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

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

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QB/T 2966-2014: Functional toothpastes

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.
QB/T 2966-2014
LIGHT INDUSTRY STANDARD OF
THE PEOPLE REPUBLIC OF CHINA
ICS 71.100.40
Classification No. Y43
Record No. 46807-2014
Replacing QB 2966-2008
Functional toothpastes
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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 0.45??m filterable membrane to filter and the solution shall be obtained.
B.5 Determination
B.5.1 Chromatographic conditions
Chromatographic column: C18 250mm??4.6mm, 5??m.
Mobile phase: methanol + water (73+27).
Flow rate: 1mL/min.
Detector: UV detector with a wavelength of 274nm.
Column temperature: 40??C.
B.5.2 Reference substance solution
Annex C
(informative)
Determination of potassium content
C.1 Reagents
a) Hydrofluoric acid;
b) Hydrochloric acid
c) Nitric acid;
d) Nitric acid solution: (1+1);
e) Nitric acid: 1%;
f) Hydrogen peroxide: 30%;
g) Dissolved acetylene: meet requirements of GB 6819-2004;
h) Potassium standard stock solution: Accurately weigh 1.9068g of
potassium chloride that has been burnt at 500??C~600??C to constant
weight. Dissolve in water. Dilute to 1000mL. Potassium concentration is 1000mg/L. When it is used, dilute it to 100mg/L potassium standard stock solution.
C.2 Instruments
a) Atomic absorption spectrophotometer: wavelength is 769.9nm;
b) Potassium hollow cathode lamp;
c) Electronic balance: resolution is 0.0001g.
C.3 Preparation of sample solution
Randomly take 1 sample toothpaste. Discard about 20mm paste of head.
Weigh 0.25g of toothpaste sample (to the nearest of 0.0001g) in a 50mL beaker. Add 1.5mL of hydrochloric acid. Add 4.5mL of (1+1) nitric acid to dissolve. Add 5 drops of 30% hydrogen peroxide. Heat to slightly boiling. If red-brown gas appears during the digestion process, continue to add a small amount of dilute nitric acid for digestion. Heat till it is nearly dried. Then use 1% nitric acid solution to set volume into a 50mL volumetric flask. Shake well for testing. At the same time, conduct blank test.
Annex E
(informative)
Determination of saponins in Panax notoginseng (Tianqi)
E.1 Instruments
a) High performance liquid chromatograph: equipped with ultraviolet detector; b) Micro-sampler: 20??L;
c) Ultrasonic cleaning machine;
d) Electronic balance: resolution is 0.0001g.
E.2 Reagents
a) Ginsenoside Rg1 reference substance (China National Institute for the Control of Pharmaceutical and Biological Products);
b) Ginsenoside Rb1 reference substance (China National Institute for the Control of Pharmaceutical and Biological Products);
c) Notoginsenoside R1 reference substance (China National Institute for the Control of Pharmaceutical and Biological Products);
e) Methanol: chromatographically pure; [Translator: d) is missing in original text]
f) Acetonitrile: chromatographically pure.
E.3 Preparation of reference substance solution
Respectively weigh the right amount of ginsenoside Rg1, ginsenoside Rb1 and notoginsenoside R1 reference substances (to the nearest of 0.0001g). Add methanol to make a mixed solution containing 0.1mg of each reference
substance per 1mL as the reference substance solution.
E.4 Preparation of sample solution
Randomly take a sample toothpaste. Discard 20mm~30mm paste of head.
Weigh 4.5g of toothpaste sample (to the nearest of 0.0001g) in a 150mL beaker. Add 10mL of water. Slightly heat and use a glass rod to stir, making it completely dissolve. Add methanol solution to 100mL. Weigh the mass. Conduct ultrasonic extraction 30min. Take it out. Place still till it is cool. Then weigh the mass again. Use methanol to make up for the lost mass. Shake well. Filter. Take the filtrate F.3.7 Chloroform.
