LY/T 3152-2019Sapindus mukurossi Saponin (English PDF)

3.1 Saponin

Sapindus saponin, Sapindus mukurossi Saponin, is a group of pentacyclic triterpenoids and different sugar ligands such as arabinose and rhamnose the resulting mixture has the structural formula shown in the figure.

COOH

(p) Ara1Rham (p) Ara2 a aa Ara-arabinosyl Rham-rhamnosyl

3.2 Saponin solution

The liquid Sapindus saponin product obtained by the process of crushing, extracting, filtering, and concentrating the skin of Sapindus.

3.2 Saponin powder

Powdered Sapindus saponin product obtained by smashing, extracting, filtering, concentrating, drying and other processes of Sapindus.

5.1 Sensory requirements

Saponin solution. viscous brown liquid, spicy, irritating to the nasal mucosa.

Saponin powder. light yellow to brown yellow powder, bitter and spicy, irritating to the nasal mucosa.

5.2 Physical and chemical indicators

The physical and chemical indicators of saponin solution should meet the requirements of Table 1.

Table 1 Physicochemical indicators of saponin solution

Item Saponin Saponin Solution Total saponin content >= 160 mg/g Critical micelle concentration/(mg/L) 245-350 Water insoluble matter (dry basis)/(%) <= 1.0 pH value (1% aqueous solution) 4.5-7.0 Solid content/(%) >= 30 the physical and chemical indexes of saponin powder should meet the requirements of Table 2.

Table 2 Physical and Chemical Indexes of Saponin Saponin Powder

Project Saponin Saponin Powder Moisture/(%) <= 8.0 Total saponin content >= 38% (dry basis) Critical micelle concentration/(mg/L) 90-150 Water insoluble matter (dry basis)/(%) <= 1.0 pH value (1% aqueous solution) 4.5-7.0

6.1 Moisture

According to the method specified in GB 5009.3.

6.2 Total saponin content

Follow the method specified in A.2 of Appendix A.

6.3 Critical micelle concentration

According to the method specified in GB/T 11276.

6.4 Water insolubles

Follow the method specified in A.3 of Appendix A.

6.5 PH

According to the method specified in GB/T 6368.

6.6 Solid content

Weigh about 2 g of the uniform test liquid (accurate to 0.001 g) into a constant weight weighing bottle, and place the weighing bottle containing the test liquid in (105 ± 2) ° C oven, dry to constant weight, weigh (accurate to 0.001 g), and calculate.

100 (%)

Solid content

m1--mass of residual solid (g);

m0-mass of test liquid (g).

The second measurement is performed in parallel, and the relative error of the result must not exceed the average value of 2.0%.

7.1 Inspection classification

7.1.1 Factory inspection

The factory inspection items are appearance, total saponin content and pH value.

7.1.2 Type inspection

Sensory requirements, all items listed in Table 1 or Table 2.

In one of the following cases, type inspection should be carried out.

a) When the product is normally produced, it should be carried out at least once every six months;

b) When there are major changes in raw and auxiliary materials and production processes;

c) When production resumes after a long period of suspension;

d) When the quality supervision agency requests the type inspection.

7.2 Decision rules and review rules

7.2.1 It shall be inspected by the quality inspection department of the production plant, and each batch of saponin from the plant should meet the standard requirements.

7.2.2 In the inspection results, if the indicators do not meet the requirements, double sampling shall be conducted for re-inspection and re-inspection. If the retest does not meet the requirements, it is determined that the batch of products is unqualified.

7.2.3 If there is a dispute between the supplier and the purchaser about the inspection results, the two parties can take a total of 3 samples according to the sampling method cited in the standard, and save 1 copy each.

One copy was entrusted to a qualified inspection institution for arbitration analysis.

7.3 Sampling

7.3.1 Batch

a) When the finished product is put into storage, the products produced by the same production line, the same variety, and the same shift are a batch;

b) When the finished product leaves the factory, each loading location is an inspection lot.

7.3.2 Sampling

The sampling plan for each batch is calculated according to (1).

) (12/Nn =

In the formula.

n--the number of samples taken;

N--batch number.

