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CNG TY THUC TH Y ......

H S NG K SN XUT
LU HNH THUC TH Y
( sn xut trong nc )

SN PHM NG K

TP ......- Thng

MC LC H S
Trang ba
Mc lc h s
n ng k
Tm tt c tnh ca sn phm
Nhn ca sn phm
Bn hng dn s dng thuc
Thng tin k thut v cht lng ca sn phm
- Qui trnh sn xut
- Tiu chun v cht lng v phng php kim nghim
- Giy chng nhn phn tch kim nghim
- Hn s dng ( Bo co v n nh ca thuc)
Thng tin k thut v an ton v hiu lc ca sn phm
Cc ti liu khc

CNG TY THUC TH Y ......

S :

CNG HO X HI CH NGHA VIT NAM


c lp - T do - Hnh phc

/K - CT
Tp ......, ngy

thng

nm

N XIN NG K LU HNH THUC TH Y


Knh gi : Cc th Y
Cn c vo vn bn s 788/TY- QLT ngy 05.12.2003 ca Cc th Y v
vic hng dn ng k c php lu hnh thuc th y ti Vit nam :
NH SN XUT SN PHM THUC TH Y
Tn : CNG TY THUC TH Y ......
a ch:
in thoi :

Fax:

E.mail:
Chng ti xin ng k lu hnh sn phm thuc th- y sau y :
- Tn sn phm :
- Dng bo ch ca sn phm : Thuc bt.
- ng cp thuc : ng ming.
- Thnh phn Hm lng cc cht c trong sn phm :
Amoxicillin .10.000mg
Colistin sulfate ..40.000.000UI
Lactose va 100g
Dng ng gi sn phm : ng trong ti PE . lon nha c trng nhm ,
sch , hn kn vi quy cch :
+ Ti : 10g , 20g , 50g , 100g.
3

+ Lon : 50g , 100g, 500g.


- Ch nh iu tr v liu lng s dng cho tng loi ng vt :
ng vt c dng thuc : G, ln , tru , b , nga .
Ch nh iu tr : iu tr cc bnh tiu ho , h hp , c bit cc
bnh do E.Coli.
+ G : Tiu chy nng , phn c dch nhy mu nu , xanh hoc trng .
C th dn n vim rut , hoi t , vim khp , vim rn.
+ Ln : tiu chy gy mt nc , phn lng mu vng, xanh hoc trng .
c bit trong trng hp mc chng E.coli gy ph thng rut , i lo
o , u nghing , vp ng , ln t th ch ngi , nm sp , co git lin
tc , m mt sng .
Liu lng s dng cho tng loi ng vt : Pha vo nc ung hoc
trn vo thc n.
+ Tru , b , nga : 10g/100-150kgTT/ngy.
+ Ln to : 10g/70-100kgTT/ngy.
+ Ln con ,d : 10g/50 -70kgTT/ngy.
+ G , vt : 10gr/25-35kg TT/ngy.
+ Liu chung : 1g/lt nc hoc 2kg thc n. Dng 3 ngy lin tc .
+ Phng bnh : Bng liu iu tr . Dng trong 5 ngy.
- Chng ch nh :
+ Khng s dng : cho vt nui mn cm vi Penicilline.
- Thi gian ngng s dng thuc i vi ng vt khai thc tht , trng ,
sa :
+ ng vt khai thc tht : 7 ngy sau khi s dng thuc.
Khi c php lu hnh , chng ti cam oan chp hnh ng quy nh
ca php lut Vit nam v thuc th y v cc iu lut khc c lin quam.

i din nh sn xut
Ni nhn:
- Nh trn.
- Lu cng ty

TM TT C TNH SN PHM
1. Tn ca sn phm:
2. Dng bo ch ca sn phm : Thuc bt.
3. ng dng thuc : ng ming.
4. Thnh phn Hm lng cc cht c trong sn phm :
Amoxicillin .10.000mg
Colistin sulfate ..40.000.000UI
Lactose va 100g
5. Nhng c tnh ca dc l ca thuc:
5.1 c tnh dc lc hc:
5.1.1. Amoxicillin :
- Amoxicillin l khng sinh thuc nhm Penicillin , c hot tnh st
khun. C ch tc ng : Amoxicillin tc ng trn thnh t bo vi khun
bng cch c ch giai on cui ca s tng hp peptidoglycan . Phn t
Amoxicillin gn vo cc protein PBP (Protein Binding Penicillin ) c
hot tnh enzym hin din trn mng vi khun v c ch chc nng ca
cc enzyme ny trong s tng hp peptidoglycan. Ngn cn s pht trin
ca vi khun bng cch ph hu tnh thm ca thnh t bo vi khun.
- C ph khng khun rng , tc ng ln phn ln vi khun Gr(-) v vi
khun Gr(+) nh cc loi : E.coli ,Haemophillus, Salmonella , Shigella
, Corynebacteria, Clostridium, Streptococcus, Staphilococcus ,Bacillus
anthracis, Klebsiella , Listeria monocytogenes, Proteus , Brucella,
Pasteurella , Treponema pallidium,
5.1.2. Colistin sulfate :

- Colistin sulfate l khng sinh thuc nhm Popymyxin polypeptid. C tc


dng dit khun nng gn vi nng km khun .C ch tc dng :
tc ng nh mt gc cation lm xo trn mng t bo vi khun dn n lm
mt cc cht dinh dng nh amino acid , cc gc ion hu c , purin,
pyridine lm cho vi khun b bin dng v cht.
- Colistin ch yu tc ng trn vi khun Gr(-) hay gy bi nhi v khng
vi cc loi khng sinh khc do cc vi khun Gr(-) mng bo tng cha
nhiu phospholiquid nn rt nhy cm vi Colistin sulfate : Aerobact ,
Enterobact , Escherichia coli , Haemophilus, Klebsiella, Pseudomonas,
Salmonella , Shigella.
Nng c ch ti thiu ( g/ml) ca Colistin i vi mt s loi vi khun
nh :E. coli : 0,6 2,4 g/ml ;Pseudomonas : 0,6 1,2 g/ml ; Salmonella
:

