Quality control method of bone rehabilitation medicine

Abstract

The invention discloses a quality control method of a bone rehabilitation medicine. The method is characterized in that a method for detecting the content of acacetin-6-C-beta-D-glucoside in oxalis corniculata and a fingerprint spectrum detection method are additionally provided. The method has the advantages that the high performance liquid chromatography is performed for detecting; the operation is simple and convenient; the reproducibility is high; the product quality can be controlled effectively.

Description

Technical field

[0001] The invention involves the quality control method of osteo drugs and is a technical field of drugs. Background technique

[0002] The varieties chased in the national standard part (orthopedic departments) of the local standards of proprietary Chinese medicines are promoted in 2002.In qualitative identification, the high -efficiency liquid chromatography method is used to quantitatively determine the osteomycopin and alien osteosopasticin in the orsadosis.In order to further effectively control the quality of the product, we have studied and developed a method of determining the content of the grass medicinal materials.Milogy grass is the main medicine flavor in the bone Kang capsule. It has the effects of clearing heat and dampness, cooling blood and swelling, detoxifying and dispersing stasis, which is used for stunning damage.It has always been qualitative identification, and the quantitative measurement cannot be achieved. In order to further effectivel...

Examples

Embodiment 1

[0108] The detection methods in Gukang Capsules are as follows:

[0109] 1. Determination of wood sorrel content

[0110] Chromatographic conditions and system suitability test Use octadecylsilane bonded silica gel as filler; acetonitrile-0.1% phosphoric acid aqueous solution (19:81) as mobile phase; detection wavelength is 330nm. The number of theoretical plates should not be less than 3000 based on Robinin-6-C-β-D-glucoside;

[0111] Preparation of reference substance solution Accurately weigh an appropriate amount of Robinin-6-C-β-D-glucoside reference substance, add methanol to make a solution containing 2μg per 1ml, and get it;

[0112] Preparation of the test solution: Take the contents of the Gukang capsule under the item of difference in volume, mix it, take 1.0g, accurately weigh it, place it in a stoppered conical flask, accurately add 25ml of methanol, weigh it, and ultrasonic treatment 30 Let it cool for a few minutes, then weigh it again, add methanol to make up the lost...

Embodiment 2

[0122] Embodiment 2: This method can also be used in Gukang tablets, and the detection method is as follows:

[0123] 1. Determination of wood sorrel content

[0124] Chromatographic conditions and system suitability test Use octadecylsilane-bonded silica gel as filler; acetonitrile-0.1% phosphoric acid aqueous solution (20:80) as mobile phase; detection wavelength is 330nm. The number of theoretical plates should not be less than 3000 based on Robinin-6-C-β-D-glucoside;

[0125] Preparation of reference substance solution Accurately weigh an appropriate amount of Robinin-6-C-β-D-glucoside reference substance, add methanol to make a solution containing 2μg per 1ml, and get it;

[0126] Preparation of the test solution: Take 20 Gukang tablets, grind and mix them, take 1.0g, accurately weigh, place in a stoppered conical flask, accurately add 25ml of methanol, weigh the solution, ultrasonic treatment for 30 minutes, put Let it cool, weigh it again, add methanol to make up the weight lo...

Embodiment 3

[0136] Example 3: This method can also be used in Gukang granules, and the detection method is as follows:

[0137] 1. Determination of wood sorrel content

[0138] Chromatographic conditions and system suitability test Use octadecylsilane bonded silica gel as filler; acetonitrile-0.1% phosphoric acid aqueous solution (21:79) as mobile phase; detection wavelength is 330nm. The number of theoretical plates should not be less than 3000 based on Robinin-6-C-β-D-glucoside;

[0139] Preparation of reference substance solution Accurately weigh an appropriate amount of Robinin-6-C-β-D-glucoside reference substance, add methanol to make a solution containing 2μg per 1ml, and get it;

[0140] Preparation of the test solution Take the Gukang granules, grind and mix them, take 4.0g, accurately weigh, place in a stoppered Erlenmeyer flask, accurately add 50ml methanol, weigh it, ultrasonically treat for 30 minutes, let cool, Then weigh the weight, add methanol to make up the lost weight, shake w...

