THUC BT (PL 1.7)
7)
MC TIU
- Trnh by c cc ch tiu kim nghim thuc bt
- Phn bit c cc ch tiu khc nhau ca kim nghim
thuc bt vi thuc cm
THUC BT (PL 1.7)
nh ngha
Dng thuc rn, gm cc ht nh, kh ti, c
mn xc nh, cha mt hay nhiu dc cht.
Thuc bt c th dng ung, pha tim hay
dng ngoi.
Thuc bt cha mt hoc nhiu dc cht,
ngoi ra c thm cc t dc nh t dc n, t
dc dnh, t dc iu hng v, t dc mu...
THUC BT (PL 1.
NH NGHA
YU CU K THUT
PHNG PHP TH
THUC BT (PL 1.7)
c im chung:
- Dng qua ng ung, c th dng ngoi
- Cch dng: n gin, thng dng d gy tc
dng khng mong mun do dng khng ng cch
(ung trc tip khng pha vi nc), do qu liu
(khng lng bng dng c thch hp).
- Hot cht rn trong hn hp rn.
- Hm lng hot cht t mg 102 mg g
1
 YU CU K THUT
THUC BT (PL 1.7)
1. Tnh cht:
Phn loi 2. m

Thuc bt ung 3. mn
4. ng u khi lng
Thuc bt dng ngoi
5. nh tnh: theo chuyn lun
Thuc bt pha tim 6. nh lng: theo chuyn lun
7. ng u hm lng
8. Th gii hn nhim khun: thuc bt c ngun gc dc
liu,
9. Th v khun: thuc bt p, dng cho vt thng rng
hoc trn da b tn thng nng, thuc bt dng cho mt.

YU CU K THUT YU CU K THUT

1. Tnh cht:
Quan st mu sc bng mt thng, di nh sng
t nhin, vi mt lng bt va , c phn tn
u trn mt t giy trng mn. Thuc bt phi kh
ti, khng b m, vn, mu sc ng nht.
2. m
- Theo phng php Xc nh mt khi lng
do lm kh (ph lc 9.6 DVN IV) hoc phng
php nh lng nc bng thuc th Karl
Fisher (ph lc 10.3 DVN IV) tu theo ch dn
trong chuyn lun ring.

- Yu cu: 9% (tr cc ch dn khc)

2
3. mn 3. mn
Php th C bt v ry (Ph lc 3.5) Php th C bt v ry (Ph lc 3.5)

i vi bt th hoc na th th ly 25 g - 100 g nh gi (lng thuc bt qua c c ry):

bt th. Cho vo ry thch hp, lc ry theo
Qua 1 c ry: 97% lng thuc
chiu ngang quay trn ti khi xong, t nht 20 pht.
Cn ng s lng cn li trn ry v s lng Qua 2 c ry:

thu c trong hp hng. 95% lng thuc phi qua ry c ln

i vi bt na mn, mn hay rt mn th tin 40% lng thuc phi qua ry c nh
hnh nh bt th, nhng mu bt ly th khng
qu 25 g v lc ry t nht 30 pht ri ry ti khi
xong.

3. mn 4. ng u khi lng (PL 11.3)

Php th C bt v ry (Ph lc 3.5) Thuc bt n liu:
Dng c: Ry (ph lc 3.5 DVN IV) KL trung bnh (KLTB) chnh lch (%)

< 300 mg 10
C bt Dng 1 ry Dng 2 ry
300 mg 7,5
Bt th 1400 1400/355
Cch th: Cn khi lng ca mt gi (P1).
Bt na th 710 710/250
ly ht thuc ra, dng Tin hnh tng
Bt na mn 355 355/180 bng lau sch bt thuc t vi 19 n v
Bt mn 180 180/125 bm mt trong, cn khc ly ngu
khi lng v gi (P2) nhin
Bt rt mn 125 125/90
KL thuc = P1 P2

3
 4. ng u khi lng (PL 11.3) 4. ng u khi lng (PL 11.3)
Thuc bt n liu: Thuc bt a liu :
KL nhn (g/gi) chnh lch (%)
KL trung bnh (KLTB) chnh lch (%) 0,5 10
< 300 mg 10 trn 0,5 1,5 7
trn 1,5 6,0 5
300 mg 7,5
trn 6,0 3
Cch th: Cch th: Cn khi lng ca mt gi (P1).

nh gi kt qu: Khng c c qu 02 n v c khi ly ht thuc ra, dng Tin hnh tng

lng nm ngoi gii hn chnh lch quy nh v khng bng lau sch bt thuc t vi 05 n v
bm mt trong, cn khc ly ngu
c c n v no c khi lng vt gp i gii hn . khi lng v gi (P2) nhin

KL thuc = P1 P2

4. ng u khi lng (PL 11.3) 5. nh tnh (theo chuyn lun ring)

