WO2018188546A1 - 蝉花的新用途 - Google Patents

蝉花的新用途 Download PDF

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WO2018188546A1
WO2018188546A1 PCT/CN2018/082298 CN2018082298W WO2018188546A1 WO 2018188546 A1 WO2018188546 A1 WO 2018188546A1 CN 2018082298 W CN2018082298 W CN 2018082298W WO 2018188546 A1 WO2018188546 A1 WO 2018188546A1
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Prior art keywords
medicine
group
extraction
composition
blood glucose
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PCT/CN2018/082298
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English (en)
French (fr)
Inventor
王玉芹
张忠亮
孙长胜
尹彬
陈桃宝
崔俏俏
张霜霜
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浙江泛亚生物医药股份有限公司
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Publication of WO2018188546A1 publication Critical patent/WO2018188546A1/zh

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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
    • A61K36/062—Ascomycota
    • A61K36/066—Clavicipitaceae
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
    • A61K35/56—Materials from animals other than mammals
    • A61K35/63—Arthropods
    • 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
    • A61K36/062—Ascomycota
    • A61K36/066—Clavicipitaceae
    • A61K36/068—Cordyceps
    • 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
    • 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)
    • 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)
    • A61K36/23—Apiaceae or Umbelliferae (Carrot family), e.g. dill, chervil, coriander or cumin
    • A61K36/232—Angelica
    • 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
    • A61K36/254—Acanthopanax or Eleutherococcus
    • 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)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/34—Campanulaceae (Bellflower family)
    • A61K36/344—Codonopsis
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    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/36—Caryophyllaceae (Pink family), e.g. babysbreath or soapwort
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/41—Crassulaceae (Stonecrop family)
    • A—HUMAN NECESSITIES
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    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/42—Cucurbitaceae (Cucumber family)
    • A61K36/424—Gynostemma
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/46—Eucommiaceae (Eucommia family), e.g. hardy rubber tree
    • A—HUMAN NECESSITIES
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    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/48—Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
    • A61K36/481—Astragalus (milkvetch)
    • 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
    • A61K36/488—Pueraria (kudzu)
    • 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)
    • A61K36/72—Rhamnaceae (Buckthorn family), e.g. buckthorn, chewstick or umbrella-tree
    • A61K36/725—Ziziphus, e.g. jujube
    • 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)
    • A61K36/73—Rosaceae (Rose family), e.g. strawberry, chokeberry, blackberry, pear or firethorn
    • A61K36/734—Crataegus (hawthorn)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/75—Rutaceae (Rue family)
    • A61K36/752—Citrus, e.g. lime, orange or lemon
    • 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)
    • A61K36/80—Scrophulariaceae (Figwort family)
    • A61K36/804—Rehmannia
    • 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)
    • A61K36/81—Solanaceae (Potato family), e.g. tobacco, nightshade, tomato, belladonna, capsicum or jimsonweed
    • A61K36/815—Lycium (desert-thorn)
    • 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
    • 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)
    • A61K36/896—Liliaceae (Lily family), e.g. daylily, plantain lily, Hyacinth or narcissus
    • A61K36/8969—Polygonatum (Solomon's seal)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/06—Antihyperlipidemics
    • A—HUMAN NECESSITIES
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    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis
    • A61P3/10—Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N1/00—Microorganisms, e.g. protozoa; Compositions thereof; Processes of propagating, maintaining or preserving microorganisms or compositions thereof; Processes of preparing or isolating a composition containing a microorganism; Culture media therefor
    • C12N1/14—Fungi; Culture media therefor

Definitions

  • the invention relates to a new use of silk flowers, in particular to the application of silk flowers in preparing medicines or health care products having the effects of lowering blood sugar and/or blood lipids, and belongs to the field of medicine and health care.
  • Modern and Western medicine for the treatment of type 2 diabetes is mainly for "symptomatic" treatment of hyperglycemia, including sulfonylureas, biguanides, thiazolidinediones, glucosidase inhibitors and insulin itself.
  • modern drug therapy has developed over the past few decades, a new generation of drugs has emerged, but after the long-term use of drugs, side effects and treatment "secondary failure" are common, and the cost is high and should not be taken for a long time.
  • Natural medicine for the treatment of diabetes has an irreplaceable advantage of Western medicine. Because diabetes is a complex disease involving multiple diseases of the whole body, traditional Chinese medicines, especially natural medicines, have the characteristics of multiple components, multiple targets, and multiple mechanisms of action, which meet the treatment requirements of complex diseases.
  • Isaria cicadae Miquel belongs to the Ascomycot, Fezizomycotina, Sordariomycetes, Hypocreales, Cordycipitaceae of the fungus community (FUNGI).
  • Isaria is a valuable Chinese herbal medicine in China, and is a Cordyceps sinensis that is parasitic on cockroaches (commonly known as "know"). Thistle has unique and extensive effects, such as improving kidney function, anti-tumor, and improving lipid metabolism.
  • Natural medicine for the treatment of diabetes has an irreplaceable advantage of Western medicine. Because diabetes is a multi-factor, complex disease involving multiple organ diseases, it has the characteristics of multi-component, multi-target, and multiple action mechanisms, which meets the treatment requirements of complex diseases.
  • the use of traditional Chinese medicines, especially natural medicines, to produce health foods is beneficial to lower blood sugar, improve quality of life and improve work efficiency as soon as possible after exercise.
  • Research and development related to hypoglycemic products have drawn people's attention.
  • the scutellaria is used in the preparation of a medicament or a health care product having an effect of reducing fasting blood glucose.
  • the scutellaria is used in the preparation of a medicament or a health care product having a function of lowering total cholesterol, triglyceride and low density lipoprotein.
  • the silk flower is a 100% silk flower or silk flower extract or active site.
