Some standard content:
Tcs 83.180
Classification number: G39
Observation number: 16387-20C5
Light Industry Standard of the People's Republic of China
QB23542005
Qn23541998
Pharmaceutical gelatine
Pharmaceutical gelatine
Published on July 26, 2005
Implementation by National Development and Reform Commission of the People's Republic of China on January 1, 2006
All technical contents of this standard are mandatory. Preface
This standard is a revision of QB2354-1998 (2354-[998]) and is mainly modified as follows: 1. Some technical indicators of gelatin have been adjusted; 2. The water content of the sample itself is not considered during the test; 3. The freezing arc is renamed as the gel strength, and the continuous shooting ratio is changed to the continuous shooting ratio; 4. The determination of three substances, rust, and Staphylococcus aureus is added; 5. The determination of water content, gel temperature, inflammation, sulfur dioxide, water-free substances, inositol, chlorine, heavy gold layer, total number of bacteria, large plate mushrooms and Salmonella enterica is modified; 6. The inspection rules and marking, packaging, transportation and storage are changed. The content of this standard is for reference only. Appendix:
This standard is based on the traditional Chinese medicine light The Federation of Industry proposed that this standard is in: China Chemical Industry Association Listening to the glue branch of the mountain 1. This standard was drafted by the three glue product quality testing center of the light industry (Beijing), Rossello (East) Minglutai Co., Ltd., Jihai Gelatin Co., Ltd., Gulin Da'an Vocational and Technical Co., Ltd., Wetland Yihe Shengming School Co., Ltd., Xinjiang Station Pingyang County Yishi Food Additives! , Xinjiang Feiteng Cavity Industry Co., Ltd., Huisu Hai'an County Shenzhu Gelatin Co., Ltd., and the technical standard was issued for the first time in 1998: This is the first revision: This standard has been implemented since its implementation, and the end of the China Light Industry Association issued the Ding standard Q23541998 "Scope of Medicinal Gelatin
Medicinal Gelatin
QR2354-2005
This standard specifies the implementation This standard is applicable to the classification, requirements, test methods, inspection rules and standards of gelatin, including secretion, transportation and storage. This standard applies to gelatin produced from animal parts, such as pigs and pigs as raw materials. 2 Normative referenced documents
The clauses in the listed documents shall become the standard after being cited in this standard. It is a standard for use in a certain period of time. Its accompanying revision (excluding errors) or version is not applicable to this standard. However, the parties who reached an agreement based on this standard will study whether the latest version of these documents can be used. For any referenced documents that are not in accordance with the standard, the latest version shall be used for academic standards. GB/T191 Pictorial marking for packaging, storage and transportation
GB/T5009.15—2003 Determination of chromium in food C/T009.123·2M3 Determination of chromium in food
GB 6783-1994 Liang Tian Liu Glue
Chinese People's Liberation Army General Knowledge 2000 Edition Two Shu is recorded as the "Chinese People's Republic of China Two Shang 2KI Edition One Appendix Vm" Salt Inspection Method of the Chinese People's Children and the Pharmacopoeia 2nd Edition Two Creation Inheritance\"Micro 4 Material Color Control Method 3 Classification
Medicinal non-age, divided into type A and type A acid method, then type A is the thief method non-gel) to change the backlight category, and then 4 each category is divided into 200 and "00 delivery column products. 4 Requirements
4.1 Raw material requirements
4.1.1 The rice should be from non-transferred areas.
4.1.2 The rice should be from the quarantine department for health reasons. 41.3 It should not come from a place that has been treated with harmful substances. 4.1.4 Organic agents such as precious stones should not be used for degreasing. 4.2 Production process requirements
The production process should not have any semi-chemical products. 4.3 Sensory requirements
4.3.1 The product should be yellow or yellow granules, dry, clean, uniform, and free of fire debris. 432 Purchase gelatin solution "2.%" without unpleasant smell. 4.4 Physical and chemical indicators
Should meet the requirements of
QB2354-2005
Water ()
Viscosity (p/Hl)
Quality judgment except 15.67% of the bottle) / 1P:-%
Female "Quantity score
Single chemical m/gkg
Single chemical/kg
EH liquid
No additives to the product
tt/r ?
Equal (/m)
Stretch (s)/:ig/kg）
E remainder (in P: mkg)
Microbiological index
Should sign the provisions of Table 2
Southern product micro (efu/g)
Lin Yi Miao
Will not accumulate
Test method
Property glue
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Indicator requirements
4. 0--6 5
.3~6.5
Indicator safety requirements
Original grain!
