Pharmaceutical composition for treating cold and preparation method thereof

Abstract

The invention discloses a pharmaceutical composition for treating cold and a preparation method of the pharmaceutical composition. The pharmaceutical composition is prepared from the following raw materials in parts by mass: 100 to 200 parts of herba dogwood, 200 to 300 parts of radix bupleuri, 400 to 500 parts of radix ligustici sinensis, 200 to 300 parts of radix saposhnikoviae and 400 to 500 parts of radix scutellariae. Tests find that the pharmaceutical composition disclosed by the invention can effectively improve the inhibition rate of cytopathy caused by parainfluenza virus-1, respiratory syncytial virus, pancreatic virus (ADV3), coxB5 and herpes simplex virus (HSV-1) virus strains, and the bioavailability and stability of the pharmaceutical composition for treating cold are improved due to the addition of the auxiliary materials. The raw material components adopted by the pharmaceutical composition for treating cold provided by the invention are nontoxic and harmless to a human body and have no side effects, the preparation method is simple, and the preparation cost is relatively low.

Description

Technical Field

[0001] The invention belongs to the technical field of pharmaceutical compositions, and in particular relates to a pharmaceutical composition for treating colds and a preparation method thereof. Background Art

[0002] Cold is a common acute upper respiratory tract viral infectious disease, which is mostly caused by rhinovirus, parainfluenza virus, respiratory syncytial virus, echovirus, coxsackie virus (CoxB5), herpes simplex virus (HSV-1), adenovirus (ADV3), etc. The clinical manifestations are mostly nasal congestion, sneezing, runny nose, fever, cough, pharyngitis, headache, etc. It is more common in winter, spring and when the seasons change. Most of the drugs currently used to treat colds are oral preparations of Western medicines. These drugs are prone to various adverse reactions when playing a therapeutic role, and the metabolism of Western medicines can cause the burden on the kidneys and liver to increase. Since Chinese medicine has less side effects on the human body during the treatment of diseases, the use of Chinese medicine ingredients to develop drugs has been a research hotspot in the field of medicine. Therefore, it is very necessary to develop a Chinese medicine composition that effectively inhibits viruses and has the effect of treating colds. Summary of the invention

[0003] In view of the deficiencies in the above-mentioned prior art, the present invention provides a pharmaceutical composition for treating colds, which, through a combination of dog flower, bupleurum, ligusticum ligusticum, siler, and scutellaria baicalensis in a specific mass ratio, each Chinese medicine raw material component synergistically improves the inhibition rate of cytopathic effects caused by parainfluenza virus-1, respiratory syncytial virus, ADV3, CoxB5, and HSV-1 virus strains, and the addition of auxiliary materials can significantly improve the stability of the composition. The raw material components used in the pharmaceutical composition for treating colds provided by the present invention are non-toxic and harmless to the human body, have no side effects, are simple in preparation method, and have low preparation cost.

[0004] The object of the present invention is to provide a medicinal composition for treating colds, comprising the following raw materials in parts by weight: 100-200 parts of dogwood flower, 200-300 parts of bupleurum, 400-500 parts of ligusticum chuanxiong, 200-300 parts of siler, and 400-500 parts of scutellaria baicalensis.

[0005] The dog flower is a perennial shrub plant, with a pungent and slightly bitter taste, clearing away heat and dampness, dispersing blood stasis and reducing swelling. It is used for colds and fevers, headaches, mastitis, acute gastroenteritis, dysentery, etc.; Bupleurum is a plant of the Umbelliferae family, with a bitter taste and non-toxicity, clearing away heat from the deficiency, and is used for colds and fevers, alternating colds and heat, liver depression and qi stagnation, etc.; Ligusticum chuanxiong is a plant of the Umbelliferae family, with a pungent and warm taste, dispelling wind, dispersing cold, removing dampness, and relieving pain, and is used for colds caused by wind and cold, rheumatism and pain, etc.; Saposhnikovia divaricata: pungent and sweet, slightly warm in nature, has the effects of dispelling wind and relieving exterior symptoms, overcoming dampness and relieving pain, and stopping spasms, and is used for external symptoms, urticaria itching, rheumatism and pain, tetanus, spleen deficiency and dampness, etc.; Scutellaria baicalensis is a perennial herb of the Labiatae family, with a bitter taste and non-toxicity, and has the effects of clearing heat and drying dampness, and is used for symptoms such as damp-heat fever, chest tightness, and damp-heat diarrhea, jaundice, etc.

