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Astragalus
This product is the dried root of Astragalus membranaceus (Fisch.) Bge. var. mongholicus (Bge.) Hsiao or Astragalus membranaceus (Fisch.) Bge. of the Leguminosae family. It is dug up in spring and autumn, the fibrous roots and root heads are removed, and then dried in the sun.
This product is cylindrical, some with branches, thicker at the top, 30 to 90 cm long, 1 to 35 cm in diameter. The surface is light brown or light brown, with irregular longitudinal wrinkles or grooves. It is hard and tough, not easy to break, with strong fiber and powdery cross section, yellowish white cortex, light yellow wood, with radial texture and cracks, and the center of old roots is occasionally rotten, dark brown or hollow. It has a faint smell and a slightly sweet taste. It has a slight beany smell when chewed.
(1) Cross section of this product: There are many rows of cork cells; the inner layer of the cork is 3 to 5 rows of thick-horned cells. The outer side of the phloem rays is often curved and has cracks; the fibers are bundled, thick-walled, lignified or slightly lignified, and arranged alternately with the sieve tube groups; stone cells can sometimes be seen near the inner layer of the cork. The cambium is ringed. Xylem vessels are scattered singly or gathered in groups of 2 to 3; there are wood fibers between vessels; stone cells can sometimes be seen singly or in groups of 2 to 4 in the rays. Thin-walled cells contain starch grains. The powder is yellowish white. The fibers are bundled or scattered, with a diameter of 8 to 30 μm, thick walls, and longitudinal cracks on the surface. The primary wall is often separated from the secondary wall, and the two ends are often broken into whiskers or relatively flat. The bordered pit vessels are colorless or orange-yellow, and the bordered pits are closely arranged. Stone cells are rare, round, oblong or irregular in shape, and have thicker walls.
(2) According to the thin layer chromatography method (General Rule 0502), 5 to 10 R of the test solution and reference solution under the item [Determination of Content] are taken and spotted on the same silica gel G thin layer plate. The lower layer solution of chloroform-methanol-water (13:7:2) is used as the developing agent. The plate is developed, taken out, dried, sprayed with 10% sulfuric acid ethanol solution, heated at 105°C until the spots are clearly colored, and examined under sunlight and ultraviolet light (365nm). In the chromatogram of the test sample, at the corresponding position in the chromatogram of the reference sample, the same brown spots appear under sunlight; the same orange-yellow fluorescent spots appear under ultraviolet light (365nm).
(3) Take 2g of the powder of this product, add 30ml of ethanol, heat and reflux for 20 minutes, filter, evaporate the filtrate, add 15ml of 0.3% sodium hydroxide solution to the residue to dissolve, filter, adjust the pH value of the filtrate to 5-6 with dilute hydrochloric acid, shake and extract with 15ml of ethyl acetate, separate the ethyl acetate solution, filter with filter paper covered with an appropriate amount of anhydrous sodium sulfate, and evaporate the filtrate to dryness. Add 1ml of ethyl acetate to dissolve the residue as the test solution. Take another 2g of Astragalus control medicinal material and prepare the control medicinal material solution in the same way. According to the thin layer chromatography method (General Rule 0502), take 100ml of each of the above two solutions and spot them on the same silica gel G thin layer plate, use chloroform-methanol (10:1) as the developing solvent, develop, take out, dry, fumigate with ammonia vapor, and examine under ultraviolet light (365nm). In the chromatogram of the test product, at the corresponding position of the chromatogram of the control medicinal material, a main fluorescent spot of the same color appears.
The moisture content shall not exceed 10.0% (General Rule 0832 Method 2).
The total ash content shall not exceed 5.0% (General Rule 2302).
Heavy metals and harmful elements shall be determined according to the lead, cadmium, arsenic, mercury and copper determination methods (General Rule 2321 Atomic Absorption Spectrophotometry or Inductively Coupled Plasma Mass Spectrometry).
The lead content shall not exceed 5mg/kg; the cadmium content shall not exceed 1mg/kg; the arsenic content shall not exceed 2mg/kg; the mercury content shall not exceed 0.2mg/kg; the copper content shall not exceed 20mg/kg.