0,15 0,6 g/ml

5.2. c tnh dc ng hc :
5.2.1. Amoxicillin :
- Sau khi cp thuc, Amoxicillin hp thu nhanh khong 40-50% , bn trong
d dy . Nng hot tnh trong mu t c nhanh. .Phn tn tt trong
dch ngo bo , kh khuch tn vo trong nhau thai, mng tng bo , no
tu . Phn b km m xng , trung bnh phi. Thi gian bn hu
khong 0,8 1,5 gi ,lin kt vi protein huyt tng khong 18 -20% .
trong mt , nng gp 9-10 ln trong mu ,S bi thi ch yu dng cn
hot tnh qua thn ( 60%) v mt ( 10 -20% ).
- Amoxicillin c hiu qu trong iu tr cc bnh sau :
* B : Bnh tiu phn trng v bnh vim phi trn b, bnh vim rut v
nhim trng mu b do Salmonella , bnh thi mng , bnh vim v do
E.coli , vim t cung v st nhau, vim thn.
* Heo : Vim rut v vim phi , ng du son , vim t cung.
7

* Gia cm : vim rut do E.coli v nhim Clostridium.


5.2.2. Colistin sulfate :
- Tim di da hay tim tnh mch thuc hp thu tt v t nng ti a
trong mu trong 50 pht vi nng 5g/ml liu 2,5mg/kg th trng . Sau
khi tim 2 gi thuc c phn phi khp ni tr no v ko di 8 -12 gi
sau khi tim . Bi tit tng i nhanh v hu ht qua thn , rt t qua mt .
Thi gian bn hu 2gi.
- Ch nh iu tr trong cc bnh trn ng tiuho nh vim rut , tiu
chy phn trng , ph thng hn , trc khun E.coli , bnh h hp mn tnh
ca g , bnh vim d dy do cc vi khun Gr(-) d nhy cm vi Colistin
nh : E.coli , Klebsiella, Pseudomonas, Salmonella , Shigella.
5.3. Thng tin v s phi hp khng sinh:
- Amoxicillin l mt khng sinh dit khun do tc ng trnthnh t bo vi
khun khi chng ang thi k phn sinh. Colistin tc ng trn mng tng
bo ca cc vi khun . tiu dit vi khun bng cch gy ri lon tnh th
thu ca mng t bo vi khun.
- S phi hp Amoxicillin vi Colistin gii hn s pht tn ca chng
khong ngoi t bo ( mu, bch tuyt , mt , nc tiu ) . Do cch thc tc
ng ca chng , s phi hp hai khng sinh ny rt ngn thi gian iu tr
xung t 2 -4 ngy.
6. Nhng ch nh v iu tr v liu lng s dng :
6.1 Ch nh iu tr : iu tr cc bnh tiu ho , h hp , c bit
cc bnh do E.Coli.
+ G : Tiu chy nng , phn c dch nhy mu nu , xanh hoc trng .
C th dn n vim rut , hoi t , vim khp , vim rn.
+ Ln : tiu chy gy mt nc , phn lng mu vng, xanh hoc trng .
c bit trong trng hp mc chng E.coli gy ph thng rut , i lo
8

o , u nghing , vp ng , ln t th ch ngi , nm sp , co git lin


tc , m mt sng .
7. Nhng cnh bo khi s dng :
7.1 Lu c bit khi s dng :
- Thuc pha vo nc khng qu 12 gi.
- iu chnh liu cho th b bnh thn
- Cho th ung nhiu nc.
7.2 Tng tc vi cc thuc khc , cc dng tng tc khc:
- Khi phi hp thuc vi aminosid , macrolide , sulfamide lm tng hiu
lc ca thuc.
- Khi phi hp thuc vi Chloramphenicol lm gim hiu lc ca thuc.
- Khi phi hp thuc vi Corticosteroid dng lu bi nhim n .
- Khng nn phi hp thuc vi cc khng sinh thuc cng nhm
Aminosid ; lactam do lm tng c tnh trn tai v thn.
7.3 Tc dng khng mong mun khi s dng theo ch dn v liu dng
c khuyn co :
- C th tc dng khng mong mun khi s dng liu lng theo khuyn
co.
- Vim thn cp tnh .
7.4 Tc dng khng mong mun khi s dng thuc qu liu :
- Biu hin d ng : Ni m ay , tng bch cu , triu chng thn kinh.
- Gy ri lon ng tiu ho : Bun nn , ma , tiu chy mt nc .
7.5 Thng tin v s dng thuc cho gia sc mang thai, cho sa v gia cm
trng :
- Thuc i qua c nhau thai.
- Bi tit qua sa.

