CN113413412A - A composition containing oxymatrine and its application in preparing medicine for treating heart disease - Google Patents
A composition containing oxymatrine and its application in preparing medicine for treating heart disease Download PDFInfo
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- CN113413412A CN113413412A CN202110600195.3A CN202110600195A CN113413412A CN 113413412 A CN113413412 A CN 113413412A CN 202110600195 A CN202110600195 A CN 202110600195A CN 113413412 A CN113413412 A CN 113413412A
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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
- A61K36/489—Sophora, e.g. necklacepod or mamani
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
- A61K31/4353—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom ortho- or peri-condensed with heterocyclic ring systems
- A61K31/4375—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom ortho- or peri-condensed with heterocyclic ring systems the heterocyclic ring system containing a six-membered ring having nitrogen as a ring heteroatom, e.g. quinolizines, naphthyridines, berberine, vincamine
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- 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
- A61P9/10—Drugs for disorders of the cardiovascular system for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/30—Extraction of the material
- A61K2236/33—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
- A61K2236/333—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using mixed solvents, e.g. 70% EtOH
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/30—Extraction of the material
- A61K2236/35—Extraction with lipophilic solvents, e.g. Hexane or petrol ether
Abstract
The invention relates to the technical field of medicines, and particularly discloses a composition containing oxymatrine and application thereof in preparing a medicine for treating heart diseases. The composition containing oxymatrine is characterized by comprising a sophora flavescens extract and oxymatrine. The sophora flavescens extract is prepared by a method comprising the following steps: (1) extracting radix Sophorae Flavescentis with ethanol to obtain radix Sophorae Flavescentis ethanol extract; (2) suspending the ethanol extract of radix Sophorae Flavescentis with water, and extracting with ethyl acetate to obtain ethyl acetate extract; (3) and (3) passing the ethyl acetate extract through a silica gel column, eluting by adopting a mixed organic solvent, collecting an eluted part, concentrating and drying to obtain the sophora flavescens extract. Research shows that the composition obtained by combining the sophora flavescens extract prepared by the method with oxymatrine has excellent effect of treating ischemic heart disease.
Description
Technical Field
The invention relates to the technical field of medicines, in particular to a composition containing oxymatrine and application thereof in preparing a medicine for treating heart diseases.
Background
Ischemic heart disease is a heart disease caused by myocardial ischemia and hypoxia due to changes in coronary circulation. Among all chronic diseases, the first lethal cause is ischemic heart disease; in the medicines for treating ischemic heart diseases, western medicines play an important role. But the western medicines have large toxic and side effects and are not suitable for long-term administration; therefore, the development of a medicament for treating ischemic heart disease by using traditional Chinese medicines as raw materials has important significance.
Kuh-seng, name of traditional Chinese medicine; is the dried root of Sophora flavescens ait of Leguminosae, and has the effects of clearing heat, eliminating dampness, killing parasite, and promoting urination. Can be used for treating dysentery, hematochezia, jaundice, anuria, leucorrhea with red and white discharge, pudendal swelling, pudendal pruritus, eczema, skin pruritus, scabies, tinea, leprosy, and trichomonal vaginitis. Because the single use of the sophora flavescens has poor treatment effect on heart diseases, the prior art usually combines the sophora flavescens with a plurality of other traditional Chinese medicinal materials to treat the heart diseases. Therefore, it is of great significance to develop a composition having an excellent therapeutic effect on heart diseases, using sophora flavescens as a raw material.
Disclosure of Invention
In order to overcome the defect of the variety of the medicaments for treating heart diseases from the traditional Chinese medicine sources, the invention provides a composition containing oxymatrine; the oxymatrine-containing composition has an excellent effect of treating heart diseases.
The technical problem to be solved by the invention is realized by the following technical scheme:
a composition containing oxymatrine comprises radix Sophorae Flavescentis extract and oxymatrine.
