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CN116173170A - A pharmaceutical composition for treating respiratory diseases, and its preparation method - Google Patents

A pharmaceutical composition for treating respiratory diseases, and its preparation method Download PDF

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CN116173170A
CN116173170A CN202310148737.7A CN202310148737A CN116173170A CN 116173170 A CN116173170 A CN 116173170A CN 202310148737 A CN202310148737 A CN 202310148737A CN 116173170 A CN116173170 A CN 116173170A
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pharmaceutical composition
iris
ethyl acetate
ginger
extract
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CN116173170B (en
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穆琰
柴倩雯
田月伟
李世强
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Hebei Yipin Pharmaceutical Co ltd
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Hebei Yipin Pharmaceutical Co ltd
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/88—Liliopsida (monocotyledons)
    • A61K36/906—Zingiberaceae (Ginger family)
    • A61K36/9068—Zingiber, e.g. garden ginger
    • 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
    • A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
    • A61K31/42—Oxazoles
    • A61K31/422—Oxazoles not condensed and containing further heterocyclic rings
    • 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)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00—Drugs for disorders of the respiratory system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00—Drugs for disorders of the respiratory system
    • A61P11/06—Antiasthmatics
    • 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
    • A61K2236/331—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using water, e.g. cold water, infusion, tea, steam distillation or decoction
    • 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
    • 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
    • A61K2236/50—Methods involving additional extraction steps
    • A61K2236/51—Concentration or drying of the extract, e.g. Lyophilisation, freeze-drying or spray-drying
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
    • Y02A—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
    • Y02A50/00—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
    • Y02A50/30—Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change

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Abstract

The invention provides a pharmaceutical composition for treating respiratory diseases, which comprises an active ingredient of a compound shown in a formula (I) and a ginger iris extract, wherein the weight ratio of the compound shown in the formula (I) to the raw Jiang Yuanwei flower extract is 1:0.5-0.7; compared with the prior art, the pharmaceutical composition provided by the invention can exert the synergistic effect of the compound shown in the formula (I), ginger and iris, and improve the curative effect of clinical application.

Description

A pharmaceutical composition for treating respiratory diseases, and its preparation method
Technical Field
The invention relates to the field of pharmaceutical preparations, in particular to a pharmaceutical composition for treating respiratory diseases and a preparation method thereof
Background
Ginger is widely used not only as a spice for enhancing the delicacy of foods, but also as an indispensable medicinal material in a traditional Chinese medicine prescription. In particular, borneol (boneol), cineole (cineole), citral (citrol), phenol (phenol), alkaloid (alkaloid) and the like which are essential oil components of aromatic substances contained in ginger can remove bad smell or taste such as fishy smell and stop central vomiting, while gingerol (gingerol) and shogaol (shogaol) which are spicy components have strong bactericidal effect on bacteria such as typhoid bacillus or vibrio cholerae
The iris is big and beautiful, the leaves are green and dark green, and the ornamental value is high. A variety of flowers and plants are used for ornamental gardens, can be used for arranging flower beds in gardens, planting in water-wet furrow lands and pond-side lakesides, or can be arranged into iris-dedicated gardens, and can also be used as cut flowers and ground cover plants, and are important garden plants. The extract tectoridin has effects of promoting blood circulation, dispelling blood stasis, dispelling pathogenic wind, removing dampness, removing toxic substance, and removing food stagnation.
Chinese patent CN113905734a discloses a novel Pan Telin inhibitor, the structure of which is shown in formula (I), which can treat respiratory diseases caused by inflammation.
Figure BDA0004090102870000011
Disclosure of Invention
The invention aims to provide a pharmaceutical composition for treating respiratory diseases with good curative effect.
In a first aspect of the invention, a pharmaceutical composition for treating respiratory diseases is provided, wherein the active ingredients of the pharmaceutical composition consist of a compound shown in a formula (I) and an extract of rhizoma zingiberis officinale-iris, and the weight ratio of the compound shown in the formula (I) to the extract of raw Jiang Yuanwei flowers is 1:0.5-0.7.