7.6 Chng ch nh :
- Khng s dng thuc cho vt nui mn cm vi Penicillin.
7.7. Cnh bo i vi ngi dng thuc cho ng vt :
- Khi pha thuc cho vt nui ung trc tip hoc trn thc n ngi pha
thuc phi mang dng c chuyn dng pha . Trong mi trng hp
thuc v vt dng phi ni ring bit trnh xa tm vi ca tr em.
8. Thi gian ngng s dng thuc :
- Sn phm khai thc tht :sau 7 ngy.
9. Thng tin v s dng sn phm:
9.1 Hn s dng thuc:
- Trc khi m sn phm u tin : 2 nm .
- Sau khi m sn phm : 07 ngy.
9.2 Nhng lu khi bo qun sn phm :
- Bo qun ni kh mt .Trnh nh sng trc tip .Bo qun tt nht 1530C. xa tm tay tr em , khng gn thc n , nc ung.
- Sau khi m bao b nn y kn li , ni kh ro , thong mt , trnh nh
sng.
9.3 Tnh cht v dung lng ca bao b ng gi sn phm : ng trong ti
PE . lon nha c trng nhm , sch , hn kn vi quy cch :
+ Ti : 10g , 20g , 50g , 100g.
+ Lon : 50g , 100g, 500g.
9.4 Nhng ch dn c bit i vi vic loi b cc phn ca sn phm
khng c s dng :
- Khng c a cc phn thuc cn d tha ca qu trnh pha ch nh
nc ra bn pha ch sn phm vo cc b x k nc thi vi sinh v s lm
h hi n h thng vi sinh. Cc bao b trong v ngoi ca thuc khng c
ti s dng ng cc loi thc phm cho ngi .
10

10. Tn v a ch nh sn xut :
CNG TY
a ch:
in thoi :

Fax:

E.mail:
i din nh sn xt

11

NHN CA SN PHM
1. Nhn trc tip trn n v ng gi nh nht :
2. Nhn hp:
Thuc bt ung
CH DNG TRONG TH Y

TL.T: 100g

THNH PHN , c trong 100g thnh phm:


Amoxicillin .10.000mg
Colistin sulfate ..40.000.000UI
Lactose va 100g
CNG DNG: iu tr cc bnh tiu ho , h hp , c bit cc bnh do E.Coli.
+ G : Tiu chy nng , phn c dch nhy mu nu , xanh hoc trng . C th dn n vim
rut , hoi t , vim khp , vim rn.
+ Ln : tiu chy gy mt nc , phn lng mu vng, xanh hoc trng . c bit trong
trng hp mc chng E.coli gy ph thng rut , i lo o , u nghing , vp ng , ln
t th ch ngi , nm sp , co git lin tc , m mt sng .
CCH DNG & LIU LNG: Pha vo nc ung hoc trn vo thc n.
+ Tru , b , nga : 10g/100-150kgTT/ngy.
+ Ln to : 10g/70-100kgTT/ngy.
+ Ln con ,d : 10g/50 -70kgTT/ngy.
+ G , vt : 10gr/25-35kg TT/ngy.
+ Liu chung : 1g/lt nc hoc 2kg thc n. Dng 3 ngy lin tc .
+ Phng bnh : Bng liu iu tr . Dng trong 5 ngy.
CHNG CH NH
Khng s dng : cho vt nui mn cm vi Penicilline.
THI GIAN NGNG S DNG THUC
Tht ( Tt c cc loi ) : 7 ngy
BO QUN : ni kh ro ,thong mt, trnh nh sng trc tip.
Sn xt ti : CNG TY THUC TH Y ......
SK:
SL :
SKS :
HSD :

12

BN HNG DN DNG THUC


Thuc bt ung
Thnh phn : Trong 100g thnh phm
Amoxicillin .10.000mg
Colistin sulfate ..40.000.000UI
Lactose va 100g
Dng bo ch : Thuc bt .
ng dng thuc : ng ming
Quy cch ng gi :
- ng trong ti PE . lon nha c trng nhm , sch , hn kn vi quy cch :
+ Ti : 10g , 20g , 50g , 100g.
+ Lon : 50g , 100g, 500g.
Ch nh : iu tr cc bnh tiu ho , h hp , c bit cc bnh do
E.Coli.
+ G : Tiu chy nng , phn c dch nhy mu nu , xanh hoc trng .
C th dn n vim rut , hoi t , vim khp , vim rn.
+ Ln : tiu chy gy mt nc , phn lng mu vng, xanh hoc trng .
c bit trong trng hp mc chng E.coli gy ph thng rut , i lo
o , u nghing , vp ng , ln t th ch ngi , nm sp , co git lin
tc , m mt sng .
Liu lng v cch dng :
Trn vo thc n hay ho vo nc cho ung.
Tr bnh :

Tru , b , nga : 10g/100-150kgTT/ngy.


Ln to : 10g/70-100kgTT/ngy.

13

Ln con ,d : 10g/50 -70kgTT/ngy.


G , vt : 10gr/25-35kg TT/ngy.
Liu chung : 1g/lt nc hoc 2kg thc n. Dng 3 ngy lin
tc .
Phng bnh : Bng liu iu tr . Dng trong 5 ngy.
Chng ch nh :
+ Khng s dng : cho vt nui mn cm vi Penicilline.
Tc dng ph :
- C th xut hin phn ng shock phn v nhng rt him.
- Vim thn cp tnh .
Lu c bit :
- Thuc pha vo nc khng qu 12 gi.
- Dng cn thn trong trng hp vt nui b suy thn.
Ch :
- c k hng dn trc khi dng.
- Mi thng tin chi tit xin hi bc s th y.
- xa tm vi tr em.
- Khng s dng cc bao gi ng thc phm cho ngi.
- Khng dng thuc qu hn ghi trn nhn.
- Khng dng thuc nu thy vn cc hoc ng bnh.
Thi gian ngng s dng thuc :
- Tht ( cc loi ) : 07 ngy.
Bo qun : Ni kh mt , trnh nh sng trc tp, nhit khng qu
30C.
Hn dng : 24 thng k t ngy sn xut.
Tiu chun p dng : Theo tiu chun C s .

