A Chinese medicine composition and its application in preparing antibacterial and antiviral drugs

Abstract

The present invention relates to the technical field of traditional Chinese medicine, and in particular to a Chinese medicine composition and its application in the preparation of antibacterial and antiviral drugs. The Chinese medicine composition comprises the following raw materials: forsythia, isatis root, patchouli, gypsum, roasted ephedra, menthol, rhubarb, stir-fried bitter almonds and rhodiola rosea. The antiviral composition has a significant antipyretic effect, and has significant antiviral, antibacterial, antitussive and laxative effects. It can be used for symptoms of high fever, sore throat, cough, shortness of breath, thirst, dry stool, yellow and greasy tongue coating, bright red tongue, and floating pulse, and can be prepared into a drug for preparing the above symptoms.

Description

Technical Field

[0001] The present invention relates to the technical field of traditional Chinese medicine, and in particular to a traditional Chinese medicine composition and application thereof in the preparation of antibacterial and antiviral drugs. Background Art

[0002] Sore throat is a common upper respiratory tract disease, most of which are caused by viruses or bacteria. Sore throat may be accompanied by symptoms such as runny nose, mild cough, low fever, etc., or it may be accompanied by high fever, cough, dry stool and other symptoms. Especially in the latter case, due to the severe symptoms, patients often take antipyretic and analgesic drugs such as acetaminophen and ibuprofen to reduce fever, and take antibiotics to kill pathogenic microorganisms in order to achieve the purpose of rapid symptom relief. However, antipyretic and analgesic drugs such as acetaminophen and ibuprofen have certain liver damage and gastrointestinal side effects, and the antipyretic effect is not long-lasting. The drug needs to be used again after 4 to 6 hours, which leads to aggravation of adverse reactions. Antibiotics can damage the nervous system, kidneys, and blood system. If used improperly, they can also cause pathogens to mutate and become drug-resistant bacteria, and may cause other complications due to drug resistance and drug side effects. In addition, antipyretic and analgesic drugs can inhibit mucus secretion and dry the intestines. Antibiotics may also cause intestinal flora imbalance. Both of them cannot relieve dry stools and aggravate the symptoms. Therefore, Western medicine is not effective in treating sore throat accompanied by symptoms such as high fever, cough, and dry stool. Summary of the invention

[0003] In view of the technical problem that current Western medicine has poor therapeutic effect on sore throat accompanied by symptoms such as high fever, cough, and dry stool, the present invention provides a Chinese medicine composition and its use in the preparation of antibacterial and antiviral drugs.

[0004] In order to achieve the above-mentioned object of the invention, the embodiment of the present invention adopts the following technical solution:

[0005] On the one hand, an embodiment of the present invention provides an antibacterial and antiviral Chinese medicine composition, comprising the following raw materials in proportions by weight: 7 to 13 parts of Forsythia suspensa, 7 to 13 parts of Isatis indigotica, 3 to 7 parts of Patchouli, 22 to 38 parts of Gypsum, 3 to 8 parts of roasted Ephedra, 2 to 4 parts of Menthol, 4 to 8 parts of Rhubarb, 4 to 8 parts of stir-fried bitter almonds and 11 to 18 parts of Rhodiola rosea.

[0006] In the antibacterial and antiviral Chinese medicine composition provided by the present invention:

[0007] Forsythia suspensa is slightly cold in nature and enters the lung, heart, and gallbladder meridians. It is light and clear in nature and is good at clearing heat and detoxifying. It is especially good at clearing heart fire and dispersing wind-heat in the upper part of the body. It can also eliminate carbuncles and disperse nodules.

[0008] Isatis root is cold in nature and enters the heart meridian and stomach meridian. It is good at clearing away heat and fire toxins, cooling blood and relieving sore throat, reducing swelling and dispersing nodules.

[0009] Patchouli is slightly warm in nature and enters the spleen, stomach, and lung meridians. It can not only transform dampness and turbidity in the middle-jiao spleen and stomach, and harmonize the stomach and stop vomiting, but it can also transform dampness and relieve exterior symptoms, dissipate heat and detoxify, and it is warm in nature without being dry.

[0010] Gypsum is very cold in nature and enters the lung and stomach meridians. It can both expel heat and release heat internally. It is an important medicine for clearing lung heat and relieving stomach fire, and it also has the effect of absorbing moisture.

[0011] Roasted ephedra is warm in nature and enters the lung and bladder meridians. It moistens the lungs and relieves cough, clears the lungs and relieves asthma, induces sweating, relieves exterior symptoms, and promotes diuresis.

[0012] Menthol is cool in nature and enters the lung and liver meridians. It can dispel wind and heat, clear the head and eyes, relieve sore throat and rash, and soothe the liver and promote qi circulation.

