Cov tshuaj yeeb tshuaj yog hais txog cov tshuaj yeeb tshuaj siv hauv kev tsim khoom ntawm ntau yam kev npaj. Nws yog cov khoom muaj txiaj ntsig zoo hauv kev npaj. Nws yog cov hmoov, siv lead ua, extract, thiab lwm yam uas npaj los ntawm cov tshuaj synthesis, cog extraction lossis biotechnology thiab siv los ua tshuaj, tab sis tsis tuaj yeem coj ncaj qha los ntawm cov neeg mob.

Lub ntsiab txhais zoo meej ntawm API hauv ICH Q7A: txhua yam khoom siv lossis sib xyaw ntawm cov khoom tsim los siv rau hauv kev tsim tshuaj thiab dhau los ua cov khoom xyaw nquag ntawm cov tshuaj thaum siv tshuaj. Cov tshuaj no muaj cov tshuaj pharmacological lossis lwm yam cuam tshuam ncaj qha hauv kev kuaj mob, kev kho mob, cov tsos mob nyem, kev kho mob lossis kev tiv thaiv kab mob ntawm cov kab mob, lossis tuaj yeem cuam tshuam rau kev ua haujlwm lossis cov qauv ntawm lub cev.

Lub active ingredient ntawm cov tshuaj. Tsuas yog thaum cov ntaub ntawv raw tau ua tiav rau hauv kev npaj tshuaj tuaj yeem ua cov tshuaj rau kev kho mob.

API tuaj yeem muab faib ua ob pawg raws li nws qhov chaw: tshuaj lom neeg cov tshuaj thiab tshuaj lom neeg.

Cov tshuaj hluavtaws kuj tseem tuaj yeem muab faib ua cov tshuaj inorganic hluavtaws thiab cov tshuaj organic hluavtaws. Inorganic synthetic tshuaj yog inorganic compounds (tsawg heev yog cov ntsiab), xws li txhuas hydroxide thiab magnesium trisilicate siv los kho gastric thiab duodenal rwj; Organic synthetic tshuaj yog cov tshuaj feem ntau (xws li tshuaj aspirin, chloramphenicol, caffeine, thiab lwm yam) ua los ntawm cov organic chemical raw cov ntaub ntawv los ntawm ntau cov tshuaj lom neeg cov tshuaj tiv thaiv.

Cov tshuaj chemical ntuj kuj tuaj yeem muab faib ua cov tshuaj biochemical thiab tshuaj phytochemical raws li lawv qhov chaw. Cov tshuaj tua kab mob feem ntau yog tsim los ntawm microbial fermentation thiab koom rau hauv qeb ntawm biochemistry. Nyob rau hauv xyoo tas los no, ntau yam tshuaj tua kab mob semi-synthetic yog cov khoom uas ua ke biosynthesis thiab tshuaj synthesis. Ntawm cov ntaub ntawv raw, ntau yam, tso zis thiab tso tawm tus nqi ntawm cov khoom siv hluavtaws suav nrog qhov loj tshaj plaws thiab yog tus ncej tseem ceeb ntawm kev lag luam kws tshuaj. Qhov zoo ntawm raw khoom txiav txim siab qhov zoo ntawm kev npaj, yog li nws cov qauv zoo yog nruj heev. Lub teb chaws thoob plaws ntiaj teb tau tsim cov qauv tshuaj pharmacopoeia hauv teb chaws nruj thiab cov txheej txheem tswj kom zoo rau cov khoom siv dav siv.

Cov tshuaj yeeb tshuaj yog hais txog cov tshuaj yeeb tshuaj siv hauv kev tsim khoom ntawm ntau yam kev npaj. Nws yog cov khoom muaj txiaj ntsig zoo hauv kev npaj. Nws yog cov hmoov, siv lead ua, extract, thiab lwm yam uas npaj los ntawm cov tshuaj synthesis, cog extraction lossis biotechnology thiab siv los ua tshuaj, tab sis tsis tuaj yeem coj ncaj qha los ntawm cov neeg mob.

Lub ntsiab txhais zoo meej ntawm API hauv ICH Q7A: txhua yam khoom siv lossis sib xyaw ntawm cov khoom tsim los siv rau hauv kev tsim tshuaj thiab dhau los ua cov khoom xyaw nquag ntawm cov tshuaj thaum siv tshuaj. Cov tshuaj no muaj cov tshuaj pharmacological lossis lwm yam cuam tshuam ncaj qha hauv kev kuaj mob, kev kho mob, cov tsos mob nyem, kev kho mob lossis kev tiv thaiv kab mob ntawm cov kab mob, lossis tuaj yeem cuam tshuam rau kev ua haujlwm lossis cov qauv ntawm lub cev.

Lub active ingredient ntawm cov tshuaj. Tsuas yog thaum cov ntaub ntawv raw tau ua tiav rau hauv kev npaj tshuaj tuaj yeem ua cov tshuaj rau kev kho mob.

API tuaj yeem muab faib ua ob pawg raws li nws qhov chaw: tshuaj lom neeg cov tshuaj thiab tshuaj lom neeg.

Cov tshuaj hluavtaws kuj tseem tuaj yeem muab faib ua cov tshuaj inorganic hluavtaws thiab cov tshuaj organic hluavtaws. Inorganic synthetic tshuaj yog inorganic compounds (tsawg heev yog cov ntsiab), xws li txhuas hydroxide thiab magnesium trisilicate siv los kho gastric thiab duodenal rwj; Organic synthetic tshuaj yog cov tshuaj feem ntau (xws li tshuaj aspirin, chloramphenicol, caffeine, thiab lwm yam) ua los ntawm cov organic chemical raw cov ntaub ntawv los ntawm ntau cov tshuaj lom neeg cov tshuaj tiv thaiv.

Cov tshuaj chemical ntuj kuj tuaj yeem muab faib ua cov tshuaj biochemical thiab tshuaj phytochemical raws li lawv qhov chaw. Cov tshuaj tua kab mob feem ntau yog tsim los ntawm microbial fermentation thiab koom rau hauv qeb ntawm biochemistry. Nyob rau hauv xyoo tas los no, ntau yam tshuaj tua kab mob semi-synthetic yog cov khoom uas ua ke biosynthesis thiab tshuaj synthesis. Ntawm cov ntaub ntawv raw, ntau yam, tso zis thiab tso tawm tus nqi ntawm cov khoom siv hluavtaws suav nrog qhov loj tshaj plaws thiab yog tus ncej tseem ceeb ntawm kev lag luam kws tshuaj. Qhov zoo ntawm raw khoom txiav txim siab qhov zoo ntawm kev npaj, yog li nws cov qauv zoo yog nruj heev. Lub teb chaws thoob plaws ntiaj teb tau tsim cov qauv tshuaj pharmacopoeia hauv teb chaws nruj thiab cov txheej txheem tswj kom zoo rau cov khoom siv dav siv.