The inventor surprisingly discovers in the research that the treatment effect of the sophora flavescens extract prepared by the method of the invention and oxymatrine on ischemic heart disease is better than that of the sophora flavescens extract prepared by the method of the invention and oxymatrine which is a monomer compound, and the excellent effect of treating ischemic heart disease is achieved; the active ingredient in the sophora flavescens extract prepared by the method of the invention and oxymatrine play a role in synergistically treating ischemic heart disease.
Preferably, the mass ratio of the sophora flavescens extract to the oxymatrine is 5-10: 1.
further preferably, the mass ratio of the sophora flavescens extract to the oxymatrine is 6-8: 1.
most preferably, the mass ratio of the sophora flavescens extract to the oxymatrine is 7: 1.
preferably, the sophora flavescens extract is prepared by a method comprising the following steps:
(1) extracting radix Sophorae Flavescentis with ethanol to obtain radix Sophorae Flavescentis ethanol extract;
(2) suspending the ethanol extract of radix Sophorae Flavescentis with water, and extracting with ethyl acetate to obtain ethyl acetate extract;
(3) and (3) passing the ethyl acetate extract through a silica gel column, eluting by adopting a mixed organic solvent, collecting an eluted part, concentrating and drying to obtain the sophora flavescens extract.
Preferably, the extraction in the step (1) is heating reflux extraction, and the extraction time is 1-2 h; the ethanol is 70-95% by volume.
Preferably, the dosage ratio of the radix sophorae flavescentis to the ethanol is 1g: 5-15 mL.
Preferably, the specific method for elution by using the mixed organic solvent in the step (3) is as follows:
eluting with a mixed organic solvent composed of cyclohexane and ethyl acetate in a volume ratio of 95-90: 5-10 to remove impurities, and then eluting with a mixed organic solvent composed of cyclohexane and ethyl acetate in a volume ratio of 87-85: 13-15; collecting the eluted part eluted by the mixed organic solvent consisting of cyclohexane and ethyl acetate in a volume ratio of 87-85: 13-15, concentrating and drying to obtain the sophora flavescens extract.
Further preferably, the specific method for eluting with the mixed organic solvent in the step (3) is as follows:
eluting with a mixed organic solvent consisting of cyclohexane and ethyl acetate in a volume ratio of 93:7 to remove impurities, and then eluting with a mixed organic solvent consisting of cyclohexane and ethyl acetate in a volume ratio of 86: 14; collecting the eluted part eluted by the mixed organic solvent of cyclohexane and ethyl acetate with the volume ratio of 86:14, concentrating and drying to obtain the sophora flavescens extract.
Further preferably, the specific method for eluting with the mixed organic solvent in the step (3) is as follows:
eluting with a mixed organic solvent composed of cyclohexane and ethyl acetate, wherein the volume ratio of the cyclohexane to the ethyl acetate is 95-90: 5-10 by 3-5 times of the column volume, and then eluting with a mixed organic solvent composed of cyclohexane and ethyl acetate, wherein the volume ratio of the cyclohexane to the ethyl acetate is 87-85: 13-15 by 5-8 times of the column volume; collecting the eluted part eluted by the mixed organic solvent consisting of cyclohexane and ethyl acetate in a volume ratio of 87-85: 13-15, concentrating and drying to obtain the sophora flavescens extract.
Most preferably, the mixed organic solvent composed of cyclohexane and ethyl acetate with the volume ratio of 93:7 is used for eluting and impurity removal at first, and then the mixed organic solvent composed of cyclohexane and ethyl acetate with the volume ratio of 86:14 is used for eluting at second, wherein the volume ratio of the mixed organic solvent is 4 times of the column volume; collecting the eluted part eluted by the mixed organic solvent of cyclohexane and ethyl acetate with the volume ratio of 86:14, concentrating and drying to obtain the sophora flavescens extract.