[0006] The inventors found during the experiment that the pharmaceutical composition prepared by using a specific proportion of dogtail flower, bupleurum, ligusticum ligusticum, siler, and scutellaria baicalensis can improve the inhibition rate of cytopathic effects caused by parainfluenza virus-1, respiratory syncytial virus, ADV3, CoxB5, and HSV-1 virus strains. The active components coordinate and promote each other, and have a good synergistic effect.

[0007] In some embodiments of the present invention, the pharmaceutical composition for treating colds comprises the following raw materials in parts by weight: 130-180 parts of dogwood flower, 230-270 parts of bupleurum, 420-490 parts of ligusticum chuanxiong, 210-260 parts of siler, and 440-480 parts of scutellaria baicalensis.

[0008] In some embodiments of the present invention, the pharmaceutical composition for treating colds comprises the following raw materials in parts by weight: 160 parts of dogwood flower, 250 parts of bupleurum, 470 parts of ligusticum chuanxiong, 240 parts of siler, and 460 parts of scutellaria baicalensis.

[0009] In some embodiments of the present invention, the pharmaceutical composition for treating colds further comprises the following raw materials in parts by weight: 10 to 15 parts of chlorpheniramine maleate and 0.5 to 1 part of acetaminophen.

[0010] Another object of the present invention is to provide a method for preparing the pharmaceutical composition for treating colds, comprising the following steps:

[0011] S1. Mix Ligusticum chuanxiong and Saposhnikovia divaricata, extract volatile oil by steam distillation, and obtain volatile oil, medicinal residue and aqueous solution after distillation;

[0012] S2. The residue is mixed with dog flower, bupleurum, water, decocted, filtered, and the filtrate is added to the distilled aqueous solution, concentrated, and a clear paste is obtained;

[0013] S3. Add ethanol to the clear paste, stir, let stand, recover the supernatant, and concentrate the supernatant to obtain a thick paste;

[0014] S4. Mix the thick paste with the scutellaria powder, dry, crush, add chlorpheniramine maleate and acetaminophen, mix, granulate, spray the volatile oil, mix, and obtain a pharmaceutical composition.

[0015] In some embodiments of the present invention, in S1, the extraction time is 1 to 3 hours.

[0016] In some embodiments of the present invention, in S1, the amount of water used in the steam distillation method is 6 to 8 times the total mass of Ligusticum chuanxiong and Saposhnikovia divaricata.

[0017] In some embodiments of the present invention, in S2, the decocting step is performed 3 times, each time for 2 hours.

[0018] In some embodiments of the present invention, in S2, the relative density of the concentrated mixture at 80° C. is 1.14 to 1.18.

[0019] In some embodiments of the present invention, in S2, the cooking temperature is 60-80° C. and the cooking time is 20-40 min.

[0020] In some embodiments of the present invention, in S3, the mass ratio of the clear paste to the ethanol is 3:7.

[0021] In some embodiments of the present invention, in S3, the concentration is performed until the relative density of the supernatant at 50-60° C. is 1.31-1.35.

[0022] Another object of the present invention is to provide the use of the medicinal composition for treating colds in the preparation of medicines for treating colds.

[0023] In some embodiments of the present invention, the symptom of a cold is at least one of fever, headache, nasal congestion, sneezing, sore throat, or general malaise and aches.

[0024] In some embodiments of the present invention, the medicine for treating colds includes the pharmaceutical composition.

[0025] In some embodiments of the present invention, the medicine for treating colds further comprises pharmaceutically acceptable excipients.

[0026] In some embodiments of the present invention, the auxiliary material is selected from at least one of starch, sucrose and dextrin.

[0027] In some embodiments of the present invention, the dosage form of the drug is granules, tablets, capsules, powders, suspensions or pills.