Other organochlorine pesticide residues shall be determined according to the pesticide residue determination method (General Rule 2341 Organochlorine Pesticide Residue Determination Method - Method 1). Pentachloronitrobenzene shall not exceed 0.1mg/kg.
Determined according to the cold leaching method under the water-soluble extract determination method (General Rule 2201), it shall not be less than 17.0%.
Astragalus membranaceus was determined according to the high performance liquid chromatography method (General Rule 0512).
Chromatographic conditions and system suitability test: Octadecylsilane bonded silica gel was used as filler; acetonitrile-water (32:68) was used as mobile phase; evaporative light scattering detector was used for detection. The theoretical plate number calculated based on the Astragalus membranaceus peak should not be less than 4000.
Preparation of reference solution: Take an appropriate amount of Astragalus membranaceus reference substance, weigh it accurately, and add 80% methanol to make a solution containing 0.5 mg per 1 ml. Preparation of test solution Take about 1g of the powder of this product (passed through No. 4 sieve), weigh accurately, place in a stoppered conical flask, accurately add 50ml of 80% methanol solution containing 4% concentrated ammonia test solution (take 4ml of concentrated ammonia test solution, add 80% methanol to 100ml, shake well), stopper, weigh, heat and reflux for 1 hour, cool, weigh again, make up the lost weight with 80% methanol solution containing 4% concentrated ammonia test solution, shake well, filter, accurately measure 25ml of the filtrate, evaporate to dryness, dissolve the residue with 80% methanol, transfer to a 5ml volumetric flask, add 80% methanol to the scale, shake well, filter, take the filtrate, and get it. Determination method Accurately aspirate 20 (or 50) and 10 of the reference solution, respectively, and 10~200 of the test solution, inject into the liquid chromatograph, determine, and calculate with the external standard two-point method logarithmic equation to get it. This product, calculated on a dry basis, contains not less than 0.080% astragalus membranaceus methyl ester (C41 H68 O14).
The determination of calycosin glucosin is carried out according to the high performance liquid chromatography method (General Rule 0512). Chromatographic conditions and system suitability test: Octadecylsilane bonded silica gel is used as filler; acetonitrile is used as mobile phase A, 0.2% formic acid solution is used as mobile phase B, and gradient elution is performed according to the provisions in the following table; the detection wavelength is 260nm.
The theoretical plate number calculated based on the calycosin glucosin peak should not be less than 3000.
Time (min) | Mobile phase A (%) | Mobile phase B (%) |
0〜20
|
20→40 | 80→60 |
20〜30
|
40 | 60 |
Raw Material Selection
Quality Inspection
Processing
Packaging
Quality Control
Storage and Transportation
Raw Material Selection
Chinese Herbal Medicine Cultivation: We strictly select Chinese herbal medicine cultivation bases from authentic medicinal material production areas to ensure the high quality of Chinese medicinal materials.
Herbal Medicine Procurement: We procure high-quality Chinese herbs from around the world to ensure that the herbs are pure, natural, and pollution-free.
Quality Inspection
Raw Material Testing: All purchased Chinese herbs must undergo strict quality inspection before entering the warehouse, including sensory indicators such as appearance, smell, and color, as well as physical and chemical indicators such as component analysis, heavy metal detection, and pesticide residue testing.
Processing
Cleaning: Thoroughly clean the Chinese herbs using clean water sources to remove dirt, impurities, and microorganisms.
Cutting: Based on the characteristics of different Chinese herbs, we adopt appropriate cutting processes, including slicing, segmenting, and shredding, to ensure the efficacy of the herbs and ease of use.
Drying: Use traditional sun-drying and modern drying techniques to ensure that the moisture content of Chinese herbs meets national standards, maintaining the efficacy and storage life of the herbs.
Selection
Screening: Carefully select the Chinese herbs to remove impurities, fragments, and non-conforming items, ensuring the purity and high quality of the herbs.
Sorting: Sort the herbs according to their specifications and grades to ensure product consistency and standardization.