The inventor researches show that in the preparation process of the sophora flavescens extract, the elution condition of a silica gel column is very critical to whether effective components with the effect of treating the ischemic heart disease can be obtained; the effect of the composition obtained by combining the sophora flavescens extract and the oxymatrine prepared by the method of the invention on treating the ischemic heart disease is superior to that of the composition obtained by singly using the sophora flavescens extract or singly using the oxymatrine, and the effect of synergistically treating the ischemic heart disease can be realized. The composition obtained by combining the sophora flavescens extract and the oxymatrine prepared by adopting the elution condition of other silica gel columns has smaller therapeutic effect on ischemic heart disease than the composition of the invention and smaller therapeutic effect than the oxymatrine; does not exhibit a synergistic effect in treating ischemic heart diseases.
The invention also provides application of the oxymatrine-containing composition in preparing a medicine for treating heart diseases.
Preferably, the heart disease is ischemic heart disease.
Has the advantages that: the invention provides a brand-new composition containing oxymatrine; research shows that the composition obtained by combining the sophora flavescens extract prepared by the method with oxymatrine has excellent effect of treating ischemic heart disease.
Detailed Description
The present invention will be described in further detail with reference to specific examples, but the present invention is not limited to these examples in any way.
EXAMPLE 1 preparation of oxymatrine-containing composition
Mixing the sophora flavescens extract and oxymatrine according to the mass ratio of 7:1, uniformly mixing to obtain the composition containing the oxymatrine;
the sophora flavescens extract is prepared by the following method:
(1) heating and refluxing a traditional Chinese medicine radix sophorae flavescentis with 95% ethanol by volume for 1.5 hours to obtain an extracting solution, and concentrating and drying the extracting solution to obtain a radix sophorae flavescentis ethanol extract; wherein the dosage ratio of the radix sophorae flavescentis to the ethanol is 1g to 10 mL;
(2) suspending the ethanol extract of radix Sophorae Flavescentis with water, adding ethyl acetate for extraction, concentrating the ethyl acetate extractive solution, and drying to obtain ethyl acetate extract; wherein the dosage ratio of the sophora flavescens ethanol extract to the water and the ethyl acetate is 1g:50mL:50 mL;
(3) passing the ethyl acetate extract through a silica gel column (the mass of the silica gel in the silica gel column is 30 times of that of the ethyl acetate extract; the silica gel is 200-300 meshes), eluting with a mixed organic solvent composed of cyclohexane and ethyl acetate with a volume ratio of 93:7 of 4 times of the column volume to remove impurities, and then eluting with a mixed organic solvent composed of cyclohexane and ethyl acetate with a volume ratio of 86:14 of 6 times of the column volume; collecting the eluted part eluted by the mixed organic solvent of cyclohexane and ethyl acetate with the volume ratio of 86:14, concentrating and drying to obtain the sophora flavescens extract.
EXAMPLE 2 preparation of oxymatrine-containing composition
Mixing the sophora flavescens extract and oxymatrine according to the mass ratio of 10: 1, uniformly mixing to obtain the composition containing the oxymatrine;
the sophora flavescens extract is prepared by the following method:
(1) heating and refluxing traditional Chinese medicine radix sophorae flavescentis with ethanol with the volume fraction of 70% for 2 hours to obtain an extracting solution, and concentrating and drying the extracting solution to obtain an ethanol extract of the radix sophorae flavescentis; wherein the dosage ratio of the radix sophorae flavescentis to the ethanol is 1g to 15 mL;
(2) suspending the ethanol extract of radix Sophorae Flavescentis with water, adding ethyl acetate for extraction, concentrating the ethyl acetate extractive solution, and drying to obtain ethyl acetate extract; wherein the dosage ratio of the sophora flavescens ethanol extract to the water and the ethyl acetate is 1g:30mL:30 mL;
(3) passing the ethyl acetate extract through a silica gel column (the mass of the silica gel in the silica gel column is 30 times of that of the ethyl acetate extract; the silica gel is 200-300 meshes), eluting with a mixed organic solvent composed of cyclohexane and ethyl acetate with a volume ratio of 95:5 of 5 times of the column volume to remove impurities, and then eluting with a mixed organic solvent composed of cyclohexane and ethyl acetate with a volume ratio of 87:13 of 8 times of the column volume; collecting the eluted part eluted by the mixed organic solvent consisting of cyclohexane and ethyl acetate with the volume ratio of 87:13, concentrating and drying to obtain the sophora flavescens extract.