[0013] Rhubarb is cold in nature and enters the spleen, stomach, large intestine, liver, and pericardium meridians. It has a settling nature, can lead heat downward, and has a strong laxative effect. It can purge accumulation, cleanse the intestines and stomach, and remove the old and bring in the new. It can both clear away heat and toxins and clear away heat in the blood. It has the effects of cooling blood, detoxifying, activating blood circulation and removing blood stasis.

[0014] Fried bitter almonds are slightly warm in nature and slightly toxic. They belong to the lung meridian and large intestine meridian, and have the effects of relieving cough and asthma, and moistening the intestines and promoting bowel movements.

[0015] Rhodiola rosea is mild in nature and enters the lung and heart meridians. It has the functions of replenishing qi and clearing the lungs, invigorating qi and activating blood circulation, unblocking meridians and relieving asthma, dispersing blood stasis and reducing swelling.

[0016] In the antibacterial and antiviral Chinese medicine composition, gypsum clears lung heat and produces body fluid, isatis root treats sore throat, and rhubarb relieves diarrhea and heat. The three are used together to clear both the exterior and the interior, and are the main medicine. With roasted ephedra, combined with gypsum, it can disperse lung heat and clear away stagnant heat. Isatis root and menthol can clear away throat discomfort. Rhubarb is combined with forsythia to clear the upper part and promote the lower part, and they work together to treat the troubles of Yangming. The three medicines are the assistant medicines. Apricot kernel is used to prevent ephedra and gypsum from promoting excessive release, patchouli prevents coldness from damaging the spleen, and rhodiola rosea nourishes the muscles and enhances immunity. The three are the assistant medicines.

[0017] The whole prescription can be used for the symptoms of high fever, sore throat, cough, shortness of breath, thirst, dry stool, yellow and greasy tongue coating, bright red tongue, and floating pulse through the compatibility of the above medicinal flavors. Animal experiments, antibacterial experiments and clinical application effects have proved that the antibacterial and antiviral Chinese medicine composition has a significant antipyretic effect and has significant antiviral, antibacterial, antitussive and laxative effects.

[0018] Preferably, the antibacterial and antiviral Chinese medicine composition comprises the following raw materials in proportions by weight: 8-11 parts of Forsythia suspensa, 8-11 parts of Isatis indigotica, 4-6 parts of Patchouli, 25-35 parts of Gypsum, 4-7 parts of roasted Ephedra, 2-3 parts of Menthol, 5-7 parts of Rhubarb, 5-7 parts of stir-fried bitter almonds and 13-17 parts of Rhodiola rosea.

[0019] Preferably, the antibacterial and antiviral Chinese medicine composition comprises the following raw materials in proportion by weight: 10 parts of Forsythia suspensa, 10 parts of Isatis indigotica, 5 parts of Patchouli, 30 parts of Gypsum, 6 parts of roasted Ephedra, 3 parts of Menthol, 6 parts of Rhubarb, 6 parts of stir-fried bitter almonds and 15 parts of Rhodiola rosea.

[0020] In actual use of this prescription, each weight portion above is 1g, which is the dosage per dose. Use 1 to 2 doses per day depending on the condition of the disease.

[0021] In the second aspect, the embodiment of the present invention also provides a method for preparing the above-mentioned antibacterial and antiviral Chinese medicine composition, comprising the following operations: weighing each raw material according to the raw material ratio in the above-mentioned antibacterial and antiviral Chinese medicine composition, extracting the volatile oil of the patchouli, filtering the residue and forsythia, isatis root, gypsum, roasted ephedra, rhubarb, fried bitter almond and rhodiola rosea after decoction extraction, collecting the obtained filtrate, drying, and obtaining a decoction extract; adding the volatile oil of the patchouli to the obtained decoction extract and mixing evenly, then adding the menthol and mixing evenly to obtain the antibacterial and antiviral Chinese medicine composition. The obtained product can be further processed into oral dosage forms such as tablets, granules, powders, capsules, syrups, oral liquids, etc. according to the actual needs of clinical use or dosage form requirements.

[0022] The decoction extract can be prepared by the following operation process: decocting the gypsum for 15 to 25 minutes, adding the residue after extracting volatile oil from patchouli, as well as forsythia, isatis root, roasted ephedra, stir-fried bitter almonds and rhodiola rosea, and then adding rhubarb and continuing to decoct for 5 to 10 minutes, filtering, and collecting the filtrate.

[0023] The amount of water used to decoct the gypsum can be 6 to 9 times the total weight of the gypsum, forsythia, isatis root, roasted ephedra, fried bitter almonds and rhodiola rosea. After the gypsum is decocted, the forsythia, isatis root, roasted ephedra, fried bitter almonds and rhodiola rosea are directly added and decocted for 2 to 3 times, each time for 25 to 40 minutes, preferably decocted for 2 times, each time for 30 minutes. After adding rhubarb, continue to decoct for preferably 8 minutes.