[0028] Another object of the present invention is to provide a method for preparing the drug, comprising the following steps:

[0029] S1. Mix Ligusticum chuanxiong and Saposhnikovia divaricata, extract volatile oil by steam distillation, and obtain volatile oil, medicinal residue and aqueous solution after distillation;

[0030] S2. The residue is mixed with dog flower, bupleurum, water, decocted, filtered, and the filtrate is added to the distilled aqueous solution, concentrated, and a clear paste is obtained;

[0031] S3. Add ethanol to the clear paste, stir, let stand, recover the supernatant, concentrate the supernatant, and thicken the paste;

[0032] S4. Mix the thick paste with the scutellaria powder, dry, crush, add chlorpheniramine maleate and acetaminophen, mix, granulate, spray the volatile oil, mix, add auxiliary materials, and prepare the medicine in the form of granules, tablets, capsules, powders, suspensions or pills.

[0033] In some embodiments of the present invention, in S1, the extraction time is 1 to 3 hours.

[0034] In some embodiments of the present invention, in S1, the amount of water used in the steam distillation method is 6 to 8 times the total amount of Ligusticum chuanxiong and Saposhnikovia divaricata.

[0035] In some embodiments of the present invention, in S2, the decocting step is performed 3 times, each time for 2 hours.

[0036] In some embodiments of the present invention, in S2, the relative density of the concentrated mixture at 80° C. is 1.14 to 1.18.

[0037] In some embodiments of the present invention, in S2, the cooking time is 20 to 40 minutes.

[0038] In some embodiments of the present invention, in S3, the mass ratio of the clear paste to the ethanol is 1-2:3-4.

[0039] In some embodiments of the present invention, in S3, the concentration is performed until the relative density of the supernatant at 50-60° C. is 1.31-1.35.

[0040] Compared with the prior art, the present invention has the following beneficial effects:

[0041] (1) The pharmaceutical composition of Herba Lycopodii, Radix Bupleuri, Radix Ligustici Radix, Radix Saposhnikoviae and Radix Scutellariae provided by the present invention greatly improves the inhibition rate of cytopathic effects caused by parainfluenza virus-1, respiratory syncytial virus, ADV3, CoxB5 and HSV-1 virus strains.

[0042] (2) The Chinese medicinal materials such as Bupleurum, Ligusticum chuanxiong, and Saposhnikovia divaricata contained in the pharmaceutical composition of the present invention contain a variety of phenolic compounds, which can form insoluble or unstable complexes with acetaminophen or chlorpheniramine maleate, thereby affecting the virus inhibition rate and stability of the pharmaceutical composition for treating colds. The addition of excipients improves the bioavailability and stability of the pharmaceutical composition for treating colds.

[0043] (3) Compared with the prior art, the pharmaceutical composition prepared by the present invention has better antiviral ability, higher stability, lower preparation cost and simpler preparation method. DETAILED DESCRIPTION

[0044] In order to enable those skilled in the art to better understand the technical solutions of the present invention, the technical solutions of the present invention will be clearly and completely described below in conjunction with the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work should fall within the scope of protection of the present invention.

[0045] Example 1: This example provides a pharmaceutical composition for treating colds, and the specific preparation steps are as follows:

[0046] S1. The 400 parts by mass of Ligusticum chuanxiong and 300 parts by mass of Saposhnikovia divaricata were mixed, 4900 parts by mass of water were added, and the volatile oil was extracted by steam distillation, and the extraction time was 2 hours to obtain volatile oil, dregs and an aqueous solution after distillation, respectively;

[0047] S2. The residue was mixed with 151.8 parts by mass of dog flower, 300 parts by mass of bupleurum, and 1000 parts by mass of water, decocted at 60 to 80 ° C for 30 min, decocted 3 times, each time for 2 hours, cooled, filtered, and the filtrate was added to the distilled aqueous solution, and concentrated to a relative density of 1.14 to 1.18 at 80 ° C to obtain a clear paste;

[0048] S3. Add ethanol to the clear paste to make the alcohol content of the clear paste to 70wt%, stir for 30min, let stand for 10min, recover the supernatant, and concentrate the supernatant to a relative density of 1.31 to 1.35 at 50 to 60°C to obtain a thick paste;

[0049] S4. The thick paste is mixed with 400 parts by mass of Scutellaria baicalensis powder, dried, crushed, 10 parts by mass of chlorpheniramine maleate and 1 part by mass of acetaminophen are added, mixed, granulated, sprayed with the volatile oil, mixed, and a pharmaceutical composition is obtained.

