Anti-sense detoxification capsule pharmaceutical composition, preparation method and application thereof

Abstract

This invention belongs to the field of traditional Chinese medicine treatment, specifically relating to an anti-cold and detoxifying capsule pharmaceutical composition, its preparation method, and its application. The composition comprises the following components in parts by weight: 25-35 parts Angelica dahurica, 40-50 parts Scutellaria baicalensis, 2-5 parts flavonoids, 0.5-2 parts Imperatorin, 1-5 parts Artemisia capillaris, 1-5 parts phloroglucinol compounds, and 0.1-0.5 parts organic acids. The component-based composition provided by this invention has a good effect in preventing and treating wind-heat colds, and the components exhibit good synergistic effects.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine treatment, specifically relating to the anti-cold and detoxifying capsule pharmaceutical composition, its preparation method, and its application. Background Technology

[0002] Anti-influenza and Detoxifying Capsules are a hospital-prepared medicine composed of 11 traditional Chinese medicines, including honeysuckle, isatis root, and scutellaria. Clinically, they are effective in treating wind-heat type colds and viral infections such as influenza, mumps, and encephalitis. This standard is formulated to better control drug quality and ensure safe and effective clinical use.

[0003] The complex composition and numerous ingredients of the anti-cold and detoxifying capsules present numerous challenges to research on the drug's material basis, and their efficacy in treating wind-heat colds and their inflammatory complications requires further improvement. Simplifying the formulation and precisely matching active ingredients are crucial for elucidating the mechanism of action, and how to select ingredients to achieve higher efficacy is a technical challenge that urgently needs to be addressed for complex prescriptions. Summary of the Invention

[0004] To overcome the shortcomings of existing technologies, this invention provides an anti-cold and detoxifying capsule pharmaceutical composition, its preparation method, and its application. The anti-cold and detoxifying capsule has heat-clearing and detoxifying properties and is used for wind-heat colds and influenza.

[0005] The objective of this invention is achieved through the following technical solutions:

[0006] The anti-influenza and detoxification capsule pharmaceutical composition comprises the following components in parts by weight: 25-35 parts Angelica dahurica, 40-50 parts Scutellaria baicalensis, 2-5 parts flavonoids, 0.5-2 parts Imperatorin, 1-5 parts Artemisia capillaris, 1-5 parts phloroglucinol, and 0.1-0.5 parts organic acids.

[0007] Furthermore, the phloroglucinol compounds include ABA and ABBA in a mass ratio of 1-5:1.

[0008] Furthermore, the organic acid is selected from one or more of oleanolic acid, vanillic acid, and lauric acid.

[0009] Furthermore, the organic acid is oleanolic acid.

[0010] Further, by weight, the flavonoids comprise a mixture of forsythoside A, puerarin, and luteolin in a mass ratio of 1:0.5-1:1-3.

[0011] Another object of the present invention is to provide a method for preparing the above-mentioned composition, comprising the following steps:

[0012] (1) Mix Angelica dahurica and Scutellaria baicalensis, add additives for soaking and pretreatment, filter, add water for extraction, and obtain dregs 1 and extract 1.

[0013] (2) Extract the residue 1 with ethanol, filter, and obtain extract 2;

[0014] (3) Mix extract 1 and extract 2, concentrate and dry to obtain the extract;

[0015] (4) The extract, flavonoids, imperatorin, artemisia argyione, phloroglucinol and organic acid are mixed together to obtain the product.

[0016] Further, the additive mentioned in step (1) is an aqueous solution containing 0.02-0.05% lecithin and 0.01-0.02% polyglycerol fatty acid ester by mass concentration;

[0017] Preferably, the polyglycerol fatty acid ester is triglyceride monostearate;

[0018] Furthermore, the pretreatment time in step (1) is 20-40 min;

[0019] Furthermore, the extraction temperature in step (1) is 60-70℃, the number of extractions is 1-2, and the extraction time is 0.5-1h.

[0020] Further, the ethanol mentioned in step (2) is 55-70% ethanol by volume, and the extraction is performed by heating and reflux extraction for 1-2 hours.

[0021] Furthermore, after mixing, pharmaceutically acceptable excipients are added to prepare an oral formulation.

[0022] Another object of the present invention is to provide the use of the above composition in the preparation of a medicine for preventing and treating wind-heat colds or influenza, mumps, and encephalitis caused by viruses.

[0023] The beneficial effects of this invention are:

[0024] (1) The composition provided by this invention has a good effect in preventing and treating wind-heat colds, and has identified most of the effective components, making up for the defects of complex components and unclear efficacy of traditional Chinese medicine. It is of great significance for improving drug quality and ensuring medication safety.