  • the extract or the effective part is prepared by extracting the sassafras according to a conventional method, and the conventional extraction method includes decoction extraction, ultrasonic extraction, osmotic extraction, immersion extraction, reflux extraction, water extraction and alcohol precipitation, and the extraction solvent includes water. Or 40-80% ethanol solution.
  • the sassafras may be combined with other medicinal and medicinal herbs to form a composition
  • the medicinal and medicinal herbs comprising qi and spleen, such as dried tangerine peel, fragrant scent, medlar, rose, sea buckthorn; Invigorating drugs, such as ginseng, American ginseng, Taizishen, Codonopsis, Ganoderma lucidum, Chinese yam, Astragalus, Atractylodes, licorice, jujube, Eucommia, walnut, Rhodiola; blood medicine, such as angelica, rehmannia, white peony, Polygonum, Ejiao ; Yin medicine, such as lily, Ophiopogon japonicus, Dendrobium, Polygonatum, medlar, mulberry, black sesame; digestion drugs, such as hawthorn, malt, grain buds; Lishui drugs, such as medlar, coix
  • the composition of the sassafras or its combination with the Chinese medicine for medicine and food can be further added into a clinically acceptable auxiliary preparation, including a tablet, a hard capsule, a soft capsule, a granule. , pills, powders, oral liquids, inhalants, injections, etc.
  • the invention further provides a traditional Chinese medicine composition having hypoglycemic effect, wherein the raw material medicine composition is: 0.5-2 parts by weight of medlar, 2-10 parts by weight of Angelica sinensis, and 2-10 parts by weight of jujube.
  • the composition of the raw material of the traditional Chinese medicine composition is: 0.7-1.8 parts by weight of sassafras, 2.2-8 parts by weight of angelica, and 2.2-8 parts by weight of jujube;
  • the composition of the raw material of the traditional Chinese medicine composition is: 0.9-1.5 parts by weight of sassafras, 2.5-7 parts by weight of angelica, and 2.5-7 parts by weight of jujube;
  • the composition of the raw material of the traditional Chinese medicine composition is: 1 part by weight of sassafras, 5 parts by weight of angelica, and 5 parts by weight of jujube.
  • the traditional Chinese medicine composition may be any form composed of the above-mentioned traditional Chinese medicine as a raw material, such as a composition obtained by pulverizing the above-mentioned traditional Chinese medicine, or an extract obtained by mixing the above traditional Chinese medicine according to a conventional extraction method, or the extract is further passed through.
  • the effective part obtained by the purification and purification process may also be a conventional oral dosage form prepared by further preparing the extract/effective part according to a conventional preparation process;
  • the conventional extraction method comprises immersion extraction, decoction extraction, reflux extraction, osmosis extraction, ultrasonic extraction, steam distillation, etc.
  • the extraction solvent comprises water, 20 to 95% ethanol solution
  • the purification and purification process comprises water extraction Alcohol precipitation, extraction, silica gel column separation, macroporous resin column separation, etc.
  • the conventional oral dosage forms include powders, tablets, capsules, granules, oral liquids, pills, and the like.
  • Filling agents include: starch, pregelatinized starch, lactose, mannitol, chitin, microcrystalline cellulose, sucrose, etc.; disintegrating agents include: starch, pregelatinized starch, microcrystalline cellulose, sodium carboxymethyl starch, Cross-linked polyvinylpyrrolidone, low-substituted hydroxypropylcellulose, croscarmellose sodium, etc.; lubricants include: magnesium stearate, sodium lauryl sulfate, talc, silica, etc.; suspending agent Including: polyvinylpyrrolidone, microcrystalline cellulose, sucrose, agar, hydroxypropyl methylcellulose, etc.; binders include: starch slurry, polyvinylpyrrolidone, hydroxypropyl methylcellulose, etc.; sweeteners include: Saccharin sodium, aspartame, sucrose, cyclamate, glycyrrhetinic acid, etc.; flavoring
  • the sassafras flower of the present invention is a scorpion flower body or a sassafras spore powder.
  • the silk flower is a flowering fruit body.
  • the quality requirements of the silk flower involved in the invention should be consistent with a heavy metal residual amount of less than 5 ppm, a pesticide residue of less than 10 ppm, and a yellow or yellowish-like appearance.
  • the flowering fruit body used meets the standards set by the Ministry of Health for food (the total number of bacteria is less than 1000 grams, the number of molds is less than 100 grams, and E. coli should not be detected).
  • the traditional Chinese medicine for medicine and food used in the composition of the scented flower in the present invention is contained in the 2015 edition of the Pharmacopoeia of the People's Republic of China, and meets the quality requirements of the various medicinal drugs in the pharmacopoeia in quality.
  • the results of the study show that the combination of the Chinese herbal medicine of the present invention alone or in combination with the medicine and the food can significantly reduce the fasting blood glucose level of the model rats; and improve the oral glucose tolerance and the low density lipoprotein content of the model rats;
  • the reduction of total cholesterol and triglyceride levels was not significantly different from that of the metformin group, which was confirmed to have an effect of improving blood sugar and blood lipids, indicating that thistle has a significant effect on improving blood sugar and blood lipids.
  • SPF healthy SD male rats animal compartment temperature 25 ° C +-2, relative humidity 55% +-5%, light 12 / 12h, free access to food and drinking water. Rats were fed for 1 week and then fasted for 12 h. Except for 10 blanks, the other were fed with different high-fat diets for 8 weeks. After the feeding, 25 mg/kg of STZ was intraperitoneally injected. After the injection, the rats' diet, drinking water, urine output and hair color were observed every day, and the changes of body weight and death were recorded. One week later, the fasting blood glucose level and oral glucose tolerance of the model rats were detected, and the blood lipids of the rats were measured by jugular vein blood sampling.
  • the indicators (total cholesterol, triglycerides, high-density lipoprotein, low-density lipoprotein) were used to determine the model, with a fasting blood glucose level greater than 11.1 mmol/l, and oral glucose tolerance (OGGT) was abnormal compared to the normal group.