[0024] Optionally, the drying is to dry the obtained filtrate at ≤50°C. The filtrate may be concentrated at ≤50°C before drying. Treating the filtrate at a lower temperature can reduce the decomposition or volatilization of the active ingredients at high temperature. The concentration method may be reduced pressure concentration, and the drying method may be spray drying, reduced pressure drying or freeze drying.

[0025] In a third aspect, an embodiment of the present invention further provides the use of the above-mentioned antibacterial and antiviral Chinese medicine composition in the preparation of a medicine for treating high fever.

[0026] In a fourth aspect, an embodiment of the present invention further provides the use of the above-mentioned antibacterial and antiviral Chinese medicine composition in the preparation of a medicine for treating sore throat.

[0027] In a fifth aspect, an embodiment of the present invention further provides the use of the above-mentioned antibacterial and antiviral Chinese medicine composition in the preparation of a medicine for treating cough and reverse cough.

[0028] In a sixth aspect, an embodiment of the present invention further provides the use of the above-mentioned antibacterial and antiviral Chinese medicine composition in the preparation of a medicine for treating dry stool.

[0029] In a seventh aspect, an embodiment of the present invention further provides the use of the above-mentioned antibacterial and antiviral Chinese medicine composition in the preparation of a medicine for treating at least two symptoms of high fever, sore throat, cough and dry stool.

[0030] Clinically verified, the above-mentioned antibacterial and antiviral Chinese medicine composition has a good therapeutic effect on the symptoms of high fever, sore throat, cough, shortness of breath, thirst, dry stool, yellow and greasy tongue coating, bright red tongue, and floating pulse. Therefore, it can be used to prepare a medicine for treating one or more symptoms of high fever, sore throat, cough, and dry stool.

[0031] In an eighth aspect, an embodiment of the present invention further provides an antiviral and / or antibacterial drug, which includes the above-mentioned antibacterial and antiviral Chinese medicine composition. DETAILED DESCRIPTION

[0032] In order to make the purpose, technical scheme and advantages of the present invention clearer, the present invention is further described in detail below in conjunction with specific embodiments. It should be understood that the specific embodiments described herein are only used to explain the present invention and are not intended to limit the present invention. The experimental methods used in the following examples are conventional methods in the art unless otherwise specified.

[0033] The forsythia, isatis root, patchouli, gypsum, roasted ephedra, menthol, rhubarb, stir-fried bitter almonds and rhodiola rosea used in the following examples all comply with the relevant provisions under each medicinal material item of the main text of the Chinese Pharmacopoeia (2015 edition) Volume I.

[0034] Unless otherwise specified, the raw materials, reagents, etc. used in the following examples were obtained from commercial sources.

[0035] Example

[0036] The embodiments of the present invention provide an antibacterial and antiviral Chinese medicine composition. In each embodiment, the raw material composition of each dose is shown in Table 1 (unit: g).

[0037] Table 1 Raw material composition of the antibacterial and antiviral Chinese medicine composition of each embodiment

[0038] raw material Example 1 Example 2 Example 3 Example 4 Example 5 Forsythia 10 8 11 7 13 Isatis root 10 8 11 7 13 Patchouli 5 4 6 3 7 plaster 30 25 35 22 38 Roasted Ephedra 6 4 7 3 8 Menthol 3 2 3 2 4 rhubarb 6 5 7 4 8 Fried bitter almonds 6 5 7 4 8 Rhodiola rosea 15 13 17 11 18

[0039] The embodiment of the present invention also provides a method for preparing the antibacterial and antiviral Chinese medicine composition in the above embodiment. According to the raw material ratio in the antibacterial and antiviral Chinese medicine composition in the above embodiment, each raw material is weighed, the volatile oil of the patchouli is extracted, the gypsum is decocted for 15 to 25 minutes, and then the residue after the volatile oil of patchouli is extracted, as well as forsythia, isatis root, roasted ephedra, fried bitter almond and rhodiola are added and decocted 2 to 3 times, each time for 25 to 40 minutes, and then rhubarb is added and continued to be decocted for 5 to 10 minutes, filtered, and spray dried at 40 to 50 ° C to obtain a decoction extract; the volatile oil of patchouli is added to the obtained decoction extract and mixed evenly, and then menthol is added and mixed evenly to obtain. The specific parameter conditions in the preparation method of each embodiment are shown in Table 2.