[0050] Example 2: This example provides a pharmaceutical composition for treating colds, and the specific preparation steps are as follows:

[0051] S1. The 450 parts by mass of Ligusticum chuanxiong and 200 parts by mass of Saposhnikovia divaricata were mixed, 4900 parts by mass of water were added, and the volatile oil was extracted by steam distillation, and the extraction time was 2 hours to obtain volatile oil, dregs and an aqueous solution after distillation;

[0052] S2. The residue was mixed with 198.7 parts by mass of dog flower, 200 parts by mass of bupleurum, and 1000 parts by mass of water, decocted at 60 to 80 ° C for 30 min, decocted 3 times, each time for 2 hours, cooled, filtered, and the filtrate was added to the distilled aqueous solution, and concentrated to a relative density of 1.14 to 1.18 at 80 ° C to obtain a clear paste;

[0053] S3. Add ethanol to the clear paste to make the alcohol content of the clear paste to 70wt%, stir for 30min, let stand for 10min, recover the supernatant, and concentrate the supernatant to a relative density of 1.31 to 1.35 at 50 to 60°C to obtain a thick paste;

[0054] S4. The thick paste is mixed with 498.6 parts by mass of Scutellaria baicalensis powder, dried, crushed, 15 parts by mass of chlorpheniramine maleate and 0.5 parts by mass of acetaminophen are added, mixed, granulated, sprayed with the volatile oil, mixed, and a pharmaceutical composition is obtained.

[0055] Example 3: This example provides a pharmaceutical composition for treating colds, and the specific preparation steps are as follows:

[0056] S1. The 500 parts by mass of Ligusticum chuanxiong and 250 parts by mass of Saposhnikovia divaricata were mixed, 4900 parts by mass of water were added, and the volatile oil was extracted by steam distillation, and the extraction time was 2 hours to obtain volatile oil, dregs and an aqueous solution after distillation;

[0057] S2. The residue was mixed with 100 parts by mass of dog flower, 250 parts by mass of bupleurum, and 1000 parts by mass of water, decocted at 60 to 80 ° C for 30 min, decocted 3 times, each time for 2 hours, cooled, filtered, and the filtrate was added to the distilled aqueous solution, and concentrated to a relative density of 1.14 to 1.18 at 80 ° C to obtain a clear paste;

[0058] S3. Add ethanol to the clear paste to make the alcohol content of the clear paste to 70wt%, stir for 30min, let stand for 10min, recover the supernatant, and concentrate the supernatant to a relative density of 1.31 to 1.35 at 50 to 60°C to obtain a thick paste;

[0059] S4. The thick paste is mixed with 450 parts by mass of Scutellaria baicalensis powder, dried, crushed, 12 parts by mass of chlorpheniramine maleate and 0.8 parts by mass of acetaminophen are added, mixed, granulated, sprayed with the volatile oil, mixed, and a pharmaceutical composition is obtained.

[0060] Comparative Example 1: This comparative example provides a pharmaceutical composition for treating colds. Compared with Example 3, the difference is that a single dogwood flower is used. The specific preparation steps are as follows:

[0061] S1. 4900 parts by mass of water were added to 750 parts by mass of paparazzi flowers, and the volatile oil was extracted by steam distillation, and the extraction time was 2 hours to obtain volatile oil, dregs and an aqueous solution after distillation, respectively;

[0062] S2. The residue was mixed with 350 parts by mass of dog flower and 1000 parts by mass of water, decocted at 60 to 80 ° C for 30 min, decocted 3 times for 2 hours each time, cooled, filtered, and the filtrate was added to the distilled aqueous solution, and concentrated to a relative density of 1.14 to 1.18 at 80 ° C to obtain a clear paste;

[0063] S3. Add ethanol to the clear paste to make the alcohol content of the clear paste to 70wt%, stir for 30min, let stand for 10min, recover the supernatant, and concentrate the supernatant to a relative density of 1.31 to 1.35 at 50 to 60°C to obtain a thick paste;

[0064] S4. The thick paste is mixed with 450 parts by mass of dog flower powder, dried, crushed, 12 parts by mass of chlorpheniramine maleate and 0.8 parts by mass of acetaminophen are added, mixed, granulated, sprayed with the volatile oil, mixed, and a pharmaceutical composition is obtained.

