WO2019228210A1 - Utilisation pharmaceutique de la composition comprenant radix astragali, radix puerariae et herba erigerontis - Google Patents

Utilisation pharmaceutique de la composition comprenant radix astragali, radix puerariae et herba erigerontis Download PDF

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WO2019228210A1
WO2019228210A1 PCT/CN2019/087605 CN2019087605W WO2019228210A1 WO 2019228210 A1 WO2019228210 A1 WO 2019228210A1 CN 2019087605 W CN2019087605 W CN 2019087605W WO 2019228210 A1 WO2019228210 A1 WO 2019228210A1
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composition
astragalus
parts
macular edema
extract
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PCT/CN2019/087605
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English (en)
Chinese (zh)
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白礼西
段俊国
孙克宏
秦少容
郑飞鸣
卿玉玲
黄静
张颖
刘世琪
王磊
原欢欢
冉亚东
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重庆太极实业（集团）股份有限公司
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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
    • 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
    • A61K36/481—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
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P27/00—Drugs for disorders of the senses
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P27/00—Drugs for disorders of the senses
    • A61P27/02—Ophthalmic agents
    • 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
    • A61P3/08—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

Definitions

  • the present application relates to a composition containing Astragalus, Puerariae and Erigeron breviscapus and its use. Specifically, the present application relates to the use of a composition containing Astragalus, Puerariae and Erigeron breviscapus in treating macular disease.
  • the macula is a shallow funnel-shaped depression with a diameter of about 2 mm located at the posterior pole of the retina.
  • a small depression in the center is a macular fovea.
  • the macular area is the main part of the visual signal produced by the retina. Any lesion in the macular area will affect vision and even lead to the serious consequences of blindness. With the development of medicine, the harm of traditional blinding eye diseases such as "cataract" has been greatly reduced, and the serious impact of macular diseases on vision has become more prominent.
  • Macular edema is a pathological change process caused by different intraocular diseases, which can be secondary to many diseases such as diabetes, uveitis, retinal vein occlusion, and cataract surgery.
  • Clinically diagnosed macular edema refers to the accumulation of fluid between cells in the central part of the macula, which can seriously threaten the central vision of patients, and is the main cause of vision loss caused by various eye diseases.
  • the long-term existence of macular edema will eventually lead to irreversible retinal atrophy and fibrosis, which will permanently lose central vision.
  • the present application provides the use of a composition comprising astragalus, kudzu root and breviscapine in the manufacture of a medicament for treating or preventing macular edema in an individual.
  • the present application provides a method for treating or preventing macular edema, which comprises administering to a subject a therapeutically or prophylactically effective amount of a composition comprising astragalus root, pueraria root, and breviscapine.
  • the present application provides a composition comprising astragalus root, pueraria root and breviscapine for treating or preventing macular edema.
  • the present application provides a composition comprising astragalus root, puerarin root, and breviscapine.
  • the aforementioned macular edema is macular edema.
  • the macular edema is diabetic macular edema.
  • the above composition and a pharmaceutically acceptable carrier are formulated into a pharmaceutically acceptable dosage form, preferably a capsule, oral solution, powder, tablet, granule, pill, syrup or eye drop, More preferably, it is a capsule.
  • the above composition is administered orally, eye drops, enemas, subcutaneously, intramuscularly or intraperitoneally, and preferably the composition is administered orally.
  • the composition is administered at a dose of 30 to 100 mg / kg body weight, preferably 50 to 70 mg / kg body weight per day.
  • the composition is for oral administration 1 to 3 times per day, such as 2 or 3 times per day.
  • the composition is administered for a duration of 1 to 52 weeks, preferably 12-24 weeks, such as 24 weeks.
  • the above composition comprises the following raw materials in a weight ratio: 10-40 parts of astragalus, 10-30 parts of pueraria root, and 10-30 parts of breviscapine.
  • the above composition comprises the following active ingredients in a weight ratio: 1-10 parts of astragalus extract, 50-125 parts of pueraria root extract, and 20-60 parts of breviscapine extract.