[0040] Table 2 Preparation parameters of each example

[0041]

[0042]

[0043] Comparative Example 1

[0044] The comparative example of the present invention provides an antibacterial and antiviral Chinese medicine composition, based on the raw material composition of Example 1, removing roasted ephedra, and increasing the amount of patchouli, which has similar effects to roasted ephedra and can relieve symptoms. The raw materials in each dose are: 10g of forsythia, 10g of isatis root, 11g of patchouli, 30g of gypsum, 3g of menthol, 6g of rhubarb, 6g of fried bitter almonds and 15g of rhodiola. The preparation method is the same as that of Example 1.

[0045] Comparative Example 2

[0046] The comparative example of the present invention provides an antibacterial and antiviral Chinese medicine composition, based on the raw material composition of Example 1, removing Forsythia suspensa, and increasing the amount of Radix Isatidis, which has similar effects to Forsythia suspensa and can clear away heat and detoxify. The raw materials in each dose are: 20g of Radix Isatidis, 5g of Patchouli, 30g of Gypsum, 6g of Roasted Ephedra, 3g of Menthol, 6g of Rhubarb, 6g of Stir-fried Bitter Apricot and 15g of Rhodiola rosea. The preparation method is the same as that of Example 1.

[0047] Effect Example 1

[0048] This effect example provides a toxicity test of a single intragastric administration of the antibacterial and antiviral Chinese medicine composition to mice, in order to observe the possible toxic reactions after taking the antibacterial and antiviral Chinese medicine composition of the present invention.

[0049] 1. Materials

[0050] 1.1 Trial Drugs

[0051] The raw materials and preparation methods of Examples 1 to 5 were prepared, respectively ground evenly, dispersed with 0.5% CMC-Na, and prepared into a concentration of 2 g crude drug / ml as the test solution.

[0052] 1.2 Experimental animals

[0053] ICR mice, SPF grade, 240 mice, 20-22 g, half male and half female, were purchased from Beijing Weitonglihua Laboratory Animal Technology Co., Ltd., license number: SCXK (Beijing) 2016-0011.

[0054] 2. Methods

[0055] 2.1 Grouping and Dosing

[0056] Male and female mice were randomly divided into 6 groups, 20 mice in each group, respectively, a blank control group and 5 example groups (Example 1 group, Example 2 group, Example 3 group, Example 4 group and Example 5 group), each example group was gavaged with the test solution of Examples 1 to 5 obtained in 1.1, the volume was 0.4 ml / 10 g body weight (maximum volume), and the drug was administered twice a day, with an interval of 6 hours, and the blank control group was given an equal amount of drinking water. All animals were fasted overnight before administration, but not water.

[0057] 2.2 Observation indicators, time and content

[0058] After each administration, the animals were observed for 2 hours continuously, and the appearance, behavior, secretions, excretions, death and poisoning reactions (symptoms, starting time, severity, duration, reversibility of poisoning reactions) of the animals were observed, and the time of occurrence and duration of abnormal symptoms were recorded in detail. The animals were observed continuously for 14 days after administration, and the weight and food intake of the animals were recorded once a day on the 1st, 2nd, 3rd, 4th, 7th and 14th days after administration. After the observation period, the surviving animals were euthanized and grossly dissected. When changes in the volume, color, texture, etc. of the organs were found, the changed organs were subjected to histopathological examination.

[0059] 2.4 Data Analysis

[0060] The experimental data were statistically analyzed using SPSS 18.0 software, and the results were expressed as mean ± standard deviation. Indicates that independent samples two-sided T test was used.

[0061] 3. Results

[0062] 3.1 Impact on general condition

[0063] No abnormality was observed in the general conditions of the blank control group and each embodiment group.

[0064] 3.2 Effects on body weight and food intake

[0065] There was no significant statistical difference in the body weight of the male and female animals in each example group compared with the vehicle control group; and there was no significant difference in the food intake compared with the blank control group. See Tables 3-6.

[0066] Table 3. Changes in body weight of male animals in the single oral administration toxicity test in ICR mice (g)

[0067]

[0068]

[0069] Table 4. Body weight changes of female animals in the single oral administration toxicity test in ICR mice (g)

[0070]

[0071] Table 5. Changes in food intake of male animals in the single oral administration toxicity test of ICR mice (g / day / piece)

[0072]

[0073] Table 6. Changes in food intake of female animals in the single oral administration toxicity test of ICR mice (g / day / piece)

[0074]

[0075] 3.3 Gross anatomy

[0076] After the observation period, the mice in the blank control group and each example group were subjected to gross anatomy, and no obvious abnormalities were found in the heart, liver, spleen, lung, kidney, brain, stomach, intestine, thymus, reproductive organs, bladder, etc.

[0077] 4. Conclusion

[0078] The maximum dosage for oral administration to mice was 160 g crude drug / kg, and no toxic reactions related to the test substance were observed at this dosage.

