WO2017032285A1 - 一种参苓白术颗粒及其制备方法 - Google Patents
一种参苓白术颗粒及其制备方法 Download PDFInfo
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/06—Fungi, e.g. yeasts
- A61K36/07—Basidiomycota, e.g. Cryptococcus
- A61K36/076—Poria
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/25—Araliaceae (Ginseng family), e.g. ivy, aralia, schefflera or tetrapanax
- A61K36/258—Panax (ginseng)
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/28—Asteraceae or Compositae (Aster or Sunflower family), e.g. chamomile, feverfew, yarrow or echinacea
- A61K36/284—Atractylodes
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/34—Campanulaceae (Bellflower family)
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/34—Campanulaceae (Bellflower family)
- A61K36/346—Platycodon
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/48—Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/48—Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
- A61K36/484—Glycyrrhiza (licorice)
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/62—Nymphaeaceae (Water-lily family)
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/88—Liliopsida (monocotyledons)
- A61K36/894—Dioscoreaceae (Yam family)
- A61K36/8945—Dioscorea, e.g. yam, Chinese yam or water yam
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/88—Liliopsida (monocotyledons)
- A61K36/899—Poaceae or Gramineae (Grass family), e.g. bamboo, corn or sugar cane
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/88—Liliopsida (monocotyledons)
- A61K36/899—Poaceae or Gramineae (Grass family), e.g. bamboo, corn or sugar cane
- A61K36/8994—Coix (Job's tears)
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/88—Liliopsida (monocotyledons)
- A61K36/906—Zingiberaceae (Ginger family)
- A61K36/9064—Amomum, e.g. round cardamom
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
Definitions
- the invention belongs to the field of traditional Chinese medicine preparations, and particularly relates to a new ginseng Baizhu granule for treating spleen and stomach, benefiting lung qi, especially for treating spleen and stomach weakness, eating less stool, shortness of breath cough and limb fatigue, and preparation method thereof .
- Shenqi Baizhu granules derived from the "Chinese Pharmacopoeia" have the effect of replenishing the spleen and stomach, benefiting the lungs, and are used for spleen and stomach weakness, eating less stools, shortness of breath, coughing, and fatigue.
- the prescription consists of:
- the preparation process of Shenqi Baizhu Granules which is included in the prescriptions for the preparation of traditional Chinese medicines (20th volume), is as follows: extracting volatile oil from Amomum villosum L. and Atractylodes macrocephala L., and extracting the aqueous solution after distillation; collecting the medicinal residue and other ginseng, etc. The mixture was boiled, filtered, and the filtrate was combined with the above aqueous solution and concentrated to a paste.
- CN1788783A discloses a preparation method of Shenqi Baizhu Granules.
- the specific process is: the above ten flavors, yam crushed into fine powder, spare; extract the volatile oil from the amomum, the distilled aqueous solution is collected separately; the dregs and ginseng, bran fried atractylodes plus 95% ethanol 4 times soak for 24 hours, The mixture was heated under reflux for 3 hours, filtered, and the filtrate was recovered to ethanol, and concentrated to a clear paste having a relative density of 1.0 (65 ° C); the dregs were further added with 50% ethanol 4 times, heated under reflux for 3 hours, filtered, and the filtrate was recovered for ethanol.
- the ginseng Baizhu granules prepared by the above method have a packing size of 3 g/bag, three times a day, 2 to 3 g each time.
- Shenqi Baizhu Granule has a good effect on the treatment of spleen and stomach weakness syndrome in children.
- Shenqi Baizhu granules are added to water, the liquid medicine is turbid, the sensory impression is not good, and the mouthfeel is not good; the child patient is unwilling to take it, and the medication is poorly compliant.
- Shenqi Baizhu granules have no single-dose packaging for children.
- no usage or dosage of the child is mentioned, which makes the preparation of the preparation non-standard and easy in children.
- the dose is not accurate; if the dose is insufficient, it will not produce the desired effect and prolong the cycle of treatment and rehabilitation. Therefore, it is necessary to provide Shenqi Baizhu Granules which are specially suitable for children, and improve the preparation method of Shenqi Baizhu Granules, on the one hand to improve the curative effect, on the other hand to improve the compliance of children to meet the needs of clinical children.