14

NHNG THNG TIN K THUT V CHT LNG SN PHM


A. QUI TRNH SN XUT THUC BT
S dng trong Th y
1. M u :
- K hiu :
- C quan sn xut : Cng ty Thuc th y ......
- Phm vi v thi gian hiu lc: k t ngy Cc Th y xt duyt .
2. Cng thc : Trong 100g thnh phm
Amoxicillin .10.000mg
Colistin sulfate ..40.000.000UI
Lactose va 100g
3. c im nguyn ph liu :
Amoxicillin

t tiu chun Dc in Vit nam III 2002

Colistin sulfate

t tiu chun Dc in BP ( Veterinary ) 2001

T dc

t tiu chun Dc in Vit nam III 2002

4. c im thnh phm
4.1. Hnh thc bn ngoi : Thuc bt mu trng hoc ng vng , ti xp ,
ng nht .
4.2. Cht lng thnh phm : t tiu chun c s .
4.3. Quy cch ng gi:
+ Ti PE c trng nhm 10g, 20g , 50g , 100g , cha hot cht tng ng.
+ Lon nha c trng nhm 50g, 100g, 500g cha hot cht tng ng.
4.4. Bo qun : Ni kh mt , trnh nh sng trc tp.
5. Vt t , my mc trang thit b :
TT

Tn thit b ,my mc

S lng
15

c im

Cht liu

1
Cn k thut
3
2
Cn phn tch
1
3
My trn
1
4
My ry
1
5
T sy
1
6
My ng gi
1
7
My hn lia
3
8
My h mng co
2
9
Thng ng
3
10
My in date
1
6. S CC GIAI ON SN XUT
Ph gia

0 -60 kg
0-2kg
380volt
380volt
380volt
5-20G
380volt
220volt
100-200 lt
220 volt

Hot cht

Thit b PC

Trn say mn
KN - BTP
San l
Bao b
Soi chn

Vo hp
KN - TP
Nhp

7. M t cc qu trnh sn xt
7. X l bao b:
- Bao b ngoi c kim tra trc khi sn xat.
16

St
St
Inox
Inox
Inox
Inox
Inox
St
Inox
Inox

- Tt c bao b phi gi gn sch s , kh ro.


- Nhn lnh cho l sn xut , kim chn nhn ng kch c , mu sc ,
ch vit , sau ng SKS , HSD cho tht chun xc.
- Hp ng thuc ng quy nh v oc ng SKS v HSD chun xc ,
ngay ngn.
7.2. Chun b dng c
- Cn chnh cn cho tht chnh xc , v sinh sch s.
- Cc dng c pha ch phi c ra sch , sy kh.
- My ng SKS cn chnh cho chnh xc s l , SKS v HSD .
- My san l nh lng c v sinh sch s v iu chnh th tch ph
hp vi chai cn ng.
7.3. Kim tra v cn nguyn liu , ph liu
Tt c cc nguyn liu , ph liu u c kim tra theo cc tiu ch sau:
- Phiu kim nghim ca nh cung cp v nh sn xut . Nguyn ph liu
tiu chun sn xut c dn nhn mu xanh ca c s.
- Trng lng cn theo lnh sn xt.
- Cn tng nguyn ph liu v ring tng loi.
- Chnh cn trc khi cn.
7.4. Pha ch
- Ho tan Sulfadimethoxin vo 50% dung mi , lc u cho n khi

Sulfadimethoxin tan hon ton.


- Thm dung mi va 100% .
- Kim tra pH Lc v trng .
7.5 Kim nghim bn thnh phm

17

Ly mu theo SOP ly mu kim nghim bn thnh phm ( Phng php


kim nghim ), nu sn phm t cc tiu ch ca Tiu chun c s th
c php a vo san l.
7.6. Phn liu san l
Dng my chit chai san l t ng.Cn chnh my cho ng vi th tch
ca chai cn ng. Trong qu trnh phn liu cn thng xuyn kim tra
th tch thnh phm trnh tnh trng sai st v th tch . Sau khi ng
nt tin hnh hp tit trng 100C trong 30 pht .
7.7. Kim tra v soi chn
- Kim tra bng cm quan nguyn liu , ph liu , bao b , nhn mc:
Trc , trong v sau khi sn xut .
- Kim tra cn , ong, o , m : Trong tt c qu trnh sn xt.
- Kim tra bn thnh phm , thnh phm : Trong v sau khi sn xut ch
yu l mu sc , th tch v kn.
- Soi tng chai thuc mt trn n soi thuc, loi b cc chai khng t
yu cu v trong hay c hin tng bt thng.
- Tt c cc sn phm c chn lc loi b cc sn phm khng ph
hp nh h, nhn lch ,in sai . ring sn phm loi thi ny ra mt khu
vc ring , c nhn hng Khng t yu cu ch x l.
7.8. Dn nhn
Dn tng nhn c kim tra k v ng du SKS v HSD y vo
sn phm c soi chn. Nhn phi c dn sao cho ngay ngn ,
phng , khng c dy bn vo nhn.
7.9. Vo hp
Tng sn phm sau khi c nhn y c ng vo tng hp . Hp
cng c c kim tra k v ng du SKS v HSD y ng

18

quy nh. y np hp v dn nhn nim phong tem sn phm vo np


hp. Xp cc hp thuc vo thng carton theo quy nh.
y np hp , dn kn thng, dn y nhn u hm sau ng ai
thng. Ch kim nghim thnh phm.
7.10. Kim nghim thnh phm
Sn phm c ng hp , c ly mu in hnh theo quy ch ly
mu . Kim nghim thnh phm c tin hnh theo phng php kim
nghim TCCS. Nu sn phm t y cc tiu ch th cp phiu kim
nghim thnh phm t tiu chun v mi c php nhp thnh phm
vo kho. Trng hp khng t , lp bin bn li v x l theo quy
nh chung.
7.11 Nhp kho
Sn phm sau khi c giy chng nhn t tiu chun c nhp kho ,
bo qun v phn phi theo quy nh chung.
4. Phng php kim sot , kim nghim
Giai
on
Trc
khi
sn
xt