  • the medicament of the present application is prepared from the raw materials of Astragalus, Puerariae and Erigeron breviscapus or the water or organic solvent extract of Astragalus, Puerariae and Erigeron breviscapus as active ingredients, and a pharmaceutically acceptable carrier Made.
  • the raw materials of Astragalus, Puerariae and Erigeron breviscapus are weighed in a certain weight ratio, and the extracts of Astragalus, Puerariae and Erigeron breviscapus are respectively prepared, and other active ingredients or pharmacy are added according to the preparation method of the traditional dosage form of traditional Chinese medicine.
  • the acceptable carriers are made into different dosage forms, such as capsules, tablets, granules, pills, eye drops and other dosage forms.
  • OCT optical coherence tomography
  • Figure 3 is the change in macular foveal thickness in the eyes of patients with macular edema detected by OCT, which shows that the eyes of each group were treated with high dose, medium dose, low dose composition and placebo for 12 weeks and 24 weeks, respectively.
  • composition comprising astragalus, kudzu root and breviscapine is capable of treating or preventing macular edema, such as diabetic macular edema.
  • the application provides the use of a composition comprising astragalus root, pueraria root and breviscapine in the manufacture of a medicament for treating macular edema.
  • the macular edema is macular edema. In certain embodiments, the macular edema is diabetic macular edema.
  • Macular cystoid edema is a common fundus disease, but it is not an independent disease, but a manifestation of many fundus diseases in the macula.
  • Common diseases that cause macular cystoid edema include: retinal vein occlusion, diabetic retinopathy, retinal vasculitis, premacular retinal membrane of the macula, retinal capillary telangiectasia or Coats disease, uveitis, cataract or other internal eye surgery, etc. .
  • Diabetic macular edema refers to retinal thickening or hard exudative deposits caused by the accumulation of extracellular fluid in the diameter of the optic disc within a range of optic disc diameter caused by diabetes. Diabetic macular edema is a common cause of visual impairment in diabetic patients.
  • treatment includes inhibiting, curing, reducing, relieving or delaying macular edema and related symptoms.
  • the composition of the present application is formulated with a pharmaceutically acceptable carrier into a pharmaceutically acceptable dosage form, preferably an eye drop, an oral solution, a capsule, a tablet or a granule, more preferably a capsule .
  • “Pharmaceutically acceptable carrier” refers to carriers that do not interfere with the effectiveness of the biological activity of the active ingredient, including those routinely used in the pharmaceutical field.
  • the pharmaceutically acceptable carrier of the present application may be a solid or a liquid, and includes pharmaceutically acceptable excipients, buffers, emulsifiers, stabilizers, preservatives, diluents, encapsulants, fillers, and the like.
  • pharmaceutically acceptable buffers include phosphates, acetates, citrates, borates, carbonates, and the like.
  • compositions of the present application may be presented in unit dosage form and may be prepared by any method known in the pharmaceutical art. All methods include the step of combining the active ingredient of the present application with one or more pharmaceutically acceptable carriers. Generally, the composition is prepared by combining the active ingredient with a liquid carrier, a solid carrier, or both, and then the prepared product is shaped as required. The specific method of formulation will depend on the route of administration chosen. In some embodiments, the composition can be manufactured by conventional mixing, dissolving, granulating, tabletting, milling, emulsifying, encapsulating, capturing, or lyophilizing methods.
  • the composition is administered orally, eye drops, enemas, subcutaneously, parenterally, intravenously, intraarterially, intracranially, intrathecally, intraperitoneally, topically, intranasally, or intramuscularly.
  • the combination is administered orally.
  • a composition such as the present application can be formulated with capsules, tablets, pills, lozenges, liquids, gels, syrups, slurries, Suspension, etc.
  • suitable excipients include bulking agents such as sugars such as lactose, sucrose, mannitol, and sorbitol; cellulose formulations such as corn starch, wheat starch, rice Starch, potato starch, gelatin, tragacanth, methyl cellulose, carboxypropyl methyl cellulose, sodium carboxymethyl cellulose and / or povidone; granulating agents and binders and the like.
  • disintegrating agents may be added, such as the cross-linked polyvinyl pyrrolidone, agar, or alginic acid or a salt thereof such as sodium alginate.
