar to the sample insertion point 31 (the bottom second collection point 42a, the central second collection point 42b, the surface layer second collection point 42c, and A bottom third sampling point 43a, a central third sampling point 43b, and a surface layer third sampling point 43c) were defined.
Further, in consideration of the influence of the sample collection work on the granular material, when collecting from the same insertion point, in order from the point where the depth from the surface of the granular material is shallow (in the case of the first insertion point 31, the surface layer) Part first collection point 41c → center part first collection point 41b → bottom part first collection point 41a).
[0038]
For the sampler 111 which is the second example of the conventional sampler and the sampler 1 which is one embodiment of the present invention, a total of nine samples are collected, and the collected weight of each sample is measured. The average value [mg], maximum value [mg], minimum value [mg], and relative standard deviation (RSD) [%] of the collected weight were obtained. The measurement results are shown in FIG.
The target weight at the time of sample collection is 195 [mg], which is 3 times the dose of 65 [mg] as the dosage unit of Formulation A, and 65 [mg] as the dosage unit of Formulation A is weighed from the sample after collection. Then, this was used as a sample for obtaining mixing uniformity.
[0039]
The average value [%] of the uniformity of mixing shown in FIG. 10 is obtained by analysis with respect to the content [mg] of the active ingredient to be contained in the dosage unit of Formulation A (0.5 [mg] in this experiment). The percentage of the average value [mg] of the main drug content (value converted to the dosage unit) is expressed as a percentage.
[0040]
The maximum value [%] of the uniformity of mixing shown in FIG. 10 is obtained by analysis with respect to the content [mg] of the active ingredient to be contained in the dosage unit of Formulation A (0.5 [mg] in this experiment). The percentage of the maximum [mg] of the main drug content (value converted to the dosage unit) in a total of 9 specimens is expressed as a percentage.
[0041]
The minimum value [%] of the uniformity of mixing shown in FIG. 10 is obtained by analysis with respect to the content [mg] of the active ingredient to be contained in the dosage unit of Formulation A (0.5 [mg] in this experiment). The percentage of the minimum amount [mg] of the main drug content (value converted to the dosage unit) in the total of 9 specimens is expressed as a percentage.
[0042]
The RSD [%] of the mixing uniformity shown in FIG. 10 is a relative standard deviation of the average value of the mixing uniformity.
[0043]
As shown in FIG. 10, when a sample is collected with an existing sampler (sampler 111 which is a second example of a conventional sampler), the RSD (%) of the collected weight is collected with the sampler 1 of the present invention. It can be seen that the variation in the collected weight of a total of 9 samples collected is larger in the existing sampler.
[0044]
This is considered to be caused by the difference in the structure of the portion that encloses the specimen between the sampler 1 and the sampler 111.
That is, in the case of the sampler 111, the opening direction of the receiving portion (dent) 115 that encloses the specimen is substantially perpendicular to the insertion direction of the sampler 111 into the granular material (opened on the side surface of the body of the sampler 111). Therefore, even if the sampler 111 is inserted to the specimen collection position, it is presumed that the receiving unit 115 may not be filled with powder particles. Therefore, in order to enclose the receiving part 115 after the powdery particles are filled densely, the outer tube 113 is swung left and right a plurality of times, and the scraping member 117 scrapes the powdery substances into the receiving part 115. There is a need.
[0045]
On the other hand, in the case of the sampler 1 of the present invention, since the opening direction of the receiving portion 19 of the upper eyelid 3 is substantially parallel to the insertion direction of the sampler 1 into the granular material, the sampler 1 has been inserted to the specimen collection position. Sometimes the powder is densely packed in the receiving part 19. Further, the opening direction of the receiving portion 22 of the lower collar 4 is substantially the same as the sliding direction when the lower collar 4 abuts on the upper collar 3, so that when the lower collar 4 abuts on the upper collar 3 In the receiving portion 22, powder particles are closely packed. Therefore, in the case of the sampler 1 of the present invention, there is little variation in the collected weight of the specimen, and it is possible to reliably collect a sample with a desired weight.
[0046]
In addition, as shown in FIG. 10, when a sample is collected with an existing sampler (sampler 111, which is a second example of a conventional sampler), the sample with the sampler 1 of the present invention is also used for RSD (%) of mixing uniformity. It can be seen that the variation in the mixing uniformity of a total of nine samples collected is larger in the existing sampler than in the case of the above.
[0047]
This means that the sampler 1 and the sampler 111 are different in the structure of the portion in which the sample is sealed, as in the case of the existing sampler, the variation in the collected weight of the 9 samples collected in the same lot is larger. Is considered to be a major factor.