- the present invention provides a novel ginseng atractylodes granule and a preparation method thereof.
- the new Shenqi Baizhu granules after adding an appropriate amount of water to disperse, obtain a clear solution, and the mouthfeel is good; thereby improving the compliance of the child taking the medicine.
- the new ginseng atractylodes granules of the present invention have comparable clinical total efficacy compared with prior art granules, but have a significantly stronger effect on improving spleen and stomach weakness in children than prior art granules; Usage and dosage of children.
- a ginseng atractylodes granule comprising a raw material medicine extract and an auxiliary material;
- the raw material medicine composition is: ginseng 400 parts by weight, ⁇ 400 parts by weight, bran atractylodes 400 parts by weight, yam 400 parts by weight, fried white lentils 300 parts by weight 200 parts by weight of lotus seeds, 200 parts by weight of braised coix seed, 200 parts by weight of Amomum vulgaris, 200 parts by weight of platycodon, 400 parts by weight of licorice;
- the auxiliary materials include citric acid, stevioside and lactose; A clear solution was obtained after water dispersion.
- the ginseng atractylodes granules are administered to a child in need of 3-5 years old, 1 g per time, 3 times a day; the ginseng atractylodes granules are administered to a child 5-14 years old, 2 g per day, daily 3 times.
- Another object of the present invention is to provide a method for preparing the above-mentioned Shenqi Baizhu Granules, wherein the raw material composition of the Shenqi Baizhu Granules is:
- ginseng 400 parts by weight of ginseng, 400 parts by weight of glutinous rice, 400 parts by weight of bran atractylodes, and 400 weight of yam 300 parts by weight of fried white lentils, 200 parts by weight of lotus seeds, 200 parts by weight of bran fried coix seed, 200 parts by weight of Amomum villosum, 200 parts by weight of Campanulaceae, 400 parts by weight of licorice;
- the preparation method comprises the following steps:
- step 2 The drug residue obtained in step 2 is soaked with ginseng, atractylodes, and platycodon grandiflorum for 80 hours with 80% to 95% ethanol.
- the volume of ethanol is 8 to 12 times the weight of the medicinal material, heated under reflux for 2 to 3 hours, filtered, and the filtrate is filtered.
- the ethanol is recovered and concentrated to a clear paste having a relative density of 1.10 to 1.20 at 65 ° C; the dregs are further added with 30% to 60% ethanol for 2 to 3 hours, and the volume of the ethanol is 8 to 10 times the weight of the medicinal material, filtered, and the filtrate is filtered.
- the ethanol is recovered and concentrated to a clear paste having a relative density of 1.10 to 1.20 at 80 ° C, and the dregs are reserved;
- the dregs obtained in step 3 are decoctioned with medlar, yam, fried white lentils, lotus seeds, bran fried coix seed, licorice and six flavors of water, the first time 1 to 3 hours, the second time 1 to 2 hours, each The volume of the sub-added water is 8 to 12 times the weight of the medicinal material, and the two decoctions are combined, filtered, and the filtrate is combined with the distilled aqueous solution obtained in the step 2, allowed to stand, filtered, and the filtrate is concentrated to a relative density of 80 ° C. When it is 1.15 ⁇ 1.30, the two kinds of clear paste obtained in step 3 are added, and further concentrated to a clear paste having a relative density of 1.10 to 1.25 at 80 ° C, and spray-dried to obtain a spray-dried powder;
- the amomum is firstly added to the sand kernel by 8 to 12 times the weight of the amomum for 1 hour, and then the volatile oil of the amomum is extracted.
- the amomum is firstly immersed in the water of 10 times the weight of the sand kernel for 1 hour, and the volatile oil of the amomum villosum is extracted.
- the Amomum villosum is extracted by the steam distillation method for 4 to 8 hours; more preferably 6 hours.
- the drug residue obtained in the step 2 is extracted with ginseng, atractylodes, and platycodon first with 95% ethanol, and then extracted with 50% ethanol.
- the volume of the 95% ethanol is 8 to 10 times the weight of the extracted medicinal material, and the volume of the 50% ethanol is 8 times the weight of the extracted medicinal material.