EXAMPLE 3 preparation of oxymatrine containing composition
Mixing the sophora flavescens extract and oxymatrine according to a mass ratio of 5:1, uniformly mixing to obtain the composition containing the oxymatrine;
the sophora flavescens extract is prepared by the following method:
(1) heating and refluxing a traditional Chinese medicine radix sophorae flavescentis with 80% ethanol by volume for 1 hour to obtain an extracting solution, and concentrating and drying the extracting solution to obtain a radix sophorae flavescentis ethanol extract; wherein the dosage ratio of the radix sophorae flavescentis to the ethanol is 1g to 8 mL;
(2) suspending the ethanol extract of radix Sophorae Flavescentis with water, adding ethyl acetate for extraction, concentrating the ethyl acetate extractive solution, and drying to obtain ethyl acetate extract; wherein the dosage ratio of the sophora flavescens ethanol extract to the water and the ethyl acetate is 1g:40mL:40 mL;
(3) loading the ethyl acetate extract into a silica gel column (the mass of the silica gel in the silica gel column is 30 times of that of the ethyl acetate extract; the silica gel is 200-300 meshes), eluting by using a mixed organic solvent composed of cyclohexane and ethyl acetate with the volume ratio of 90:10 of 3 times of the column volume to remove impurities, and then eluting by using a mixed organic solvent composed of cyclohexane and ethyl acetate with the volume ratio of 85:15 of 8 times of the column volume; collecting the eluted part eluted by the mixed organic solvent consisting of cyclohexane and ethyl acetate with the volume ratio of 85:15, concentrating and drying to obtain the sophora flavescens extract.
Comparative example 1 preparation of oxymatrine-containing composition
Mixing the sophora flavescens extract and oxymatrine according to the mass ratio of 7:1, uniformly mixing to obtain the composition containing the oxymatrine;
the sophora flavescens extract is prepared by the following method:
(1) heating and refluxing a traditional Chinese medicine radix sophorae flavescentis with 95% ethanol by volume for 1.5 hours to obtain an extracting solution, and concentrating and drying the extracting solution to obtain a radix sophorae flavescentis ethanol extract; wherein the dosage ratio of the radix sophorae flavescentis to the ethanol is 1g to 10 mL;
(2) suspending the ethanol extract of radix Sophorae Flavescentis with water, adding ethyl acetate for extraction, concentrating the ethyl acetate extractive solution, and drying to obtain ethyl acetate extract; wherein the dosage ratio of the sophora flavescens ethanol extract to the water and the ethyl acetate is 1g:50mL:50 mL;
(3) loading the ethyl acetate extract into a silica gel column (the mass of the silica gel in the silica gel column is 30 times of that of the ethyl acetate extract; the silica gel is 200-300 meshes), eluting and removing impurities by using a mixed organic solvent composed of cyclohexane and ethyl acetate with a volume ratio of 99:1 of 4 times of the column volume, and then eluting by using a mixed organic solvent composed of cyclohexane and ethyl acetate with a volume ratio of 96:4 of 6 times of the column volume; collecting the eluted part eluted by the mixed organic solvent consisting of cyclohexane and ethyl acetate with the volume ratio of 96:4, concentrating and drying to obtain the sophora flavescens extract.
