QB/T 2966-2014 English PDF (QBT2966-2014)

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QB/T 2966-2014: Functional toothpastes
QB/T 2966-2014
LIGHT INDUSTRY STANDARD OF
THE PEOPLE’S REPUBLIC OF CHINA
ICS 71.100.40
Classification No. Y43
Record No. 46807-2014
Replacing QB 2966-2008
Functional toothpastes
功效型牙膏
ISSUED ON: JULY 09, 2014
IMPLEMENTED ON: NOVEMBER 01, 2014
Issued by: Ministry of Industry and Information Technology of the
People's Republic of China
Table of Contents
Foreword ... 3 
1 Scope ... 4 
2 Normative references ... 4 
3 Terms and definitions ... 5 
4 Requirements ... 5 
5 Test methods ... 6 
6 Testing rules ... 8 
7 Marks ... 8 
Annex A (informative) Determination of fluorine content ... 9 
Annex B (informative) Determination of paeonol content ... 10 
Annex C (informative) Determination of potassium content ... 12 
Annex D (informative) Determination of strontium content ... 15 
Annex E (informative) Determination of saponins in Panax notoginseng (Tianqi)
... 16 
Annex F (informative) Chromatographic identification of thin layer of
ginsenoside and panax notoginseng saponins ... 19 
Annex G (informative) Determination of active componet of grass coral ... 22 
Functional toothpastes
1 Scope
This Standard specifies the terms and definitions, requirements, test methods,
inspection rules and marks of functional toothpastes.
This Standard is applicable to the toothpaste products in which by adding
functional ingredients to toothpaste, the toothpaste has the functions of auxiliary
prevention, alleviation of oral problems or a certain improvement of the dental
condition, and promotes its efficacy, marks its effect on the packaging.
Toothpastes that implement this Standard shall first meet the requirements of
GB 8372.
2 Normative references
The following referenced documents are indispensable for the application of
this document. For dated references, only the edition cited applies. For undated
references, the latest edition of the referenced document (including any
amendments) applies.
GB/T 601, Chemical Reagent - Preparations of Standard Volumetric
Solutions
GB/T 603, Chemical reagent - Preparations of reagent solutions for use in
test methods
GB/T 6682, Water for analytical laboratory use - Specification and test
methods
GB 6819, Dissolved acetylene
GB 8372, Toothpaste
GB/T 15337, General rules for atomic absorption spectrometric analysis
GB 22115, General requirements on raw materials of toothpastes
QB/T 2968, Determination of strontium chloride in toothpastes
WS/T 326, Efficacy evaluation of toothpaste
Order of the General Administration of Quality Supervision, Inspection and
Quarantine [2005] No. 75, Measures for Measurement Supervision and
Administration of Quantitative Packaging Commodities
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1 functional toothpastes
The toothpaste that by adding functional components, in addition to the basic
function of toothpaste, it can also help prevent or reduce certain oral problems
and promote oral health. Its basic functions include: cleaning the mouth,
reducing dental stains, reducing soft dirt, whitening teeth, reducing plaque,
refreshing breath, refreshing taste, maintaining the health of teeth and
periodontal tissues (including gums), and protecting oral health.
3.2 functional components
Ingredients that help functional toothpaste achieve one or more functions in
addition to its basic functions. The efficacy of the functional toothpaste mainly
includes: preventing caries, inhibiting plaque, anti-dentin sensitivity, reducing
gum-related problems, removing stains and whitening, anti-calculus, reducing
bad breath, and other functions that have been verified to improve the efficacy
of oral problems.
4 Requirements
4.1 Raw material
The raw materials used in the production of functional toothpaste shall meet the
requirements of GB 22115.
4.2 Hygiene indicators
The hygiene indicators shall be in accordance with GB 8372.
4.3 Sensory, physical and chemical indicators
Sensory, physical and chemical indicators are in accordance with GB 8372.
4.4 Efficacy evaluation and safety requirements
a) The efficacy evaluation study shall be conducted on the basis of the safety
evaluation of the functional components;
b) The efficacy involved in WS/T 326 is performed according to the
evaluation method of WS/T 326;
c) Toothpaste products that claim to have same efficacy, use the same
functional components, and have an added amount not less than the
proved, do not need efficacy evaluation;
d) For the efficacy evaluation report (including clinical evaluation report and
laboratory evaluation report), at least one shall be issued by the institution
that meets one of the following qualifications:
1) Grade III Class A oral medical institutions (including the School of
Stomatology, Stomatological Specialty Hospitals and General Hospital
Stomatological Departments) with the qualification of "Pharmaceutical
Clinical Trial Institute" of the State Food and Drug Administration
(SFDA). If it is a stomatology department of a general hospital, it must
have had the stomatology qualification certificate of "Drug Clinical Trial
Agency";
2) School of stomatology / specialized hospital, awarded by the Ministry
of Health as a key clinical specialty (stomatology);
3) Provincial stomatological hospital (the project leader must have passed
the national drug clinical trial technical training and passed the
assessment, and obtained the GCP certificate).
e) The laboratory evaluation report can also be issued by a national or
provincial third-party laboratory organization whose qualification is
qualified.
5.4 Safety
In order to ensure the safety of the product, the components added in the
functional toothpaste shall meet the requirements of GB 22115.
5.5 Qualitative or quantitative determination of functional components
The enterprise tests the functional components according to the measurement
method (recommended but not limited to) described in the annex of this
Standard. It can also issue a report after being detected by a domestic third-
party testing agency. If there are other functional components and their
determination methods, they shall be supplemented and perfected in the
in accordance with WS/T 326. There is currently no prescribed method for efficacy evaluation, which
shall be conducted in accordance with the principles prescribed in this Standard.
Annex B
(informative)
Determination of paeonol content
B.1 Instrument
High performance liquid chromatography.
B.2 Reagents
B.2.1 Paeonol reference substance (China National Institute for the Control of
Pharmaceutical and Biological Products).
B.2.2 Methanol: chromatographically pure.
B.3 Preparation of reference substance solution
Weigh 0.01g of paeonol reference substance (to the nearest of 0.0001g) in a
volumetric flask. Add methanol to dissolve and make 0.032mg/mL paeonol
solution.
B.4 Preparation of sample solution
Weigh 0.2g of sample (to the nearest of 0.0001g) in a stoppered test tube.
Accurately add 10mLof methanol. Use a glass rod to stir the toothpaste sample.
Conduct ultrasonic extraction 30min. Place still. Pour the supernatant into a
centrifuge tube. Centrifuge at 2000r/min for 5min. Use a 0.45µm filterable
membrane to filter and the solution shall be obtained.
B.5 Determination
B.5.1 Chromatographic conditions
Chromatographic column: C18 ...