- the present invention provides a preparation method of Shenqi Baizhu Granule, and the raw material composition of the Shenqi Baizhu Granule is:
- ginseng 400 parts by weight of ginseng, 400 parts by weight of glutinous rice, 400 parts by weight of bran atractylodes, 400 parts by weight of yam, 300 parts by weight of fried white lentils, 200 parts by weight of lotus seeds, 200 parts by weight of bran fried coix seed, 200 parts by weight of Amomum villosum L., Campanulaceae 200 Parts by weight, licorice 400 parts by weight;
- the preparation method comprises the following steps:
- the dregs obtained in step 3 are decocted with medlar, yam, fried white lentils, lotus seeds, bran fried coix seed, licorice and six flavors of water, the first time for 2 hours, the second time for 1.5 hours, the volume of water added each time. It is 10 times the weight of the medicinal material, two decoctions are combined, filtered, and the filtrate is combined with the distilled aqueous solution obtained in step 2, allowed to stand, filtered, and the filtrate is concentrated to 80 ° C and the relative density is 1.15 to 1.30.
- the two kinds of clear paste obtained in step 3 are further concentrated to a clear paste having a relative density of 1.15 to 1.20 at 80 ° C, and spray-dried to obtain a spray-dried powder;
- step 2 taking the spray-dried powder obtained in the step 4, adding 1% by weight of the spray-dried powder of citric acid, 0.01% to 0.05% of stevioside, and a proper amount of lactose, mixing, dry-forming into granules, and spraying
- the volatile oil of Amomum villosum obtained in step 2 is mixed to prepare 1000 parts by weight of particles;
- Another object of the present invention is to provide a ginseng atractylodes granule prepared by the above preparation method, which is obtained by adding an appropriate amount of water to obtain a clear solution.
- composition of 1000 parts by weight of Shenqi Baizhu Granules obtained by the preparation method of the present invention is:
- the spray-dried powder the volatile oil of Amomum villosum L.
- the spray-dried powder has a weight of 0.5% to 1% of citric acid
- the spray-dried powder has a weight of 0.01% to 0.05% of stevioside, and the balance is lactose.
- the amount of the spray-dried powder and the volatile oil of Amomum villosum L. prepared by the preparation method of the present invention is also not fixed, and the corresponding amount of lactose is also used. It will be adjusted according to the actual conditions so that the total amount of the granules is 1000 parts by weight.
- Still another object of the present invention is to provide a method for using the above-mentioned Astragalus membranaceus granules.
- the ginseng atractylodes granules are prepared by the above preparation method; the methods of use include weak spleen and stomach, less food and stool, shortness of breath and cough, Children with weak limbs, 1g every 3-5 years, 3 times a day; 2g every 5-14 years, 3 times a day.
- another object of the present invention is to provide the above-mentioned Shenqi Baizhu Granules, or the Shenqi Baizhu Granules prepared by the above preparation method for preparing a medicine for treating children with spleen and stomach weakness, eating less stool, shortness of breath cough, and limb fatigue. use.
- Shenqi Baizhu granule provided by the invention can be used not only for children's disease, but also for spleen and stomach weakness, eating less stool, shortness of breath, cough, limb fatigue, and can also be used for adults to see the above symptoms. When used in adults, the amount can be increased accordingly. In general, the adult dose is 3g each time, 3 times a day.
- the "parts by weight” as used in the present invention means the proportional relationship of the weight of each of the medicinal herbs and the finally prepared ginseng atractylodes granules. According to the actual situation, 1 part by weight may be 1 g, 1 kg, 100 g, or any other mass (e.g., 20 g, 50 g, etc.). When 1 part by weight is 1 g, 1000 g of ginseng atractylodes granules were prepared according to the above preparation method, and 1 g per bag was dispensed into 1000 bags.
- concentration of ethanol described in the specification of the present invention refers to a volume percent concentration.
- the granule prepared by the invention has high content of active ingredients, indicating high extraction efficiency and better ensuring the efficacy.