Comparative example 1 is different from example 1 in that the silica gel elution condition of the sophora flavescens extract in comparative example 1 is different, and the elution condition is out of the range of the present invention. The silica gel elution conditions for comparative example 1 were: eluting and removing impurities by using a mixed organic solvent consisting of cyclohexane and ethyl acetate in a volume ratio of 99: 1; eluting with a mixed organic solvent composed of cyclohexane and ethyl acetate at a volume ratio of 96:4, collecting the eluted part eluted with the mixed organic solvent composed of cyclohexane and ethyl acetate at a volume ratio of 96:4, concentrating, and drying to obtain the radix Sophorae Flavescentis extract; in the embodiment 1, a mixed organic solvent consisting of cyclohexane and ethyl acetate with the volume ratio of 93:7 is used for eluting and impurity removal; eluting with a mixed organic solvent composed of cyclohexane and ethyl acetate with a volume ratio of 86:14, collecting the eluted part eluted with the mixed organic solvent composed of cyclohexane and ethyl acetate with a volume ratio of 86:14, concentrating and drying to obtain the radix Sophorae Flavescentis extract.
Comparative example 2 preparation of oxymatrine-containing composition
Mixing the sophora flavescens extract and oxymatrine according to the mass ratio of 7:1, uniformly mixing to obtain the composition containing the oxymatrine;
the sophora flavescens extract is prepared by the following method:
(1) heating and refluxing a traditional Chinese medicine radix sophorae flavescentis with 95% ethanol by volume for 1.5 hours to obtain an extracting solution, and concentrating and drying the extracting solution to obtain a radix sophorae flavescentis ethanol extract; wherein the dosage ratio of the radix sophorae flavescentis to the ethanol is 1g to 10 mL;
(2) suspending the ethanol extract of radix Sophorae Flavescentis with water, adding ethyl acetate for extraction, concentrating the ethyl acetate extractive solution, and drying to obtain ethyl acetate extract; wherein the dosage ratio of the sophora flavescens ethanol extract to the water and the ethyl acetate is 1g:50mL:50 mL;
(3) loading the ethyl acetate extract into a silica gel column (the mass of the silica gel in the silica gel column is 30 times of that of the ethyl acetate extract; the silica gel is 200-300 meshes), eluting with a mixed organic solvent composed of cyclohexane and ethyl acetate with a volume ratio of 85:15 of 4 times of the column volume to remove impurities, and then eluting with a mixed organic solvent composed of cyclohexane and ethyl acetate with a volume ratio of 80:20 of 6 times of the column volume; collecting the eluted part eluted by the mixed organic solvent consisting of cyclohexane and ethyl acetate with the volume ratio of 80:20, concentrating and drying to obtain the sophora flavescens extract.
Comparative example 2 is different from example 1 in that the silica gel elution condition of the sophora flavescens extract in comparative example 2 is different, and the elution condition is out of the range of the present invention. The silica gel elution conditions for comparative example 2 were: eluting and removing impurities by using a mixed organic solvent consisting of cyclohexane and ethyl acetate in a volume ratio of 85: 15; eluting with mixed organic solvent composed of cyclohexane and ethyl acetate at volume ratio of 80:20, collecting eluate part eluted with mixed organic solvent composed of cyclohexane and ethyl acetate at volume ratio of 80:20, concentrating, and drying to obtain radix Sophorae Flavescentis extract; in the embodiment 1, a mixed organic solvent consisting of cyclohexane and ethyl acetate with the volume ratio of 93:7 is used for eluting and impurity removal; eluting with a mixed organic solvent composed of cyclohexane and ethyl acetate with a volume ratio of 86:14, collecting the eluted part eluted with the mixed organic solvent composed of cyclohexane and ethyl acetate with a volume ratio of 86:14, concentrating and drying to obtain the radix Sophorae Flavescentis extract.
