Pharmaceutical composition and application thereof

Abstract

The invention discloses a pharmaceutical composition, the pharmaceutical composition comprises a traditional Chinese medicine extract and citric acid, the traditional Chinese medicine extract is prepared from the following raw materials in parts by weight: 5-20 parts of fig, 1-30 parts of achyranthes aspera, 1-30 parts of honeysuckle, 1-30 parts of moutan bark, 1-20 parts of blackberry lily, 1-20 parts of radix ophiopogonis, 1-20 parts of adenophora tetraphylla and 1-20 parts of liquorice. The traditional Chinese medicine extract and the citric acid are combined for use, the inhibition effect on escherichia coli, staphylococcus aureus and salmonella is remarkably improved, and acute pharyngitis and chronic pharyngitis can be treated.

Description

Technical Field

[0001] The invention belongs to the field of medical technology, and in particular relates to a pharmaceutical composition for treating acute and / or chronic pharyngitis and an application thereof. Background Art

[0002] Pharyngitis is a very common clinical disease. If acute pharyngitis is not cured in time, it may be complicated by otitis media, sinusitis, laryngitis, tracheitis, bronchitis and even pneumonia.

[0003] Currently, there are many medicines for the treatment of pharyngitis in clinical practice. However, considering the convenience and effectiveness, it is better to take tablets orally. This can not only have a sustained effect, but also reach the lesions directly, which is beneficial to the improvement of pharyngeal lesions.

[0004] Patent CN1253184C discloses a lozenge for treating acute and chronic pharyngitis and its preparation method, which is made of 8 kinds of Chinese medicines such as fig, Achyranthes bidentata, honeysuckle, peony bark, and Belamcanda chinensis, and has the effects of clearing away heat and detoxification, reducing swelling and relieving sore throat, and nourishing the lungs and stomach. It is suitable for acute pharyngitis and acute attack of chronic pharyngitis, and treats both the symptoms and the root cause. The above 8 kinds of Chinese medicines are also the main prescriptions of compound fig lozenges.

[0005] Compound fig lozenges are a drug that has been marketed by Suzhong Pharmaceutical for many years. They can clear away heat and detoxify, reduce swelling and relieve sore throat. They are suitable for patients with acute pharyngitis (and acute exacerbation of chronic pharyngitis) with wind-heat syndrome and lung-stomach heat syndrome, with symptoms such as sore throat, dryness, burning sensation, thirst, fever or slight aversion to cold, loss of appetite, dry stool, red tongue with yellow fur, and rapid pulse. In view of its existing effective application, in addition to further improving its formula composition and preparation method, how to improve its antibacterial activity is also an important research and development topic. Summary of the invention

[0006] Purpose of the invention: The technical problem to be solved by the present invention is to provide a pharmaceutical composition for treating acute and chronic pharyngitis with better antibacterial activity in view of the deficiencies in the prior art.

[0007] The present application achieves the purpose of enhancing the antibacterial activity by combining a traditional Chinese medicine extract with citric acid on the basis of the basic formula of the compound fig lozenge.

[0008] In order to solve the above technical problems, the present invention discloses a pharmaceutical composition of the present invention, which has good antibacterial effect and plays a better role in treating pharyngitis, and can provide an application for preparing a drug for treating pharyngitis.

[0009] The pharmaceutical composition comprises a Chinese herbal medicine extract and citric acid. The Chinese herbal medicine extract is prepared from the following raw materials in parts by weight, wherein the raw materials comprise: 5 to 20 parts of figs, 1 to 30 parts of rhizoma achyranthis Bidentatae, 1 to 30 parts of flos lonicerae, 1 to 30 parts of peony barks, 1 to 20 parts of belamcanda chinensis, 1 to 20 parts of ophiopogon japonicus, 1 to 20 parts of adenophora australis, and 1 to 20 parts of licorice.

[0010] Wherein, the manufacturing process comprises the following steps:

[0011] 1) extracting the peony bark by distillation with water according to the formula ratio, and collecting the distillate and the peony bark residue;

[0012] 2) cooling and filtering the distillate from step 1), collecting the filtrate and the filter residue paeonol, and drying the filter residue;

[0013] 3) combining the peony bark residue obtained in step 1) with the remaining components in the formula to obtain a residue mixture, and extracting the obtained residue mixture with 73% to 84% ethanol aqueous solution, 33% to 44% ethanol aqueous solution, and water in sequence to perform a first extraction, a second extraction, and a third extraction; combining the extracts from each extraction with the filtrate obtained in step 2), concentrating the extract to a relative density of 1.04 to 1.17, and drying to obtain an extract powder;

[0014] 4) mixing the extract powder with the filter residue after drying in step 2) to obtain a Chinese medicine extract.

[0015] Furthermore, the Chinese medicine extract is made from the following raw materials in parts by weight: 5-20 parts of figs, 1-30 parts of Achyranthes bidentata, 1-30 parts of honeysuckle, 1-30 parts of peony bark, 1-20 parts of Belamcanda chinensis, 1-20 parts of Ophiopogon japonicus, 1-20 parts of Adenophora australis, and 1-20 parts of licorice.

[0016] Furthermore, 5-15 parts of figs, 2.0-10.0 parts of Achyranthes bidentata, 2.0-10.0 parts of honeysuckle, 1.0-6.0 parts of Belamcanda chinensis, 2.0-10.0 parts of Paeonia suffruticosa, 1.0-8.0 parts of Ophiopogon japonicus, 1.0-8.0 parts of Adenophora australis, and 1.0-4.0 parts of Licorice.