Thuc bt a liu : C s la chn phng php nh tnh:
KL nhn (g/gi) chnh lch (%) Tnh cht l ho ca hot cht.
0,5 10 tan ca hot cht v cc t dc c trong ch phm.
trn 0,5 1,5 7
Cc k thut ng dng trong nh tnh thuc bt - cm:
trn 1,5 6,0 5
Phn ng mu c trng.
trn 6,0 3
nh gi kt qu: o im nng chy
So
Tt c phi c khi lng nm trong gii hn nu trn o ph IR: cc pic c trng. snh
so vi KL nhn. o ph UV: max. vi
Nu c mt n v c khi lng nm ngoi gii hn cht
Sc k lp mng Rf
, tin hnh th li vi nm n v khc ly ngu chun
nhin. Khng c c qu mt n v / 10 n v Sc k kh (GC) tR.
em th c khi lng nm ngoi gii hn qui nh. Sc k lng hiu nng cao (HPLC) tR.

4
 6. nh lng (theo chuyn lun ring) 6. nh lng (& 11.3)

C s la chn phng php nh lng:

(PL 11.1) Lng hot Gii hn cho
- Tnh cht l ho ca hot cht.
Loi thuc cht ghi nhn php (%)
- tan ca hot cht v cc t dc c trong ch
phm Thuc bt,

Cc k thut ng dng Thuc cm,

Mi hm lng 10%
Chun th tch: Iod, nitrit, acid baz Thuc dng ngoi
o hp thu UV; So mu; o so snh (Thuc m, Cao xoa ...)
o hunh quang: mu th v Nu khng c qui nh trong chuyn lun ring, lng ch
mu chun
Sc k kh (GC) . phm em th c ly t mt s lng n v ch phm
cng iu kin
Sc k lng hiu nng cao (HPLC). qui nh theo PL 11.3 c lm ng u (20 n v cho
thuc bt n liu, 05 n v cho thuc bt a liu)
nh lng sinh vt

7. ng u hm lng (PL 11.2) 7. ng u hm lng (PL 11.2)

Thuc bt khng dng pha tim:
Tr khi c ch dn khc, php th ny p dng cho thuc
Ln S.L Kt qu
bt ung, tim c trnh by trong cc n v ng
1 10 Khng t: nu c qu ba n v c hm lng
gi 1 liu, trong c cc dc cht c hm lng di 2
nm ngoi gii hn 85 - 115%, hoc c hoc c
mg hoc di 2% (kl/kl) so vi khi lng thuc hoc c mt hay nhiu n v c hm lng nm ngoi
khi lng thuc bng hay nh hn 40 mg (ng gi trong gii hn 75-125% ca HLTB.

1 liu). Nu 2 -3 n v c gi tr hm lng nm ngoi khong gii hn

Php th ng u hm lng c tin hnh sau php
th nh lng v hm lng dc cht t trong gii hn
qui nh.
15%, th li trn 20 n v khc ly ngu nhin
2 20 t: nu c khng qu 3/30 n v em th c
hm lng nm ngoi gii hn 85 - 115 % v
khng c n v no c hm lng nm
ngoi gii hn 75-125 % ca HLTB.
HLTB: hm lng trung bnh ?

5
 7. ng u hm lng (PL 11.2) V D
Thuc bt pha tim (xem bi thuc tim PL 1.19) Thnh phn 2 cng thc thuc bt Oresol
Ln S.L Kt qu
Khi lng
1 10 Khng t: nu c qu mt n v c hm
Thnh phn ORS- ORS- Citrat
lng nm ngoi gii hn 85 - 115%, hoc c
Hydrocarbonat (B) (C)
hoc c mt hay nhiu n v c hm lng
Natri clorid 3,5 3,5
nm ngoi gii hn 75-125% ca HLTB.
Kali clorid 1,5 1,5
Nu 1 n v c gi tr hm lng nm ngoi khong gii hn
15%, th li trn 20 n v khc ly ngu nhin
Natri citrat 0 2,9
Natri hydrocarbonat 2,5 0
2 20 t: nu c khng qu 1/30 n v em th c
hm lng nm ngoi gii hn 85 - 115 % v
Glucose khan 20,0 20,0
khng c n v no c hm lng nm Tng s khi lng 27,5 g 27,9 g
ngoi gii hn 75-125 % ca HLTB.
HLTB: hm lng trung bnh ?

V D

Thuc bt gi paratamol tr em
Cng thc: Acetaminophen : 325 mg
Thiamine chlohydrate : 10 mg
Chlorpheniramine maleate : 2 mg

Thuc bt si bt HAPACOL 150

Cng thc: Acetaminophen : 150 mg
Chlorpheniramine maleate : 1 mg

Thuc cm Citrina
- Acid citric: 6.0 g
- Natri hydrocarbonate: 7,2 g
- T dc va : 100 g