  • solid dosage forms can be sugar coated or enteric coated using standard techniques.
  • suitable carriers, excipients or diluents include water, glycerol, oil, alcohol.
  • flavoring agents, preservatives, colorants, and the like can be added.
  • the composition of the present application is administered at a dose of 30 to 100 mg / kg body weight per day, preferably 40-80 mg / kg body weight, more preferably 50-70 mg / kg body weight, such as 30, 35, 40, 45, 50, 55, 60, 65, 70, 75, 80, 85, 90, 95, 100 mg / kg body weight or a dose between any two of the above values.
  • the composition is administered 1, 2, 3, 4 or more times per day, and the composition can also be administered less than 1 time per day, for example, every 2, 3, 4, 5 , 6, 7, 8, 9, 10, 11, 12, 13, or 14 days, or every 1 or 2 weeks, or a range defined by any of the foregoing values.
  • the number of daily administrations is constant (e.g., 2 or 3 times daily). In other embodiments, the number of administrations is variable. The number of dosing may be based on the effectiveness of the composition, the observed side effects, the particular route of administration, the particular characteristics of the individual, the history and risk factors (such as age, weight and general health, etc.), another medication-related change, or the dosage form And change.
  • the composition is administered for a duration of 1-52 weeks, such as 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24, 32, 36, 48, or 52 weeks, or the number of weeks between any two of the above, or about the time period described.
  • the composition is administered continuously for 12 weeks, 16 weeks, 18 weeks, 20 weeks, 22 weeks, 24 weeks, or more weeks. In some embodiments, the composition is administered continuously until the individual no longer requires treatment.
  • the present application provides a method of treating or preventing macular edema, comprising administering to a subject a therapeutically effective or preventatively effective amount of a composition comprising astragalus root, puerarin root, and breviscapine.
  • a therapeutically effective or prophylactically effective composition comprising astragalus root, pueraria root and breviscapine in treating or preventing macular edema in an individual.
  • the "therapeutically effective amount” or “prophylactically effective amount” can be determined according to specific circumstances, and those skilled in the art can easily grasp the actual required dosage, for example, according to the patient's weight, age and condition. determine.
  • a pharmaceutically acceptable carrier included in the composition, they can be mixed according to a conventional method in the pharmaceutical field to prepare a desired drug.
  • a composition comprising astragalus root, puerarin root, and breviscapine can improve the vision of a patient with macular edema.
  • the macular edema is diabetic macular edema.
  • the efficacy of the above-mentioned composition for improving the vision of patients with macular edema presents a certain dose-response relationship.
  • a composition comprising astragalus root, pueraria radiata and breviscapine can be used to reduce the thickness of the macular fovea in an individual with macular edema and / or reduce the volume of the macular fovea in an individual with macular edema, Thereby improving the degree of macular edema.
  • the individual has diabetic macular edema.
  • the individual is at risk for diabetic macular edema.
  • the composition of the present application has a dose-effect relationship in reducing the thickness of the macular fovea and / or reducing the volume of the macular fovea.
  • the effect of the composition of the present application in reducing the thickness of the macular fovea becomes more pronounced as the course of treatment is prolonged.
  • a composition comprising astragalus root, pueraria root and breviscapine is capable of reducing intraocular pressure in a subject suffering from macular edema.
  • the individual has diabetic macular edema.
  • the individual is at risk for diabetic macular edema.
  • the difference of the effect of the composition of the present application on reducing intraocular pressure in patients with macular edema compared with the placebo-treated group becomes more significant with time.
  • the composition comprising astragalus root, pueraria root and breviscapine in the present application has no significant difference in the incidence of adverse events and adverse reactions compared with the placebo group in the treatment of macular edema in an individual, indicating that The medicine of the present application has no obvious toxic and side effects in the treatment of macular edema and has high safety.
  • “Individual” as used herein refers to mammals, including primates and non-primates, such as humans, apes, monkeys, cows, horses, pigs, sheep, goats, dogs, cats, and rats such as rats And mouse rodents and more.