  • the abnormality of the blood lipid index compared with the normal group was a criterion.
  • Model rats were randomly divided into 4 groups, namely, blank group, model group, low-dose group, high-dose group, metformin group, and 10 groups in each group.
  • Oral administration (ig) was administered at a dose of 0.166 g/kg/day for the flowering body, 0.50 g/kg/day for the sassafras, and 0.045 g/kg/day for the metformin.
  • the blank group and the model group ig5 ⁇ CMC-Na solution were administered continuously for 60 days.
  • the scorpion body is boiled twice with water for 1 hour each time, and the decoction is combined for use.
  • each group Six weeks after administration in each group, the experimental animals were fasted for 8 hours. The animals were weighed. After the fasting blood glucose was measured, each group was intragastrically administered with 40% glucose solution at a dose of 2 g/kg, and 30 min and 1 h after gavage. Blood glucose was measured by taking blood from 2 tail veins, and the change in area under the blood glucose curve at each time point in each group was observed and calculated:
  • the mean difference between the groups and the blank group was statistically significant (p ⁇ 0.05), indicating the stability of the model and the difference in treatment.
  • the results showed that the rats could significantly reduce the content of triglyceride, total cholesterol and low density lipoprotein in serum after 60 days of continuous gavage of the fruit body and metformin.
  • the difference between the sputum administration group and the metformin administration group was significant (p ⁇ 0.05), indicating that the total cholesterol and triglyceride index of scutellaria was better than metformin.
  • the results are shown in Table 3.
  • the scutellariae body of the present invention can significantly improve the blood lipid level of the model rats; the blood lipids are significantly increased after the rats are induced by the high fat diet, and the scorpion fruit body has the content of lowering total cholesterol and triglyceride; Density lipoprotein and the effect of improving high-density lipoprotein content indicate that the scorpion scorpion has a significant hypolipidemic effect.
  • Animal grouping and administration SD model rats were randomly divided into blank group, model group, sassafras composition group (A-H), and metformin control group, with 10 rats in each group.
  • Oral administration (ig) was administered at a dose of 0.50 g/kg/day for the composition of the sassafras, and 0.045 g/kg/day for metformin.
  • the blank group and the model group ig5 ⁇ CMC-Na solution were administered continuously for 60 days.
  • Composition A scorpion fruit body 2.5g, sea buckthorn 3g, acanthopanax 6g;
  • Composition B 5g of safflower, 2g of dried tangerine peel, 1g of ginseng, 2g of Polygonatum odoratum, 1g of Hawthorn, 2g of seabuckthorn, 2g of pueraria, 1g of glutinous rice;
  • Composition C scorpion fruit body 2g, Gynostemma pentaphyllum 2g, Astragalus 1g, tangerine peel 2g, Rhodiola 1g, Yam 1g;
  • Composition D scorpion fruit body 1g, dried tangerine peel 2g;
  • Composition E scorpion fruit body 3g, ginseng ginseng 2g, astragalus 5g, Codonopsis pilosula 6g;
  • Composition F scorpion fruit body 1g, angelica 5g, jujube 5g;
  • Composition G scorpion fruit body 3g, Eucommia ulmoides 10g;
  • Composition H scorpion fruit body 2g, rehmannia 3g, Polygonatum 5g, Pseudostellariae 5g, ⁇ 5g;
  • the raw materials are combined with water to cook twice, each time for 1 hour, and the decoction is combined, concentrated, and used.
  • each group Six weeks after administration in each group, the experimental animals were fasted for 8 hours. The animals were weighed. After the fasting blood glucose was measured, each group was intragastrically administered with 40% glucose solution at a dose of 2 g/kg, and 30 min and 1 h after gavage. Blood glucose was measured by taking blood from 2 tail veins, and the change in area under the blood glucose curve at each time point in each group was observed and calculated:
  • the composition of the safflower fruit body of the invention can significantly improve the blood lipid level of the model rat; the blood lipid is obviously increased after the rat is induced by the high fat diet, and the scorpion fruit body composition has the content of reducing total cholesterol and triglyceride;
  • the effect of low-density lipoprotein and improvement of high-density lipoprotein content indicates that the scorpion body foot composition has a significant effect of improving blood lipids.
  • Scorpion fruit body 6g sea buckthorn 5g, acanthopanax senticosus 4g;
  • calyx chinensis 5g of calyx chinensis, 2g of dried tangerine peel, 1g of ginseng, 2g of Polygonatum odoratum, 1g of Hawthorn, 2g of seabuckthorn, 2g of pueraria, 1g of glutinous rice;
  • the above raw materials are taken in proportion, mixed, and pulverized.
  • Licord fruit body 1.5g, Gynostemma pentaphyllum 3.5g, Astragalus 0.8g, tangerine peel 4g, Rhodiola rosea 0.8g, Yam 2g;
  • each drug substance was taken in proportion, and a tablet was prepared according to the method of Example 2.
  • compositions of the compositions of Examples 1-30 all significantly improved blood sugar and blood lipids.