Technical field

[0001] The invention involves the quality control method of osteo drugs and is a technical field of drugs. Background technique

[0002] The varieties chased in the national standard part (orthopedic departments) of the local standards of proprietary Chinese medicines are promoted in 2002.In qualitative identification, the high -efficiency liquid chromatography method is used to quantitatively determine the osteomycopin and alien osteosopasticin in the orsadosis.In order to further effectively control the quality of the product, we have studied and developed a method of determining the content of the grass medicinal materials.Milogy grass is the main medicine flavor in the bone Kang capsule. It has the effects of clearing heat and dampness, cooling blood and swelling, detoxifying and dispersing stasis, which is used for stunning damage.It has always been qualitative identification, and the quantitative measurement cannot be achieved. In order to further effectivel...

Examples

Embodiment 1

[0108] The detection methods in Gukang Capsules are as follows:

[0109] 1. Determination of wood sorrel content

[0110] Chromatographic conditions and system suitability test Use octadecylsilane bonded silica gel as filler; acetonitrile-0.1% phosphoric acid aqueous solution (19:81) as mobile phase; detection wavelength is 330nm. The number of theoretical plates should not be less than 3000 based on Robinin-6-C-β-D-glucoside;

[0111] Preparation of reference substance solution Accurately weigh an appropriate amount of Robinin-6-C-β-D-glucoside reference substance, add methanol to make a solution containing 2μg per 1ml, and get it;

[0112] Preparation of the test solution: Take the contents of the Gukang capsule under the item of difference in volume, mix it, take 1.0g, accurately weigh it, place it in a stoppered conical flask, accurately add 25ml of methanol, weigh it, and ultrasonic treatment 30 Let it cool for a few minutes, then weigh it again, add methanol to make up the lost...

Embodiment 2

[0122] Embodiment 2: This method can also be used in Gukang tablets, and the detection method is as follows:

[0123] 1. Determination of wood sorrel content

[0124] Chromatographic conditions and system suitability test Use octadecylsilane-bonded silica gel as filler; acetonitrile-0.1% phosphoric acid aqueous solution (20:80) as mobile phase; detection wavelength is 330nm. The number of theoretical plates should not be less than 3000 based on Robinin-6-C-β-D-glucoside;

[0125] Preparation of reference substance solution Accurately weigh an appropriate amount of Robinin-6-C-β-D-glucoside reference substance, add methanol to make a solution containing 2μg per 1ml, and get it;

[0126] Preparation of the test solution: Take 20 Gukang tablets, grind and mix them, take 1.0g, accurately weigh, place in a stoppered conical flask, accurately add 25ml of methanol, weigh the solution, ultrasonic treatment for 30 minutes, put Let it cool, weigh it again, add methanol to make up the weight lo...

Embodiment 3

[0136] Example 3: This method can also be used in Gukang granules, and the detection method is as follows:

[0137] 1. Determination of wood sorrel content

[0138] Chromatographic conditions and system suitability test Use octadecylsilane bonded silica gel as filler; acetonitrile-0.1% phosphoric acid aqueous solution (21:79) as mobile phase; detection wavelength is 330nm. The number of theoretical plates should not be less than 3000 based on Robinin-6-C-β-D-glucoside;

[0139] Preparation of reference substance solution Accurately weigh an appropriate amount of Robinin-6-C-β-D-glucoside reference substance, add methanol to make a solution containing 2μg per 1ml, and get it;

[0140] Preparation of the test solution Take the Gukang granules, grind and mix them, take 4.0g, accurately weigh, place in a stoppered Erlenmeyer flask, accurately add 50ml methanol, weigh it, ultrasonically treat for 30 minutes, let cool, Then weigh the weight, add methanol to make up the lost weight, shake w...

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