[0025] (2) In the preparation process of this invention, Angelica dahurica and Scutellaria baicalensis are pretreated before extraction, and then extracted together with water and ethanol. This is beneficial to the extraction of effective components and improves the efficacy of antipyretic and analgesic effects.

[0026] (3) Through screening, the present invention unexpectedly discovered that imperatorin and artemisia argyione have a good synergistic effect in antipyretic and analgesic properties of this prescription. Detailed Implementation

[0027] The technical solution of the present invention will be further described below with reference to the embodiments.

[0028] Example 1

[0029] The pharmaceutical composition of this embodiment consists of the following components in parts by weight, as detailed in Table 1.

[0030] Table 1

[0031]

[0032]

[0033] The preparation method is as follows:

[0034] (1) Mix Angelica dahurica and Scutellaria baicalensis, add 1 times the amount of aqueous solution containing 0.03% lecithin and 0.01% triglyceride monostearate for soaking and pretreatment for 30 min, then filter, add 8 times the amount of water to the medicinal material and extract twice at 65℃, each extraction for 0.5 h, combine the extracts to obtain dregs 1 and extract 1;

[0035] (2) Add 3 times the volume of 60% ethanol to the residue 1, heat and reflux for 1 hour, filter, and obtain extract 2;

[0036] (3) Mix extract 1 and extract 2, concentrate and dry to obtain mixed extract;

[0037] (4) Mix the mixed extract, forsythoside A, puerarin, luteolin, imperatorin, artemisia argyi, ABA, ABBA and oleanolic acid evenly to obtain the final product.

[0038] Example 2

[0039] The pharmaceutical composition of this embodiment consists of the following components in parts by weight, as detailed in Table 2.

[0040] Table 2

[0041] Components weight Angelica dahurica 35 Scutellaria baicalensis 50 Forsythoside A 1 Puerarin 1 Luteolin 3 Pre-Europalis 2 Artemisia capillaris 5 ABA 4 Mianma Guanzhong Su ABBA 1 Oleanolic acid 0.5

[0042] The preparation method is as follows:

[0043] (1) Mix Angelica dahurica and Scutellaria baicalensis, add 1 times the amount of aqueous solution containing 0.05% lecithin and 0.02% triglyceride monostearate for soaking and pretreatment for 40 min, then filter, add 8 times the amount of water to the medicinal material and extract twice at 70℃, each extraction for 0.5 h, combine the extracts to obtain dregs 1 and extract 1;

[0044] (2) Add 3 times the volume of 70% ethanol to the residue 1, heat and reflux for 2 hours, filter, and obtain extract 2;

[0045] (3) Mix extract 1 and extract 2, concentrate and dry to obtain mixed extract;

[0046] (4) Mix the mixed extract, forsythoside A, puerarin, luteolin, imperatorin, artemisia argyi, ABA, ABBA and oleanolic acid evenly to obtain the final product.

[0047] Example 3

[0048] The pharmaceutical composition of this embodiment consists of the following components in parts by weight, as detailed in Table 3.

[0049] Table 3

[0050] Components weight Angelica dahurica 25 Scutellaria baicalensis 40 Forsythoside A 1 Puerarin 0.5 Luteolin 1 Pre-Europalis 0.5 Artemisia capillaris ketone 1 ABA 1 Mianma Guanzhong Su ABBA 0.1 Oleanolic acid 2

[0051] The preparation method is as follows:

[0052] (1) Mix Angelica dahurica and Scutellaria baicalensis, add 1 times the amount of aqueous solution containing 0.02% lecithin and 0.01% triglyceride monostearate for 20 min for soaking and pretreatment, then filter, add 8 times the amount of water to the medicinal material and extract at 60℃ for 1 h to obtain dregs 1 and extract 1;

[0053] (2) Add 3 times the volume of 55% ethanol to the residue 1 and heat under reflux for 1 hour. Filter to obtain extract 2.

[0054] (3) Mix extract 1 and extract 2, concentrate and dry to obtain mixed extract;

[0055] (4) Mix the mixed extract, forsythoside A, puerarin, luteolin, imperatorin, artemisia argyi, ABA, ABBA and oleanolic acid evenly to obtain the final product.