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Abstract

蝉花在制备具有降血脂/降血糖作用的药物或保健品中的应用，所述蝉花单独或与药食两用的中药合用可降低血液总胆固醇、甘油三酯、低密度脂蛋白的含量。

Description

蝉花的新用途 技术领域
本发明涉及蝉花的新用途，具体涉及蝉花在制备具有降低血糖和/血脂作用的药物或保健品中的应用，属于医药保健领域。
背景技术
现代及西方医学对2型糖尿病的药物治疗主要是针对高血糖症的“对症”治疗，开发的药物包括磺脲类、双胍类、噻呻烷二酮类、葡糖苷酶抑制剂以及胰岛素本身。尽管现代药物疗法经过几十年的发展，新一代的药物不断出现，但是在长期用药后普遍出现副作用及治疗“继发失效”，且成本较高不宜长期服用。天然药物治疗糖尿病具有西药不可替代的优势。由于糖尿病是一种多病因的、涉及全身多脏器病变的复杂疾病，中药特别是天然药物具有多成分、多靶点、多种作用机制的特点，符合复杂疾病的治疗要求。
蝉花(Isaria cicadae Miquel)属于真菌界(FUNGI)的子囊菌门(Ascomycot)、盘菌亚门(Pezizomycotina)、粪壳菌纲(Sordariomycetes)、肉座菌目(Hypocreales)、虫草科(Cordycipitaceae)、棒束孢属(Isaria)，是我国名贵的中药材，是寄生在蝉(俗称“知了”)上的一种虫草菌。蝉花具有独特而广泛的功效，如改善肾功能，抗肿瘤、改善脂质代谢等。近年来，随着对蝉花虫草的开发的深入，蝉花虫草的降血糖作用逐渐凸显，尤其在2型糖尿病的治疗过程中，其不仅可以显著降低病人的血糖并维持血糖的长期稳定而且尚未发现其他降糖药物服用后所述的不良反应及症状。现代及西方医学对2型糖尿病的药物治疗主要是针对高血糖症的“对症”治疗，开发的药物包括磺脲类、双胍类、噻呻烷二酮类、葡糖苷酶抑制剂以及胰岛素本身。尽管现代药物疗法经过几十年的发展，新一代的药物不断出现，但是在长期用药后普遍出现副作用及治疗“继发失效”，且成本较高不宜长期服用。
天然药物治疗糖尿病具有西药不可替代的优势。由于糖尿病是一种多病因的、涉及全身多脏器病变的复杂疾病，具有多成分、多靶点、多种作用机 制的特点，符合复杂疾病的治疗要求。过服用降血糖及的中药特别是天然药物制成保健食品有利于运动后尽快地降低血糖，提高生活质量和提高工作效率。对降糖产品的相关研究和开发引起人们的关注。
发明内容
本发明的目的在于提供蝉花降血糖和/或降血脂的用途。
本发明的目的是通过如下技术方案实现的：
蝉花在制备具有降血糖和血脂作用的药物或保健品中的应用。
进一步，所述蝉花在制备具有降低空腹血糖作用的药物或保健品中的应用。
进一步，所述蝉花在制备具有改善口服葡糖糖耐受量作用的药物或保健品中的应用。
进一步，所述蝉花在制备具有降低总胆固醇、甘油三酯及低密度脂蛋白作用的药物或保健品中的应用。
在一些实施方式中，所述蝉花为100％蝉花或蝉花提取物或有效部位。所述提取物或有效部位为蝉花按常规方法提取制备得到，所述常规提取方法包括煎煮提取、超声提取、渗漉提取、浸渍提取、回流提取、水提醇沉等，提取溶剂包括水或40～80％乙醇溶液。
在一些实施方式中，所述蝉花可与其他药食两用中药合用组成组合物，所述药食两用中药包括理气健脾药，如陈皮、香附、枳实、玫瑰花、沙棘；补气药，如人参、西洋参、太子参、党参、灵芝、山药、黄芪、白术、甘草、大枣、杜仲、核桃仁、红景天；补血药，如当归、熟地、白芍、何首乌、阿胶；补阴药，如百合、麦冬、石斛、玉竹、枸杞子、桑椹、黑芝麻；消食药，如山楂、麦芽、谷芽；利水药，如茯苓、薏仁、冬瓜皮；发散风热药，如粉葛、薄荷、桑叶、菊花、柴胡；化瘀药，如三七、茜草、蒲黄；安神药，如酸枣仁、远志、合欢皮、绞股蓝；祛风湿药，如刺五加、桑寄生。其中，各中药日用剂量在药典规定的常规范围之内。
在一些实施方式中，所述蝉花或其与药食两用中药合用组成的组合物可进一步加入临床可接受的辅料制成药物制剂，包括片剂、硬胶囊剂、软胶囊 剂、颗粒剂、丸剂、散剂、口服液、吸入剂、注射剂等。
本发明进一步提供一种具有降血糖作用的中药组合物，其原料药组成为：蝉花0.5-2重量份、当归2-10重量份、大枣2-10重量份。
优选的，所述中药组合物的原料药组成为：蝉花0.7-1.8重量份、当归2.2-8重量份、大枣2.2-8重量份；
进一步优选的，所述中药组合物的原料药组成为：蝉花0.9-1.5重量份、当归2.5-7重量份、大枣2.5-7重量份；
最优选的，所述中药组合物的原料药组成为：蝉花1重量份、当归5重量份、大枣5重量份。
所述中药组合物可以是以上述中药为原料组成的任何形式，如上述中药混合后经粉碎得到的组合物，或上述中药混合/分别按常规提取方法提取得到的提取物，或提取物进一步经过精制纯化工艺得到的有效部位，还可以是所述提取物/有效部位进一步按照常规制剂工艺制备得到的常规口服剂型；