[0079] Effect Example 2

[0080] This effect example provides an experiment on the effect of the above antibacterial and antiviral Chinese medicine composition on LPS-induced fever in rats, so as to observe the antipyretic effect of taking the antibacterial and antiviral Chinese medicine composition of the present invention.

[0081] 1. Materials

[0082] 1.1 Trial Drugs

[0083] According to the raw material composition and preparation method of Examples 1 to 5 and Comparative Examples 1 and 2, the raw materials were prepared and ground evenly, dispersed with 0.5% CMC-Na, and prepared into a concentration of 0.3 g crude drug / ml as the test solution.

[0084] 1.2 Experimental animals

[0085] SD rats, SPF grade, 96, 180-200 g, male, were purchased from Beijing Weitonglihua Laboratory Animal Technology Co., Ltd., license number: SCXK (Beijing) 2016-0011.

[0086] 2. Methods

[0087] 2.1 Grouping and Dosing

[0088] Rats were randomly divided into 8 groups, each with 12 rats, including a model control group, 5 example groups (example group 1, example group 2, example group 3, example group 4 and example group 5), comparative example group 1 and comparative example group 2. Each example group was gavaged with the test solution of examples 1 to 5 obtained in 1.1, and comparative example group 1 and comparative example group 2 were gavaged with the test solution of comparative examples 1 and 2 obtained in 1.1, respectively, with a gavage volume of 1 ml / 100 g body weight. The model control group was given an equal amount of drinking water. After 30 minutes of administration, the rectal temperature of each group of rats was measured once and recorded as T0, and then 20 μg / kg LPS (prepared with physiological saline) was intraperitoneally injected for modeling, with a volume of 5 ml / kg. The rectal temperature was measured every 1 hour after modeling and recorded as T x , for 5 consecutive hours, calculate the body temperature difference △T, △T = T x -T0.

[0089] 2.2 Data Analysis

[0090] The experimental data were statistically analyzed using SPSS 18.0 software, and the results were expressed as mean ± standard deviation. Indicated by one-way analysis of variance.

[0091] 3. Results

[0092] The body temperature difference of the rats in the model control group showed a significant upward trend 1-5 hours after the model was established by intraperitoneal injection of LPS. Compared with the model control group, the body temperature difference of the rats in the embodiment group was significantly reduced 2 hours and 3 hours after the model was established (P<0.05), and the body temperature difference of the rats in the comparative example group was significantly reduced 3 hours after the model was established (P<0.05). See Table 7.

[0093] Table 7 Effects of LPS-induced fever in rats

[0094]

[0095] Note: Compared with the model control group: *P<0.05.

[0096] 4. Conclusion

[0097] The antibacterial and antiviral Chinese medicinal composition of the present invention has the effect of inhibiting fever caused by intraperitoneal injection of LPS in rats, and the antibacterial and antiviral Chinese medicinal composition provided by the embodiment of the present invention is superior to the comparative example.

[0098] Effect Example 3

[0099] This effect example provides the effect of the above antibacterial and antiviral Chinese medicine composition on the cough of mice caused by ammonia spray, so as to observe the antitussive effect of taking the antibacterial and antiviral Chinese medicine composition of the present invention.

[0100] 1. Materials

[0101] 1.1 Trial Drugs

[0102] According to the raw material composition and preparation method of Examples 1 to 5 and Comparative Examples 1 and 2, the raw materials were prepared and ground evenly, dispersed with 0.5% CMC-Na, and prepared into a concentration of 0.4 g crude drug / ml as the test solution.

[0103] 1.2 Experimental animals

[0104] KM mice, SPF grade, 108 mice, 20-22 g, male, were purchased from Beijing Weitonglihua Laboratory Animal Technology Co., Ltd., license number: SCXK (Beijing) 2016-0011.

[0105] 2. Methods

[0106] 2.1 Grouping and Dosing

[0107] Mice were randomly divided into 9 groups, 12 in each group, namely a normal control group, a model control group, 5 example groups (example group 1, example group 2, example group 3, example group 4 and example group 5), comparative example group 1 and comparative example group 2. Each example group was gavaged with the test solution of examples 1 to 5 obtained in 1.1, and comparative example group 1 and comparative example group 2 were gavaged with the test solution of comparative examples 1 and 2 obtained in 1.1, respectively. All were continuously gavaged for 5 days, once a day, with a capacity of 0.2 ml / 10g body weight. The normal control group and the model control group were given an equal amount of drinking water. 30 minutes after the last administration, the animals were placed in a 10cm×10cm×10cm acrylic box to induce coughing, the WH-801 ultrasonic nebulizer was adjusted to the second gear, and an ammonia solution with a concentration of about 13% was sprayed at a constant speed for 6s, the spray tube was removed, and the spray tube mouth was exposed. The cough latency of the mice and the number of coughs within 3 minutes were recorded.