Except for ten hearts, large points, only use the test that is confirmed to be the test, and ask or large real water or sweep the standard water. Determination! The reason why the blood flow to the body is not due to the special system is to reduce the blood flow, and the blood score is shown in the wave. Don't worry about the body's health. Please ask for the third
:! Preparation of test solution
R 2352-2035
Take a certain amount of medicinal solution, accurate to 0.1, put it into a clean container, add a certain amount of water, and keep it in a water bath at 65°C for 2h to allow it to fully absorb and swell. Then cover the container with water at 65°C for 15min to dissolve into the solution. Add the tablets and the foam.
5.2 Moisture content
5.2.1 Principle
Calculate the reduction of non-glue content of the tablets by drying them at 1°C. 5.2.2 Apparatus
5.22.1 Aluminum box or stainless steel box: 5.2.2.21 Analytical balance: Control the temperature at (105-2).
5. 2 3 Steps
5.21.1 Place 1 glass bottle in a weighing box (105+2: ... The inclined support is here, heat 2h--4, in the drying = weighing bottle old, take out and place under the 1 device, cool down the working room fence, divide it into your own.
? 33 will be marked to the 40.5 layer of the mountain box, take out the 1 exchanger, flush to the amount, and move on the analytical level. The difference is small 2,
5.2.4 results
Wu factory moisture content of zero products,: the number of small, nuclear type. X, one 8. x100
four general
style ten water content or, some
stable to the quality of the test year, the unit is grams (name: secret test volume after the research, the single type is grams () tea is the meaning of the decision, the single is grams (:
introduction to the source of love after the unit,
5.2.5 density
grams of the conditions of the test results obtained under the conditions of the single test results can not be used in the heart of the 4 road. 5.3 freezing strength
5.3.1 trace
under the conditions of strict reduction, with a diameter of 2.7ur mass scan, pressed into the bite surface of about 6.6% of the good and 4mm below, the blood is the representative source strength, with Blom as the single 5. 3.2 Quick Group
5.32.1 Special force instrument: "LHRA" Xuzhi analyzer is now domestically produced freezing force test: 5.3 2.2+: signal diameter 12.70±0.013>11: 5.3.2.3 Heat dissipation: capacity 150ml.. inner diameter 59mm high Austrian 85tm. 5.3.2.4 Constant current: currency control rate is (10=0.1) 3.2.5 Water bath part: can be warmed (65:):
5.2.3 Analysis steps
5.3.3.1 Starting and retreating: 6.67 times, 120: cooling rate is about 30,, 10=0.1) flow error QB 2354-2005
Cool for 16h-18h:
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5.3.3.2 Take the sample out of the warm water and wipe it, then place it on the test bench. Use the tester to wash with a 4mm thick cloth, and adjust the speed to 0.5mms or mm/s. The test strength should be determined. The sample should be tested within 2min. 5.3.4 Result expression
The test value should be expressed in 1km. The result should be expressed in 1km.
5. 3 5 Precision
The approximate difference between two independent results obtained by repeated measurements should be 10mMmg5.4.4.1 Principle
At 0°C, use a drop pool (6.6% %) 10% flow rate to adjust the cylinder, reheat and adjust the value 5.4.2 Instruments
5.4.2.1 Viscometer: 10% flow rate, standard capillary tube set from the top or bottom: see adjustment 1, the instrument has a flow rate of 10% flow rate, and the temperature is adjusted to (+1) 5.4.2.2 Super thermostat: adjust to 60-01>. 5.4.2.3 Temperature: accurate to 0.1s.
54.2.4: Angle of heat: 250mL
54.25: Adjust to (651).
54.2.6 Temperature: 0.1°C.
Medium is flask
Blaine viscometer
5.4.3 Analysis steps
QB23542005
5.4.3.1 (:=Prepare the bright red drop wave in the flask, 6.67%), change the starting step to 10mL, cool the glue to about 61°C. 5.4.32 Turn on the super thermostat, change the temperature of the water in the vibrometer clamp to (60°C + 0.1°C): 5.4.3.3 Hold the capillary end with the hand stopper to prevent air or bubbles from entering, and quickly pour the glue solution into the meter until it reaches 2cm~.3cm above the upper scale line.
5.4.31 Take the shortness into account in the degree of maturity. When the ratio of the steam gun is set at (6D0.1)C, cut the rubber halfway to the upper mark. 5.4.3.5 Place a stopwatch on the capillary tube when the liquid level reaches the lower mark. Note the time and keep the accuracy to 0.1 5.
