Xyoo 2025 ib tsab ntawm Suav Pharmacopoeia, siv rau lub Kaum Hlis 1st, qhia txog kev hloov kho ntau yam rau cov qauv zoo hauv lub cev. Peb qhov kev hloov kho tseem ceeb - tsom mus rau brittleness, microbial tswj, thiab kev txheeb xyuas qhov seem - tau ua kom muaj kev lag luam zoo, ua kom muaj kev vam meej thiab txhim kho kev nyab xeeb thoob plaws cov khoom siv.
1. Yuav tsum muaj Brittleness: Txhim kho Mechanical Strength Standards
Lub brittleness txwv, qhov taw qhia tseem ceeb ntawm capsule durability nyob ze saib xyuas los ntawm cov chaw tsim tshuaj, tau raug nruj mus rau qib tsis tau pom dua:
Kev Hloov Kho Cov Cai: Qhov siab tshaj plaws tso cai ntawm cov tshuaj ntsiav tawg hauv kev ntsuam xyuas brittleness tau raug txo los ntawm Tsawg dua los yog sib npaug rau 5 rau Tsawg dua lossis sib npaug rau 2 .
Technical Complement: Ib qho tshiab 30mm specification xeem raj tau raug ntxiv los xyuas kom meej qhov tseeb ntawm cov loj - loj capsules, hais txog qhov kev thov loj hlob rau exported loj - cov khoom loj .
Qhov laj thawj & Kev cuam tshuam: Qhov kev hloov kho no teb rau ob qhov kev xav tau hauv kev lag luam tseem ceeb: (1) lub zog siv hluav taws xob siab ntawm cov tshuaj suav patent thiab qis - cov qauv dej noo, uas zoo li ua rau cov tshuaj capsule brittleness ntau dua; thiab (2) nruj me ntsis thoob ntiaj teb cov qauv rau exported capsules . Rau cov chaw tsim khoom, qhov no tso cai hloov kho tshiab hauv kev xaiv cov khoom siv raw (xws li, siab -purity gelatin lossis HPMC) thiab cov txheej txheem precision- xws li optimizing dip-coating thickness uniformity thiab pwm kub tswj- kom txo tus nqi tawg. Qhov tseem ceeb, cov tuam txhab ua lag luam zoo li Kailai Capsule twb tau txais tsawg dua lossis sib npaug rau 2 cov tshuaj ntsiav tawg ua lawv tus qauv tswj sab hauv, ua raws li cov cai tshiab pharmacopoeia .
2. Microbial Control: Cov cai nruj ib puag ncig cov av noo thiab kuaj pom
Kev tswj hwm microbial txwv tau ntxiv dag zog los ntawm ob qho tib si kev tswj hwm ib puag ncig thiab kev ntsuam xyuas raws tu qauv:
Humidity Mandate: Cov chaw tsim khoom yuav tsum tswj cov av noo qis dua 30% txhawm rau tiv thaiv pwm kev loj hlob. Qhov kev qhia tshwj xeeb no yog kev tshawb fawb hauv cov dej noo (aw) cov hauv paus ntsiab lus: pwm yuav tsum muaj qhov tsawg kawg nkaus aw ntawm 0.75-0.85 rau kev loj hlob, thiab tswj cov av qis dua 30% zoo txo cov dej dawb hauv cov tshuaj ntsiav, txo qis rau qib uas suppress microbial proliferation .
Kev Ntsuas Kev Txhim Kho: Cov tshuaj pharmacopoeia tam sim no txhawb cov kev xav tau rau kev tshaj tawm kev siv tau zoo thiab suav cov hauv paus ntsiab lus. Rau kev kuaj aerobic microbial suav, dilutions yielding Tsawg dua lossis sib npaug ntawm 250 CFU yog qhov nyiam, thaum Tsawg dua lossis sib npaug li 50 CFU dilutions raug pom zoo rau cov pwm / cov poov xab suav kom paub tseeb qhov tseeb.
Kev cuam tshuam kev lag luam: Cov neeg tsim khoom yuav tsum tau nqis peev rau hauv siab -kev ua haujlwm dehumidification thiab cov cuab yeej saib xyuas cov av hauv lub sijhawm tiag. Piv txwv li, cov chaw lag luam hauv Zhejiang Xinchang tau koom ua ke "capsule huab MES 2.0" cov txheej txheem los taug qab ib puag ncig tsis zoo, ua kom muaj kev ua raws li 30% av noo txwv. Qhov kev kho dua tshiab no yog qhov tseem ceeb tshwj xeeb rau cov tshuaj suav tshuaj ntsiav tshuaj, uas yav dhau los ntsib kev phom sij ntau dua microbial vim muaj cov khoom siv raw khoom sib xyaw.
3. Kev Tshawb Fawb Txog Kev Tshawb Fawb: Kev Ntsuas Ib txhij ntawm Ethylene Oxide thiab 2-Chloroethanol
Ib qho kev hloov kho tshiab hauv kev sim cov khoom seem sib xyaw ua ke ua haujlwm thiab rhiab heev, hais txog kev txhawj xeeb txog kev nyab xeeb cuam tshuam nrog kev ua kom tsis muaj menyuam los ntawm cov khoom:
Kev Tshawb Pom Tshiab Scope: Kev sim ib txhij rau ethylene oxide (EO) thiab 2-chloroethanol residues yog tam sim no yuav tsum tau, siv headspace gas chromatography nrog nplaim ionization nrhiav tau.
Kev Ua Haujlwm Leap: Txoj kev sib xyaw ua ke txhawb kev tshawb pom kev ua haujlwm tau zoo los ntawm 50% piv rau cov txheej txheem kev sim cais thiab txhim kho kev nkag siab los ntawm 10-fold . Qhov no tau qhib los ntawm qib siab GC-FID nta, suav nrog kev tswj qhov kub thiab txias (± 0.1 degree) thiab yim-theem kev pab cuam, uas txhim kho kev sib cais sib cais thiab teeb pom kev zoo.
Kev Nyab Xeeb Kev Ruaj Ntseg: 2-chloroethanol, ib qho tshuaj lom los ntawm EO sterilization, yav tas los tsis muaj kev tswj hwm tab sis tam sim no poob rau hauv kev saib xyuas nruj vim nws muaj peev xwm ua rau muaj kev phom sij rau kev noj qab haus huv. Rau cov chaw tsim khoom siv EO kom tsis muaj menyuam, qhov no yuav tsum muaj cov txheej txheem tshem tawm cov khoom seem; conversely, cov lag luam zoo li Kailai Capsule, uas zam EO sterilization nkaus, tau txais kev sib tw los ntawm kev tshem tawm cov kev xav tau kev ntsuam xyuas.