JP5884736B2 - 大建中湯のバイオアッセイ方法およびこれを用いる品質管理方法 - Google Patents
大建中湯のバイオアッセイ方法およびこれを用いる品質管理方法 Download PDFInfo
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Description
大建中湯のバイオアッセイ試験:
(1)被験試料の調製:
表1の配合割合の生薬混合物を、その混合物重量の10倍量の精製水で1時間、100℃で加熱抽出し、粉末化することにより無コウイ大建中湯エキス末を得た。この無コウイ大建中湯エキス末を100mg/mL濃度のDMSO懸濁液とし、これを、88.8mg/mL濃度の膠飴水溶液に対して1:9の割合で混和し、90mg/mL濃度の大建中湯溶液を調製した。これを0.1%BSA−Hanks緩衝液*で希釈して9mg/mL濃度としたのち15分間の超音波処理を行い、大建中湯被験試料を調製した。
1リットルの蒸留水に1gウシ血清アルブミン、1gブドウ糖、8g塩化ナトリウム、400mg塩化カリウム、47.9mgリン酸一水素ナトリウム(無水)、60mgリン酸二水素カリウム(無水)、46.8mg塩化マグネシウム(無水)、48.8mg硫酸マグネシウム(無水)、140mg塩化カルシウム(無水)を溶解し、pH7.2〜7.4に調製した。
ラット膵臓癌細胞株RIN−14B(DSファーマバイオメディカル社製)を、10%牛胎児血清(FBS)を加えたRPMI1640培地(10mmol/L HEPES、1.5g/L NaHCO3、100U/mL ペニシリン Gおよび100μg/mL ストレプトマイシン)中で継代培養し、セロトニン産生細胞とした。なお、細胞の回収にあたっては、トリプシン−EDTA液を用いた。
上記(2)で得られたセロトニン産生細胞を、96穴平底プレートに3×104cells/100μL/wellで分注した。72時間の前培養を行なった後、培養上清を上記(1)で得た各被験試料を含む0.1%BSA−Hanks緩衝液に置換し、5%炭酸ガスインキュベーターの中で更に1時間培養した。
EIA法による5−HT放出測定は、EIA セロトニン・キット(ベックマン・コールター社製)を用い、製品の添付プロトコールに準じて行った。
次に、(3)で得られた測定用試料のうち、900μg/mL大健中湯のものと、コントロールのものの培養試料液について、HPLCを用い、これに含まれる5−HTを検出した。その結果を図2の(a)および(b)に示す(5−HTの保持時間は、(a)で16.27分、(b)で16.11分である)。
微量生体試料分析システム:HTEC−500(EICOM)
データ処理装置:EPC−300(EICOM)
データ解析ソフトウェア:PowerChrom version
2.5.7(eDAQ)
分析カラム:EICOMPAK CA−5ODS
2.1mmΦ×150mm
プレカラム:EICOM PREPAKSET−CA
3.0mmΦ×4mm
移動相:80% 0.1M リン酸緩衝液(Na+)pH6
20% メタノール
500mg/L 1−オクタンスルホン酸ソーダ(SDS)
50mg/L EDTA・2Na+
流速:230μL/min
分析温度:25℃
設定加電圧:+450mV(+400〜+450mV) vs
Ag/AgCl
作用電極:グラファイト電極 WE−3G
ガスケット:GS−25
分析カラム:80%
Claims (4)
- 培養セロトニン産生細胞に、大建中湯の濃度として27〜900μg/mLの範囲で大建中湯を含有する被験試料を添加し、次いで培養上清中のセロトニン含量を測定する大建中湯の薬理活性のバイオアッセイ方法により、大建中湯として臨床的に薬理効果が認められた基準製剤と被検製剤を同一条件で薬理活性を評価し、基準製剤と被検製剤の同等性を評価することを特徴とする大建中湯製剤の品質管理方法。
- セロトニン産生細胞が、エンテロクロマフィン様細胞である請求項第1項記載の大建中湯製剤の品質管理方法。
- セロトニン産生細胞が、RIN−14B細胞、QGP−1細胞およびKRJ−I細胞から選ばれる細胞株である請求項第1項または第2項記載の大建中湯製剤の品質管理方法。
- 大建中湯の濃度として90〜900μg/mLの範囲でバイオアッセイ方法を行う請求項第1〜3項の何れかに記載の大建中湯製剤の品質管理方法。
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