54.4 Calculation of results
The clamp length of the sample is expressed in milli-period·second (Pa·s). Calculate using the following formula (2, N=1.005Ar-
The Blaine viscosity of the sample is expressed in milli-second (mP): 1.005
A, B
The relative density of the gelatin solution (%.67) at 400 °C is expressed in ml/liter (ml). The flow time is expressed in seconds;
is a viscosity meter constant, which is measured by calibration. Calculate the viscosity to one decimal place. 5.4.5 Precision
The absolute difference between two independent results obtained under repeatability conditions should not exceed 0.1mPa·3: 5.4.6 Calibration
Perform according to 5.4.6 of G6783-1994
5.5 Viscosity reduction
5.5.1 Principle
Determine the viscosity reduction of pharmaceutical gelatin solution (6.6%) after incubation at {37±[)C for 24h. 5.5.2 Instrument
Moisture meter: Return 5.4.2.1
5.5.2.3
5, 5.2.4
Super gripper: Constant temperature can be adjusted to (60±0.1) it. Stopwatch: hold 15.
Three flasks, 250mL
Water bath: can be set to (651)℃.
5.5. 2. 5
5.5.2.6Steam: sugar to 0.1℃.
5. 5. 2.
Incubator: can be controlled at (37±1)℃. 5.5.3 Analysis steps: Add 120 ml of prepared gelatin (6%) into a flask that has been dried over a long period of time. Seal the flask with cotton wool. 5.5.3.1: 5.5.3.2: Place the flask in an incubator at (37 ± 1°C) for 24 h. 5.5.3.3: Add the incubated gelatin bath solution to the flask. 5.4.3: Determine the viscosity of the sample. 5.5.4: Calculate the viscosity of the sample. The viscosity is reduced by X. The value is expressed in %. Calculate by formula (3): X = -2 ×100
Cheng expansion viscosity decrease: 6:
QB28542005
and-test effect original station diffusion, unit is milli-(mPa-s); H: viscosity of the test solution after 24h, single particle is fear, second (mPa-8). The result of the calculation is expressed to the decimal point: price. 5.5.5 Precision
The initial value of two independent viscosity results obtained under repeated injection conditions should not be less than 1%, 5.6 Transmittance
5. 6.1 Principle
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Standard: 43, the transmittance of the drug drop solution is measured by spectrophotometry: 6.67% under a temperature of 4.50m62.0m. 5. 6.2 Apparatus
UV-capable spectrophotometer.
5.6.3 Analysis steps
5.6.3.1 Prepare the colorimetric instrument (6.67). Warm it to 465.6.3.2 Place the drop into a 10mm colorimetric tube and adjust the wavelength of the luminescence spectrophotometer to 450nm. 5.6.3.445, measure the transmittance.
5.6.3.5 Adjust the wavelength to 620nm and replace it with 5.6.3.4. 56.4 Result expression
The transmittance measured at each wavelength is expressed as %. 5.6.5 Precision room temperature The two independent results obtained under the condition of annual interest are not subject to any time difference, 1, 5.7 Ash content 5.7.1 Principle The ash content of the medicinal substance is called the ash content: The ash content is determined by the burning weight method. 5.7.2 Apparatus 5.7.2.1 Temperature analysis: The temperature is controlled within the range of (600 ± 10). b.7.2 2
5793 minutes. 5.7.2.4 Chai 1-apparatus.
5.7.3 Analysis steps
5.7.3.2 Weigh 1g of the test piece, accurate to 1m: 5.7.3.3 Place the sample on a low heat plate until all organic damage is completely removed: 5.734 and any scale (60010) are removed and kept at a low temperature until the black mass becomes less and the white mass flows out from the bottom.
5.7.3.5 Place the sample in a desiccator and cool to room temperature, then weigh the piece. 53. For the three-fold operation of 5.7.3.4~5.7.3.5, if the difference between the two weighted products is less than 2mg, 5.7.4 boundary calculation code
Let Kishimoto's life, the effective value is expressed as "calculated according to formula (4). x,-m mx1n
The same one-six points of the content, do not
add the quality of the donation and the carbon price, the single should be grams (g): full plate, unit is grams ():
The quality of the single lot is the point ().
The calculation result is expressed to the decimal place.