其中，所述常规提取方法包括浸渍提取、煎煮提取、回流提取、渗漉提取、超声提取、水蒸汽蒸馏等；提取溶剂包括水、20～95％乙醇溶液；所述精制纯化工艺包括水提醇沉、萃取、硅胶色谱柱分离、大孔树脂柱分离等；所述常规口服剂型包括散剂、片剂、胶囊剂、颗粒剂、口服液、丸剂等。
为使上述剂型能够实现，需在制备这些剂型时加入药学可接受的辅料，例如：填充剂、崩解剂、润滑剂、助悬剂、粘合剂、甜味剂、矫味剂、防腐剂、基质等。填充剂包括：淀粉、预胶化淀粉、乳糖、甘露醇、甲壳素、微晶纤维素、蔗糖等；崩解剂包括：淀粉、预胶化淀粉、微晶纤维素、羧甲基淀粉钠、交联聚乙烯吡咯烷酮、低取代羟丙纤维素、交联羧甲基纤维素钠等；润滑剂包括：硬脂酸镁、十二烷基硫酸钠、滑石粉、二氧化硅等；助悬剂包括：聚乙烯吡咯烷酮、微晶纤维素、蔗糖、琼脂、羟丙基甲基纤维素等；粘合剂包括：淀粉浆、聚乙烯吡咯烷酮、羟丙基甲基纤维素等；甜味剂包括：糖精钠、阿斯帕坦、蔗糖、甜蜜素、甘草次酸等；矫味剂包括：甜味剂及各种香精；防腐剂包括：尼泊金类、苯甲酸、苯甲酸钠、山梨酸及其盐类、苯扎溴铵、醋酸氯乙定、桉叶油等；基质包括：PEG6000，PEG4000，虫蜡等。
本发明所述蝉花为蝉花子实体或蝉花孢子粉。优选的，所述蝉花为蝉花 子实体。
本项发明中所涉及的蝉花其质量要求应符合重金属残留量小于5ppm，农药残留量小于10ppm，外观为黄色或类黄色粉末。此外所使用的蝉花子实体符合卫生部对食品所规定的标准(细菌总数小于1000克，霉菌数小于100克，不应检出大肠杆菌)。本发明中所涉及蝉花配伍组合物中所用的药食两用的中药均收载于中华人民共和国药典2015年版一部，并在质量上符合药典中各味药物相应的质量要求。
研究结果显示，本发明的蝉花单独或与药食两用的中药合用可明显降低模型大鼠的空腹血糖值；具有改善模型大鼠的口服葡萄糖耐受量、降低低密度脂蛋白的含量；降低总胆固醇和甘油三酯的含量，并与得到肯定具有改善血糖及血脂作用的对照组二甲双胍组比较无显著差异，表明蝉花具有明显的改善血糖及血脂的作用。
实验例1蝉花改善血糖及血脂作用研究
1.动物模型的建立
SPF级健康SD雄性大鼠，动物房室温度25℃+-2、相对湿度55％+-5％，光照12/12h，自由获取食物和饮水。大鼠适应性饲养1周后禁食12h。除空白10只外，其余给予不同高脂饲料喂养8周，饲养完毕后后一次性腹腔注射25mg/kg的STZ。注射完毕每天观察大鼠饮食、饮水、排尿量、毛色变化，记录体重变化、死亡情况；1周后，检测模型大鼠的空腹血糖值及口服葡萄糖耐受量，颈静脉采血测定大鼠的血脂各项指标(总胆固醇、甘油三酯、高密度脂蛋白、低密度脂蛋白)以确定成模情况，以空腹血糖值大于11.1mmol/l，口服糖耐量(OGGT)相比正常组出现异常，血脂指标相比正常组出现异常升高为评判指标。
2.试验方法
动物分组及给药：模型大鼠随机分为4组，即空白组，模型组、蝉花低剂量组，蝉花高剂量组，二甲双胍对照组，每组10只。灌胃(ig)给药，给药剂量分别为：蝉花子实体0.166g/kg/天，蝉花子实体0.50g/kg/天；二甲双 胍0.045g/kg/天。空白组及模型组ig5‰CMC-Na溶液，连续给药60天。
蝉花子实体用水煎煮两次，每次1小时，合并煎液，备用。
3.观察指标
(1)空腹血糖测定：给药六周后，实验动物禁食8小时，尾静脉采血，利用罗氏血糖仪及相应试纸测定各组大鼠的空腹血糖值，并做记录，测定原理为试纸上的酶经大肠杆菌E重组表达，将血液中的葡萄糖转化为葡萄酸内酯，进而产生无害的直流电流，因此判读血糖值。
(2)口服葡萄糖耐受量：各组给药六周后，实验动物禁食8小时，动物称定体质量，测定空腹血糖后各组按2g/kg的剂量灌胃给予40％的葡萄糖溶液，与灌胃后的30min、1h、2尾静脉取血测定血糖值，观察各组别各时间点血糖曲线下面积的变化并进行计算：
血糖曲线下面积＝1/2×(0小时血糖值+0.5小时血糖值)×0.5+1/2×(2小时血糖值+0.5小时血糖值)×1.5
(3)血清中总胆固醇、甘油三酯、高密度脂蛋白、低密度脂蛋白的测定：各组给药六周后，实验动物禁食8小时，各组别大鼠颈静脉采血，置于5ml离心管，室温静置30min，3500rpm离心15min，分离血清，用总胆固醇、甘油三酯、高密度脂蛋白、低密度脂蛋白试剂盒分别在全自动生化分析仪上测定，并记录结果。
4.实验结果
4.1本发明的蝉花子实体对空腹血糖影响
根据SPSS18.0方差分析(one way ANOVA)结果显示，与模型组相比，蝉花子实体组和二甲双胍组可明显降低模型大鼠的空腹血糖值，结果有显著性差异(p<0.05)，且蝉花子实体组和二甲双胍对照组之间组互相比较差异不显著。结果见表1。
表1蝉花子实体对模型大鼠空腹血糖的影响(n＝10)
组别 空腹血糖值(mmol/l)
空白组 4.7±0.4
模型组 28.4±5.4 *
子实体低剂量组 22.4±3.9 *#
子实体高剂量组 20.7±4.1 *#
二甲双胍组 23.9±6.2 *#
注：*.与空白对照组比较，有显著性差异(p<0.05)
#.与模型对照组比较，有显著性差异(p<0.05)
4.2本发明的蝉花子实体对口服葡萄糖耐受量的影响