Figure BDA0004090102870000021
Further, in the above pharmaceutical composition, the weight ratio of the compound represented by formula (I) to the raw Jiang Yuanwei flower extract is 1:0.6-0.7, preferably 1:0.65-0.68, more preferably 1:0.67.
In the above composition, the rhizoma Zingiberis recens rhizoma Iridis Tectori extract is preferably rhizoma Zingiberis recens rhizoma Iridis Tectori ethanol ethyl acetate extract.
In the above composition, the iris is preferably blue or purple iris.
In the composition, the weight ratio of the ginger to the iris japonica is 1:2-3; preferably 1:2.4.
In another aspect, the invention provides a method for preparing the ginger iris ethanol ethyl acetate extract.
A preparation method of ginger iris flower ethyl acetate extract comprises the following steps:
step (1): cleaning rhizoma Zingiberis recens and flos Iridis Tectori respectively, and air drying;
step (2): taking ginger and iris in a weight ratio of 1:2-3, adding water in an amount which is 5-6 times of the weight ratio, decocting for 1-3 times, each time for 2.5-3.0 hours, mixing the water decoctions, and concentrating under reduced pressure until the density is 1.02-1.05;
step (3): adding 1-3 times of ethanol ethyl acetate mixed solvent into the concentrated solution obtained in the step (2), stirring for 2-3 hours, standing for 12-16 hours, filtering, concentrating the filtrate under reduced pressure to obtain thick paste about 1.2-1.25, and obtaining the ginger iris ethanol ethyl acetate extract.
In the above preparation method, in the step (1), the iris is blue or purple iris.
In the preparation method, in the step (2), the weight ratio of ginger to iris is 1:2.4.
In the step (3), the volume ratio of the ethanol to the ethyl acetate in the mixed solvent of the ethanol and the ethyl acetate is 1:3-6, preferably 1:4.2-4.7; more preferably 1:4.5.
The 'times' in the step (2) and the step (3) are based on the weight sum of ginger and iris, for example, in the step (2), the weight sum of ginger and iris is 1Kg, in the step (2), the 'adding water with the weight ratio of 5-6 times' is 'adding water with the weight ratio of 5-6 Kg', and in the step (3), the 'adding ethanol ethyl acetate mixed solvent with the weight ratio of 1-3 times' is 'adding ethanol ethyl acetate mixed solvent with the weight ratio of 1-3 Kg'.
Further, the pharmaceutical composition also comprises pharmaceutically acceptable auxiliary materials.
Further, the pharmaceutical composition is an oral pharmaceutical composition, and can be oral freeze-dried powder, granules, oral liquid, tablets and the like.
The pharmaceutically acceptable excipients may be any excipient known in the art suitable for oral administration of medicaments.
In one embodiment of the invention, the adjuvant is HS-15.
It is another object of the present invention to provide a method for preparing the above pharmaceutical composition for treating respiratory diseases.
A preparation method of a pharmaceutical composition for treating respiratory diseases is characterized by comprising the following steps of
S1, adding a compound shown in a formula (I) and a ginger iris extract into water for injection, adding HS-15, stirring for 1-2 hours, and filtering into a freeze dryer.
S2, freeze drying
In step S1, the weight ratio of the compound of formula (I) to HS-15 is 1:3-4, preferably 1:3.4-3.5. In the step S1, the filter is a filter of 1.0 μm, 0.45 μm or 0.22 μm.
In the step S2, the freeze drying is divided into a pre-freezing stage, a primary sublimation stage and a secondary drying stage; the pre-freezing stage is that the temperature is reduced to-25 ℃ within 20-40min, and the temperature is maintained at-25 ℃ for 30-60min; cooling to-45deg.C within 30-50 min, and maintaining at-45deg.C for 150-180min; the primary sublimation stage is to raise the temperature to-2 ℃ within 120-150 minutes, maintain the temperature to-2 ℃ for 600-660min, and maintain the vacuum degree not higher than 0.3mbar; the secondary drying stage is to maintain the vacuum degree not higher than 0.3mbar; heating to 40deg.C within 120-150 min, and maintaining at 40deg.C for 200-240min; cooling to 20deg.C within 55-65 min, and maintaining at 20deg.C for 20-40min.