- the determination of the polysaccharide and ginsenoside Rg1 content of Experiment 2 and Experimental Example 3 showed that the granules prepared by the present invention and Comparative Example 3 (Shenzhen Baizhu granules disclosed in Publication No. CN1788783A) were higher than Comparative Example 1 in the above-mentioned index components. 2, and the content of Example 1 is the highest, which is a preferred embodiment.
- the commercially available Shenqi Atractylodes preparation has only the usage and packaging specifications of adults.
- the invention determines the usage and dosage of different children's age groups and special packaging specifications, which makes children's medication more convenient and accurate.
- the origin, manufacturer and supply batch number of the above raw materials are as follows:
- the preparation method comprises the following steps:
- the dregs obtained in the step 2 are soaked with ginseng, atractylodes, and platycodon grandiflorum plus 95% ethanol for 10 times (volume/weight multiple) for 24 hours, heated under reflux for 3 hours, filtered, and the filtrate is recovered to ethanol, and concentrated to a relative density of 1.15 ⁇ 1.20 (65°C) clearing paste; the dregs are further added with 50% ethanol 8 times (volume/weight multiple) for 3 hours, filtered, and the filtrate is recovered and concentrated to a relative density of 1.12 ⁇ 1.13 (80 °C). Clearing paste, dregs spare;
- the above-mentioned preparation method of Shenqi Baizhu granules the main functions are: spleen and stomach, benefiting lung; for children with spleen and stomach weakness, eating less stool, shortness of breath cough, limb fatigue. Dosage usage is: children 3-5 years old each time 1g, 3 times a day; 5 years old - 4 years old each time 2g, 3 times a day.
- the preparation method comprises the following steps:
- the dregs obtained in the step 2 are soaked with ginseng, atractylodes and platycodon grandiflorum plus 12 times ethanol (volume/weight multiple) for 12 hours, heated under reflux for 3 hours, filtered, and the filtrate is recovered to ethanol and concentrated to relative density. It is a clear paste of 1.10 ⁇ 1.15 (65 °C); the dregs are further added with 30 times of 30% ethanol (volume/weight multiple) for 2 hours, filtered, and the filtrate is recovered and concentrated to a relative density of 1.12 to 1.13 (80). °C) clearing paste, dregs spare;
- the above-mentioned preparation method of Shenqi Baizhu granules the main functions are: spleen and stomach, benefiting lung; for children with spleen and stomach weakness, eating less stool, shortness of breath cough, limb fatigue. Dosage usage is: Children 3-5 Each year 1g, 3 times a day; 5 years old - 14 years old each time 2g, 3 times a day.
- the preparation method comprises the following steps:
- the slag obtained in the step 3 is decocted with the remaining scorpion and the like, and the water is decocted twice, the first time for 1 hour, the second time for 1 hour, and the water is added 8 times each time, filtered, and the filtrate is obtained in step 2.
- the distilled aqueous solution is combined, allowed to stand, filtered, and the filtrate is concentrated to a relative density of 1.25 to 1.30 (80 ° C), and the two kinds of clearing pastes obtained in the step 3 are added to continue to be concentrated to a relative density of 1.15 to 1.20 (80).
- the above-mentioned preparation method of Shenqi Baizhu granules the main functions are: spleen and stomach, benefiting lung; for children with spleen and stomach weakness, eating less stool, shortness of breath cough, limb fatigue. Dosage usage is: children 3-5 years old each time 1g, 3 times a day; 5 years old - 4 years old each time 2g, 3 times a day.
- the Shenqi Baizhu oral liquid is prepared by the following method:
- the ginseng is pulverized into fine powder, and 1400ml and 1000ml of 50% ethanol are added respectively, and the mixture is heated and refluxed for secondary extraction (the reflux temperature and the reflux speed are appropriately adjusted), the first time is 1.5 hours, the second time is 1 hour, and the filter is filtered and refluxed.
- the extracts were combined, and the ethanol was recovered under reduced pressure to a syrup to obtain a concentrated liquid, which was stored in a refrigerator.
- step 4 Mix the concentrated liquid obtained in step 1 and step 3, add appropriate amount of water, stir, statically filter, add the volatile oil and distillate obtained in step 2 to the filtrate, add appropriate amount of Tween-80 and sorbitol, and add water. The total amount is adjusted to 3300 ml, and the solution is prepared, filtered, filtrated, autoclaved, packaged, and obtained.