各组给药六周后，实验动物禁食8小时，动物称定体质量，测定空腹血糖后各组按2g/kg的剂量灌胃给予40％的葡萄糖溶液，与灌胃后的30min、1h、2尾静脉取血测定血糖值，观察各组别各时间点血糖曲线下面积的变化并进行计算：
血糖曲线下面积＝1/2×(0小时血糖值+0.5小时血糖值)×0.5+1/2×(2小时血糖值+0.5小时血糖值)×1.5，spss18.0方差分析显示蝉花子实体组和二甲双胍对照组与模型组相比均有显著性差异(p<0.05)，说明蝉花子实体具有改善模型大鼠的口服葡萄糖耐受量的作用。但蝉花子实体组与二甲双胍组进行组间比较，没有显著性差异(p＞0.05)，说明蝉花子实体高剂量组与二甲双胍组对改善模型大鼠的口服葡萄糖耐受量的作用效果没有差异。测定结果见表2。
表2蝉花子实体对改善模型大鼠的口服葡萄糖耐受量的作用的影响结果(n＝10)
组别 血糖曲线下面积
空白组 13.4±3.2
模型组 76.6±9.2 *
子实体低剂量组 39.7±4.9 *#
子实体高剂量组 37.6±8.1 *#
二甲双胍组 42.7±6.3 *#
注：*.与空白对照组比较，有显著性差异(p<0.05)
#.与模型对照组比较，有显著性差异(p<0.05)
4.3血清中总胆固醇、甘油三酯、高密度脂蛋白、低密度脂蛋白的测定： 各组给药六周后，实验动物禁食8小时，各组别大鼠颈静脉采血，置于5ml离心管，室温静置30min，3500rpm离心15min，分离血清，用总胆固醇、甘油三酯、高密度脂蛋白、低密度脂蛋白试剂盒分别在全自动生化分析仪上测定，并记录结果。
根据SPSS18.0方差分析，各组与空白组比较均数差异有统计学意义(p<0.05)，说明了模型的稳定性和治疗差异性。模型组与蝉花子实体组和二甲双胍对照组均数差异有统计学意义(p<0.05)。说明大鼠经连续灌胃蝉花子实体及二甲双胍60天后，能显著降低血清中甘油三酯、总胆固醇、低密度脂蛋白的含量。对于总胆固醇指标，蝉花给药组与二甲双胍给药组比较，差异具有显著性意义(p<0.05)，说明蝉花改善总胆固醇和甘油三脂指标优于二甲双胍。而对于高低密度脂蛋白蝉花给药组和二甲双胍组差异没有显著性意义。结果见表3。
表3蝉花子实体对血清中总胆固醇、甘油三酯、高密度脂蛋白、低密度脂蛋白的影响结果(n＝10)
Figure PCTCN2018082298-appb-000001
注：*.与空白对照组比较，有显著性差异(p<0.05)
#.与模型对照组比较，有显著性差异(p<0.05)
$.与二甲双胍对照组比较，有显著性差异(p<0.05)
空腹血糖及口服葡萄糖耐受量是全面反映生物体血糖程度的核心指标，上述实验结果表明，蝉花子实体具有明显降血糖作用。
研究结果显示，本发明的蝉花子实体可明显改善模型大鼠的血脂程度；大鼠经高脂饲料诱导后，血脂明显升高，蝉花子实体具有降低总胆固醇和甘 油三酯的含量；降低低密度脂蛋白和改善高密度脂蛋白含量的作用，表明蝉花子实体具有明显的降血脂的作用。
实验例2蝉花组合物降低血糖及血脂作用研究
1.试验方法：
动物分组及给药：SD模型大鼠随机分组，即空白组，模型组、蝉花组合物组(A-H)，二甲双胍对照组，每组10只。灌胃(ig)给药，给药剂量分别为：蝉花子实体组合物折合成蝉花给药量0.50g/kg/天；二甲双胍0.045g/kg/天。空白组及模型组ig5‰CMC-Na溶液，连续给药60天。
实验药物：
组合物A：蝉花子实体2.5g，沙棘3g、刺五加6g；
组合物B：蝉花子实体5g、陈皮2g、人参1g、玉竹2g、山楂1g、沙棘2g、粉葛2g、茯苓1g；
组合物C：蝉花子实体2g、绞股蓝2g、黄芪1g、陈皮2g、红景天1g、山药1g；
组合物D：蝉花子实体1g、陈皮2g；
组合物E：蝉花子实体3g、太子参2g、黄芪5g、党参6g；
组合物F，蝉花子实体1g、当归5g、大枣5g；
组合物G，蝉花子实体3g、杜仲10g；
组合物H，蝉花子实体2g、熟地3g、玉竹5g、太子参5g、枸杞5g；
二甲双胍对照组；
蝉花各配方组，将原料药合并水煎煮两次，每次1小时，合并煎液，浓缩，备用。
2.观察指标
(1)空腹血糖测定：给药六周后，实验动物禁食8小时，尾静脉采血，利用罗氏血糖仪及相应试纸测定各组大鼠的空腹血糖值，并做记录，测定原理为试纸上的酶经大肠杆菌E重组表达，将血液中的葡萄糖转化为葡萄酸内酯，进而产生无害的直流电流，因此判读血糖值。
(2)口服葡萄糖耐受量：各组给药六周后，实验动物禁食8小时，动物称定体质量，测定空腹血糖后各组按2g/kg的剂量灌胃给予40％的葡萄糖 溶液，与灌胃后的30min、1h、2尾静脉取血测定血糖值，观察各组别各时间点血糖曲线下面积的变化并进行计算：
血糖曲线下面积＝1/2×(0小时血糖值+0.5小时血糖值)×0.5+1/2×(2小时血糖值+0.5小时血糖值)×1.5
(3)血清中总胆固醇、甘油三酯、高密度脂蛋白、低密度脂蛋白的测定：各组给药六周后，实验动物禁食8小时，各组别大鼠颈静脉采血，置于5ml离心管，室温静置30min，3500rpm离心15min，分离血清，用总胆固醇、甘油三酯、高密度脂蛋白、低密度脂蛋白试剂盒分别在全自动生化分析仪上测定，并记录结果。