8.1 Product labels and signs

Product labels and signs are implemented in accordance with GB 7718, and the product name is clearly marked, the shelf life is clearly stated, and the text and graphics on the outer packaging the indication shall comply with the GB/T 191 standard.

8.2 Product packaging

Packaging should be tight and strong, moisture-proof and pollution-proof. Products are packed in corrugated paper drums, and food-grade plastic bags are used for lining, or according to customer requirements.

8.3 Transport

The product must be transported lightly, protected from the sun, rain, and away from heat sources. It must not be transported with hazardous, toxic and easily contaminated items.

8.4 Storage

The product should be stored in a dry, ventilated and clean indoor warehouse to avoid moisture. It should not be mixed with toxic and susceptible pollutants. Product warranty Period. two years.

Appendix A

(Normative appendix) Testing method A.1 General provisions the reagents and water used in this standard refer to analytical reagents and third-grade water as specified in GB/T 6682 unless other requirements are specified. test when the solution used in the test is not specified, it refers to an aqueous solution.

A.2 Determination of total saponin content A.2.1 Instruments and equipment A.2.1.1 Spectrophotometer. 1 cm cuvette.

A.2.1.2 Water bath.

A.2.1.3 Analytical balance with a sensitivity of 0.1 mg.

A.2.1.4 25 mL volumetric flask.

A.2.1.5 10 mL test tube with stopper.

A.2.1.6.200 mL graduated cylinder.

A.2.1.7 5 mL pipette.

A.2.2 Reagents

A.2.2.1 absolute ethanol.

A.2.2.2 Vanillin.

A.2.1.3 77% concentrated sulfuric acid.

A.2.1.4 Saponin quality control.

A.2.3 Determination

Mapping of saponin quality control standard curve. Weigh 25 mg of the saponin quality control prepared, and dissolve it in 50% ethanol.

Make up to 25 mL. Take 0.1, 0.2, 0.3, 0.4, 0.5 mL of standard solution, put them in test tubes with stoppers, and add water to the solution volume to 0.5 mL, Accurately add 0.5 mL of 80% vanillin solution, add 4 mL of 77% sulfuric acid solution in an ice water bath, shake well, heat at 60 °C for 15 minutes, and then After cooling in a cold water bath for 10 min, the absorbance was measured at 462 nm and a standard curve was drawn.

Weigh 25 mg of saponin powder test sample or 75 mg of saponin liquid test sample, repeat the above measurement to obtain the absorbance, and calculate Total saponin content.

A.2.4 Calculation

The relationship between the absorbance (X) of saponin quality control standard curve and the saponin concentration (Y) of Sapindii saponin was. Y = aX b, R2 > 0.999.

Calculate the total saponin content in Sapindus indica according to formula (A.1).

) (Saponin total saponin content 1.0 % 1m ) ( NVbaX ..................x-x xx X-sample absorbance;

V-sample volume (mL);

m0--sample mass (mg);

w-moisture content, see 6.1 for the measuring method;

N-dilution factor.

A.2.5 Allowable error the second measurement is performed in parallel, and the relative error of the result must not exceed the average value of 2.0%.

A.3 Determination of water-insoluble matter A.3.1 Instruments and equipment A.3.1.1 Electric heating oven.

A.3.1.2 Analytical balance with a sensitivity of 0.1 mg.

A.3.1.3 100 mL beaker.

A.3.2 Determination

Weigh 6-8 g of the sample into a 100 mL beaker, add 50 mL of distilled water to dissolve it, transfer to a constant weight filter paper for filtration, and filter residue on the filter paper Wash with distilled water until it is colorless, then put it into an oven at (105 ± 2) °C, bake to constant weight, weigh and calculate.

A.3.3 Calculation

Water insoluble content is calculated according to formula (A.2) A.2) 0 %) 1 (0 21 (..................x-x wm mm S-water insoluble content;

m1--mass of filter paper and filter residue after constant weight (g);

m2--mass of filter paper (g);

m0-the mass of the sample (g);

w-moisture content, see 6.1 for the measuring method.

A.3.4 Allowable error the second measurement is performed in parallel, and the relative error of the result must not exceed the average value of 2.0%.