Kim sot- Kim


nghim
Nguyn ph liu

Ch tiu

Phng php

Thc hin

t tiu chun

Dc in

Phng kim
nghim

Cn, ong, o ,m

s lng

i chiu

T trng sn
xt

ng cng thc,
ng quy trnh

i chiu

Dc s ph
trch k thut

trong

Phi trong

Soi trn n

T trng sn
xt

Mu sc, mi, v

Nh quy nh

Cm quan

Th tch

Theo quy nh
cho tng loi

ong bng ng
ong

T trng sn
xt
T trng sn
xt

Bn thnh phm

Tiu chun c s

Tiu chun c
s

Phng kim
nghim

Cng thc , quy trnh


Trong
khi
sn
xt

Sau
khi

19

sn
xut

Thnh phm

Tiu chun c s

Tiu chun c
s

Phng kim
nghim

Nhp kho

ng nhn, ng
s lng, dng
quy cch

i chiu

Th kho v
ngi giao nhp
hng

Ghi
ch

9. K thut an ton lao ng


9.1. My mc : Kim tra my mc theo ni dung
* ng v tr
* V sinh sch s
* Khng nhim in
* cc pha in theo cng sut my
* Lp t hon chnh, sn sng hot ng
9.2. Ngi vn hnh my
* c hun luyn s dng
* Nm c yu cu s dng my
* Mang mc trang b bo h ng quy nh
9.3. Vn hnh my
* Sau khi kim tra ton b my
* ng in
* Khi c hin tng bt thng phi dng ngay sn xut
9.4. Sau khi vn hnh my
* Ct in
* V sinh my , lau kh
* Bc my chng bi bn
9.5. An ton in , phng chng chy ,n

20

* Phi thc hin ng v y cc quy nh an ton in ,phng chng


chy ,n
10. Ch v sinh
10.1. Nh xng : Thng thong, sch s m bo cc yu cu v sinh.
10.2. Dng c : Sch s , khng dnh vt l , ho cht. Trc khi sn xat
c lau chi cn thn .Sau khi sn xut phi c v sinh , ng ni
quy nh.
10.3. V sinh c nhn : Cng nhn sn xt c sc khe lm vic, khng
bnh tt . Hc tp cc quy nh bt buc v v sinh trc , sau khi sn
xt.
10.4. My mc : Trc khi sn xut kim tra v sinh ca my , sau khi sn
xut v sinh trc khi kt thc ca sn xut.
11. D phm v ph phm
11.1. D phm :
Nhng chai v phi thu hi hu ch khng c ti ch.Phn dung dch
khng c x vo phn lng x l nc thi ca phn xng thuc tim
m ring x l theo nguyn tc.
11.2. Ph phm:
Nhng chai ng my khng trng lng hay ng nt khng kn c
tho ra tp trung ng li v i nt cho chc.
12. Cc yu t c th gy nhim n sn phm trong qu trnh sn
xut
- Khi cn nguyn liu: Ngi cn nguyn liy phi ch n bao b ng
nguyn liu cho tng m khng bi bn t bao b c ln vo.
- Khi pha ch, ngi pha ch phi tun th nghim ngt cc quy trnh v
sinh c nhn v quy trnh pha ch. Sau khi kim nghim bn thnh phm
cn tin hnh san l ngay .
21

- Khi san l bn thnh phm : Trong phng v trng, trnh sn phm tip
xc lu vi khng kh bng cch y nt cao su v sit nt nhm ngay
sau khi thuc c chit vo chai.
- Thng ng thnh phm trn my chit chai phi l thng INOX c np
kn.
13. H s km theo :
- Tiu chun c s cht lng thuc
- Xut x cng thc thuc.
NGI VIT QUY TRNH

Tp ......, ngy

thng

Gim c

22

nm

B.TIU CHUN CHT LNG V PHNG PHP KIM


NGHIM
TIU CHUN C S
Tn n v sn xut :

THUC TH Y

K hiu v hiu tiu

CNG TY THUC TH

DUNG DCH

chun :
C hiu lc t ngy :

Y ......

THUC BT

1. c tnh thnh phm


1.1 Tn thuc :
Hot cht chnh : Amoxicillin , Colistin sulfate .
1.2 Dng bo ch : Thuc bt
1.3 Cng thc pha ch:
Amoxicillin .10.000mg
Colistin sulfate ..40.000.000UI
Lactose va 100g
2. Cc ch tiu cht lng thnh phm
2.1 Ch tiu cht lng nguyn liu
Amoxicillin

