CNG HO X HI CH NGHA VIT NAM

QCVN 4-23:2011/BYT

QUY CHUN K THUT QUC GIA

V PH GIA THC PHM - CHT TO BT
National technical regulation on Food Additive Foaming agent

H NI - 2011

Li ni u
QCVN 4-23:2011/BYT do Ban son tho quy chun k thut quc gia v Ph gia thc phm v cht h
tr ch bin bin son, Cc An ton v sinh thc phm trnh duyt v c ban hnh theo Thng t s
01/2011/TT-BYT ngy 13 thng 01 nm 2011 ca B trng B Y t.

QUY CHUN K THUT QUC GIA

V PH GIA THC PHM - CHT TO BT
National technical regulation on Food Additive Foaming agent
I. QUY NH CHUNG
1. Phm vi iu chnh
Quy chun k thut quc gia (sau y gi tt l Quy chun) ny quy nh cc yu cu k thut v qun l
v cht lng, v sinh an ton i vi cc cht to bt c s dng vi mc ch lm ph gia thc
phm.
2. i tng p dng
Quy chun ny p dng i vi:
2.1. T chc, c nhn nhp khu, xut khu, sn xut, bun bn v s dng cc cht to bt lm ph gia thc
phm (sau y gi tt l t chc, c nhn).
2.2. C quan qun l nh nc c lin quan.
3. Gii thch t ng v ch vit tt:
3.1. Cht to bt: l ph gia thc phm c cho vo thc phm nhm to ra hoc duy tr s phn tn
ng nht ca pha kh trong thc phm dng lng hoc dng rn.
3.2. JECFA monograph 1 - Vol. 4 (JECFA monographs 1 - Combined compendium of food additive
specifications; Joint FAO/WHO expert committee on food additives; Volume 4 - Analytical methods, test
procedures and laboratory solutions used by and referenced in the food additive specifications; FAO,
2006): Cc yu cu k thut i vi ph gia thc phm, Tp 4 Cc phng php phn tch, quy trnh th
nghim, dung dch th nghim c s dng (hoc tham chiu) trong yu cu k thut i vi ph gia
thc phm; JECFA bin son; FAO ban hnh nm 2006.
3.3. M s C.A.S (Chemical Abstracts Service): M s ng k ha cht ca Hip hi Ha cht Hoa K.
3.4. TS (test solution): Dung dch thuc th.
3.5. ADI (Acceptable daily intake): Lng n vo hng ngy chp nhn c.
3.6. INS (International numbering system): H thng m s quc t v ph gia thc phm.
II. YU CU K THUT, PHNG PHP TH V LY MU
1. Yu cu k thut v phng php th i vi cht chit xut t Quillaia s dng lm cht to bt c
quy nh ti ph lc ban hnh km theo Quy chun ny.
2. Cc yu cu k thut quy nh trong Quy chun ny c th theo JECFA monograph 1 - Vol. 4, ngoi
tr mt s php th ring c m t trong ph lc. Cc phng php th c hng dn trong Quy
chun ny khng bt buc phi p dng, c th s dng cc phng php th khc tng ng.
3. Ly mu theo hng dn ti Thng t 16/2009/TT-BKHCN ngy 02 thng 6 nm 2009 ca B Khoa
hc v Cng ngh v hng dn kim tra nh nc v cht lng hng ha lu thng trn th trng v
cc quy nh khc ca php lut c lin quan.
III. YU CU QUN L
1. Cng b hp quy
1.1. Cht to bt phi c cng b ph hp vi cc quy nh ti Quy chun ny.