  • the present application provides a composition comprising astragalus root, pueraria root and breviscapine.
  • the above composition is used to treat or prevent macular edema in an individual.
  • the composition of the present application is prepared from raw materials containing the following weight ratios: 10-40 parts of astragalus, 10-30 parts of pueraria root, and 10-30 parts of breviscapine.
  • the composition of the present application is prepared from raw materials containing the following weight ratios: 20-30 parts of astragalus root, 20-40 parts of pueraria root, and 20-30 parts of breviscapine.
  • the composition of the present application is prepared from raw materials containing the following weight ratios: 20 parts of astragalus, 30 parts of pueraria root, and 20 parts of breviscapine.
  • the composition of the present application is prepared from the raw materials of Astragalus membranaceus, Pueraria flavescens, Erigeron breviscapus or water or organic solvent extract as the active ingredient, plus a pharmaceutically acceptable excipient or auxiliary ingredient.
  • the composition comprises the following weight ratio components: 1-10 parts of astragalus extract, 50-125 parts of kudzu root extract, and 20-60 parts of breviscapine extract.
  • the composition comprises astragalus root extract, puerarin root extract, erigeron root extract, wherein puerarin root extract contains no less than 60% of total isoflavones based on puerarin, and no less than puerarin 20%; Astragalus extract contains no less than 50% of total saponin based on astragaloside IV and no less than 5% of astragaloside IV; flavescens extract contains no less than 35% of total flavonoids based on rutin. Baicalin is not less than 3%.
  • the weight ratio of the composition is: 1-10 parts of astragalus extract, 50-125 parts of kudzu root extract, and 20-60 parts of erigeron extract.
  • the weight ratio of the composition is: 1 part of astragalus extract, 70 parts of kudzu root extract, and 25 parts of erigeron extract.
  • the present application includes a method for preparing a composition of astragalus, pueraria, and breviscapine, including the following steps:
  • Pueraria pulverized into coarse powder extracted with 60-95% ethanol, filtered, combined filtrates, recovered ethanol, concentrated, passed through a macroporous adsorption resin column, eluted with water, discarded the water eluent, and then used 10-95 % Ethanol elution, collecting the ethanol eluate, recovering the ethanol, concentrating into a thick paste, drying under reduced pressure, pulverizing into a fine powder to obtain a kudzu root extract;
  • Astragalus is pulverized into coarse powder, and extracted by heating under reflux with 60-95% ethanol, filtered, combined filtrates, recovered ethanol, concentrated, added sodium hydroxide to an alkali content of 2-5%, dynamic extraction with n-butanol 2 -5 times, combine n-butanol solution, wash with 2-5% sodium hydroxide solution, then wash with water, discard the washing solution, combine n-butanol solution, concentrate under reduced pressure to near dry, add acetone and wash until light color, The precipitate was dried under reduced pressure and pulverized into a fine powder to obtain astragalus extract;
  • Erigeron breviscapus decoction combined with decoction, filtered, concentrated and passed through a macroporous adsorption resin column, eluted with water, discard the water eluent, continue to elute with 10-95% ethanol, collect ethanol to elute Liquid, recovered ethanol, concentrated into a thick paste, dried under reduced pressure, and pulverized into a fine powder to obtain Erigeron breviscapus extract;
  • Astragalus extract, Pueraria lobata extract and Erigeron breviscapus extract prepared in steps b, c and d are mixed, and a pharmaceutically acceptable carrier is added to prepare a commonly used pharmaceutical preparation.
  • the weight ratio of the raw materials may be 20-30 parts of astragalus root, 20-40 parts of pueraria root, and 20-30 parts of breviscapine.
  • Astragalus can be 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, or 30 servings
  • Pueraria can be 20, 22, 24, 26, 28, 30, 32, 34, 36, 38 Or 40 servings
  • Erigeron breviscapus can be 20, 21, 22, 23, 24, 25, 26, 27, 28, 29 or 30 servings.
  • the weight ratio of the raw materials may be 20 parts of astragalus, 30 parts of kudzu root, and 20 parts of breviscapine.
  • the drug raw materials of the present application can be prepared into a commonly used pharmaceutical preparation.
  • the obtained dry powder with three flavors as the main component is added into the auxiliary dosage form according to the traditional preparation method of traditional Chinese medicine to make different dosage forms, such as tablets, granules, pills, capsules and eye drops.
  • 30 kg of astragalus root, 40 kg of pueraria root, and 30 kg of breviscapine are directly weighed to obtain powder.
