Method for measuring dissolution rate of andrographolide pills
A technology of andrographolide, determination method, applied in the directions of measuring devices, instruments, scientific instruments, etc., to achieve a good linear effect
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Embodiment 1
[0123] 1. Experimental materials
[0124] 1.1 Reagents and reagents
[0125] Andrographolide reference substance: China National Institute for the Control of Pharmaceutical and Biological Products Batch number: 110797-200307
[0126] Andrographolide Pills: Tasly Pharmaceutical Group Co., Ltd.
[0127] (Lot numbers: 120203, 120204, 120205, 120523)
[0128] Methanol: Tianjin Concord Technology Co., Ltd.
[0129] Ultrapure water: self-made by the company
[0130] 1.2 Instruments
[0131] Intelligent Drug Dissolution Apparatus: Tianda Tianfa Company Model: RCZ-8B
[0132] Dissolution sampling collection system: Tianfa Tianfa Company Model: RZQ-8D sampling collection system composition
[0133] High performance liquid chromatograph: American Waters Company Model: Waters 2965-2489
[0134] Column: Waters XBridge TM Shield RP18 (100×4.6mm, 3.5μm)
[0135] S / N: 01273132014001
[0136] 1.3 Chromatographic conditions
[0137] Mobile phase: methanol-water (volume ratio 50:50);...
Embodiment 2
[0143] 1. Experimental materials
[0144] With embodiment 1.
[0145] 1.2 Instruments
[0146] With embodiment 1.
[0147] 1.3 Chromatographic conditions
[0148] Mobile phase: methanol-water (volume ratio 40:60); column temperature: 40°C; flow rate: 0.8ml / min; detection wavelength: 225nm.
[0149] Determination of dissolution rate:
[0150] (1) Preparation of the reference substance solution: an appropriate amount of the reference substance of andrographolide, accurately weighed, add an appropriate amount of methanol to dissolve, quantitatively dilute with 0.5% sodium lauryl sulfate solution to prepare a solution containing about 0.13 mg of andrographolide per 1 ml solution, as a reference substance solution;
[0151] (2) Preparation of the test solution: get 1 bag of andrographolide dripping pills, adopt the slurry method to measure the dissolution rate of andrographolide dripping pills, take 0.5% sodium lauryl sulfate solution 1000ml as the dissolution medium, and the ...
Embodiment 3
[0154] 1. Experimental materials
[0155] With embodiment 1.
[0156] 1.2 Instruments
[0157] With embodiment 1.
[0158] 1.3 Chromatographic conditions
[0159] Mobile phase: methanol-water (volume ratio 60:40); column temperature: 30°C; flow rate: 1.2ml / min; detection wavelength: 225nm.
[0160] Determination of dissolution rate:
[0161] (1) Preparation of reference substance solution: an appropriate amount of andrographolide reference substance, accurately weighed, add an appropriate amount of methanol to dissolve, quantitatively dilute with 1% Brij solution to make a solution containing about 0.17mg of andrographolide per 1ml, as a reference substance solution;
[0162] (2) Preparation of test solution: get 1 bag of andrographolide dripping pills, adopt the slurry method to measure the dissolution rate of andrographolide dropping pills, take 1% Brij solution 1000ml as the dissolution medium, the rotating speed is 50 revolutions per minute, the temperature After 45 ...
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