[0065] Comparative Example 2: This comparative example provides a pharmaceutical composition for treating colds. Compared with Example 3, the difference is that a single Bupleurum is used. The specific preparation steps are as follows:

[0066] S1. 4900 parts by mass of water were added to 750 parts by mass of Bupleurum, and the volatile oil was extracted by steam distillation. The extraction time was 2 hours, and the volatile oil, the residue and the aqueous solution after distillation were obtained;

[0067] S2. The residue was mixed with 350 parts by mass of Bupleurum and 1000 parts by mass of water, decocted at 60 to 80 ° C for 30 min, decocted 3 times for 2 hours each time, cooled, filtered, and the filtrate was added to the distilled aqueous solution and concentrated to a relative density of 1.14 to 1.18 at 80 ° C to obtain a clear paste;

[0068] S3. Add ethanol to the clear paste to make the alcohol content of the clear paste to 70wt%, stir for 30min, let stand for 10min, recover the supernatant, and concentrate the supernatant to a relative density of 1.31 to 1.35 at 50 to 60°C to obtain a thick paste;

[0069] S4. Mix the thick paste with 450 parts by mass of Bupleurum powder, dry, crush, add 12 parts by mass of chlorpheniramine maleate and 0.8 parts by mass of acetaminophen, mix, granulate, spray the volatile oil, mix, and obtain a pharmaceutical composition.

[0070] Comparative Example 3: This comparative example provides a pharmaceutical composition for treating colds. Compared with Example 3, the difference is that a single Ligusticum chuanxiong is used. The specific preparation steps are as follows:

[0071] S1. 4900 parts by mass of water were added to 750 parts by mass of Ligusticum chuanxiong, and the volatile oil was extracted by steam distillation. The extraction time was 2 hours, and the volatile oil, the residue and the aqueous solution after distillation were obtained;

[0072] S2. The residue was mixed with 350 parts by mass of Ligusticum chuanxiong and 1000 parts by mass of water, decocted at 60 to 80°C for 30 min, decocted 3 times for 2 hours each time, cooled, filtered, and the filtrate was added to the distilled aqueous solution, and concentrated to a relative density of 1.14 to 1.18 at 80°C to obtain a clear paste;

[0073] S3. Add ethanol to the clear paste to make the alcohol content of the clear paste to 70wt%, stir for 30min, let stand for 10min, recover the supernatant, and concentrate the supernatant to a relative density of 1.31 to 1.35 at 50 to 60°C to obtain a thick paste;

[0074] S4. Mix the thick paste with 450 parts by mass of Ligusticum chuanxiong powder, dry, and crush, add 12 parts by mass of chlorpheniramine maleate and 0.8 parts by mass of acetaminophen, mix, granulate, spray the volatile oil, mix, and obtain a pharmaceutical composition.

[0075] Comparative Example 4: This comparative example provides a pharmaceutical composition for treating colds. Compared with Example 3, the difference is that a single Saposhnikovia divaricata is used. The specific preparation steps are as follows:

[0076] S1. Add 4900 parts by mass of water to 750 parts by mass of windproof, extract the volatile oil by steam distillation, the extraction time is 2 hours, and obtain volatile oil, dregs and aqueous solution after distillation respectively;

[0077] S2. The residue was mixed with 350 parts by mass of Saposhnikovia divaricata and 1000 parts by mass of water, decocted at 60 to 80 ° C for 30 min, decocted 3 times for 2 hours each time, cooled, filtered, and the filtrate was added to the distilled aqueous solution, and concentrated to a relative density of 1.14 to 1.18 at 80 ° C to obtain a clear paste;

[0078] S3. Add ethanol to the clear paste to make the alcohol content of the clear paste to 70wt%, stir for 30min, let stand for 10min, recover the supernatant, and concentrate the supernatant to a relative density of 1.31 to 1.35 at 50 to 60°C to obtain a thick paste;

[0079] S4. Mix the thick paste with 450 parts by mass of Saposhnikovia powder, dry, and crush, add 12 parts by mass of chlorpheniramine maleate and 0.8 parts by mass of acetaminophen, mix, granulate, spray the volatile oil, mix, and obtain a pharmaceutical composition.