3.实验结果
4.1本发明的蝉花子实体组合物对空腹血糖影响
根据SPSS18.0方差分析(one way ANOVA)结果显示，与模型组相比，蝉花子实体组合物和二甲双胍组可明显降低模型大鼠的空腹血糖值，结果有显著性差异(p<0.05)。结果见表5。
表5蝉花子实体各组方对模型大鼠空腹血糖的影响(n＝10)
组别 空腹血糖值(mmol/l)
空白组 4.7±0.4
模型组 28.4±5.4
二甲双胍组 23.9±6.2*
组合物A 22.4±3.9*
组合物B 23.7±5.24*
组合物C 26.49±4.73*
组合物D 21.12±3.74*
组合物E 19.35±2.78*
组合物F 17.10±5.96*
组合物G 21.14±4.71*
组合物H 24.06±5.67*
注：*.与模型对照组比较，有显著性差异(p<0.05)
3.2本发明的蝉花子实体组合物对口服葡萄糖耐受量的影响
各组给药六周后，实验动物禁食8小时，动物称定体质量，测定空腹血糖后各组按2g/kg的剂量灌胃给予40％的葡萄糖溶液，与灌胃后的30min、1h、2尾静脉取血测定血糖值，观察各组别各时间点血糖曲线下面积的变化并进行计算：
血糖曲线下面积＝1/2×(0小时血糖值+0.5小时血糖值)×0.5+1/2×(2小时血糖值+0.5小时血糖值)×1.5，spss18.0方差分析显示蝉花子实体各配方组和二甲双胍对照组与模型组相比均有显著性差异(p<0.05)，说明蝉花子实体组合物具有明显改善模型大鼠的口服葡萄糖耐受量的作用。结果见表6。
表6蝉花子实体组合物对改善模型大鼠的口服葡萄糖耐受量的作用的影响结果(n＝10)
组别 血糖曲线下面积
空白组 13.4±3.2
模型组 76.6±9.2
二甲双胍组 42.7±6.3*
组合物A 47.6±4.7*
组合物B 52.4±5.6*
组合物C 62.7±6.6*
组合物D 55.1±5.6*
组合物E 44.6±4.7*
组合物F 37.1±3.4*
组合物G 42.4±5.8*
组合物H 43.5±7.2*
注：*.与模型对照组比较，有显著性差异(p<0.05)
3.3血清中总胆固醇、甘油三酯、高密度脂蛋白、低密度脂蛋白的测定：各组给药六周后，实验动物禁食8小时，各组别大鼠颈静脉采血，置于5ml离心管，室温静置30min，3500rpm离心15min，分离血清，用总胆固醇、 甘油三酯、高密度脂蛋白、低密度脂蛋白试剂盒分别在全自动生化分析仪上测定，并记录结果。
根据SPSS18.0方差分析，模型组与蝉花子实体组合舞和二甲双胍对照组均数差异有统计学意义(p<0.05)。说明经连续灌胃蝉花子实体组合物及二甲双胍60天后，能显著降低大鼠血清中甘油三酯、总胆固醇、低密度脂蛋白的含量，结果见表7。
表7蝉花子实体对血清中总胆固醇、甘油三酯、高密度脂蛋白、低密度脂蛋白的影响结果(n＝10)
Figure PCTCN2018082298-appb-000002
注：*.与模型对照组比较，有显著性差异(p<0.05)
空腹血糖及口服葡萄糖耐受量是全面反映生物体血糖程度的核心指标，上述实验结果表明蝉花子实体具有明显的降血糖作用。
本发明的蝉花子实体各组合物可明显改善模型大鼠的血脂程度；大鼠经高脂饲料诱导后，血脂明显升高，蝉花子实体组合物具有降低总胆固醇和甘油三酯的含量；降低低密度脂蛋白和改善高密度脂蛋白含量的作用，表明蝉花子实体足组合物具有明显的改善血脂的作用。
具体实施方式
实施例1
取蝉花子实体，粉碎，加水煎煮两次，每次1小时，合并水煎液，浓缩，真空干燥，即得。
实施例2
蝉花子实体6g，沙棘5g、刺五加4g；
按比例取上述各原料药，除蝉花子实体外，其余各原料混合后加水煎煮2次，每次1h，每次加水10倍量，滤过，合并两次滤液，浓缩至相对密度为1.10～1.12(80℃)，与蝉花子实体及适量辅料混匀后一步制粒，压片，包薄膜衣即得片剂。
实施例3
蝉花子实体1g，沙棘2g、刺五加3g；
按比例取上述各原料药，加水煎煮2次，每次1h，每次加水10倍量，滤过，合并两次滤液，浓缩至相对密度为1.10～1.12(80℃)，与适量辅料混匀后一步制粒，装入胶囊即得胶囊剂。
实施例4
蝉花子实体4g，沙棘1g、刺五加8g；
按比例取上述各原料药，加75％乙醇溶液回流提取2次，每次1h，滤过，合并两次滤液，浓缩至相对密度为1.10～1.12(80℃)，与适量辅料混匀后一步制粒，得颗粒剂。
实施例5
蝉花子实体2.5g，沙棘3g、刺五加6g；
按比例取上述各原料药，加水超声提取2次，每次40min，滤过，合并两次滤液，浓缩至相对密度为1.10～1.12(80℃)，得口服液。
实施例6
蝉花子实体5g、陈皮2g、人参1g、玉竹2g、山楂1g、沙棘2g、粉葛2g、茯苓1g；
按比例取上述各原料药，加水煎煮2次，每次1h，每次加水10倍量， 滤过，合并两次滤液，浓缩至相对密度为1.10～1.12(80℃)，与适量辅料混匀后一步制粒，压片，包薄膜衣即得片剂。
实施例7
蝉花子实体5g、陈皮4g、人参3g、玉竹3g、山楂2g、沙棘2g、粉葛3g、茯苓2g；