[0056] Comparative Example 1

[0057] The recipe is as follows:

[0058] Table 4

[0059] Components weight Angelica dahurica 30 Scutellaria baicalensis 48 Forsythoside A 1 Puerarin 0.6 Luteolin 2 Pre-Euphrates 3 Artemisia capillaris / ABA 2 Mianma Guanzhong Su ABBA 1 Oleanolic acid 0.2

[0060] The preparation method is as follows:

[0061] (1) Mix Angelica dahurica and Scutellaria baicalensis, add 1 times the amount of aqueous solution containing 0.03% lecithin and 0.01% triglyceride monostearate for soaking and pretreatment for 30 min, then filter, add 8 times the amount of water to the medicinal material and extract twice at 65℃, each extraction for 0.5 h, combine the extracts to obtain dregs 1 and extract 1;

[0062] (2) Add 3 times the volume of 60% ethanol to the residue 1, heat and reflux for 1 hour, filter, and obtain extract 2;

[0063] (3) Mix extract 1 and extract 2, concentrate and dry to obtain mixed extract;

[0064] (4) Mix the mixed extract, forsythoside A, puerarin, luteolin, imperatorin, ABA, ABBA and oleanolic acid evenly to obtain the final product.

[0065] Comparative Example 2

[0066] The recipe is as follows:

[0067] Table 5

[0068]

[0069]

[0070] The preparation method is as follows:

[0071] (1) Mix Angelica dahurica and Scutellaria baicalensis, add 1 times the amount of aqueous solution containing 0.03% lecithin and 0.01% triglyceride monostearate for soaking and pretreatment for 30 min, then filter, add 8 times the amount of water to the medicinal material and extract twice at 65℃, each extraction for 0.5 h, combine the extracts to obtain dregs 1 and extract 1;

[0072] (2) Add 3 times the volume of 60% ethanol to the residue 1, heat and reflux for 1 hour, filter, and obtain extract 2;

[0073] (3) Mix extract 1 and extract 2, concentrate and dry to obtain mixed extract;

[0074] (4) Mix the mixed extract, forsythoside A, puerarin, luteolin, artemisia argyi ketone, baicalein ABA, baicalein ABBA and oleanolic acid evenly to obtain the final product.

[0075] Comparative Example 3

[0076] The recipe is as follows:

[0077] Table 6

[0078]

[0079]

[0080] The preparation method is as follows:

[0081] (1) Mix Angelica dahurica and Scutellaria baicalensis, add 1 times the amount of aqueous solution containing 0.03% lecithin and 0.01% triglyceride monostearate for soaking and pretreatment for 30 min, then filter, add 8 times the amount of water to the medicinal material and extract twice at 65℃, each extraction for 0.5 h, combine the extracts to obtain dregs 1 and extract 1;

[0082] (2) Add 3 times the volume of 60% ethanol to the residue 1, heat and reflux for 1 hour, filter, and obtain extract 2;

[0083] (3) Mix extract 1 and extract 2, concentrate and dry to obtain mixed extract;

[0084] (4) Mix the mixed extract, forsythoside, puerarin, luteolin, imperatorin, artemisia capillaris, artemisia capillaris ketone, ABA, ABBA and oleanolic acid evenly to obtain the product.

[0085] Comparative Example 4

[0086] This comparative pharmaceutical composition, by weight, consists of the following components, as detailed in Table 7.

[0087] Table 7

[0088] Components weight Angelica dahurica 30 Scutellaria baicalensis 48 Forsythoside A 1 Puerarin 0.6 Luteolin 2 Pre-Europalis 1 Artemisia capillaris 2 ABA 2 Mianma Guanzhong Su ABBA 1 Oleanolic acid 0.2

[0089] The preparation method is as follows:

[0090] (1) Mix Angelica dahurica and Scutellaria baicalensis, soak them in an aqueous solution containing 0.04% lecithin for 30 min, then filter them. Add 8 times the amount of water to the herbs and heat and reflux twice for 0.5 h each time. Combine the extracts to obtain dregs 1 and extract 1.

[0091] (2) Add 3 times the volume of 60% ethanol to the residue 1, heat and reflux for 1 hour, filter to obtain extract 2;

[0092] (3) Mix extract 1 and extract 2, concentrate and dry to obtain mixed extract;

[0093] (4) Mix the mixed extract, forsythoside A, puerarin, luteolin, imperatorin, artemisia argyi, ABA, ABBA and oleanolic acid evenly to obtain the final product.

[0094] Pharmacological efficacy test, antipyretic test

[0095] Laboratory animals: SD rats, half male and half female, 6-8 weeks old, purchased from Guangdong Vital River Laboratory Animal Technology Co., Ltd. During the experiment, the animals consumed normal feed and water. They were fasted for 24 hours prior to the experiment.

[0096] The animals were randomly divided into 8 groups, with 10 animals in each group, half male and half female. The groups were the acetaminophen group and the experimental group.

[0097] The experimental group consisted of 7 groups: Examples 1-3 (3 groups) and Comparative Examples 1-4 (4 groups).