[0080] Comparative Example 5: This comparative example provides a pharmaceutical composition for treating colds. Compared with Example 3, the difference is that a single Scutellaria baicalensis is used. The specific preparation steps are as follows:

[0081] S1. 750 parts by mass of Scutellaria baicalensis was added to 4900 parts by mass of water, and the volatile oil was extracted by steam distillation. The extraction time was 2 hours, and the volatile oil, the residue and the aqueous solution after distillation were obtained;

[0082] S2. The residue was mixed with 350 parts by mass of Scutellaria baicalensis and 1000 parts by mass of water, decocted at 60 to 80 ° C for 30 min, decocted 3 times, each time for 2 hours, cooled, filtered, and the filtrate was added to the distilled aqueous solution, and concentrated to a relative density of 1.14 to 1.18 at 80 ° C to obtain a clear paste;

[0083] S3. Add ethanol to the clear paste to make the alcohol content of the clear paste to 70wt%, stir for 30min, let stand for 10min, recover the supernatant, and concentrate the supernatant to a relative density of 1.31 to 1.35 at 50 to 60°C to obtain a thick paste;

[0084] S4. The thick paste is mixed with 450 parts by mass of Scutellaria baicalensis powder, dried, crushed, 12 parts by mass of chlorpheniramine maleate and 0.8 parts by mass of acetaminophen are added, mixed, granulated, sprayed with the volatile oil, mixed, and a pharmaceutical composition is obtained.

[0085] Performance test: Inhibitory effect on cytopathic effects caused by virus strains.

[0086] The tested viruses used in the present invention are parainfluenza virus-1, respiratory syncytial virus, ADV3, CoxB5 and HSV-1. The positive control group used is 0.15mg / ml Arbidol hydrochloride for the treatment of colds on the market, the blank control group used is an equal volume of normal saline, and the sample groups are 0.15mg / ml of the pharmaceutical compositions of Examples 1 to 3 and Comparative Examples 1 to 5. Take 100μl of the positive control group, the blank control group and the sample group with a pipette gun and add them to 96-well plates for culture, wherein the 96-well plates are inoculated with parainfluenza virus-1, respiratory syncytial virus, ADV3, CoxB5 and HSV-1, respectively, and the culture temperature of the 96-well plates is 35±3°C, and the maximum inhibition effect of each group is observed, wherein, "+" indicates mild inhibition, "++" indicates moderate inhibition, "+++" indicates high inhibition, and "-" indicates no inhibition.

[0087] Table 1. Inhibitory effects of virus strains on cytopathic effects.

[0088]

[0089]

[0090] As can be seen from Table 1, Examples 1 to 3 of the present invention have higher inhibition rates on the cytopathic effects caused by parainfluenza virus-1, respiratory syncytial virus, ADV3, CoxB5 and HSV-1 virus strains compared to Arbidol hydrochloride as a positive control group and normal saline as a blank control group.

[0091] Antipyretic test:

[0092] The present invention selects male mice weighing 20-25g as experimental animals, uses arbidol hydrochloride currently available on the market for treating colds as a positive control group, and uses an equal volume of physiological saline as a blank control group.

[0093] The specific test method is as follows: 3 days before the test, mice whose basal body temperature changes no more than 0.3°C are selected as qualified test mice. Qualified mice were randomly divided into 10 groups, 10 mice in each group, including a blank control group, a positive control group, Example 1 group, Example 2 group, Example 3 group, Comparative Example 1 group, Comparative Example 2 group, Comparative Example 3 group, Comparative Example 4 group, and Comparative Example 5 group. Among them, Example 1-3 groups and Comparative Example 1-5 groups were respectively gavaged with a dosage of 5 mg / kg, the positive control group was gavaged with arbidol hydrochloride at a dosage of 5 mg / kg, and the blank control group was gavaged with an equal volume of normal saline. 1 hour after the administration, each group of mice was subcutaneously injected with 12% dry yeast (10 mL / kg) to induce fever. After the fever, the body temperature of each group of mice was measured at 0.5 h, 1 h, 2 h, 4 h and 8 h, respectively, and the body temperature change value ΔT of each group of mice at different times after the fever was induced was calculated. The calculation method is: ΔT=Tt-T0, wherein Tt is the body temperature at a certain time point after the fever, T0 is the basal body temperature, and the average value is recorded.