- the ginseng atractylodes granules are prepared by the following method:
- step 2 The dregs of step 2 and the rest of the ginseng and other eight flavors, boiled three times with water, the first 1.5 hours, the second and third times each for 1 hour, each time adding 10 times, the combined decoction, filtered, filtrate and The above aqueous solutions are combined and concentrated to a clear paste having a relative density of 1.20 to 1.25 (55 ° C);
- step 3 The dregs obtained in step 3 are soaked with ginseng, atractylodes and 95% ethanol for 4 hours, heated under reflux for 3 hours, filtered, and the filtrate is recovered to ethanol and concentrated to a clear density of 1.0 (65 ° C).
- the dregs are further added with 50% ethanol in 4 times, heat refluxed for 3 hours, filtered, and the filtrate is recovered into ethanol, and concentrated to a clear paste having a relative density of 1.12 to 1.13 (80 ° C), and the dregs are reserved;
- step 5 The thick paste obtained in step 5 is added to the yam fine powder of 100 mesh sieve, mixed, dried at 60 ° C, and pulverized; 1 part of dry paste and 0.4 parts of lactose powder are mixed, and granules are prepared by using 70% ethanol. Spray the volatile oil of Amomum villosum L., mix well, and make 1000g of granules, and dispense, 3g/bag.
- the ginseng Baizhu granules prepared in Examples 1-3 of the present invention have significantly better solubility than the comparative example 3, and the taste is sweet and sour, and the acceptance of children is significantly higher than that of the respective 1-3.
- the medicinal solution of the granules of Comparative Example 3 was precipitated in a large amount, and the mouthfeel was poor for children, dysphagia was difficult, and the degree of acceptance was the lowest.
- a variety of medicinal materials such as medlar and ginseng in the prescription of Atractylodes sinensis contain polysaccharides that can improve the immunity of the human body.
- the content of polysaccharides can be used as one of the indicators of the efficacy of the preparation. Therefore, the polysaccharide content of the preparations prepared in the respective examples and comparative examples was determined by the following method.
- the glucose reference solution 0, 0.1, 0.2, 0.4, 0.6, 0.8, and 1.0 mL were accurately aspirated in turn, placed in a 50 ml volumetric flask, and water was added to the mark and shaken.
- Accurately measure 2ml of each solution place it in a test tube, add 1ml of 4% phenol solution, mix well, quickly add 7.0ml of sulfuric acid, shake well, keep in 40 ° C water bath for 30 minutes, take out, set in ice water bath 5 Minutes, take out, take the first part as a blank, according to the spectrophotometry (2015 edition of the Chinese Pharmacopoeia General Principles 0401), measure the absorbance at the wavelength of 490nm, take the absorption as the ordinate, the concentration as the abscissa, draw the standard curve .
- the polysaccharides prepared in the oral solution prepared in Comparative Example 1 and the granules prepared in Comparative Example 2 have significantly lower polysaccharide content than other samples, indicating that the extraction method of Comparative Example 1 and Comparative Example 2 is insufficient for the extraction of polysaccharides, which is not conducive to drug efficacy. fully use.
- the content of the polysaccharide in each of the granules of Examples 1-3 and Comparative Example 3 was substantially the same, and the content of Example 1 was the highest, indicating that the preparation method of Example 1 is a more preferable aspect in terms of extraction of the polysaccharide.
- test solution is taken from granules, finely ground, accurately weighed 10.0g, precision added to 100ml of methanol, weighed, heated and refluxed for 1 hour, allowed to cool, then weighed, and the weight of the lost weight was compensated with methanol. , filtered. Precisely take 50ml of the filtrate and evaporate it in an evaporating dish. Add 50ml of water to the residue to dissolve. Add petroleum ether (60 ⁇ 90°C) twice, 30ml each time, discard the ether solution, and water the water is saturated with n-butanol.
- the measurement method accurately absorbs 10 ⁇ l of each of the reference solution and the test solution, and injects into a high-performance liquid chromatograph, and measures, that is, it is obtained.
- the specific results are shown in Table 3.