1.2. Phng thc, trnh t, th tc cng b hp quy c thc hin theo Quy nh v chng nhn hp
chun, chng nhn hp quy v cng b hp chun, cng b hp quy ban hnh km theo Quyt nh s
24/2007/Q-BKHCN ngy 28 thng 9 nm 2007 ca B trng B Khoa hc v Cng ngh v cc quy
nh ca php lut.
2. Kim tra i vi cht to bt
Vic kim tra cht lng, v sinh an ton i vi cht to bt phi thc hin theo cc quy nh ca php
lut.
IV. TRCH NHIM CA T CHC, C NHN
1. T chc, c nhn phi cng b hp quy ph hp vi cc quy nh k thut ti Quy chun ny,
ng k bn cng b hp quy ti Cc An ton v sinh thc phm v bo m cht lng, v sinh an
ton theo ng ni dung cng b.
2. T chc, c nhn ch c nhp khu, xut khu, sn xut, bun bn v s dng cht to bt sau khi hon tt
ng k bn cng b hp quy v bo m cht lng, v sinh an ton, ghi nhn ph hp vi cc quy nh ca
php lut.
V. T CHC THC HIN
1. Giao Cc An ton v sinh thc phm ch tr, phi hp vi cc c quan chc nng c lin quan hng
dn trin khai v t chc vic thc hin Quy chun ny.
2. Cn c vo yu cu qun l, Cc An ton v sinh thc phm c trch nhim kin ngh B Y t sa i,
b sung Quy chun ny.
3. Trng hp hng dn ca quc t v phng php th v cc quy nh ca php lut vin dn trong
Quy chun ny c sa i, b sung hoc thay th th p dng theo vn bn mi.

PH LC
YU CU K THUT V PHNG PHP TH I VI CHT CHIT XUT T QUILLAIA (DNG 1)
1. Tn khc, ch s

Quillaja extract, Soapbark extract, Quillay bark extract, Bois de

Panama, Panama bark extract, Quillai extract.
ADI : 0 - 1mg/kg th trng (tnh cho c dng 1 v 2)
INS 999i

2. nh ngha

Cht chit xut t quillaia (dng 1) thu c t qu trnh chit vi

nc v hoc g ca thn v cnh Quillaja saponaria Molina (h
Rosaceae). Ch phm cha saponin triterpenoid trong ch
yu l glycosid ca acid quillaic. Polyphenol v tanin l nhng
thnh phn chnh, ngoi ra cn c mt vi loi ng v calci
oxalat.
Ch phm chit xut t quillaia (dng 1) thng mi dng lng
hoc bt sy phun c cht mang nh lactose, maltitol hoc
maltodextrin. Sn phm dng lng thng c bo qun bng
natri benzoat hoc ethanol.

Tn ha hc

Saponin triterpenoid (quillaia saponin), glycosid ca acid quillaic

M s C.A.S.

68990-67-0

Khi lng phn t

Cc saponin dng monomer c khi lng phn t khong 1.800

2.300, ph hp vi mt triterpen gm 8 10 monosaccharid.

3. Cm quan

Dng lng mu nu hoc dng bt mu nu sng c nh hng

4. Chc nng

Cht nh ho, cht to bt

5. Yu cu k thut

5.1. nh tnh
tan

Tan tt trong nc ; khng tan trong ethanol, aceton, methanol

v butanol.

To bt

Phi c phn ng to bt c trng.

Sc k

Thi gian lu ca pic chnh ca mu tng ng vi pic saponin

chnh (QS-18) ca chun (m t trong phn Phng php th)

Mu sc v c

Phi c mu sc v c c trng.

5.2. tinh khit

Nc

Dng bt : Khng c qu 6% (theo phng php Karl Fischer)

Gim khi lng khi sy kh

Dng lng : 50 80% (sy 2 g mu nhit 1050C trong 5 gi)

pH

3,7 5,5 ( i vi nng dung dch 4%)

Tro

Khng c qu 14% theo ch phm kh (dng 1 g mu i vi

dng bt; i vi mu dng lng s dng phn cn li sau khi
sy kh)

Tanin

Khng c qu 8% theo ch phm kh (m t trong phn

Phng php th)

Ch

Khng c qu 2,0 mg/kg.

5.3. Hm lng

Hm lng saponin : khng c thp hn 20% v khng c

qu 26% tnh theo ch phm kh.

6. Phng php th
6.1. nh tnh
To bt

Ho tan 0,5 g mu dng bt trong 9,5 g nc hoc 1 ml mu

dng lng trong 9 ml nc. Cho 1 ml hn hp v 350 ml nc
vo trong ng ong loi 1.000 ml. Bt kn ng ong v lc mnh
30 ln, yn. Ghi li mc bt (ml) sau 30 pht. Bnh thng
mc bt t khong 150 ml bt.