Packaging
Packaging Handling: In a clean packaging workshop, use modern packaging equipment to package the Chinese herbs, ensuring the sealing and hygiene of the packaging and extending the product's shelf life.
Label Identification: Each package is labeled with detailed information, including the name of the herb, specification, place of origin, production date, etc., ensuring the traceability of the product.
Quality Control
Process Monitoring: Strict quality monitoring is carried out at every stage of production to ensure that the products meet national standards and customer requirements.
Final Inspection: Every batch of products undergoes final quality inspection before leaving the factory, including appearance, composition, and microbial indicators, ensuring the safety and efficacy of the products.
Storage and Transportation
Storage: Store the products in warehouses that comply with GSP standards to ensure product quality and stability. Warehouse environment control includes temperature, humidity, and ventilation, ensuring that the herbs do not get damp or deteriorate.
Transportation: Use professional logistics transportation methods to ensure the safety and integrity of the products during transportation, delivering them to customers on time. We cooperate with multiple international logistics companies to ensure fast and efficient global delivery.
Raw Material Selection
Chinese Herbal Medicine Cultivation: We strictly select Chinese herbal medicine cultivation bases from authentic medicinal material production areas to ensure the high quality of Chinese medicinal materials.
Herbal Medicine Procurement: We procure high-quality Chinese herbs from around the world to ensure that the herbs are pure, natural, and pollution-free.
Quality Inspection
Raw Material Testing: All purchased Chinese herbs must undergo strict quality inspection before entering the warehouse, including sensory indicators such as appearance, smell, and color, as well as physical and chemical indicators such as component analysis, heavy metal detection, and pesticide residue testing.
Processing
Cleaning: Thoroughly clean the Chinese herbs using clean water sources to remove dirt, impurities, and microorganisms.
Cutting: Based on the characteristics of different Chinese herbs, we adopt appropriate cutting processes, including slicing, segmenting, and shredding, to ensure the efficacy of the herbs and ease of use.
Drying: Use traditional sun-drying and modern drying techniques to ensure that the moisture content of Chinese herbs meets national standards, maintaining the efficacy and storage life of the herbs.
Selection
Screening: Carefully select the Chinese herbs to remove impurities, fragments, and non-conforming items, ensuring the purity and high quality of the herbs.
Sorting: Sort the herbs according to their specifications and grades to ensure product consistency and standardization.
Packaging
Packaging Handling: In a clean packaging workshop, use modern packaging equipment to package the Chinese herbs, ensuring the sealing and hygiene of the packaging and extending the product's shelf life.
Label Identification: Each package is labeled with detailed information, including the name of the herb, specification, place of origin, production date, etc., ensuring the traceability of the product.
Quality Control
Process Monitoring: Strict quality monitoring is carried out at every stage of production to ensure that the products meet national standards and customer requirements.
Final Inspection: Every batch of products undergoes final quality inspection before leaving the factory, including appearance, composition, and microbial indicators, ensuring the safety and efficacy of the products.
Storage and Transportation
Storage: Store the products in warehouses that comply with GSP standards to ensure product quality and stability. Warehouse environment control includes temperature, humidity, and ventilation, ensuring that the herbs do not get damp or deteriorate.
Transportation: Use professional logistics transportation methods to ensure the safety and integrity of the products during transportation, delivering them to customers on time. We cooperate with multiple international logistics companies to ensure fast and efficient global delivery.
Processing
Cleaning: Thoroughly clean the Chinese herbs using clean water sources to remove dirt, impurities, and microorganisms.
Cutting: Based on the characteristics of different Chinese herbs, we adopt appropriate cutting processes, including slicing, segmenting, and shredding, to ensure the efficacy of the herbs and ease of use.
Drying: Use traditional sun-drying and modern drying techniques to ensure that the moisture content of Chinese herbs meets national standards, maintaining the efficacy and storage life of the herbs.
Selection
Screening: Carefully select the Chinese herbs to remove impurities, fragments, and non-conforming items, ensuring the purity and high quality of the herbs.
Sorting: Sort the herbs according to their specifications and grades to ensure product consistency and standardization.
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