- the ginsenoside content of Examples 1-3 and Comparative Example 1 and Comparative Example 3 of the present invention is higher than that of Comparative Example 2, and the contents of Examples 1-3 and Comparative Example 3 are substantially equivalent, both higher than Comparative Examples 1 and 2 . Therefore, the preparation method of the present invention and the preparation method of Comparative Example 3 are more reasonable from the extraction effect of the ginsenoside component represented by ginsenoside Rg1. Among them, the ginsenoside Rg1 content of Example 1 is the highest, which is a more preferable scheme.
- Example 1 To observe the effects of Example 1 and Comparative Examples 1-3 on intestinal mucosal barrier function in young rats with chronic diarrhea.
- Test drugs Example 1, Comparative Example 2, Comparative Example 3 prepared Shenqi Baizhu Granules and Comparative Example 1 prepared Shenqi Baizhu oral liquid
- the rats in each group were given the corresponding drugs once a day, and the blank control group and the natural recovery group were given an equal volume of sterile distilled water for 2 weeks.
- urine was collected to detect the ratio of lactulose/mannitol (L/M) in the urine, and femoral blood was collected to detect plasma endotoxin.
- Test group 40 cases, the Shenqi Baizhu granules prepared in Example 1 of the present invention were administered: children 3-5 years old, 1 g each time, 3 times a day; 5 years old - 14 years old, 2 g each time, 3 times a day.
- Control group 40 cases, given the preparation of Comparative Example 3, Shenqi Baizhu granules: children 3-5 years old each time 1g, 3 times a day; 5 years old - 14 years old each time 2g, 3 times a day.
- the course of treatment is 3 weeks.
- the total effective rate of the test group was 100%, and the cure rate was 82.5%; the total effective rate of the control group was 90%, and the cure rate was 65%.
- the test group was superior to the control group in terms of the improvement of the specific stool frequency.
- the specific results are shown in Table 6.
- the test group was also superior to the control group in terms of compliance and ease of administration.