That is, in the case of the sampler 111, since the outer tube 113 is swung and scraped in the process of filling the receiving body 115 with the powder body, the powder body enclosed in the receiving section 115 is likely to be remixed. In addition, as described above, in order to reliably fill the receiving portion 115 with the granular material, the outer tube 113 is rotated a plurality of times to the left and right, but in this case, remixing at the sample collection point further proceeds.
[0048]
On the other hand, in the case of the sampler 1 of the present invention, once the lower collar 4 is slid / abutted toward the upper collar 3, the powder particles are reliably held in the receiving portions 19 and 22, and the lower collar 4 In this sliding operation, the powder particles at the sample collection position are not remixed, so there is little variation in mixing uniformity due to sample collection work, and samples that reflect the actual mixing condition of the powder particles are collected. Is possible.
In the present invention, the granular material collecting part constituted by the lower rod 4 and the upper rod 3 is offset outward from the outer peripheral surface of the body 2 when viewed from the longitudinal direction of the body 2, and the sampler 1 is inserted. It is possible to collect a granular material at a site that is not easily affected by the above.
Further, the holding surfaces of the powder particles in the receiving portions 19 and 22 are made substantially perpendicular to the sliding direction of the lower rod 4 and the sliding direction of the lower rod 4 is made to coincide with the take-out direction of the sampler 1. At the time of drawing, the collected powder particles are not easily affected by the inflow of powder particles from other parts. Therefore, it is possible to collect the specimen while holding the granular material while providing a certain gap between the lower rod 4 and the upper rod 3 (without contacting the upper rod 3 and the lower rod 4). For this reason, it is possible to collect a sample with a small external force, and it is possible to reduce the external force applied to the sample at the time of collection and to reduce the state change of the sample (a small amount of powder) before and after collection. It is. That is, the specimen can be collected in a state closer to the actual mixed state.
[0049]
【The invention's effect】
Since the present invention is configured as described above, the following effects can be obtained.
[0050]
That is, as shown in claim 1, a sampler for collecting powder particles,
A body, an upper collar provided on the outer peripheral surface of the trunk, and a lower collar that slides in a longitudinal direction of the trunk between a position that contacts the upper collar and a position that is separated from the upper collar, Since the receiving part for accepting the granular material is provided in either the upper or lower eyelid or both the upper and lower eyelids at the part where the powder comes into contact, the granular material is re-mixed in the process of sample collection Therefore, it is possible to collect a small amount of sample without any improvement, and the reliability of sample collection work is improved.
[0051]
As shown in claim 2, since either the upper or lower eyelid or both the upper and lower eyelids are detachably attached to the fuselage, depending on the type of granular material to be handled, analysis conditions, etc. It is possible to easily change the amount of specimen to be collected.
[0052]
Since the opening direction of the receiving portion provided on the upper eyelid and the insertion direction of the sampler into the granular material are substantially coincident with each other, the position within the receiving portion when the sampler is inserted to the specimen collection position. Therefore, it is possible to prevent the sample collection operation from affecting the mixing uniformity of the sample and improve the reliability of the analysis result of the sample.
[0053]
According to a fourth aspect of the present invention, the body includes a cylindrical body having an upper collar attached to a side surface, and a sliding body that is slidably inserted into the cylindrical body and has a lower collar attached thereto. It is possible to operate the lower eyelid provided at the tip of the sampler with a simple structure with strength. In addition, since the structure is simple, it is easy to clean after completion of the sample collection operation.
[0054]
According to a fifth aspect of the present invention, the lower arm is swung in the circumferential direction of the body at a position away from the upper arm, so that in the process of inserting the sampler into the granular material, the lower arm is in front of the insertion direction of the upper arm. It is possible to prevent the influence of the mixing uniformity of the sample without remixing the powder and improve the reliability of the analysis result of the sample.
[0055]
As shown in claim 6, since the lower rod 4 and the upper rod 3 are in contact with each other, they can be fixed. Therefore, when the sampler is pulled out from the granular material, the lower rod is accidentally operated and sealed in the receiving portion. The collected specimen (a small amount of powder) is not mixed with the powder at a position different from the specimen collection position, and the specimen collection operation can be performed reliably.
[0056]
As shown in claim 7, since the scale is provided on the body, it is possible to move the upper eyelid and the lower eyelid to the specimen collecting position with high accuracy and excellent workability.
[Brief description of the drawings]
FIG. 1 is a side view of a sampler according to an embodiment of the present invention.
