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QB/T 2966-2014 PDF English (QB 2966-2008: Older version)Search result: QB/T 2966-2014 (QB 2966-2008 Older version)
QB/T2966-2014 (QBT2966-2014): PDF in EnglishQB/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 250mm×4.6mm, 5µm. 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: 20µL; 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 t.......Source: https://www.ChineseStandard.net/PDF.aspx/QBT2966-2014 |