VC XIN BCG

Vaccinum BCG cryodessicatum

nh ngha
Vc xin BCG ng kh l ch phm vi khun Calmette v Guerin sng dng tim trong da phng
bnh lao. Vc xin c sn xut dng ng kh v hon nguyn ngay trc khi dng vi dung
dch hi chnh th ch hp.

Sn xut
Vc xin BCG c sn xut t h thng chng ging. Chng c la chn v bo qun n nh.
Phng php sn xut phi cho sn lng vc xin BCG n nh v c kh nng gy mn cm i
vi tuberculin cho ngi v bo v c ng vt th n ghim chng li bnh lao. Chng sn xut
phi an ton i vi ngi v ng vt th nghim. Vc xin BCG c sn xut ti Vit Nam t
chng BCG 1173P2-Pasteur Paris.
Chng c nui trong mi trng Sauton - khoai ty, sau cy chuyn sang mi trng Sa uton
lng. Sau khi gt vi khun, BCG c ch thnh hn dch vc xin thun nht v ng kh.
Vc xin c iu ch t canh cy phi c tch bit khi chng gc ban u bng nhng ln cy
chuyn v khng c cy chuyn qu 8 ln.
Chng sn xut
Chng gc phi c thit lp v duy tr m bo tnh n nh, c kh nng gy mn cm i vi
tuberculin cho ngi v chut lang, khng gy bnh cho ngi v ng vt th nghim .
Vc xin BCG phi c bo qun trnh nh sng mt tri: Ton b quy trnh sn xut phi c
thit k sao cho t nui cy sn xut vc xin n kim nh, bo qun u khng tip xc trc tip
vi nh sng mt tri, tia cc tm.

Kim nh vc xin bn thnh phm cui cng

V khun: Ph lc 15.7 .
Pht hin Mycobacteria gy bnh:
Ch c dng nhng mu vc xin BCG bn thnh phm cui cng cho th nghim ny khi bo
qun 4 OC khng qu 72 gi sau khi gt.
Th nghim ny thng c tin hnh trn mu bn thnh phm v mu vc xin BCG thnh phm
nu cn thit. Ph lc 15.9.
m vi khun BCG
C th o trc tip m vi khun BCG trong huyn dch vc xin BCG bn thnh phm cui cng
bng cch cn trng lng kh hoc gin tip bng cch o mt quang hc ca huyn dch vi
khun c hiu chun tng ng vi trng lng kh .
sng: Ph lc 15.1.

Kim nh vc xin thnh phm

Hnh dng bn ngoi v tc to huyn dch : Bt trng, kh, bong, khng teo; nhanh chng to
thnh huyn dch ng nht sau 1 pht hon nguyn vi nc mui sinh l.
Mt quang hc (o bng quang ph k bc sng 490 nm, lc mu xanh l cy): Ch s mt
quang hc phi t l 0,5.
phn tn: Ph lc 15.3.
Vc xin BCG ng kh c hon nguyn trong nc mui sinh l c m 1 mg/ml. o mt
quang hc ca hn dch vc xin 2 bc sng: 434 nm v 630 nm v tnh kt qu theo cng
thc.
Tiu chun chp thun: phn tn cho php l 0,9.
chn khng : 95% tng s ng phi t chn khng. Ph lc 15.2.
m tn d : 3% (phng php Karl Fischer). Ph lc 15.35.
V khun: Ph lc 15.7.
Nhn dng:
Nhn dng BCG qua knh hin vi khng nh tnh khng axt ca vi khun v quan st hnh thi
khun lc trn mi trng c.
Th nghim an ton chung:
Th nghim an ton chung cho vc xin BCG ch tin hnh trn chut nht trng: 5 chut nh t trng
17-22 g/con. Tim di da 1 mg vc xin BCG/1ml/chut. Theo di v cn trng lng tng chut
trong 7 ngy. Nu trong thi gian 7 ngy theo di c bt k chut no b gim cn hoc cht phi
nhc li th nghim ln 2 vi s lng chut v mu gp i.
Tiu chun chp thun: Sau 7 ngy theo di, c 5 chut u kho mnh, ln cn, khng c biu hin
bnh l.
Th nghim an ton c hi u (Pht hin mycobacteria gy bnh):
Th nghim ny thng c tin hnh trn mu bn thnh phm v mu vc xin BCG thnh phm
nu cn thit . Ph lc 15.9.
Kim tra phn ng da :
Tim trong da cho t nht 4 chut lang cng gii (nu l chut ci th khng c thai), c phn ng
m tnh vi tuberculin, trng lng 250 -400g/con. Tim cho mi chut 0,1 ml vc xin ca tng m
pha long 1/1; 1/10; 1/100 (ca vc xin th v vc xin mu chun). Theo di thng tn ti ch
tim hng tun, trong 4 tun. Sau 4 tun, kim tra phn ng tuberculin bng cch tim trong da 5
TU/0,1ml/chut. c kt qu phn ng sau 24 gi.
Tiu chun chp thun: Phn ng da i vi vc xin th v vc xin mu chun phi khng c s
khc bit ng k.
Kim tra sng :
Xc nh sng trong vc xin hon nguyn bng cch m s lng khun lc trn mi trng
Lowenstein-Jensen. S lng n v sng p hi nm trong khong 1.10 6 - 6.106 vs/mg BCG. Ph
lc 15.1.
Tnh n nh nhit:
S n v sng ca vc xin BCG sau khi 37 OC/28 ngy phi t t nht l 20% so vi 4 OC/28
ngy. Ph lc 15.1.

Bo qun - hn dng:
Vc xin BCG ng kh cn c bo qun trong iu kin nhit 2 - 8OC v trnh nh sng mt
tri, hn dng t nht 24 thng. Sau khi hon nguyn vc xin phi c bo qun trnh nh sng
mt tri iu kin 2 -8OC v ch c s dng trong khong thi gian ti a l 4 gi.

Nhn, hp:
Nhng thng tin i vi nhn, hp, t hng dn s dng phi p ng nhng yu cu quy nh
trong Thng t s 04/2008/TT-BYT, ngy 12/5/2008 ca B Y t v Hng dn ghi nhn thuc.