[0108] 2.2 Data Analysis

[0109] The experimental data were statistically analyzed using SPSS 18.0 software, and the results were expressed as mean ± standard deviation. Indicated by one-way analysis of variance.

[0110] 3. Results

[0111] 3.1 Effects of ammonia on cough in mice

[0112] Compared with the model control group, the cough latency of mice in the embodiment group and the comparative example group was significantly prolonged (P<0.05), and the number of coughs was significantly reduced (P<0.05), and the cough latency of the embodiment group was longer than that of the comparative example group, and the number of coughs was less than that of the comparative example group. See Table 8.

[0113] Table 8 Effects of ammonia on cough in mice

[0114]

[0115] Note: Compared with the model control group: *P<0.05.

[0116] 4. Conclusion

[0117] In vivo administration of the antibacterial and antiviral Chinese medicinal composition of the present invention has a significant inhibitory effect on the cough of mice caused by ammonia spray, and the antibacterial and antiviral Chinese medicinal composition provided by the embodiment of the present invention is superior to the comparative example.

[0118] Effect Example 4

[0119] This effect example examines the antibacterial and antiviral Chinese medicine composition's antibacterial effect on Gram-positive bacteria and Gram-negative bacteria to observe the antibacterial effect of the antibacterial and antiviral Chinese medicine composition of the present invention.

[0120] 1. Materials

[0121] 1.1 Trial Drugs

[0122] The preparation was carried out according to the raw materials and preparation methods of Examples 1 to 5 and Comparative Examples 1 and 2.

[0123] 1.2 Test strains

[0124] Gram-positive bacteria: Staphylococcus aureus (ATCC6538), Streptococcus pyogenes (ATCC19615);

[0125] Gram-negative bacteria: Escherichia coli (ATCC35218), Pseudomonas aeruginosa (ATCC9027).

[0126] 1.3 Culture medium

[0127] Beef extract peptone solid medium: 0.5 g beef extract, 0.5 g sodium chloride, 1.0 g peptone, 100 mL water, pH 7.0-7.2. Sterilize at 121°C, 0.1 MPa for 20 min.

[0128] Beef extract peptone liquid culture medium: 0.5g beef extract, 0.5g sodium chloride, 1.0g peptone, 2.0-4.0g agar powder, 100mL water, pH 7.0-7.2. Sterilize at 121℃, 0.1MPa for 20min.

[0129] 2. Methods

[0130] The 5th generation nutrient agar slant culture (24 h) of the test strain was washed with sterile water and diluted with the above beef extract peptone liquid medium to prepare a 10 6 cfu / ml bacterial suspension.

[0131] The test drugs of each embodiment and comparative example in 1.1 were ground evenly, dissolved in dimethyl sulfoxide, prepared into a concentration of 500 mg crude drug / ml, and filtered through a 0.22 μm microporous filter membrane to prepare a sample solution.

[0132] The sample solutions of each embodiment and comparative example are operated as follows: Take a sterilized 96-well plate and add 100 μL of beef extract peptone liquid culture medium to the 1st to 11th wells respectively. Take 100 μL of sample solution and add it to the 1st well. After mixing evenly, draw 100 μL from the 1st well and add it to the 2nd well. After mixing evenly, draw 100 μL from the 2nd well and add it to the 3rd well. Do this until the 10th well. Finally, draw 100 μL from the 10th well and discard it. Take 100 μL of bacterial suspension and add it to the 1st to 12th wells of the 96-well plate. Add 100 μL of dimethyl sulfoxide to the 12th well as a negative control. Three parallel tests are set for each of the above groups.

[0133] 3. Results

[0134] The above 96-well plate was placed in a 37°C constant temperature incubator for 24 hours and then observed against a black background to obtain the minimum inhibitory concentration of each sample. The results are shown in Table 9.

[0135] Table 9 Minimum inhibitory concentration of samples (based on crude drugs)

[0136]

[0137] 4. Conclusion

[0138] The antibacterial and antiviral Chinese medicinal composition of the present invention has an inhibitory effect on both Gram-positive bacteria and Gram-negative bacteria, and the antibacterial and antiviral Chinese medicinal composition provided by the embodiment of the present invention is superior to the comparative example.

[0139] Effect Example 5

[0140] This effect example provides the effect of the above antibacterial and antiviral Chinese medicine composition on influenza A (H1N1) virus in vitro, so as to observe the antiviral effect of taking the antibacterial and antiviral Chinese medicine composition of the present invention.