- Shenqi Baizhu Granule prepared by the preparation method of the present invention has certain advantages in treating children with spleen and stomach weakness syndrome, and has good safety and is suitable for children's application.
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Abstract
Description
原料药名称 | 产地(中国) | 供应商名称 |
人参 | 吉林 | 北京华邈中药工程技术开发中心 |
砂仁 | 海南 | 亳州市宏宇中药饮片有限公司 |
桔梗 | 内蒙 | 亳州市宏宇中药饮片有限公司 |
茯苓 | 安徽 | 亳州市宏宇中药饮片有限公司 |
白术(炒) | 浙江 | 亳州市宏宇中药饮片有限公司 |
山药 | 河北 | 亳州市宏宇中药饮片有限公司 |
白扁豆(炒) | 广西 | 亳州市宏宇中药饮片有限公司 |
莲子 | 湖南 | 亳州市宏宇中药饮片有限公司 |
麸炒薏苡仁 | 贵州 | 亳州市宏宇中药饮片有限公司 |
甘草 | 甘肃 | 亳州市宏宇中药饮片有限公司 |
组别 | 多糖含量(mg/g或mg/ml) |
实施例1 | 768.39 |
实施例2 | 742.05 |
实施例3 | 747.63 |
对比例1 | 56.8 |
对比例2 | 371.76 |
对比例3 | 743.18 |
供试品 | 人参皂苷Rg1含量(mg/g或mg/ml) |
实施例1 | 1.39 |
实施例2 | 1.35 |
实施例3 | 1.36 |
对比例1 | 1.23 |
对比例2 | 0.68 |
对比例3 | 1.34 |
组别 | 动物数(只) | 给药剂量 | 尿量(mL) | 乳果糖/甘露醇(L/M) |
空白对照组 | 10 | - | 8.5±1.4 | 0.20±0.06 |
自然恢复组 | 10 | - | 8.0±1.8 | 0.29±0.06** |
谷氨酰胺组 | 10 | 6.0g/kg | 8.3±1.7 | 0.21±0.05# |
实施例1 | 10 | 0.9g/kg | 8.0±1.3 | 0.20±0.04# |
对比例1 | 10 | 3ml/kg | 8.1±1.2 | 0.23±0.05# |
对比例2 | 10 | 1.8g/kg | 8.2±1.6 | 0.25±0.04 |
对比例3 | 10 | 0.9g/kg | 8.2±1.4 | 0.24±0.04 |
组别 | 动物数(只) | 给药剂量(g/kg) | 内毒素(U/L) |
空白对照组 | 10 | - | 8.3±1.7 |
自然恢复组 | 10 | - | 14.4±2.9** |
谷氨酰胺组 | 10 | 6.0 | 11.4±1.9# |
实施例1 | 10 | 0.9g/kg | 11.1±1.7## |
对比例1 | 10 | 3ml/kg | 11.6±1.8# |
对比例2 | 10 | 1.8g/kg | 12.9.0±1.6 |
对比例3 | 10 | 0.9g/kg | 11.5±1.5# |
组别 | 治疗前大便次数 | 治疗后大便次数 | 治疗前大便异常人数 | 治疗后大便异常人数 |
试验组 | 平均6.8次/d | 平均1.4次/d | 40 | 5 |
对照组 | 平均6.6次/d | 平均1.8次/d | 40 | 8 |
Claims (12)
- 一种参苓白术颗粒,包括原料药提取物和辅料;所述原料药组成为:人参400重量份、茯苓400重量份、麸炒白术400重量份、山药400重量份、炒白扁豆300重量份、莲子200重量份、麸炒薏苡仁200重量份、砂仁200重量份、桔梗200重量份、甘草400重量份;所述辅料包括柠檬酸、甜菊苷及乳糖;所述参苓白术颗粒加适量水分散后得到澄清的溶液。
- 根据权利要求1所述的参苓白术颗粒,其特征在于,所述参苓白术颗粒给予需要的3-5岁的儿童,每次1g,每日3次;所述参苓白术颗粒给予需要的5-14岁的儿童,每次2g,每日3次。