t tiu chun Dc in Vit nam III 2002

Colistin sulfate

t tiu chun Dc in BP ( Veterinary ) 2001

T dc

t tiu chun Dc in Vit nam III 2002

2.2. Cc ch tiu cht lng thnh phm:


2.2.1. Cc ch tiu cm quan
- Hnh dng bn ngoi : Bt mn .
- Mu sc : Mu trng ng vng .
- mn : Ch phm lt qua ry 350.

23

- ng nht : Bt ng nht .
- ho tan : Tan mt phn trong nc.
2.2.2. Cc ch tiu l ho :
- m : Khng qu 5%.
- Thnh phn : Nh cng thc pha ch mc 1.4.
2.2.3. Khi lng ng gi : 10g 5% , 20g 5% , 50g 5% ,100g 5% ,
500g 3% .
2.2.4. nh tnh : Ch phm phi cho phn ng ca Amoxicillin , Colistin
sulfate .
2.2.5. nh lng : Hm lng ca cc hot cht phi t t : 90 % - 100 %
so vi hm lng ghi trn nhn.
3. Phng php kim nghim :
3.1 Cc ch tiu cm quan
- Mu sc,mi v : Th bng cm quan , ch phm phi t cc yu cu
nu
- mn : Ly khong 10g ch phm ry qua ry s 350. Ch phm lt hon
ton qua ry.
- ng nht : Tri mt lp mng ln phin knh , ung knh lp quan st ,
bt phi ng nht .
- ho tan : 1g ch phm phi tan mt phn trong 10ml nc .
3.2. Cc ch tiu l ho :
- m : Phng php sy 105C n trng lng khng i .
3.3. Khi lng ng gi :
- Th theo DVN III 2002 , ch ph phi t yu cu quy nh theo tng
quy cch ng gi 10g 5% , 20g 5% , 50g 5% ,100g 5% , 500g
3% .
3.4. nh tnh :
24

* Amoxicillin : S dng 1 trong 2 phng php sau ( A v B) hoc C.


A. Phng php sc k lp mng
- Bn mng GF254.. Hot ho bn mng 100C/ 1 gi.
- H dung mi khai trin : aceton : nc : toluen : acid acetic bng ( 65
: 10 : 10 : 2,5 )
- Dung dch pha long : aceton : acid hydrochloric 0,1N (4 : 1).
- Dung dch i chng ( mu) : 5mg/ml Amoxicillin chun trong nc.
- Dung dch ch phm : Ho tan 1 lng ch phm trong nc sao cho
nng ca Amoxicillin khong 5mg/ml .
- Vt chm : 2l.
- Hin hnh : Phun dung dch ninhydrin 0,3% trong rthanol (TT) ln bn
mng .
- Kt qu : Vt chnh thu c trn sc k ca dung dch ch phm
phi ging v v tr , mu sc v kch thc vi vt chnh trn sc k
ca dung dch i chng . Vt sc k ca ch phm v mu i
chng phi c cng tr s Rf.
B. Phng php ho hc .
- Ly 1 ml dung dch ch phm , cho vo ml nc , thm vo 2ml thuc
th Fehling , xut hin ngay mu tm .
C. Phng php sc k lng cao p (HPLC)
Thc hin nh phn nh lng . Thi gian lu ca mu chun v mu
th phi tng ng nhau
Colistin sulfate : S dng 1 trong 2 phng php sau :
A : Phng php ho hc :
- Ly khong 0,1g ch phm ch phm cho vo 5ml dung dch acid HCl
v 0,5ml dung dch Iod 0,01M, dung dch khng b mt mu .

25

- Ly khong 0,1g ch phm cho vo 3ml dung dch NaOH long , lc


u , thm 1ml dung dch ng sulfate 1% , dung dch chuyn sang mu
tm xanh.
- Ly khong 0,3g ch phm ho tan vo nc , lc ,cho vo dch lc 3 -5
git BaCl2 (TT) , kt ta trng xut hin .
B. Phng php sc k lng cao p (HPLC)
Thc hin nh phn nh lng . Thi gian lu ca mu chun v mu
th phi tng ng nhau
3.5. nh lng :
3.5.1. Amoxicillin: Phng php sc k lng cao p (HPLC).
3.5.2.1. Phng php sc k lng :
- Pha ng : Dung dch mphospaht ( pH= 6) : acetonitril : methanol
( 780 : 15: 15) . Lc bng mng lc milipore 0,45 m, siu m ui
kh khong 15 pht.
- Ct C8, di 15 cm, ng knh trong 4,6 mm, kch thc ht 5m.
- u d : = 254 nm.
- Tc dng : 1,5 ml/pht.
- Th tch bm : 20l.
3.5.2.2. Chun b dung dch :
- Dung dch A ( mu chun ) : 1,5 mg/ ml Amoxicillin chun trong pha
ng . Lc bng mng lc milipore 0,45 m.
- Dung dch B ( mu th ) : Ht chnh xc 150mg ch phm cho vo
bnh nh mc 10ml , thm dung mi pha long va n vch . Lc
bng mng lc milipore 0,45 m.
+ Tin hnh : Detector o : = 254nm.
- n nh my.
- Bm dung dch A.
26

- Bm dung dch B.
- Tnh ton kt qu.
Nng phn trm ca ch phm tnh theo cng thc:
SM x C C x PM
a (%) = --------------------------- x 100
SC x MM
Trong :
SM : Din tch peak ca dung dch mu .
SC : Din tch peak ca dung dch chun .
CC : Nng ca dung dch chun.
PM : pha long ca dung dch mu.
MM : Khi lng ca mu.
3.5.2. Colistin sulfat : : Phng php sc k lng cao p (HPLC).
3.5.2.1. Phng php sc k lng :
- Pha ng : m KH2PO4 0,05M (pH = 3 ) : acetonitril ( 80 : 20) . Lc
bng mng lc milipore 0,45 m, siu m ui kh khong 15 pht.
- Ct C8, di 15 cm, ng knh trong 4,6 mm, kch thc ht 5m.
- u d : = 210 nm.
- Tc dng : 1 ml/pht.
- Th tch bm : 20l.
3.5.2.2. Chun b dung dch :
- Dung dch A ( mu chun ) : 4.000UI/ ml Colistin sulfat chun trong
pha ng . Lc bng mng lc milipore 0,45 m.
- Dung dch B ( mu th ) : Ht chnh xc 200mg ch phm cho vo
bnh nh mc 20ml , thm dung mi pha long va n vch . Lc
bng mng lc milipore 0,45 m.