[0094] Table 2. Antipyretic test results.

[0095]

[0096]

[0097] As shown in Table 2, compared with the blank control group, the body temperature change values ​​of the mice in Example 1 to 3 groups and the positive control group at 0.5h, 1h, 2h, 4h and 8h were significantly different, indicating that Arbidol hydrochloride and Examples 1 to 3 have antipyretic effects on mice with dry yeast fever. Compared with the positive control group, the body temperature change values ​​of the mice in Example 1 to 3 groups at 0.5h, 1h, 2h, 4h and 8h were significantly different, indicating that for mice with dry yeast fever, the antipyretic effect of the composition Examples 1 to 3 of the present invention is better than Arbidol hydrochloride.

[0098] Toxicity test:

[0099] The present invention uses mice as experimental animals, uses Arbidol hydrochloride, a drug for treating colds currently available on the market, as a positive control group, and uses an equal volume of physiological saline as a blank control group.

[0100] The specific test method is as follows: mice were randomly divided into 10 groups, 10 mice in each group, including a blank control group, a positive control group, Example 1 group, Example 2 group, Example 3 group, Comparative Example 1 group, Comparative Example 2 group, Comparative Example 3 group, Comparative Example 4 group, and Comparative Example 5 group, wherein the Example 1 to 3 groups and Comparative Example 1 to 5 groups were gavaged with a dose of 5 mg / kg, the positive control group was gavaged with a dose of 5 mg / kg of Arbidol hydrochloride, and the blank control group was gavaged with an equal volume of normal saline. Before gavage, fasting but not water control was performed for 12 hours; within 14 days after gavage, the death of mice was recorded regularly every day.

[0101] Table 3. Toxicity test results.

[0102]

[0103]

[0104] As shown in Table 3, after one intragastric administration, no animals died in the positive control group, the blank control group, the Example 1 to 3 groups and the Comparative Example 1 to 5 groups, indicating that Arbidol hydrochloride and the composition of the present invention, Examples 1 to 3 and Comparative Examples 1 to 5, had no obvious toxicity.

[0105] Example 4: This example provides a medicine for treating colds, and the specific preparation steps are as follows:

[0106] S1. The 500 parts by mass of Ligusticum chuanxiong and 250 parts by mass of Saposhnikovia divaricata were mixed, 4900 parts by mass of water were added, and the volatile oil was extracted by steam distillation, and the extraction time was 2 hours to obtain volatile oil, dregs and an aqueous solution after distillation;

[0107] S2. The residue was mixed with 100 parts by mass of dog flower, 250 parts by mass of bupleurum, and 1000 parts by mass of water, decocted at 60 to 80 ° C for 30 min, decocted 3 times, each time for 2 hours, cooled, filtered, and the filtrate was added to the distilled aqueous solution, and concentrated to a relative density of 1.14 to 1.18 at 80 ° C to obtain a clear paste;

[0108] S3. Add ethanol to the clear paste to make the alcohol content of the clear paste to 70wt%, stir for 30min, let stand for 10min, recover the supernatant, and concentrate the supernatant to a relative density of 1.31 to 1.35 at 50 to 60°C to obtain a thick paste;

[0109] S4. The thick paste is mixed with 450 parts by mass of Scutellaria baicalensis powder, dried, crushed, 12 parts by mass of chlorpheniramine maleate and 0.8 parts by mass of acetaminophen are added, mixed, granulated, sprayed with the volatile oil, mixed, 8 parts by mass of dextrin are added, pressed into tablets, film-coated, and obtained tablet-like medicine.

[0110] Stability test:

[0111] Because Chinese medicines such as Radix Bupleuri, Radix Ligustici Ligustici, and Radix Saposhnikoviae contain various phenolic compounds, they may form insoluble or unstable complexes with paracetamol or chlorpheniramine maleate, thereby affecting the virus inhibition rate and stability of the pharmaceutical composition for treating colds. The medicines prepared by Example 3 and Example 4 are placed under the conditions of 50°C and 70-80RH respectively for 6 months, and the contents of chlorpheniramine maleate and paracetamol active ingredients of Example 3 and Example 4 after 0 month and 6 months of storage are measured by HPLC respectively, and then the decline rate of chlorpheniramine maleate or paracetamol is calculated, and the decline rate (%)=(content after 0 month content-6 months) / 0 month content×100%.