It is another object of the present invention to provide the use of the above composition in the preparation of a medicament for treating asthma.
In one embodiment of the invention, the composition is prepared into oral freeze-dried powder, oral tablets, granules and the like. Preferably oral freeze-dried powder
Compared with the prior art, the invention has the following beneficial effects:
the active ingredients of the pharmaceutical composition disclosed by the invention consist of the specifically prepared ginger-iris extract in a specific proportion and the compound shown in the formula (I) in a specific weight ratio, and the pharmaceutical excipients HS-15 in a specific proportion are added to prepare an oral preparation, so that the synergistic effect of the compound shown in the formula (I), ginger and iris can be exerted to the greatest extent, and the curative effect of clinical application is improved.
Detailed Description
The invention discloses a pharmaceutical composition for treating respiratory diseases and a preparation method thereof, and the technical parameters can be properly improved by combining the related principles of drug extraction and pharmaceutical preparations by referring to the content of the invention by a person skilled in the art. It is expressly noted that all such similar substitutions and modifications will be apparent to those skilled in the art, and are deemed to be included within the scope of the present invention. While the invention has been described with reference to preferred embodiments, it will be apparent to those skilled in the relevant art that variations and modifications can be made in the methods and applications described herein, or in appropriate changes and combinations, without departing from the spirit and scope of the invention.
For a better understanding of the present invention, and not to limit its scope, all numbers expressing quantities, percentages, and other values used in the present application are to be understood as being modified in all instances by the term "about". Each numerical parameter should at least be construed in light of the number of reported significant digits and by applying ordinary rounding techniques.
The invention is further illustrated by the following examples, which are not intended to limit the invention in any way.
Preparation example 1: rhizoma Zingiberis recens and flos Iris Japonicae extract
Step (1): cleaning rhizoma Zingiberis recens and blue flos Iridis Tectori respectively, and air drying;
step (2): decocting rhizoma Zingiberis recens and flos Iris with weight ratio of 1:2.4 in 5 times of water for 2 times, 3.0 hr each time, mixing the water decoctions, and concentrating under reduced pressure to density of 1.02
Step (3): and (3) adding a mixed solvent of ethanol and ethyl acetate (the volume ratio of ethanol to ethyl acetate is 1:4.5) which is 2 times that of the concentrated solution obtained in the step (2), stirring for 3 hours, standing for 15 hours, filtering, and concentrating the filtrate under reduced pressure to obtain thick paste about 1.25, thus obtaining the ginger iris ethanol ethyl acetate extract.
Preparation example 2: rhizoma Zingiberis recens and flos Iris Japonicae extract
Step (1): cleaning rhizoma Zingiberis recens and purple flos Iridis Tectori respectively, and air drying;
step (2): taking ginger and iris in a weight ratio of 1:2.4, adding water in a weight ratio of 6 times, decocting for 3 times, each time for 2.5 hours, mixing the water decoctions, and concentrating under reduced pressure until the density is 1.05;
step (3): and (3) adding 3 times of ethanol ethyl acetate mixed solvent (the volume ratio of ethanol to ethyl acetate is 1:4.2) into the concentrated solution obtained in the step (2), stirring for 2 hours, standing for 12 hours, filtering, and concentrating the filtrate under reduced pressure to obtain thick paste about 1.2 to obtain the ginger iris ethanol ethyl acetate extract.
Preparation example 3: rhizoma Zingiberis recens and flos Iris Japonicae extract
Step (1) and step (2) are the same as in example 1;
the solvent in the step (3) is ethanol, namely ethanol is used for replacing an ethanol-ethyl acetate mixed solvent; the procedure is as in example 1.