27

+ Tin hnh : Detector o : = 210nm.


- n nh my.
- Bm dung dch A.
- Bm dung dch B.
- Tnh ton kt qu.
Nng phn trm ca ch phm tnh theo cng thc:
SM x C C x PM
a (%) = --------------------------- x 100
SC x MM
Trong :
SM : Din tch peak ca dung dch mu .
SC : Din tch peak ca dung dch chun .
CC : Nng ca dung dch chun.
PM : pha long ca dung dch mu.
MM : Khi lng ca mu.
4.Ghi nhn , ng gi ,bo qun
4.1 Ghi nhn : theo quy ch nhn hin hnh bao gm cc mc sau
- Tn sn phm.
- Dng bo ch.
- Thnh phn v hm lng hot cht chnh.
- Ch inh iu tr cho tng loi ng vt.
- Liu lng v cch dng cho tng loi ng vt.
- Ngy sn xut , s ng k.
- Hn s dng.
- Thi gian ngng s dng thuc.
- Tn v a ch ca nh sn xut.

28

- C dng ch CH DNG TRONG TH Y


4.2 ng gi : ng trong ti PE, lon nha trng nhm , hn kn.
- Quy cch :
+ Ti PE : 10g, 20g , 50g , 100g .
+ Lon nha : 50g, 100g, 500g
4.3 Hn s dng v bo qun :
+ Bo qun : Ni kh mt , trnh nh sng trc tp.
+ Hn dng : Khng qu 24 thng k t ngy sn xut.
Tp ......, ngy

thng

Gim c
PH TRCH SN XUT

29

nm

GIY CHNG NHN PHN TCH KIM NGHIM


1. Mu th :
Mu nghin cu

Ngy sn xt 15/03/2003

Mu nghin cu

Ngy sn xt 25/03/2003

Mu nghin cu

Ngy sn xt 19/03/2003

Tui th d kin : 24 thng k t ngy sn xt


2. Ni sn xt : Phng k thut Cng ty Thuc Th Y .......
3. Dng thuc : Thuc bt ung ng gi trong :
+ Ti PE c trng nhm 10g, 20g , 50g , 100g , cha hot cht tng ng.
+ Lon nha c trng nhm 50g, 100g, 500g cha hot cht tng ng.
4. iu kin kho st v tnh ton :
- Mu noi kh mt , nh sng thng , m tng i 65 -75%.
- Nht : 25 - 35C.
- Quy cch mu : 10g , 100g.
- Kt qu tnh ton v hm lng hot cht trong cng mt l c quy
i v trng lng ban u ca gi .
5. Phng php nghin cu:
5.1.

Theo di kim tra: 03 thng , 06 thng v 24 thng. C th rt ngn


thi gian theo di nhng ngn nht l 12 thng trong iu kin c
phng tin v phng php lm lo ho thuc.

5.2.

Tiu chun kim tra :

- Tnh cht : bt mn ti xp , mu trng - trng ng


- nh tnh : C phn ng ca Colistin sulfate.
nh lng : Theo TCCS : Hm lng ca Amoxicillin , Colistin sulfate
phi t t : 90 % - 100 % so vi hm lng ghi trn nhn.
30

5.3.

Phng php kim tra :

- Tnh cht : Bng cm quan.


- nh tnh v nh lng : Theo TCCS .
5.4.

Trang thit b theo di :

- Cn phn tch
- My xc nh m
- T m
- T sy
- My o pH
- My sc k lng cao p
- My o quang ph IR ( Hng ngoi) , UV Vis ( Kh kin v t
ngoi).
6. Kt qu theo di :
Thi
gian