- 一种参苓白术颗粒的制备方法,所述参苓白术颗粒的原料药组成为:人参400重量份、茯苓400重量份、麸炒白术400重量份、山药400重量份、炒白扁豆300重量份、莲子200重量份、麸炒薏苡仁200重量份、砂仁200重量份、桔梗200重量份、甘草400重量份;所述制备方法包括如下步骤:(1)按照上述组成准备各味药材;(2)取砂仁用水蒸气蒸馏法提取得到砂仁挥发油,蒸馏后的水溶液另器收集,药渣备用;(3)将步骤2得到的药渣同人参、白术、桔梗加80%~95%乙醇浸泡24小时,乙醇的体积是药材重量的8~12倍,加热回流2~3小时,滤过,滤液回收乙醇,并浓缩至65℃相对密度为1.10~1.20的清膏;药渣再加30%~60%乙醇回流2~3小时,乙醇的体积是药材重量的8~10倍,滤过,滤液回收乙醇,并浓缩至80℃相对密度为1.10~1.20的清膏,药渣备用;(4)步骤3得到的药渣与茯苓、山药、炒白扁豆、莲子、麸炒薏苡仁、甘草六味加水煎煮二次,第一次1~3小时,第二次1~2小时,每次加水的体积是药材重量的8~12倍,合并两次煎液,滤过,滤液与步骤2得到的所述蒸馏后的水溶液合并,静置,滤过,滤液浓缩至80℃相对密度为1.15~1.30时,加入步骤3得到的两种清膏,继续浓缩成80℃相对密度为1.10~1.25的清膏,喷雾干燥,得喷雾干燥粉;(5)取步骤4得到的所述喷雾干燥粉,加入所述喷雾干燥粉重量0.5%~1%的柠檬酸、0.01%~0.05%的甜菊苷以及适量乳糖,混匀,干法制成颗粒,喷入步骤2得到的所述砂仁挥发油,混匀,制成1000重量份颗粒;(6)取步骤5得到的所述颗粒,分装,每袋1g。
- 根据权利要求3所述的制备方法,其特征在于,所述步骤2中,将所述砂仁先加入所述砂仁重量8~12倍的水浸泡1小时,再提取所述砂仁挥发油。
- 根据权利要求4所述的制备方法,其特征在于,所述步骤2中,将所述砂仁先加入所述砂仁重量10倍的水浸泡1小时,再提取所述砂仁挥发油。
- 根据权利要求2至5中任一项所述的制备方法,其特征在于,所述砂仁经所述水蒸气蒸馏法提取出所述砂仁挥发油的时间为4~8小时;更优选为6小时。
- 根据权利要求2至6中任一项所述的制备方法,其特征在于,所述步骤3中,所述步骤2得到的药渣同人参、白术、桔梗先用95%乙醇提取,再用50%乙醇提取。
- 根据权利要求7所述的制备方法,其特征在于,所述步骤3中,95%乙醇的体积是提取药材重量的8~10倍,50%乙醇的体积是提取药材重量的8倍。
- 一种参苓白术颗粒的制备方法,所述参苓白术颗粒的原料药组成为:人参400重量份、茯苓400重量份、麸炒白术400重量份、山药400重量份、炒白扁豆300重量份、莲子200重量份、麸炒薏苡仁200重量份、砂仁200重量份、桔梗200重量份、甘草400重量份;所述制备方法包括如下步骤:(1)按照上述组成准备各味药材;(2)取砂仁,加所述砂仁重量10倍量的水,浸泡1小时,用水蒸气蒸馏法提取6小时,收集砂仁挥发油,备用;蒸馏后的水溶液另器收集,备用;药渣备用(3)将步骤2得到的药渣同人参、白术、桔梗加95%乙醇浸泡24小时,95%乙醇的体积是药材重量的8~10倍,加热回流3小时,滤过,滤液回收乙醇,并浓缩至65℃相对密度为1.10~1.20的清膏;药渣再加50%乙醇回流3小时,50%乙醇的体积是药材重量的8倍,滤过,滤液回收乙醇,并浓缩至80℃相对密度为1.10~1.20的清膏,药渣备用;(4)步骤3得到的药渣与茯苓、山药、炒白扁豆、莲子、麸炒薏苡仁、甘草六味加水煎煮二次,第一次2小时,第二次1.5小时,每次加水的体积是药材重量的10倍,合并两次煎液,滤过,滤液与步骤2得到的所述蒸馏后的水溶液合并,静置,滤过,滤液浓缩至80℃相对密度为1.15~1.30时, 加入步骤3得到的两种清膏,继续浓缩成80℃相对密度为1.15~1.20的清膏,喷雾干燥,得喷雾干燥粉;(5)取步骤4得到的所述喷雾干燥粉,加入所述喷雾干燥粉重量1%的柠檬酸、0.01%~0.05%的甜菊苷以及适量乳糖,混匀,干法制成颗粒,喷入步骤2得到的所述砂仁挥发油,混匀,制成1000重量份颗粒;(6)取步骤5得到的所述颗粒,分装,每袋1g。
- 权利要求3至9中任一项所述的制备方法制备得到的参苓白术颗粒;所述参苓白术颗粒加适量水分散后得到澄清的溶液。
- 权利要求1、2或10所述的参苓白术颗粒的使用方法,所述使用方法包括:对于脾胃虚弱、食少便溏、气短咳嗽、肢倦乏力的儿童,3-5岁每次1g,每日3次;5-14岁每次2g,每日3次。
- 权利要求1、2或10所述的参苓白术颗粒用于制备治疗儿童脾胃虚弱、食少便溏、气短咳嗽、肢倦乏力的药物的用途。
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RU2722015C1 (ru) | 2020-05-26 |
EP3338786C0 (en) | 2023-12-20 |
EP3338786B1 (en) | 2023-12-20 |
CN105056092A (zh) | 2015-11-18 |
US20180207215A1 (en) | 2018-07-26 |
AU2016312007B2 (en) | 2021-09-30 |
US10813964B2 (en) | 2020-10-27 |
JP6797202B2 (ja) | 2020-12-09 |
PL3338786T3 (pl) | 2024-04-22 |
JP2018523713A (ja) | 2018-08-23 |
CN105056092B (zh) | 2019-05-03 |
EP3338786A4 (en) | 2019-05-01 |
EP3338786A1 (en) | 2018-06-27 |
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