[0141] 1. Materials

[0142] 1.1 Trial Drugs

[0143] According to the raw materials and preparation methods of Example 1 and Comparative Example 1, the mixture was ground evenly, dissolved with dimethyl sulfoxide (DMSO) and ultrasonically assisted, concentrated to the required concentration, centrifuged, and the supernatant was filtered for later use as the test solution.

[0144] 1.2 Cells

[0145] VeroE6 cells are maintained by the Virus Laboratory of the State Key Laboratory of Respiratory Diseases, Guangzhou Institute of Respiratory Health.

[0146] 1.3 Viruses

[0147] Influenza A (H1N1) virus, titer is TCID 50 =10 -3.5 , maintained by the Influenza Room of the Institute of Viral Disease Prevention and Control, Chinese Center for Disease Control and Prevention.

[0148] 2. Methods

[0149] 2.1 MTT assay for in vitro toxicity

[0150] VeroE6 cells were seeded in 96-well plates, and 100 μL of 2×10 5 VeroE6 cells / mL were cultured at 37°C and 5% CO2, and 4 duplicate wells were set up. After the cells grew into a monolayer, the cells were divided into a blank group (without cells, only culture medium), a solvent control group (DMSO group), Example 1 group and Comparative Example 1 group. 100uL of VeroE6 cell culture medium was added to the blank group, 100uLDMSO was added to the solvent control group, different concentrations of Example 1 test solution were added to the Example 1 group, and different concentrations of Comparative Example 1 test solution were added to the Comparative Example 1 group. Each group of cells was incubated at 5% CO2 and 37°C for 48 hours, 100uL of 1mg / ml MTT solution was added, and the culture was continued for 4h, then the culture was terminated, 100uL DMSO was added to each well, and the cells were placed on a shaker and shaken at a low speed for 10 minutes. The absorbance value of each well at a wavelength of 490nm was measured on a full-wavelength scanner, and the TC value of the drug was calculated using GraphPad Prism6.0. 50 value.

[0151] 2.2 In vitro anti-influenza virus activity assay

[0152] The antiviral activity of the drug was tested by cytopathic inhibition assay. VeroE6 cells were seeded in 96-well plates, and 100 μL of 2×10 5 VeroE6 cells were cultured at 37°C and 5% CO2 for 4 replicates. When the cells grew into a monolayer, the culture medium was discarded and the cell surface was washed twice with PBS. The cells were divided into a blank group, a solvent control group, a virus control (negative control) group, an example 1 group, and a comparative example 1 group. 100 TCID 50 100uL / well of influenza A (H1N1) virus dilution was added and incubated in an incubator. After 2 hours, the virus solution was discarded and the medium containing the drug to be tested was added. The cells were incubated in the incubator for 48 hours. The cell lesions were observed and recorded every day. The degree of cell lesions was recorded according to the following 6-level standards: "-" no lesions; "±" less than 10% cell lesions; "+" about 25% cell lesions; "++" about 50% cell lesions; "+++" about 75% of cells had lesions: "++++" more than 75% lesions. The half inhibitory concentration (IC) was calculated using GraphPad Prism6.0 50 ).

[0153] 2.3 Data Analysis

[0154] Calculate the selection index SI, SI = TC 50 / IC 50 .

[0155] 3. Results

[0156] 3.1 Results of toxicity experiments on VeroE6 cells

[0157] Effect of the antibacterial and antiviral Chinese medicine composition obtained in Example 1 of the present invention on TC of VeroE6 cells 50 The antibacterial and antiviral Chinese medicine composition obtained in Comparative Example 1 had an effect on the TC of VeroE6 cells. 50 It is 3551μg / ml, see Table 10 and Table 11.

[0158] Table 10 Toxicity of the antibacterial and antiviral Chinese medicine composition obtained in Example 1 to VeroE6 cells

[0159]

[0160] Table 11 Toxicity of the antibacterial and antiviral Chinese medicine composition obtained in Comparative Example 1 to VeroE6 cells

[0161]

[0162] 3.2 Experimental results on influenza A (H1N1) virus

[0163] IC of the antibacterial and antiviral Chinese medicine composition obtained in Example 1 of the present invention against influenza A (H1N1) virus 50 is 170.4μg / ml, after calculation, SI = TC 50 / IC 50 =21.4. IC of the antibacterial and antiviral Chinese medicine composition obtained in Comparative Example 1 against influenza A (H1N1) virus 50 is 270μg / ml. After calculation, SI = TC 50 / IC 50 =13.2. See Table 12 and Table 13.

[0164] Table 12 Effects of the antibacterial and antiviral Chinese medicine composition obtained in Example 1 on influenza virus A (H1N1)

[0165]

[0166]

[0167] Table 13 Effect of the antibacterial and antiviral Chinese medicine composition obtained in Comparative Example 1 on influenza virus A (H1N1)

[0168]

[0169] 4 Conclusion

[0170] The antibacterial and antiviral Chinese medicine compositions of the embodiments of the present invention and the comparative examples both have the effect of resisting influenza A (H1N1) virus, and the antibacterial and antiviral Chinese medicine compositions provided by the embodiments of the present invention are superior to the comparative examples.