按比例取上述各原料药，加水煎煮2次，每次1h，每次加水10倍量，滤过，合并两次滤液，浓缩至相对密度为1.10～1.12(80℃)，与适量辅料混匀后一步制粒，装入胶囊即得胶囊剂。
实施例8
蝉花子实体10g、陈皮2g、人参2g、玉竹2g、山楂1g、沙棘1g、粉葛1g、茯苓2g；
按比例取上述各原料药，加水煎煮2次，每次1h，每次加水10倍量，滤过，合并两次滤液，浓缩至相对密度为1.10～1.12(80℃)，与适量辅料混匀后一步制粒，得颗粒剂。
实施例9
蝉花子实体2g、绞股蓝2g、黄芪1g、陈皮2g、红景天1g、山药1g；
按比例取上述各原料药，混合，粉碎，即得。
实施例10
蝉花子实体1.5g、绞股蓝3.5g、黄芪0.8g、陈皮4g、红景天0.8g、山药2g；
按比例取上述原料药，加60％乙醇浸泡提取3次，每次1h，滤过，合并滤液，浓缩至相对密度为1.10～1.12(80℃)，与适量辅料混匀后一步制粒，得颗粒剂。
实施例11
蝉花子实体3g、绞股蓝1g、黄芪2g、陈皮1g、红景天2g、山药0.8。
实施例12
蝉花孢子粉6g、绞股蓝1g、黄芪4g、陈皮1g、红景天3g、山药0.5g。
实施例13
蝉花子实体1g、绞股蓝6g、黄芪0.5g、陈皮6g、红景天1g、山药3g。
实施例14
蝉花子实体1g、陈皮2g。
实施例15
蝉花子实体4g、陈皮1g。
实施例16
蝉花子实体0.8g、陈皮4g。
实施例17
蝉花子实体3g、太子参2g、黄芪5g、党参6g。
实施例18
蝉花孢子粉2g、太子参4g、黄芪3g、党参10g。
实施例19
蝉花子实体6g、太子参1g、黄芪8g、党参4g。
实施例20
蝉花子实体1g、太子参5g、黄芪2g、党参12g；
实施例21
蝉花孢子粉1g、当归5g、大枣5g。
实施例22
蝉花子实体0.8g、当归7g、大枣3g。
实施例23
蝉花子实体2g、当归3g、大枣8g。
实施例24
蝉花孢子粉0.5g、当归8g、大枣2g。
实施例25
蝉花子实体1.5g、当归2g、大枣10g。
实施例26
蝉花子实体3g、杜仲10g。
实施例27
蝉花孢子粉2g、杜仲12g。
实施例28
蝉花子实体6g、杜仲6g。
实施例29
蝉花孢子粉2g、熟地3g、玉竹5g、太子参5g、枸杞5g。
实施例30
蝉花子实体5g、熟地2g、玉竹8g、太子参2g、枸杞10g。
以上实施例11-30，按比例取各原料药，按实施例2方法制备成片剂。
药理实验表明，实施例1-30的组合物制剂均有明显改善血糖及血脂的作用。

Claims (8)

  1. 蝉花在制备具有降血脂作用的药物或保健品中的应用。
  2. 如权利要求1所述的应用，其特征在于，所述蝉花在制备具有降低总胆固醇、甘油三酯和低密度脂蛋白作用的药物或保健品中的应用。
  3. 如权利要求1或2所述的应用，其特征在于，所述蝉花为100％蝉花或蝉花提取物或有效部位。
  4. 如权利要求3所述的应用，其特征在于，所述提取物或有效部位为蝉花按常规方法提取制备得到，所述常规提取方法选自煎煮提取、超声提取、渗漉提取、浸渍提取、回流提取或水提醇沉，所述提取溶剂包括水或40～80％乙醇溶液。
  5. 如权利要求1或2所述的应用，其特征在于，所述蝉花与药食两用中药合用组成组合物，所述药食两用中药选自如下药物中的任意一种或几种，理气健脾药：陈皮、香附、枳实、玫瑰花、沙棘；补气药：人参、西洋参、太子参、党参、灵芝、山药、黄芪、白术、甘草、大枣、杜仲、核桃仁、红景天；补血药：当归、熟地、白芍、何首乌、阿胶；补阴药：百合、麦冬、石斛、玉竹、枸杞子、桑椹、黑芝麻；消食药：山楂、麦芽、谷芽；利水药：茯苓、薏仁、冬瓜皮；发散风热药：粉葛、薄荷、桑叶、菊花、柴胡；化瘀药：三七、茜草、蒲黄；安神药：酸枣仁、远志、合欢皮、绞股蓝；祛风湿药：刺五加、桑寄生。
  6. 如权利要求1或2所述的应用，其特征在于，所述蝉花为蝉花子实体或蝉花孢子粉。
  7. 如权利要求6所述的应用，其特征在于，所述蝉花为蝉花子实体。
  8. 如权利要求1-5任一项所述的应用，其特征在于，所述蝉花或其与药食两用中药合用组成的组合物制备成片剂、硬胶囊剂、软胶囊剂、颗粒剂、丸剂、散剂、口服液、吸入剂或注射剂。
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CN109876020A (zh) * 2019-03-26 2019-06-14 广东省微生物研究所（广东省微生物分析检测中心） 蝉花碱水提取物在制备治疗和/或预防肠道菌群失调症及相关疾病的制剂中的用途
CN113317503A (zh) * 2021-06-20 2021-08-31 王维义 一种基于蝉花子实体的降血糖组合物及其制备方法和应用
CN115429854A (zh) * 2022-10-17 2022-12-06 大时代生物工程(深圳)有限公司 一种烟草发酵制品加工工艺

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