Comparative example 3 preparation of oxymatrine-containing composition
Mixing the sophora flavescens extract and oxymatrine according to the mass ratio of 7:1, uniformly mixing to obtain the composition containing the oxymatrine;
the sophora flavescens extract is prepared by the following method:
(1) heating and refluxing traditional Chinese medicine radix sophorae flavescentis with ethanol with the volume fraction of 15% for 1.5 hours to obtain an extracting solution, and concentrating and drying the extracting solution to obtain a radix sophorae flavescentis ethanol extract; wherein the dosage ratio of the radix sophorae flavescentis to the ethanol is 1g to 10 mL;
(2) suspending the ethanol extract of radix Sophorae Flavescentis with water, adding ethyl acetate for extraction, concentrating the ethyl acetate extractive solution, and drying to obtain ethyl acetate extract; wherein the dosage ratio of the sophora flavescens ethanol extract to the water and the ethyl acetate is 1g:50mL:50 mL;
(3) passing the ethyl acetate extract through a silica gel column (the mass of the silica gel in the silica gel column is 30 times of that of the ethyl acetate extract; the silica gel is 200-300 meshes), eluting with a mixed organic solvent composed of cyclohexane and ethyl acetate with a volume ratio of 93:7 of 4 times of the column volume to remove impurities, and then eluting with a mixed organic solvent composed of cyclohexane and ethyl acetate with a volume ratio of 86:14 of 6 times of the column volume; collecting the eluted part eluted by the mixed organic solvent of cyclohexane and ethyl acetate with the volume ratio of 86:14, concentrating and drying to obtain the sophora flavescens extract.
Comparative example 3 is different from example 1 in that in comparative example 3, ethanol with a volume fraction of 15% is used for heating reflux extraction; in example 1, ethanol with a volume fraction of 95% was used for the heating reflux extraction.
Examples of the experiments
(1) Rat model for ischemic heart disease
The molding method comprises the following steps: the SD rat is anesthetized and fixed, the rat hair in front of the chest is removed, an animal respirator is connected (the tidal volume is controlled to be 3mL/kg, the respiratory frequency is 100 times/min, the respiratory ratio is 1:1), the chest is opened between the 4 th and 5 th costa on the left side of the rat to expose the heart, the left coronary artery under the left auricle is ligated by a sterile suture needle with a thread, the thoracic cavity is closed after ligation, and the skin is sutured.
(2) Therapeutic effect of oxymatrine-containing composition on ischemic heart disease rats
The rats with ischemic heart disease obtained by molding according to the method are divided into a model group and an experimental group 1-13; meanwhile, setting a normal control group by taking normal SD rats, wherein each group comprises 10 rats; dissolving the oxymatrine-containing composition and the sophora flavescens extract prepared in the examples 1 to 3 and the comparative examples 1 to 3 by using a CMC-Na aqueous solution with the mass fraction of 1%; the experimental groups were administered by gavage for 7 days. Wherein the model group and the normal control group are respectively perfused with the CMC-Na aqueous solution with the same volume and the mass fraction of 1 percent. The left ventricular ejection fraction (EF%) and the short axis shortening (FS%) were measured 7 days after the administration using an ultrasonic apparatus, and the results are shown in table 1. The administration species in each experimental group were as follows:
experimental group 1: the oxymatrine composition of example 1 is administered by gavage at a dose of 20 mg/kg/d;
experimental group 2: the sophora flavescens extract prepared by the method in the embodiment 1 is administrated by gastric gavage according to the dosage of 20 mg/kg/d;
experimental group 3: the oxymatrine composition of example 2 is administered by gavage at a dose of 20 mg/kg/d;
experimental group 4: the sophora flavescens extract prepared by the method in the embodiment 2 is administrated by gastric gavage according to the dosage of 20 mg/kg/d;
experimental group 5: the oxymatrine composition of example 3 is administered by gavage at a dose of 20 mg/kg/d;
experimental group 6: the sophora flavescens extract prepared by the method in the embodiment 3 is administrated by gastric gavage according to the dosage of 20 mg/kg/d;
experimental group 7: the oxymatrine-containing composition described in the comparative example 1 is administered by gavage at a dose of 20 mg/kg/d;
experimental group 8: the sophora flavescens extract prepared by the method in the comparative example 1 is administrated by gastric gavage according to the dosage of 20 mg/kg/d;
experimental group 9: the oxymatrine composition described in the comparative example 2 is administered by gavage at a dose of 20 mg/kg/d;
experimental group 10: the sophora flavescens extract prepared by the method in the comparative example 2 is administrated by gastric gavage according to the dosage of 20 mg/kg/d;
experimental group 11: the oxymatrine composition described in the comparative example 3 is administered by gavage at the dosage of 20 mg/kg/d;
experimental group 12: the sophora flavescens extract prepared by the method in the comparative example 3 is administrated by gastric gavage according to the dosage of 20 mg/kg/d;
experimental group 13: the oxymatrine is administered by intragastric administration at a dosage of 20 mg/kg/d.
