Some standard content:
National Standard of the People's Republic of China
Polyvinyl chloride (PVC) sheet for packing solid medicine
678.743.22
GB5663--86
This standard applies to transparent medical polyvinyl chloride sheets made of sanitary polyvinyl chloride resin as the main raw material, through plastic refining and calendering. It is used as a material for blister packaging of solid medicines (tablets, capsules, etc.). Specifications and dimensions
The specifications and dimensions of medical polyvinyl chloride sheets shall comply with the provisions of Table 1. Table
2 Technical requirements
2.1 Appearance quality
The appearance quality shall comply with the provisions of Table 2.
Cracks, imitation marks
National convex hair cracks
Black spots, white spots and impurities
Strip bubbles
Original color is transparent and uniform
Not allowed
Not allowed
Not allowed
0.25~0.35
Not allowed for more than 1.3mm, no more than 3 pieces per 10cm* for 1.3mm and below. No more than 20 pieces per square meter for medium and light 0.3~0.1m, no more than 0.8mm and above. Not allowed
Not allowed
Not allowed for more than 3mm, no more than 10 pieces per square meter for 3m㎡ and below. No more than 2 pieces per roll, and each section should be 10 m long. 1: Not allowed
Flattened, rolled tightly, neat initial edge, no overcutting allowedNational Bureau of Standards1985-11-30Promulgated
1986-09-01Implementationwww.bzxz.net
2.2 Physical properties
The physical properties shall comply with the provisions of Table 3.
Tensile strength, kgf/cn?
Ball impact damage rate, %
Heating expansion rate, %
Water vapor penetration, g, m2 · 24 h
2.3 Chemical properties
The chemical properties shall comply with the provisions of Table 4.
Vinyl chloride monomer, PPm
Clearance
Fallout test
2.4 Acute toxicity test
Oxidizing agent
GB 5663—85
No spillage
Solution should be clear
The consumption of 0.02M potassium permanganate solution should not exceed 1.0mlHeavy metals (lead, lead)
No detection
Acute toxicity test should comply with the provisions of the plastic container for infusion in the Appendix of Part II of the 1977 edition of the Pharmacopoeia of the People's Republic of China. 3 Test methods
3.1 Appearance inspection
Observe directly at a distance of 60cm.
8.2 Tensile strength test
Perform in accordance with GB1040—79 "Plastic Tensile Test Method". 3.$ Drop ball impact damage test
8.$.1 Drop ball impact test machine: span is 100mm. 3.a.2 Sample: Take 10 test pieces with a width of 50mm and a length of 150mm. 3.3.3 Operation: Fasten the test piece to the test machine, keep the span at 100mm and the height at 600mm. Then start the instrument to let the steel ball (diameter 74~81cm, about 50g) fall freely in the middle of the span, and check the damage rate in the test. 8.4 Heating expansion rate test
GB5663--85
3.4.1 Equipment: The heating test uses an aging test box or an oven with a temperature control accuracy of ±1℃. The length measurement uses a vernier caliper with an accuracy of 0.02mml.
3.4.2 Sample: Cut two square test pieces from the hard sheet (as shown in Figure 1), each with a width of 120m㎡. Find the center and draw two lines AB and CD at 90° perpendicular to each other with a spacing of 100mm. 2++
3.4.3 Operation: Place the test piece flat on the glass plate and place it in a test box at 100±1C for 10 minutes. Take it out and cool it to room temperature, then accurately measure the length of each AB and CD line segment. 3.4.4 Calculation: First find the average of the two pieces AB and CD, and calculate the longitudinal and transverse expansion and contraction rates according to formula (1). S (%)
-Expansion rate,
L1-Distance between the marks before heating, mm; L2-Distance between the marks after heating, mm. 3.5 Water vapor permeability
Take a glass vessel with an inner diameter of 40mm and a height of 25mtm, and put an appropriate amount of phosphorus pentoxide in the vessel. Cut the test piece into pieces with a diameter of 50mm, cover it on dish F, seal it with a molten mixture of paraffin and rosin (6:4) (as shown in Figure 2), weigh it accurately, put it in a desiccator filled with water, keep it at a temperature of 25±2℃ for 24h, take it out, wipe off the water vapor outside, put it to room temperature, weigh it accurately, calculate its water vapor permeability, use a glass disc instead of the test piece as a blank control, and calculate it according to formula (2). Water vapor permeability (g/m2)
Where: A-——weight increase of the glass vessel after the test piece test, g; B
weight increase of the glass dish after the test piece test, radius of the glass vessel (inner diameter), II
pi.