Preparation example 4: rhizoma Zingiberis recens and flos Iris Japonicae extract
Step (1) and step (2) are the same as in example 1;
the solvent in the step (3) is ethyl acetate, namely, ethyl acetate is used for replacing an ethanol-ethyl acetate mixed solvent; the rest is the same as in example 1
Preparation example 5 ginger and Iris flower extract
Step (1) and step (2) are the same as in example 1;
the mixed solvent in the step (3) is an ethanol ethyl acetate mixed solvent (the volume ratio of ethanol to ethyl acetate is 1:1), and the rest is the same as in the example 1.
Preparation example 6: rhizoma Zingiberis recens and flos Iris Japonicae extract
Huang Yuanwei flowers in the step (1), namely Huang Yuanwei flowers are used for replacing blue iris flowers; the remainder is the same as in example 1;
step (2) and step (3) are the same as in example 1.
Preparation example 7: rhizoma Zingiberis recens and flos Iris Japonicae extract
Step (1) and step (3) are the same as in example 1;
the weight ratio of ginger to iris in the step (2) is 1:1.5; the procedure is as in example 1.
Preparation example 8: rhizoma Zingiberis recens and flos Iris Japonicae extract
Step (1) and step (3) are the same as in example 1;
the weight ratio of ginger to iris in the step (2) is 1:5; the procedure is as in example 1.
Examples 1-8 pharmaceutical compositions for the treatment of respiratory diseases
(1) Composition of the composition
Figure BDA0004090102870000061
(2) Preparation method
S1, adding a compound shown in a formula (I) and a ginger iris extract into water for injection, adding HS-15, stirring for 1-2 hours, and filtering through a filter of 1.0 mu m, 0.45 mu m and 0.22 mu m into a freeze dryer.
S2, freeze-drying,
pre-freezing: cooling to-25deg.C within 30min, and maintaining at-25deg.C for 45min; cooling to-45deg.C within 40min, and maintaining at-45deg.C for 180min;
primary sublimation: raising the temperature to-2 ℃ within 120 minutes, maintaining the temperature at-2 ℃ for 660 minutes, and maintaining the vacuum degree not higher than 0.3mbar;
secondary drying stage: maintaining the vacuum degree not higher than 0.3mbar; heating to 40 ℃ within 150 minutes, and maintaining the temperature at 40 ℃ for 240 minutes; the temperature is reduced by 20 ℃ within 60 minutes, and the temperature is maintained at 20 ℃ for 30 minutes.
Comparative examples 1 to 4: pharmaceutical composition for treating respiratory diseases
(1) Composition of the composition
Figure BDA0004090102870000071
(2) The preparation method comprises the following steps: as in example 1.
Example 9: test of antiasthmatics
1 materials and methods
1.1 animals
Male healthy guinea pigs (220-280 g in mass) are adaptively bred for 1 week, the room temperature is about 25 ℃, and the relative humidity is 40-70%.
1.2 test drugs
Pharmaceutical compositions prepared in examples 1 to 8 and comparative examples 1 to 4 of the present invention.
1.3 grouping and modeling
The random number was divided into model groups, examples 1 to 8 and comparative examples 1 to 4, each of which was 10. All mice were subjected to molding.
And (3) molding: model group, examples 1-8 and comparative examples 1-4, were intraperitoneally injected with 30 mg.kg on the first day -1 2mg egg protein and 100mg aluminum hydroxide are prepared into 1ml suspension for intraperitoneal injection on the next day, and then 0.01mg egg protein and 1ml suspension prepared from 100mg aluminum hydroxide are again injected into the abdominal cavity after 21d, the reinjection is performed to induce sensitization of guinea pigs, the guinea pigs are then placed in a 4L glass bell jar, and the egg protein solution with the concentration of 1% is atomized and inhaled for 30 seconds to induce asthma.
1.4 modes of administration
Starting on day 1 after induction of asthma by aerosol inhalation of 1% egg protein solution in guinea pigs, groups 1 to 8 and comparative examples 1 to 4 were administered in an amount of 15mg/kg of the compound of formula (I), 1 time a day, and the model group was given an equivalent dose of physiological saline for 5 consecutive days.