[0098] Rectal temperature was measured three times before modeling, with each measurement 1 hour apart, and the average value was recorded as the basal body temperature. Then, each group of rats was intraperitoneally injected with 15 mg / kg of 2,4-dinitrophenol to induce fever. The rats in each group were then administered the corresponding drug via gavage; specific drug administration and dosage are shown in Table 1. Rectal temperature was measured again at 1 hour, 2 hours, and 3 hours after the last administration. The temperature difference before and after fever induction was calculated, and the results are shown in Table 1.

[0099] Table 1 Fever status in different groups of rats

[0100]

[0101] Note: Compared with Example 1, △ P < 0.05.

[0102] The data in Table 1 show that the pharmaceutical composition provided by the present invention has a better effect on reducing the body temperature of rats, indicating that the drug of the present invention has a stable effect and a good antipyretic effect.

[0103] Pharmacological efficacy test, analgesic test

[0104] Experimental animals: Kunming mice, 18-22g. They were randomly divided into 9 groups of 10 mice each, half male and half female. These groups were: the model group, the positive acetaminophen group, and 7 experimental groups: Examples 1-3 (3 groups) and Comparative Examples 1-4 (4 groups).

[0105] Administration method: At the beginning of the experiment, except for the model group, each group of mice was administered the drug once by gavage. The dosage is shown in Table 2. One hour after the oral administration, each group of mice was injected intraperitoneally with 0.2 mg of 0.3% acetic acid. The number of writhing movements of each group of mice within 30 minutes was recorded. The results are shown in Table 2.

[0106] Table 2

[0107]

[0108] Note: Comparison with model group # P < 0.05 ## P < 0.01; compared with Example 1 group, △ P < 0.05.

[0109] The data in Table 2 show that the analgesic effect of the pharmaceutical composition provided by the present invention indicates that the drug of the present invention has a stable efficacy and a good antipyretic effect.

[0110] The above detailed description is a specific description of one of the feasible embodiments of the present invention. This embodiment is not intended to limit the patent scope of the present invention. All equivalent implementations or modifications that do not depart from the present invention should be included within the scope of the technical solution of the present invention.

Claims

1. A pharmaceutical composition for anti-cold and detoxifying capsules, characterized in that, The composition comprises the following components in parts by weight: 25-35 parts Angelica dahurica, 40-50 parts Scutellaria baicalensis, 2-5 parts flavonoids, 0.5-2 parts Imperatorin, 1-5 parts Artemisia capillaris, 1-5 parts phloroglucinol, and 0.1-0.5 parts organic acids. The resorcinol compounds are ABA and ABBA in a mass ratio of 1-5:

1. The organic acid is oleanolic acid; The flavonoids are a mixture of forsythoside A, puerarin and luteolin in a mass ratio of 1:0.5-1:1-3. The method for preparing the composition includes the following steps: (1) Mix Angelica dahurica and Scutellaria baicalensis, add additives for soaking and pretreatment, filter, add water for extraction, and obtain dregs 1 and extract 1; (2) Extract the residue 1 with ethanol, filter, and obtain extract 2; (3) Mix extract 1 and extract 2, concentrate and dry to obtain the extract; (4) The extract, flavonoids, imperatorin, artemisia argyione, phloroglucinol compounds and organic acids are mixed to obtain the product; The additive mentioned in step (1) is an aqueous solution containing 0.02-0.05% lecithin and 0.01-0.02% polyglycerol fatty acid ester by mass concentration.

2. A method for preparing the composition according to claim 1, characterized in that, Includes the following steps: (1) Mix Angelica dahurica and Scutellaria baicalensis, add additives for soaking and pretreatment, filter, add water for extraction, and obtain dregs 1 and extract 1; (2) Extract the residue 1 with ethanol, filter, and obtain extract 2; (3) Mix extract 1 and extract 2, concentrate and dry to obtain the extract; (4) The extract, flavonoids, imperatorin, artemisia argyione, phloroglucinol compounds and organic acids are mixed to obtain the product; The additive mentioned in step (1) is an aqueous solution containing 0.02-0.05% lecithin and 0.01-0.02% polyglycerol fatty acid ester by mass concentration.

3. The preparation method according to claim 2, characterized in that, The pretreatment time in step (1) is 20-40 min, the extraction temperature is 60-70℃, the number of extractions is 1-2, and the extraction time is 0.5-1 h.

4. The preparation method according to claim 2, characterized in that, The ethanol mentioned in step (2) is 55-70% ethanol by volume, and the extraction is performed by heating and reflux extraction for 1-2 hours.

5. The preparation method according to claim 2, characterized in that, After mixing as described in step (4), pharmaceutically acceptable excipients are added to prepare an oral formulation.

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