  • 1 kg of the above-mentioned astragalus extract, 50 kg of pueraria root extract, and 30 kg of breviscapus extract are mixed, starch is added, granulated, whole granulated, magnesium stearate is added, and tablets are obtained to obtain tablets.
  • 10 kg of the above-mentioned Astragalus extract, 125 kg of Pueraria root extract, and 60 kg of Erigeron breviscapus extract are mixed, and starch is added, granulated and whole granulated, and capsules are directly filled to obtain capsules.
  • 2 kg of the above-mentioned Astragalus extract, 80 kg of Pueraria root extract, and 40 kg of Erigeron breviscapus are mixed, starch is added, granulated and whole granulated, and capsules are directly filled to obtain pharmaceutical granules.
  • 30 kg of astragalus root, 40 kg of pueraria root and 30 kg of breviscapine are extracted according to the method described above, 20 kg of rehmannia glutinosa, 20 kg of wolfberry, 15 kg of cassia seeds, and 20 kg of weiweizi are boiled in water, concentrated, and then the above substances Mix, add starch, granulate, and granulate, add magnesium stearate, and tablet to obtain tablets.
  • the method for preparing the composition of the present application can also refer to the method in Chinese Patent CN100594913C, the entire contents of which are incorporated herein by reference in its entirety.
  • Example 1 Preparation of a composition comprising astragalus root, pueraria root and breviscapine
  • Astragalus was pulverized into a coarse powder, and heated and refluxed for three times with 90% ethanol for 1 hour each time, filtered, and the filtrates were combined, the ethanol was recovered, appropriately concentrated, sodium hydroxide was added to an alkali content of 5%, and n-butanol was added for dynamic extraction 2 times, combine the n-butanol solution, wash once with 5% sodium hydroxide solution, wash twice with water, discard the washing solution, combine the n-butanol solution, concentrate under reduced pressure to near dry, grind and wash with acetone until the color is light, take The precipitate was dried under reduced pressure and pulverized into a fine powder to obtain astragalus extract;
  • Erigeron breviscapus was decoated three times with water for 1 hour each time, combined with the decoction, filtered, and appropriately concentrated, added to the treated large-pore adsorption resin column, eluted with water, discarded the water eluent, and continued to use 70 Ethanol eluting, collecting the ethanol eluate, recovering the ethanol, concentrating into a thick paste, drying under reduced pressure, crushing into fine powder to obtain Erigeron breviscapus extract;
  • the above three fine powders are mixed with sodium carboxymethyl starch, hydroxypropyl cellulose, micronized silica gel, and magnesium stearate, and filled into capsules to obtain a composition containing astragalus root, pueraria root, and erigeron root.
  • Example 2 Therapeutic effect of the composition of the present application on diabetic macular edema
  • the dosage of each group is as follows, the course of treatment is 24 weeks:
  • Group A is a high-dose group. Each time, 4 capsules prepared according to the method described in Example 1 are administered 3 times a day. The daily dose is 66 mg / kg body weight / day.
  • Group B is a medium-dose group. Each time, 2 capsules prepared according to the method described in Example 1 are administered 3 times a day, and the daily dose is 33 mg / kg body weight / day.
  • Group C is a low-dose group, each capsule is prepared in accordance with the method described in Example 1 three times a day, the daily dose is 16.5mg / kg body weight / day;
  • Group D is a placebo group. Each time a preparation made of rice as a raw material without any active pharmaceutical ingredient is administered 3 times a day, the daily dose is 66 mg / kg body weight / day.
  • the basic hypoglycemic drugs are biguanides, sulfonylureas, insulin and insulin sensitizers;
  • OCT Optical coherence tomography
  • Optical coherence tomography was performed on the affected eyes of patients with macular edema, and the indexes of optical coherence tomography included foveal thickness and neuroepithelial volume (refer to 6mm area thickness and neuroepithelial volume).
  • composition of the present application on macular edema
  • composition of the present application improves the vision of eyes with macular edema
  • the visual acuity of four groups of target eyes with clinically diagnosed macular edema was examined, including 7 patients in the high-dose group, 11 patients in the middle-dose group, and 7 patients in the low-dose group. 13 patients in the drug group. The results are shown in Figure 1. After 12 weeks and 24 weeks of taking the drug, the patients in the high-dose and middle-dose groups showed significant improvement in vision. And 4.91, while the number of characters with improved visual acuity in the placebo group was only 1.69.