5. 7. 5 The single pair of independent dimensions under the operating point conditions is not greater than 0.2%58 Sulfur monoxide
5. 8. 1 Source
QH 2354235
Convert the subsulphuric acid salt in the medicinal preparation into a base, open the dripping, and pass the finished product through the channel to realize the micro-content. Tablet.8.2 Reagents
5.8.2.1 Peroxide drop: 3%)
5.8.2.2 Warm Yi-2 body secret fraction 20%) solution (: *1.>5.8.2.3 Alkyl oxide solution (0.1mol/L.
5.8.2.4 Reduce 2molL
Oxidation test pool Figure 2
Unit: B case, C cooling medium, D pipe: F stage
Around 2 carbon dioxide, is it fixed?
5.8.4 Analysis step
541 is introduced into A- for 150a, and is passed into the system, and the flow rate is 0Um/mrQB2354-2005
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5.8.4.2 Add wet blue-acetone to 10mL of hydrogen peroxide solution. Dissolve 0.15 ml of standard alcohol (20%) in standard alcohol (g/1.5:1). Add sodium hydroxide (0.1 IIoI/L) and slowly stir until a blue-purple color appears. Then, drop the mixture in small drops and filter it into a test tube (D). 5.8.4.3 Remove the separatory tube (50 ml) without affecting the properties of the carbon dioxide. Add 25.0 ml of 100 ml of test solution to the flask. 5.B.4.4 Use a separatory tube to add 80 ml of hydrochloric acid to the flask and boil it at 1.5.B.4.5 Open the piston of the separatory tube and Stop the introduction of carbon dioxide and stop the heating and cooling of water. 5.8.4.6 Add a small amount of water to the test tube, transfer the contents of the test tube to a 200mL wide-mouth bottle, and then heat it in a water bath for 15 minutes and cool it.
5.4.7 Add 1g/L of 1mL of hydroxybenzoic acid (volume fraction 20%), and then titrate with hydroxide solution (0.1mol/L). The color of the solution changes from yellow to blue-purple. The volume consumed is as follows. 5.8.4.8 Perform a self-satisfaction test (eliminate the fire). 5.9.6 Calculate the result
Select the real group x of dodecahydrogenation, and express the value in mg/ke, and calculate according to formula (5). =64 060×0.5×( )×3
64 060
Content of sodium dioxide in the test sample, in mg/kg; mass of sodium dioxide (SO4), in grams per kilogram (e/kmol); volume of sodium hydroxide solution consumed, in milliliters (mL); volume of sodium hydroxide solution consumed, in milliliters (ml/L); volume of sample collected, in grams (g),
Calculate the result and take the integer.
5.8.6 Precision
The absolute difference between two independent results obtained under the same conditions should not be greater than 10 mg/kg. 5.9 Peroxide
5 9. 1 Principle
The oxidizing substance is determined by the micro-method using the reducing property of 1. If there is any chemical substance in the test solution, add excess potassium iodide to produce a chemical amount of iodine, and then titrate the precipitated iodine with sodium iodide standard solution. 59.2 Reagents
5.9.2.1 Crystalline acid solution (20%)
5.9.2.2 Potassium iodide solution (20 g/L). 59.2.3 Precipitate solution (10 g/L) bzxz.net
5.9.2.4 Platinum ammonium solution (5 g/L),
5.9.2.5 Sodium thiosulfate standard solution (0.01 mml/L) 5.8.3 Analytical steps
5.9.3.1 Place the whole sample of pharmaceutical gelatin No. 10 in a 250 ml bottle, add 140 ml of water, and stir for 2 hours. Dissolve in 50°C water as quickly as possible, and gently stir to produce bubbles. Cool to a low temperature. Add the following reagents in sequence: 6 mL of molten sulfuric acid (20%), 10 mL of potassium hydroxide solution (20 g/L), 10 mL of starch solution (10 g/L) and 2 mL of ammonium sulfate solution (5 g/L) and shake at the bottom for 1 min. 5.9.3.2 Filter with sodium thiosulfate standard solution (0.01 mol/L) to make sure the solution turns blue. 5.9.3.3 Perform the following test. 59.4 Results The amount of peroxide in the test sample is expressed in grams per gram (m/kg) and is calculated according to formula (6). 34x0.5×10'[V-]c
in the test: The peroxide content in the test sample is expressed in grams per kilogram (m/kg): The molar amount of peroxide ([0, ) is expressed in milliliters (/mo)); The amount of sulfuric acid pseudo-standard solution consumed in the test is expressed in milliliters (mL): The concentration of sulfuric acid pseudo-standard solution is expressed in moles per liter
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