Ban u

Ch tiu

L 150303KS

Tnh cht

Bt mn ng nht
,mu trng

3 thng

Bt mn ng nht
,mu trng

L 190603KS

Bt mn ng nht
,mu trng

2,18%

2,33%

2,18%

nh tnh

ng

ng

ng

nh lng
Thi
gian

L 250303KS

Amoxicillin :101,12%
Colistin
:102,06%

Ch tiu

L 150303KS

Tnh cht

Bt mn ng nht
,mu trng

Amoxicillin :101,25%
Colistin
:102,29%
L 250303KS

Bt mn ng nht
,mu trng

Amoxicillin :101,36%
Colistin
:102,41%
L 190603KS

Bt mn ng nht
,mu trng

2,23%

2,34%

2,19%

nh tnh

ng

ng

ng

nh lng

Amoxicillin :100,55%
Colistin
:101,18%

31

Amoxicillin :100,74%
Colistin
:101,57%

Amoxicillin :100,18%
Colistin
:101,56%

Thi
gian

6 thng

Ch tiu

L 150303KS

Tnh cht

Bt mn ng nht
,mu trng

9 thng

12thng

2,37%

2,28%

nh tnh

ng

ng

ng

15thng

Amoxicillin :99,39%
Colistin
:99,59%

Ch tiu

L 150303KS

Tnh cht

Bt mn ng nht
,mu trng

Amoxicillin :99,69%
Colistin
:99,63%

L 250303KS

Bt mn ng nht
,mu trng

Amoxicillin :99,55%
Colistin
:99,49%

L 190603KS

Bt mn ng nht
,mu trng

2,34%

2,39%

2,31%

nh tnh

ng

ng

ng

Amoxicillin :98,54%
Colistin
:98,62%

Ch tiu

L 150303KS

Tnh cht

Bt mn ng nht
,mu trng

Amoxicillin :98,37%
Colistin
:98,45%

L 250303KS

Bt mn ng nht
,mu trng

Amoxicillin :98,60%
Colistin
:98,40%

L 190603KS

Bt mn ng nht
,mu trng

2,39%

2,47%

2,49%

nh tnh

ng

ng

ng

nh lng

Thi
gian

Bt mn ng nht
,mu trng

2,29%

nh lng

Thi
gian

Bt mn ng nht
,mu trng

L 190603KS

nh lng

Thi
gian

L 250303KS

Amoxicillin :97,77%
Colistin
:97,69%

Ch tiu

L 150303KS

Tnh cht

Bt mn ng nht
,mu trng

Amoxicillin :97,53%
Colistin
:97,19%

L 250303KS

Bt mn ng nht
,mu trng

Amoxicillin :97,31%
Colistin
:97,21%

L 190603KS

Bt mn ng nht
,mu trng

2,45%

2,51%

2,54%

nh tnh

ng

ng

ng

nh lng

Amoxicillin :96,04%
Colistin
:96,12%

Amoxicillin :96,09%
Colistin
:96,00%

32

Amoxicillin :96,00%
Colistin
:96,07%

Thi
gian

18thng

Ch tiu

L 150303KS

Tnh cht

Bt mn ng nht
,mu trng

21thng

24thng

Bt mn ng nht
,mu trng

2,48%

2,57%

2,59%

nh tnh

ng

ng

ng

Amoxicillin :94,47%
Colistin
:94,81%

Ch tiu

L 150303KS

Tnh cht

Bt mn ng nht
,mu trng

Amoxicillin :94,59%
Colistin
:94,27%

L 250303KS

Bt mn ng nht
,mu trng

Amoxicillin :94,66%
Colistin
:94,76%

L 190603KS

Bt mn ng nht
,mu trng

2,53%

2,59%

2,62%

nh tnh

ng

ng

ng

nh lng

Thi
gian

Bt mn ng nht
,mu trng

L 190603KS

nh lng

Thi
gian

L 250303KS

Amoxicillin :92,39%
Colistin
:92,55%

Ch tiu

L 150303KS

Tnh cht

Bt mn ng nht
,mu trng

Amoxicillin :92,59%
Colistin
:92,18%

L 250303KS

Bt mn ng nht
,mu trng

Amoxicillin :92,87%
Colistin
:92,85%

L 190603KS

Bt mn ng nht
,mu trng

3,25%

3,29%

3,28%

nh tnh

ng

ng

ng

nh lng

Amoxicillin :90,37%
Colistin
:90,28%

Amoxicillin :90,36%
Colistin
:91,41%

Amoxicillin :90,53%
Colistin
:91,29%

3. KT LUN:
- Dung dch tim

c kho st iu kin nu

trn. Kt qu sau 24 thng cho thy sn phm vn m bo cht lng thuc


v t tiu chun c s.
- Do Cng ty xin ng k hn dng cho sn phm thuc tim l 24
thng , k t ngy sn xut.

33

Tp ......, ngy

thng

Gim c

34

nm

V. THNG TIN K THUT V TNH AN TON V HIU LC CA


THUC
1. Tnh an ton ca thuc i vi :
* Sc kho ng vt :
- c nh ca Amoxicillin trn gia sc. Gia cm rt l thp , ch
yu xy ra d ng vi Penicillin
- Colistin khng gy c v dung np tt cho c th. Dng liu co cng
khng gy nguy him.
* Sc kho ngi tiu dng sn phm ng vt :
- Thi gian ngng s dng thuc:
+ ng vt khai thc tht : 07 ngy.
- Thuc khng nh hng n sc kho ngi tiu dng sn phmng vt .
* Sc kho ngi s dng thuc phng tr bnh cho ng vt
- Thuc khng nh hng n sc kho ca ngi s dng thuc phng
tr bnh cho ng vt.Nhng c nhn c d ng vi nhng thnh phn ca
thuc th khng nn tip xc vi thuc. Ngi trc tip s dng thuc iu
tr cho gia sc, gia cm khng nn thuc tip xc vi da v nim mc.
* Mi trng
- Khng nh hng n mi trng xung quanh.
2. Hiu lc ca thuc i vi loi ng vt c dng thuc
- Amoxicillin c hiu qu trong iu tr cc bnh sau :
* B : Bnh tiu phn trng v bnh vim phi trn b, bnh vim rut v
nhim trng mu b do Salmonella , bnh thi mng , bnh vim v do
E.coli , vim t cung v st nhau, vim thn.
* Heo : Vim rut v vim phi , ng du son , vim t cung.
* Gia cm : vim rut do E.coli v nhim Clostridium.
- Colistin sulfate c hiu qu trong iu tr cc bnh sau :

35

Cc bnh trn ng tiu ho nh vim rut , tiu chy phn trng , ph


thng hn , trc khun E.coli , bnh h hp mn tnh ca g , bnh vim d
dy do cc vi khun Gr(-) d nhy cm vi Colistin nh : E.coli ,
Salmonella , Shigella , Klebsiella , Pseudomonas
Sn phm

c ch nh iu tr cc bnh tiu ho , h

hp , c bit cc bnh do E.Coli.


+ G : Tiu chy nng , phn c dch nhy mu nu , xanh hoc trng .
C th dn n vim rut , hoi t , vim khp , vim rn.
+ Ln : tiu chy gy mt nc , phn lng mu vng, xanh hoc trng .
c bit trong trng hp mc chng E.coli gy ph thng rut , i lo
o , u nghing , vp ng , ln t th ch ngi , nm sp , co git lin
tc , m mt sng .
Tp ......, ngy

thng

Gim c
CC TI LIU KHC

36

nm