  • the data in FIG. 1 show that the composition of the present application can improve the vision of patients with macular edema, and present a certain dose and time-dependent effect.
  • the eyes of four groups of macular edema patients are examined by optical coherence tomography to obtain the foveal thickness (CRT).
  • CRT foveal thickness
  • the eyes of each group with a CRT greater than 270 ⁇ m at the time of enrollment were treated with the corresponding doses. After 24 weeks of treatment, the proportion of eyes with 5 characters in each group was increased. The results are shown in Figure 2.
  • the composition of the present application can significantly improve the vision of eyes with macular edema with a CRT greater than 270 ⁇ m, and the proportion of 5 characters in the high-dose group and the middle-dose group is significantly higher than that in the placebo group.
  • the high-dose group 24 cases
  • the medium-dose group 15 cases
  • the proportion of 5 characters by as much as 53% which was much higher than the placebo group's 17%.
  • the p-value of the medium-dose group was 0.058 and the p-value of the high-dose group was 0.130 by applying the stata chi-square test.
  • the eyes of four groups of target eyes with clinically diagnosed macular edema were examined by optical coherence tomography, and the changes in the thickness of the macular fovea were obtained.
  • Data processing was performed using SAS software.
  • the comparison between groups before and after treatment was performed using the symbol rank test, and the comparison between the four groups after treatment (high, medium, low dose and placebo groups) was performed using the Kruskal-Wallis test.
  • the change in foveal thickness reflects a quantitative effect relationship.
  • the high-dose group can significantly reduce the thickness of foveal eyes in patients with macular edema, and the middle and low-dose groups also have a certain effect.
  • the difference between the treatment group and the placebo group tends to increase (P value decreases) with the duration of the treatment. For example, the P value at 12 weeks is 0.4431 and the P value at 24 weeks is 0.1530.
  • the inventors also expanded the number of samples and studied the effect of the composition of the present application on the thickness of the fovea of the eyes of patients with diabetic retinopathy, including the above-mentioned patients.
  • the results of this study are related to the above-mentioned macular edema only.
  • the results of the patients were similar: there was a certain dose-effect trend, the differences between the groups were more obvious, and the difference increased with time (P value decreased), especially the high-dose and placebo differences were consistent.
  • the inventors have further studied the effect of the composition of the present application on the intraocular pressure of eyes with macular edema.
  • the results show that the composition of the present application can obviously reduce the intraocular pressure of patients with macular edema, and presents a certain dose-effect relationship as a whole.
  • the intraocular pressure of the affected eyes is obvious after taking the drug for 12 weeks and 24 weeks. decline.
  • the composition of the present application has a good effect in treating diabetic macular edema.
  • the above results also demonstrate the effect of the composition of the present application in improving intraocular microcirculation. Because intraocular pressure, foveal thickness, and volume are all key indicators of the edema state of the eyeball, the decrease in intraocular pressure combined with changes in foveal thickness or volume indicates that the edema of the eyeball has been improved, and this improvement effect varies with There is an increasing trend over time.

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  • Hematology (AREA)
  • Endocrinology (AREA)
  • Medicinal Preparation (AREA)

Abstract

L'invention concerne une utilisation d'une composition comprenant Radix Astragali, Radix Puerariae et Herba Erigerontis dans la préparation d'un médicament pour le traitement ou la prévention d'un oedème maculaire chez un individu.
PCT/CN2019/087605 2018-05-28 2019-05-20 Utilisation pharmaceutique de la composition comprenant radix astragali, radix puerariae et herba erigerontis WO2019228210A1 (fr)

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WO2021195904A1 (fr) * 2020-03-31 2021-10-07 重庆太极实业（集团）股份有限公司 Utilisation d'une composition contenant astragali radix, puerariae lobatae radix et erigerontis herba

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CN101032550A (zh) * 2006-06-16 2007-09-12 成都中医药大学 治疗糖尿病及其并发症的药物组合物及其制备方法和用途

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CN101036708A (zh) * 2006-03-14 2007-09-19 广东奇方药业有限公司 治疗心脑血管疾病的药物组合物

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