FIG. 2 is a side cross-sectional view of a tip portion of a sampler that is an embodiment of the present invention.
FIG. 3 is a side cross-sectional view of a root portion of a sampler that is an embodiment of the present invention.
FIG. 4 is a perspective view of a handle support member.
FIG. 5 is a view of a sampler according to an embodiment of the present invention in a preparation state as viewed from the longitudinal direction.
FIG. 6 is a side view of a tip portion of a sampler that is one embodiment of the present invention in a ready state.
FIG. 7 is a side view of a root portion of a sampler according to an embodiment of the present invention provided with a belt-like body.
FIG. 8 is a plan view showing an example of a sample collection position in a sample collection operation.
FIG. 9 is a side sectional view showing an example of a sample collection position in a sample collection operation.
FIG. 10 is a diagram showing the results of a sample collection experiment using a conventional sampler and the sampler of the present invention.
FIG. 11 is a side sectional view showing a tip portion of a first embodiment of a conventional sampler.
FIG. 12 is a side sectional view showing a tip portion of a second embodiment of a conventional sampler.
FIG. 13 is a side view of a root portion in another example of a sampler that is an embodiment of the present invention.
[Explanation of symbols]
1 Sampler
2 Torso
3 upper arm
4 Shimojo
5 Pipe (tubular body)
6 Rod shaft (sliding body)
19 Receptor (upper side)
22 Receptor (lower arm)
23 Band

Claims (7)

粉粒体を採取するサンプラーであって、
胴体と、該胴体の外周面に設けられる上杵と、該上杵に当接する位置と離間する位置との間を胴体の長手方向に摺動する下杵とを備え、上杵と下杵とが当接する部位には粉粒体を受容する受容部が上杵と下杵のいずれか一方、または上杵と下杵の両方に設けられることを特徴とするサンプラー。
A sampler for collecting powder particles,
A body, an upper collar provided on the outer peripheral surface of the trunk, and a lower collar that slides in a longitudinal direction of the trunk between a position that contacts the upper collar and a position that is separated from the upper collar, A sampler characterized in that a receiving portion for receiving a granular material is provided on either the upper eyelid or the lower eyelid or on both the upper eyelid and the lower eyelid at a site where the abutment comes into contact.
上杵と下杵のいずれか一方、または上杵と下杵の両方を胴体に対して着脱可能に取り付けたことを特徴とする請求項1に記載のサンプラー。2. The sampler according to claim 1, wherein either the upper eyelid or the lower eyelid or both the upper eyelid and the lower eyelid are detachably attached to the body. 前記上杵に設けられる受容部の開口方向と、サンプラーの粉粒体への挿入方向とが略一致することを特徴とする請求項1または請求項2に記載のサンプラー。3. The sampler according to claim 1, wherein an opening direction of a receiving portion provided on the upper eyelid substantially coincides with an insertion direction of the sampler into a granular material. 前記胴体は側面に上杵が取り付けられる筒状体と、該筒状体に摺動可能に貫装されるとともに下杵が取り付けられる摺動体とを備えることを特徴とする請求項1から請求項3までのいずれか一項に記載のサンプラー。The said trunk | drum is provided with the cylindrical body by which an upper collar is attached to a side surface, and the sliding body to which a lower collar is attached while being slidably penetrated to this cylindrical body. The sampler according to any one of 3 to 3. 前記下杵は、上杵から離間した位置において胴体の周方向に旋回することを特徴とする請求項1から請求項4までのいずれか一項に記載のサンプラー。The sampler according to any one of claims 1 to 4, wherein the lower arm turns in a circumferential direction of the body at a position separated from the upper arm. 下杵4と上杵3とが当接した状態で固定可能に構成したことを特徴とする請求項1から請求項5までのいずれか一項に記載のサンプラー。The sampler according to any one of claims 1 to 5, wherein the sampler is configured to be fixed in a state where the lower collar 4 and the upper collar 3 are in contact with each other. 前記胴体に目盛を設けたことを特徴とする請求項1から請求項6までのいずれか一項に記載のサンプラー。The sampler according to any one of claims 1 to 6, wherein a scale is provided on the body.
JP2003101539A 2003-04-04 2003-04-04 sampler Expired - Lifetime JP3704531B2 (en)

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JP5321408B2 (en) * 2008-10-24 2013-10-23 大正製薬株式会社 Rod sampler
US11927507B2 (en) 2018-04-12 2024-03-12 Pharma and Nutraceutical PD Pty Ltd Sampling device

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