F.3.7 Ethyl sulfate solution (1???10). [Translator note: F.3.7 is repeated in original text]
F.3.8 Ginsenoside Rg1 standard product (China National Institute for the Control of Pharmaceutical and Biological Products).
F.3.9 Notoginsenoside R1 standard product (China National Institute for the Control of Pharmaceutical and Biological Products).
F.4 Sample preparation and determination
F.4.1 Preparation of tested sample solution
Weigh 25g of toothpaste in a 100mL Erlenmeyer flask. Add 60mL of 95%
ethanol. Stir well. Conduct ultrasound 30min. Perform supernatant filtration. Respectively use 30mL, 20mLof 95% ethanol to wash the filter residue.
Combine the filtrate in an evaporating dish. Concentrate to thick material on a 90??C water bath. Add 30mL of water to dissolve the thick material and transfer to a separatory funnel. Use petroleum ether (boiling range is 60??C~90??C) to extract 3 times, 20mL for each time. Discard the petroleum ether layer. Use water-saturated n-butanol to extract the aqueous layer for 3 times. The amount of water-saturated n-butanol is 50mL, 25mL, 25mL, respectively. Discard the aqueous layer. The n-butanol layer is placed in an evaporating dish and evaporated to dryness on a 90??C water bath. Add 8mL of water to dissolve the residue (can be heated at 30??C to promote dissolution). Neutral alumina column is on aqueous solution (inner diameter is 17mm, length is 50mm). Use 100mL of NaOH solution (that is, 0.1mol/L???20) of which the pH is 10~10.5. 500mL of pure water, 50mL of 30% ethanol to elute in turn. Collect 30% ethanol eluent and place in evaporating dish. Evaporate on the 90??C water bath. Add 1mL of methanol to dissolve the residue as the tested product solution.
F.4.2 Preparation of standard solution
Take ginsenoside Rg1 reference substance, notoginsenoside R1 reference
substance. Respectively add methanol to make the solution that each 1mL contains 0.5mg, as the reference substance solution.
F.4.3 Determination
Test according to "Chinese Pharmacopoeia" (Edition 2005) (Annex VI B) "Thin Layer Chromatography". Respectively pipette 10??L of above three solutions. Respectively drop on the same silicone G thin layer board. Use chloroform- methanol-water (7: 3: 0.5) as the developing agent. Unfold, take out and dry. Spray with sulfuric acid and ethanol solution (1???10). Heat at 105??C until the spots are clear. In the chromatogram of the test product, the spots of the same Annex G
(informative)
Determination of active component of grass coral
G.1 Reagents
a) Methanol;
b) Chloroform;
c) Standard isopyridine stock solution: Take 0.008g of isopyridine reference substance (to the nearest of 0.0001g). Add methanol to dissolve and
prepare a standard solution containing 4??g per 1mL.
G.2 Instruments
a) High performance liquid chromatograph: wavelength is 344nm;
b) Ultrasonic cleaning machine;
c) Electronic balance: resolution is 0.0001g.
G.3 Preparation of sample solution
Table about 10g of sample (to the nearest of 0.0001g). Place in a 100mL stopper Erlenmeyer flask. Precisely add 50mL of water. Weigh the mass.
Conduct ultrasonic treatment 30min. Stand overnight. Then conduct ultrasonic treatment 30min (power is 300W, frequency is 25kHa). Take it out. Cool to room temperature. Make up for the mass. Shake well. Filter. Precisely measure 25mL of filtrate. Transfer to the separating funnel. Use chloroform to extract 3 times, 20mL each time. Combine chloroform extracts. Heat to evaporate till dry. Add methanol to dissolve the residue and move into a 25mL volumetric flask. Add methanol to the scale. Shake well for spectrum analysis. At the same time, conduct blank test.
G.4 Determination
G.4.1 Instrument conditions
Chromatographic column: C18250mm??4.6mm, 5??m.
Mobile phase: acetonitrile-0.1% phosphoric acid solution (20:80).
Flow rate: 1 mL/min.

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