3.6 Test of chloroethylene monomer (VCM) content GB5663-85
Ink hard sheet
Five-year phosphorus
According to GB 4615-81 "Determination of residual vinyl chloride monomer content in polyvinyl chloride resin". 3.7 Dissolution test
Preparation of test solution: take a test piece with a total surface area of 500cm, wash it with appropriate amount of water, cut it into small pieces, put it in a 500ml saline bottle, add 250ml of water, seal it, put it in a high-pressure steam sterilizer, heat it at 109℃ for 30min, take it out, cool it to room temperature, and use the same batch of water as a blank control. a. Density: take 50ml of the above test solution, put it in a Nessler colorimetric tube, observe it with the naked eye, and the solution should be clear. b Oxidizable substances: Take 20 ml of the above test solution, add 3 ml of 0.02 M potassium permanganate solution and 5 ml of dilute sulfuric acid, heat and boil for 10 min, cool, then add 5 ml of 0.05 M oxalic acid solution, heat to 75-80 °C in a water bath, titrate with 0.02 M potassium permanganate solution until the solution turns micro red, and continue for 15 s. The end point is that the color does not fade, and the control solution is used for blank correction. The difference between the consumption of 0.02 M potassium permanganate solution and the consumption of the two shall not exceed 1.0 ml.
c. Heavy metals (lead, potash): Take 40ml of the above test solution, put it into a Nessler colorimetric tube, add 2m! pH3.5 acetic acid buffer (take 25ml of ammonium acetate, add 25ml of water to dissolve, add 38.0ml of 7M hydrochloric acid, shake, adjust pH to 3.5 with 2M hydrochloric acid or 5M ammonia water, dilute to 100ml with water) and 1.2ml thioacetyl ammonium test solution (take 15ml of 1M sodium hydroxide solution, add 5ml of water and 20ml of malic acid, stir, take 1ml of this mixed solution, add 4% thioacetyl ammonium solution, 2ml, heat on a water bath to 205, let cool, this solution should be freshly prepared before use), shake well, let it stand for 2 minutes, no color should be shown (if it shows light yellow, it contains lead, if it shows light brown, it contains lead). 3.8 Lock
Take 2§ of test piece, put it in a snail, and slowly burn it until it carbonizes. Cool, add 1M hydrochloric acid to dissolve, evaporate to dryness, and ignite at 800℃ to completely ash. Cool, dissolve the residue with 10ml 1M hydrochloric acid, filter, add 1ml dilute sulfuric acid to the solution, shake, and no turbidity should occur. 3.9 Acute toxicity test
Wash the test piece with water, then cut it into pieces, add 50ml of pyrogen-free saline per 500cm2 of surface area, put it in a high-pressure sterilizer, sterilize it at 110℃ for 30min, take it out, cool it for use. At the same time, sterilize it with a batch of saline as a blank control solution. Select 17-20g healthy mice from the same source, 5 mice as a group, and inject 1ml of the above test solution into the tail vein of each mouse at a speed of 4-5 seconds. No abnormal reaction to the control substance should be observed at the time of injection, and no death should occur within 48 hours. If the reaction of one mouse is greater than that of the control substance, another 10 healthy mice should be selected as a group and the test should be repeated. No reaction should be significantly greater than that of the control group. Inspection rules
4.1 The quality inspection department of the manufacturer of medicinal polyvinyl chloride hard sheets shall also inspect according to this standard, and they can only leave the factory after passing the inspection. .2 Medicinal polyvinyl fluoride hard sheets must be inspected in batches, with the same formula, the same process and the same specifications as a batch, and the quantity of each batch shall not exceed 20t.
4.3 Dimensions, tolerances and appearance shall be inspected roll by roll. 4. Acceptance of physical and chemical properties: Samples shall be taken from at least one roll for each batch for inspection. The samples shall be cut 1m away from the outer end of the hard sheet. The cut hard sheet shall be a 1m long roll, marked with specifications, batch number, shift, production date and sampling time. 4.5 The inspection results shall be handled in accordance with the following provisions. 196
GB-5663—85
4.5.1 Tolerance and appearance, if any one of them is unqualified, the roll shall be a defective product. 4.5.2 If any item of the physical properties is unqualified, the original batch should be doubled for re-sampling. If it is still unqualified, the whole batch shall not be used as a pharmaceutical packaging material.
4.5.3 If any item of the chemical properties is unqualified, the whole batch shall not be used as a pharmaceutical packaging material. .6 The acute toxicity test shall be analyzed once when the first batch is put into production and when the raw materials, formula and process are changed. It can be put into production only after it is qualified. 5 Packaging, marking, transportation and storage
5.1 Medicinal polyvinyl chloride hard sheets should be quantitatively packaged, the rolls should be sealed with adhesive tape, and each roll should be packed with 2 polyethylene plastic film bags with a certificate of conformity inside, and then packed into cartons and tied with packing tape. 5.2 Each box should have a product certificate of conformity, and the manufacturer's name, product name, specification, model, roll number, batch number, weight, inspector code and production date should be stated.
5.3 During the storage period, medicinal polyvinyl chloride hard sheets should be kept in a dry, ventilated and cool place. 5.4 When transporting medical polyvinyl chloride rigid sheets, they should be loaded and unloaded gently, and should not be exposed to the sun or rain, and the packaging should be kept intact. Additional remarks:
This standard was proposed by the State Drug Administration of the People's Republic of China. This standard was drafted by Shanghai Pharmaceutical Industry Research Institute, Zhejiang Provincial Drug Inspection Institute, and Hangzhou Plastics. The main drafters of this standard were Zhu Jinping, Fu Banpei, and Wang Hanbin. 197
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