After 1h of each intragastric administration, guinea pigs were stimulated with 1% egg proteins and asthma latency was recorded. Asthma latency is the time required from inhalation of egg proteins after each episode to the onset of asthma. Asthma is judged by symptoms such as rapid respiratory rate, nodding respiratory asthma, nasal flaring, convulsion and the like.
2. Experimental results
Group of Asthma latency/second
Model group 46.37±10.39
Example 1 109.51±7.58##ΔΔ
Example 2 104.17±8.10##ΔΔ
Example 3 77.27±10.63#
Example 4 78.49±10.75#
Example 5 80.81±9.84#
Example 6 79.91±9.50#
Example 7 79.42±10.54#
Example 8 79.48±9.78#
Comparative example 1 75.90±9.25#
Comparative example 2 81.47±9.96#
Comparative example 3 84.56±10.29#
Note that: comparing to the model group, #p <0.05, #p <0.01;
Δp <0.05 compared to comparative example 1.
(1) Compared with a model control group, the pharmaceutical compositions for treating respiratory diseases prepared in the examples 1-2 can remarkably prolong the incubation period of asthma, and have very remarkable difference (P is less than 0.01), which indicates that the pharmaceutical compositions prepared in the examples 1-2 can treat asthma.
(2) Compared with comparative example 1, the pharmaceutical compositions for treating respiratory diseases prepared in examples 1-2 can significantly prolong the incubation period of asthma, and all have very significant differences (P < 0.01), which indicates that the pharmaceutical composition prepared in examples 1-2 is significantly better than the compound of formula (I) in treating asthma.
(3) Compared with a model control group, the pharmaceutical compositions for treating respiratory diseases prepared in examples 3-5 can remarkably prolong the incubation period of asthma, and all have remarkable difference (P is less than 0.05), which indicates that the pharmaceutical compositions prepared in examples 3-5 can treat asthma.
(4) The pharmaceutical compositions for treating respiratory diseases prepared in examples 3-5 are able to prolong asthma latency, but have no significant differences (P > 0.05) compared to comparative example 1, demonstrating: in the aspect of treating asthma, the pharmaceutical compositions prepared in examples 3-5 have the same effect as the compound shown in the formula (I) without obvious difference. That is, only the specific solvent extraction of the ginger iris extract in a specific ratio range can be used for synergism with the compound of formula (I) to treat respiratory diseases.
(5) Compared with a model control group, the pharmaceutical composition for treating the respiratory diseases prepared in the example 6 can remarkably prolong the incubation period of asthma, and has remarkable difference (P is less than 0.05), which indicates that the pharmaceutical composition prepared in the example 6 can treat asthma.
(6) The pharmaceutical composition for treating respiratory diseases prepared in example 6 was able to prolong asthma latency, but did not have significant differences (P > 0.05) compared to comparative example 1, demonstrating that: in the aspect of treating asthma, the pharmaceutical composition prepared in the embodiment 6 has the effect equivalent to that of the compound shown in the formula (I) and has no obvious difference. That is, only the ginger iris extract obtained from the specific iris (blue, purple) can be cooperated with the compound of formula (I) to treat respiratory diseases.
(7) Compared with a model control group, the pharmaceutical compositions for treating respiratory diseases prepared in examples 7-8 can remarkably prolong the incubation period of asthma, and all have remarkable difference (P is less than 0.05), which indicates that the pharmaceutical compositions prepared in examples 7-8 can treat asthma.
(8) The pharmaceutical compositions for treating respiratory diseases prepared in examples 7-8 are able to prolong asthma latency, but have no significant differences (P > 0.05) compared to comparative example 1, demonstrating: in the aspect of treating asthma, the pharmaceutical compositions prepared in examples 7-8 have the same effect as the compound shown in the formula (I) without obvious difference. Namely, only the ginger and iris extract obtained by extracting ginger and iris in a specific weight ratio can be used for treating respiratory diseases in a synergistic way with the compound shown in the formula (I).
(9) Compared with a model control group, the pharmaceutical composition for treating the respiratory diseases prepared in the comparative example 2 can remarkably prolong the incubation period of asthma, and has remarkable difference (P is less than 0.05), which indicates that the pharmaceutical composition prepared in the comparative example 2 can treat asthma.