[0112] Table 4. Stability test results.

[0113] content(%) Time (month) Chlorpheniramine maleate decrease rate (%) Decrease rate of acetaminophen (%) Example 3 6 12.7 13.2 Example 4 6 1.6 1.9

[0114] As shown in Table 4, compared with Example 3, the contents of chlorpheniramine maleate and acetaminophen in Example 4 after storage for 0 month and 6 months did not change significantly, indicating that the addition of excipients has a stabilizing effect on chlorpheniramine maleate and acetaminophen.

[0115] The above embodiments are only used to illustrate the technical solutions of the present invention rather than to limit the same. Although the present invention has been described in detail with reference to the above embodiments, ordinary technicians in the relevant field should understand that after reading the specification of this application, the technicians can still modify or replace the specific implementation methods of the present invention with equivalents, but these modifications or changes do not deviate from the scope of protection of the pending claims of the present application.

Claims

1. A pharmaceutical composition for treating colds, characterized in that: The medicinal composition for treating colds comprises the following raw materials in parts by weight: 100-200 parts of dogwood flower, 200-300 parts of bupleurum root, 400-500 parts of ligusticum chuanxiong, 200-300 parts of siler, and 400-500 parts of scutellaria baicalensis.

2. The pharmaceutical composition according to claim 1, characterized in that The pharmaceutical composition further comprises the following raw materials in parts by weight: 10 to 15 parts of chlorpheniramine maleate and 0.5 to 1 part of acetaminophen.

3. A method for preparing a medicinal composition for treating colds as claimed in claim 2, characterized in that: The steps include: S1. Mix Ligusticum chuanxiong and Saposhnikovia divaricata, extract volatile oil by steam distillation, and obtain volatile oil, medicinal residue and aqueous solution after distillation; S2. The residue is mixed with dog flower, bupleurum, water, decocted, filtered, and the filtrate is added to the distilled aqueous solution, concentrated, and a clear paste is obtained; S3. Add ethanol to the clear paste, stir, let stand, recover the supernatant, and concentrate the supernatant to obtain a thick paste; S4. Mix the thick paste with the scutellaria baicalensis powder, dry, crush, add chlorpheniramine maleate and acetaminophen, mix, granulate, spray the volatile oil, mix, and obtain a pharmaceutical composition.

4. Use of the medicinal composition for treating colds according to any one of claims 1 to 2 in the preparation of a medicament for treating colds.

5. The use according to claim 4, characterized in that The symptom of a cold is at least one of fever, headache, nasal congestion, sneezing, sore throat or general malaise and aches.

6. A medicine for treating colds, characterized in that: A pharmaceutical composition comprising any one of claims 1 to 2.

7. The drug according to claim 6, characterized in that Also included are pharmaceutically acceptable excipients.

8. The drug according to claim 7, characterized in that The auxiliary material is selected from at least one of starch, sucrose and dextrin.

9. The drug according to claim 7, characterized in that The dosage form of the medicine is granules, tablets, capsules, powders, suspensions or pills.

10. A method for preparing the drug according to claim 9, characterized in that: The steps include: S1. Mix Ligusticum chuanxiong and Saposhnikovia divaricata, extract volatile oil by steam distillation, and obtain volatile oil, medicinal residue and aqueous solution after distillation; S2. The residue is mixed with dog flower, bupleurum, water, decocted, filtered, and the filtrate is added to the distilled aqueous solution, concentrated, and a clear paste is obtained; S3. Add ethanol to the clear paste, stir, let stand, recover the supernatant, and concentrate the supernatant to obtain a thick paste; S4. Mix the thick paste with the scutellaria powder, dry, crush, add chlorpheniramine maleate and acetaminophen, mix, granulate, spray the volatile oil, mix, add auxiliary materials, and prepare the medicine in the form of granules, tablets, capsules, powders, suspensions or pills.

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