[0171] Effect Example 6

[0172] This effect example provides the clinical application effect of the antibacterial and antiviral Chinese medicine composition of Example 1.

[0173] 1. Cases and treatment methods

[0174] The clinical application effects of 98 patients with the same symptoms of high fever, sore throat and cough who took the antibacterial and antiviral Chinese medicine composition of Example 1 of the present invention from January 2018 to July 2020 were statistically analyzed.

[0175] The average age of the above patients was 36.7 years old (age range 15-42 years old), and the clinical symptoms were high fever, sore throat, cough, shortness of breath, thirst, dry stool, yellow and greasy tongue coating, bright red tongue, and floating pulse. Each person took one dose of the antibacterial and antiviral Chinese medicine composition provided in Example 1 of the present invention every day, and no other drugs were used during the treatment period, and a light diet and regular work and rest were followed.

[0176] 2. Treatment effect

[0177] The cure standard is the disappearance of all the above clinical symptoms.

[0178] According to statistics, the fever of the above patients subsided within 1 to 2 days of taking the medicine, and the dry stool condition was significantly alleviated or disappeared.

[0179] After 3 to 7 days of treatment, all the above clinical symptoms disappeared, the cure rate was 100%, and no gastrointestinal discomfort occurred during the treatment.

[0180] This result indicates that the antibacterial and antiviral Chinese medicine composition provided by the present invention can effectively eliminate the above clinical symptoms of patients with high fever, sore throat and cough.

[0181] The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. Any modification, equivalent substitution or improvement made within the spirit and principle of the present invention should be included in the protection scope of the present invention.

Claims

1. An antibacterial and antiviral Chinese medicine composition, characterized in that: The invention is prepared from the following raw materials in proportion by weight: 7-13 parts of forsythia, 7-13 parts of isatis root, 3-7 parts of patchouli, 22-38 parts of gypsum, 3-8 parts of roasted ephedra, 2-4 parts of menthol, 4-8 parts of rhubarb, 4-8 parts of fried bitter almond and 11-18 parts of rhodiola rosea.

2. The antibacterial and antiviral Chinese medicine composition according to claim 1, characterized in that: The invention is prepared from the following raw materials in proportion by weight: 8-11 parts of forsythia, 8-11 parts of isatis root, 4-6 parts of patchouli, 25-35 parts of gypsum, 4-7 parts of roasted ephedra, 2-3 parts of menthol, 5-7 parts of rhubarb, 5-7 parts of fried bitter almond and 13-17 parts of rhodiola rosea.

3. The antibacterial and antiviral Chinese medicine composition according to claim 2, characterized in that: The invention is prepared from the following raw materials in proportion by weight: 10 parts of forsythia, 10 parts of isatis root, 5 parts of patchouli, 30 parts of gypsum, 6 parts of roasted ephedra, 3 parts of menthol, 6 parts of rhubarb, 6 parts of fried bitter almonds and 15 parts of rhodiola rosea.

4. The method for preparing the antibacterial and antiviral Chinese medicine composition according to any one of claims 1 to 3, characterized in that: The method comprises the following operations: weighing each raw material according to the raw material ratio in the antibacterial and antiviral Chinese medicine composition, extracting the volatile oil of the patchouli, decocting the residue with forsythia, isatis root, gypsum, roasted ephedra, rhubarb, fried bitter almond and rhodiola rosea, filtering, collecting the obtained filtrate, drying, and obtaining a decoction extract; adding the volatile oil of the patchouli to the obtained decoction extract and mixing evenly, then adding the menthol and mixing evenly, and obtaining the antibacterial and antiviral Chinese medicine composition.

5. Use of the antibacterial and antiviral Chinese medicine composition according to any one of claims 1 to 3 in the preparation of a medicament for treating hyperpyrexia.

6. Use of the antibacterial and antiviral Chinese medicine composition according to any one of claims 1 to 3 in the preparation of a medicine for treating pharyngitis.

7. Use of the antibacterial and antiviral Chinese medicine composition according to any one of claims 1 to 3 in the preparation of a medicine for treating cough.

8. Use of the antibacterial and antiviral Chinese medicine composition according to any one of claims 1 to 3 in the preparation of a medicine for treating at least two symptoms of high fever, sore throat and cough.

9. An antiviral and / or antibacterial drug, characterized in that: The medicine is prepared from the antibacterial and antiviral Chinese medicine composition according to any one of claims 1 to 3.

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