The pharmaceutical composition for treating respiratory diseases prepared in comparative example 2 was able to prolong asthma latency without significant difference (P > 0.05) compared to comparative example 1, demonstrating that: in the aspect of treating asthma, the pharmaceutical composition prepared in the comparative example 2 has the effect equivalent to that of the compound shown in the formula (I) and has no obvious difference. That is, only the compound of formula (I) and the extract of rhizoma Zingiberis recens and Iris flos can produce synergistic effect to treat respiratory diseases.
Figure BDA0004090102870000091
Compared with a model control group, the pharmaceutical composition for treating the respiratory diseases prepared in the comparative example 3 can remarkably prolong the incubation period of asthma, and has remarkable difference (P is less than 0.05), which indicates that the pharmaceutical composition prepared in the comparative example 3 can treat asthma.
Figure BDA0004090102870000092
The pharmaceutical composition for treating respiratory diseases prepared in comparative example 3 was able to prolong asthma latency without significant difference (P>0.05 Description of the following): in the aspect of treating asthma, the pharmaceutical composition prepared in the comparative example 3 has the effect equivalent to that of the compound shown in the formula (I) and has no obvious difference. Namely, only the compound of the formula (I), the ginger and iris extract and the auxiliary material HS-15 in a specific weight ratio can produce synergistic effect to treat respiratory diseases. />

Claims (10)

1. A pharmaceutical composition for treating respiratory diseases comprises a compound shown in a formula (I) and ginger and iris extract, wherein the weight ratio of the compound shown in the formula (I) to the raw Jiang Yuanwei flower extract is 1:0.5-0.7:
Figure FDA0004090102860000011
2. the pharmaceutical composition of claim 1, wherein the weight ratio of the compound of formula (I) to the raw Jiang Yuanwei flower extract is 1:0.6-0.7.
3. The pharmaceutical composition of claim 1, wherein the weight ratio of the compound of formula (I) to the raw Jiang Yuanwei flower extract is 1:0.67.
4. The pharmaceutical composition of claim 1, wherein the ginger iris extract is Jiang Yuanwei flower ethanol ethyl acetate extract.
5. The pharmaceutical composition of claim 1, wherein the ginger iris ethanol ethyl acetate extract is prepared by the steps of:
step (1): cleaning rhizoma Zingiberis recens and flos Iridis Tectori respectively, and air drying;
step (2): taking ginger and iris in a weight ratio of 1:2-3, adding water in an amount which is 5-6 times of the weight ratio, decocting for 1-3 times, each time for 2.5-3.0 hours, mixing the water decoctions, and concentrating under reduced pressure until the density is 1.02-1.05;
step (3): adding 1-3 times of ethanol ethyl acetate mixed solvent into the concentrated solution obtained in the step (2), stirring for 2-3 hours, standing for 12-16 hours, filtering, concentrating the filtrate under reduced pressure to obtain thick paste about 1.2-1.25, and obtaining the ginger iris ethanol ethyl acetate extract;
in the step (3), the volume ratio of the ethanol to the ethyl acetate in the mixed solvent of the ethanol and the ethyl acetate is 1:3-6, preferably 1:4.2-4.7.
6. The pharmaceutical composition of claim 5, wherein in step (3), the volume ratio of ethanol to ethyl acetate in the mixed solvent of ethanol and ethyl acetate is 1:4.5.
7. The pharmaceutical composition of claim 5, wherein in step (1), the iris is a blue or purple iris; in the step (2), the weight ratio of ginger to iris is 1:2.4.
8. The pharmaceutical composition of claim 1, further comprising a pharmaceutically acceptable adjuvant.
9. The pharmaceutical composition of claim 1, wherein the excipient is HS-15.
10. Use of a pharmaceutical composition according to any one of claims 1 to 9 for the preparation of a medicament for the treatment of asthma.
CN202310148737.7A 2023-02-22 2023-02-22 A pharmaceutical composition for treating respiratory diseases, and its preparation method Active CN116173170B (en)

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