TABLE 1 therapeutic effect of oxymatrine-containing composition on ischemic heart disease rats
| Kind of administration | EF％ | FS％ | |
| Model set | - | 35.14 | 14.69 |
| Normal control group | - | 85.72 | 53.18 |
| Experimental group 1 | Oxymatrine containing composition as described in example 1 | 76.35 | 46.11 |
| Experimental group 2 | Sophora flavescens ait extract prepared by the method in example 1 | 62.24 | 35.45 |
| Experimental group 3 | Oxymatrine containing composition as described in example 2 | 68.75 | 40.52 |
| Experimental group 4 | Sophora flavescens ait extract prepared by the method in example 2 | 54.28 | 30.33 |
| Experimental group 5 | Oxymatrine containing composition as described in example 3 | 72.54 | 44.51 |
| Experimental group 6 | The Sophora flavescens Aiton extract prepared by the method of example 3 | 58.47 | 32.98 |
| Experimental group 7 | Oxymatrine-containing composition described in comparative example 1 | 46.25 | 25.64 |
| Experimental group 8 | Sophora flavescens ait extract prepared according to the method of comparative example 1 | 41.21 | 20.68 |
| Experimental group 9 | Composition containing oxymatrine described in comparative example 2 | 48.91 | 26.37 |
| Experimental group 10 | Sophora flavescens ait extract prepared according to the method of comparative example 2 | 44.35 | 24.39 |
| Experimental group 11 | Composition containing oxymatrine described in comparative example 3 | 43.16 | 22.01 |
| Experimental group 12 | Sophora flavescens ait extract prepared according to the method of comparative example 3 | 40.67 | 18.34 |
| Experimental group 13 | Oxymatrine | 51.17 | 28.78 |
As can be seen from the experimental data in Table 1, the EF% and FS% of the radix Sophorae Flavescentis extract prepared by the method of examples 1-3 are higher than those of oxymatrine; it is close to the normal group; this shows that the sophora flavescens extract prepared by the method of the invention has better therapeutic effect on ischemic heart disease than the monomer compound oxymatrine. In particular, the EF% and FS% of the composition containing oxymatrine, which is obtained by combining the sophora flavescens extract prepared by the method in the embodiment 1 to 3 and oxymatrine, are higher than those of the composition containing oxymatrine and prepared by singly using the sophora flavescens extract prepared by the method in the embodiment 1 to 3; this indicates that: the composition containing oxymatrine, which is obtained by combining the sophora flavescens extract prepared by the method and oxymatrine, has better treatment effect on ischemic heart disease than that of singly using the sophora flavescens extract prepared by the method and singly using monomer compound oxymatrine; the sophora flavescens extract prepared by the method of the invention and oxymatrine are combined to play a role in synergistically treating ischemic heart disease.
As can be seen from the experimental data in Table 1, the EF% and FS% of the Sophora flavescens extract prepared by the method of comparative examples 1-2 and the composition containing oxymatrine described in comparative examples 1-2 are less than that of oxymatrine and also less than that of the composition containing oxymatrine described in examples 1-3; this shows that the elution condition of the silica gel column in the preparation process of the sophora flavescens extract plays a very important role in whether the active ingredients with therapeutic effect on ischemic heart disease can be enriched. Only the sophora flavescens extract prepared under the condition of silica gel elution has higher therapeutic effect on ischemic heart disease than oxymatrine; the therapeutic effect of the sophora flavescens extract prepared under other silica gel elution conditions on ischemic heart disease is not higher than that of oxymatrine. And the composition obtained by combining the sophora flavescens extract prepared under other silica gel elution conditions with oxymatrine does not show the synergistic effect of treating ischemic heart disease.