Mu sc v c

i vi dng bt : Ho tan 0,5 g mu trong 9,5 g nc. Dung dch

khng c. hp th ca dung dch so vi nc bc sng
520 nm phi nh hn 1,2.

6.2. tinh khit

Tanin

Cn 3,0 g mu dng bt hoc lng mu dng lng tng

ng tnh theo lng ch phm kh sau khi sy. Ho tan mu
trong 250 ml nc. iu chnh pH = 3,5 bng acid acetic. Sy 25
ml dung dch thu c nhit 1050C trong thi gian 5 gi v
xc nh khi lng cht kh theo n v g (Wi). Trn 50 ml dung
dch trn vi 360 mg polyvinyl polypyrrolidon, sau khuy trong
30 pht nhit phng; li tm vi tc 8.000 vng/pht. Ly
phn dung dch trong pha trn, sy nhit 1050C, thi gian
5 gi. Cn phn cht kh thu c (Wf, n v tnh g). Hm
lng tanin (%) trong mu c tnh nh sau :
% Tanin (theo ch phm kh) = 100 x (Wi - Wf/2)/Wi

Ch

- Th theo JECFA monograph 1 - Vol.4.

- Xc nh bng k thut quang ph hp th nguyn t thch
hp cho hm lng quy nh. La chn c mu th v phng
php chun b mu da trn nguyn tc ca phng php m t
trong JECFA monograph 1 - Vol.4 phn cc phng php phn
tch cng c.

6.3. nh lng
Nguyn tc:
Saponin QS-7,QS-17, QS-18 v QS-21 c tch bng HPLC
pha o, kt qu nh lng c xem l tng hm lng
saponin c trong cht chit xut t Quillaia (dng 1)
Chun b mu:
i vi mu dng bt: Cn 0,5 g mu v ho tan trong 9,5 g
nc. Lc qua b lc c 0,2 m.
Dch chit nc (khong 550 mg cht kh/ml): Cn 1 g mu v
pha vi 9 g nc. Lc qua b lc c 0,2 m.
Trong c hai trng hp trn, th tch mu khong 10 ml.
Chun b mu chun:
Cn 1,5 g saponin tinh sch (ca cc hng SuperSap, Natural
Response, Chil; Quil-A, Superfos, an Mch hoc tng
ng, bit hm lng saponin), ho tan trong 100 ml nc.
Lc qua b lc c 0,2 m.
iu kin HPLC :
- Ct : Vydac 214TP54 ( di 4,6 x 250 mm, l 5 m) hoc loi
tng ng
- Nhit ct : nhit phng
- Bm : t ch gradient
- Dung mi A : 0,15% TFA (acid trifloroacetic) trong nc dng
cho HPLC
- Dung mi B : 0,15% TFA (acid trifloroacetic) trong acetonitril
dng cho HPLC
- Gradient :
Thi gian (pht)

% Dung mi A

% Dung mi B

70

30

40

55

45

45

70

30

- Tc dng : 1 ml/pht
- Bc sng pht hin : 220 nm
- Th tch bm mu : 20 l
Tnh kt qu: Nng saponin (mg/ml) trong dung dch c
chun b nh trn l :
Cmu = (Amu/Achun)Cchun
Trong :
- Cmu : Nng saponin (mg/ml) trong mu th
- Cchun: Nng saponin chun (mg/ml) c bm vo (v d :
Cchun = 13,5 mg/ml nu hm lng saponin ca 1,5 g mu chun
l 90%)
- Amu v Achun : Tng din tch cc pic tng ng vi 4 loi
saponin chnh (QS-7,QS-17, QS-18, QS-21) c trong mu cn
phn tch v mu chun. (Tanin v polyphenol c tch gii

trc saponin. Cc pic ca saponin xut hin sau pic chnh ca

polyphenol xem hnh ph lc).
% Saponin c trong mu th c tnh nh sau :
% Saponin = 100 x Cmu/(0,1 Wmu)
Trong :
- Wmu : Khi lng mu (mg) c ly chun b mu v 0,1 l
nghch o ca th tch mu (10 ml).
Sc k ca cht chun (15 mg cht kh/ml tng ng vi 13,5 mg saponin/ml)

Sc k ca cht chit xut t Quillaia (dng 1) (55 mg cht kh/ml)