As can be seen from the experimental data in Table 1, the EF% and FS% of the Sophora flavescens extract prepared by the method of comparative example 3 and the composition containing oxymatrine described in comparative example 3 are less than that of oxymatrine and are also less than that of the composition containing oxymatrine described in examples 1-3; this shows that the selection of the extraction solvent in the preparation of the Sophora flavescens extract plays an important role in the preparation of effective components having therapeutic effects on ischemic heart diseases. Only the lightyellow sophora root extract prepared by ethanol with the volume fraction of 70-95 percent has higher treatment effect on ischemic heart disease than oxymatrine; the therapeutic effect of the sophora flavescens extract prepared by adopting other ethanol with volume fraction on ischemic heart disease is not higher than that of oxymatrine. And the composition obtained by combining the sophora flavescens extract prepared by adopting ethanol with other volume fractions and oxymatrine does not show the effect of synergistically treating the ischemic heart disease.
Claims (9)
1. A composition containing oxymatrine is characterized by comprising a sophora flavescens extract and oxymatrine.
2. The oxymatrine-containing composition according to claim 1, wherein the mass ratio of the sophora flavescens extract to the oxymatrine is 5-10: 1.
3. the oxymatrine-containing composition according to claim 1, wherein the mass ratio of the sophora flavescens extract to the oxymatrine is 6-8: 1;
most preferably, the mass ratio of the sophora flavescens extract to the oxymatrine is 7: 1.
4. the oxymatrine-containing composition according to claim 1, wherein the sophora flavescens extract is prepared by a method comprising the steps of:
(1) extracting radix Sophorae Flavescentis with ethanol to obtain radix Sophorae Flavescentis ethanol extract;
(2) suspending the ethanol extract of radix Sophorae Flavescentis with water, and extracting with ethyl acetate to obtain ethyl acetate extract;
(3) and (3) passing the ethyl acetate extract through a silica gel column, eluting by adopting a mixed organic solvent, collecting an eluted part, concentrating and drying to obtain the sophora flavescens extract.
5. The oxymatrine-containing composition according to claim 4, wherein the extraction in step (1) is heating reflux extraction, and the extraction time is 1-2 h.
6. The oxymatrine composition according to claim 1, wherein the step (3) comprises the following steps:
eluting with a mixed organic solvent composed of cyclohexane and ethyl acetate in a volume ratio of 95-90: 5-10 to remove impurities, and then eluting with a mixed organic solvent composed of cyclohexane and ethyl acetate in a volume ratio of 87-85: 13-15; collecting the eluted part eluted by the mixed organic solvent consisting of cyclohexane and ethyl acetate in a volume ratio of 87-85: 13-15, concentrating and drying to obtain the sophora flavescens extract.
7. The oxymatrine composition according to claim 6, wherein the step (3) comprises the following steps:
eluting with a mixed organic solvent consisting of cyclohexane and ethyl acetate in a volume ratio of 93:7 to remove impurities, and then eluting with a mixed organic solvent consisting of cyclohexane and ethyl acetate in a volume ratio of 86: 14; collecting the eluted part eluted by the mixed organic solvent of cyclohexane and ethyl acetate with the volume ratio of 86:14, concentrating and drying to obtain the sophora flavescens extract.
8. Use of the oxymatrine composition of any one of claims 1 to 7 in the manufacture of a medicament for treating heart disease.
9. The use according to claim 8, wherein said heart disease is ischemic heart disease.
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Cited By (1)
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| CN114539259A (en) * | 2022-02-24 | 2022-05-27 | 深圳海创生物科技有限公司 | Active alkaloid compound, radix Sophorae Flavescentis extract and its application in preparing product with skin pruritus resisting effect |
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