[0017] Further, 9-13 parts of figs, 4.0-8.0 parts of Achyranthes bidentata, 4.0-8.0 parts of honeysuckle, 2.0-4.0 parts of Belamcanda chinensis, 4.0-8.0 parts of Paeonia suffruticosa, 3.0-6.0 parts of Ophiopogon japonicus, 3.0-6.0 parts of Adenophora australis, and 1.0-3.0 parts of Licorice.

[0018] Furthermore, 9.6-12 parts of figs, 4.0-6.0 parts of Achyranthes bidentata, 4.0-6.0 parts of honeysuckle, 2.0-3.0 parts of Belamcanda chinensis, 4.0-6.0 parts of Paeonia suffruticosa, 3.0-4.0 parts of Ophiopogon japonicus, 3.0-4.0 parts of Adenophora australis, and 1.0-2.0 parts of Licorice.

[0019] Furthermore, 9.6-10 parts of figs, 4.8-6.0 parts of Achyranthes bidentata, 4.6-6.0 parts of honeysuckle, 2.4-3.0 parts of Belamcanda chinensis, 4.6-6.0 parts of Paeonia suffruticosa, 3.2-4.0 parts of Ophiopogon japonicus, 3.2-4.0 parts of Adenophora australis, and 1.4-2.0 parts of Licorice.

[0020] As a specific implementation scheme, the Chinese medicine extract is made of the following raw materials in parts by weight: 10.0 parts of fig, 4.8 parts of rhizoma achyranthis Bidentatae, 4.6 parts of flos lonicerae, 2.4 parts of rhizoma scutellariae, 4.6 parts of moutan bark, 3.2 parts of ophiopogon japonicus, 3.2 parts of adenophora australis, and 1.4 parts of licorice;

[0021] As another specific implementation scheme, the Chinese medicine extract is made of the following raw materials in parts by weight: 10 parts of figs, 5.0 parts of Achyranthes bidentata, 5.0 parts of honeysuckle, 2.5 parts of Belamcanda chinensis, 5.0 parts of Paeonia suffruticosa, 3.3 parts of Ophiopogon japonicus, 3.3 parts of Adenophora australis, and 1.3 parts of Licorice.

[0022] As yet another specific embodiment, the Chinese medicine extract is made of the following raw materials in parts by weight: 10.0 parts of fig, 6.0 parts of Achyranthes bidentata, 6.0 parts of honeysuckle, 3.0 parts of Belamcanda chinensis, 6.0 parts of Paeonia suffruticosa, 4.0 parts of Ophiopogon japonicus, 4.0 parts of Adenophora australis, and 2.0 parts of Licorice.

[0023] As yet another specific embodiment, the Chinese medicine extract is made of the following raw materials in parts by weight: 10 parts of figs, 5.2 parts of Achyranthes bidentata, 5.2 parts of honeysuckle, 2.2 parts of Belamcanda chinensis, 4.8 parts of Paeonia suffruticosa, 3.3 parts of Ophiopogon japonicus, 3.3 parts of Adenophora australis, and 1.3 parts of Licorice.

[0024] In the pharmaceutical composition of the present invention, the mass ratio of the Chinese herbal medicine extract to citric acid is 60-200:1, preferably 70-190:1, preferably 80-180:1, more preferably 90-180:1, and even more preferably 90-160:1.

[0025] In some embodiments, the citric acid is citric acid monohydrate or anhydrous citric acid.

[0026] In step 1), in some embodiments, during the boiling process of the water distillation extraction, the steam pressure is 0.01-0.5 MPa, and during the distillation process of the water distillation extraction, the steam pressure is below 0.15 MPa.

[0027] In some embodiments, the solid-liquid ratio of the peony bark to water is 1 g: (5-15) mL; in some embodiments, the solid-liquid ratio of the peony bark to water is 1 g: (8-12) mL; in some embodiments, the solid-liquid ratio of the peony bark to water is 1 g: 10 mL.

[0028] In some embodiments, the extraction temperature is 70-130°C; in some embodiments, the extraction temperature is 90-110°C; in some embodiments, the extraction temperature is 100°C;

[0029] In some embodiments, the extraction time is 200 to 300 min; in some embodiments, the extraction time is 225 to 275 min; in some embodiments, the extraction time is 250 min.

[0030] In step 2),

[0031] In some embodiments, the dried filter residue is dried below 50°C; in some embodiments, the dried filter residue is dried at 20-50°C; in some embodiments, the dried filter residue is dried at 20-40°C; in some embodiments, the dried filter residue is dried at room temperature.

[0032] In step 3),

[0033] The amount of ethanol aqueous solution used is 10 to 15 times the mass of the total raw materials, and the amount of water used is 10 to 20 times the mass of the total raw materials. Reflux extraction is used and the extraction time is 1 to 3 hours.

[0034] In some embodiments, the temperature of the first extraction is 75-95° C.; in some embodiments, the temperature of the first extraction is 80-90° C.; in some embodiments, the temperature of the first extraction is reflux temperature.

[0035] In some embodiments, the temperature of the second extraction is 90-110° C.; in some embodiments, the temperature of the second extraction is 95-105° C.; in some embodiments, the temperature of the second extraction is reflux temperature.

[0036] In some embodiments, the temperature of the third extraction is 90-110° C.; in some embodiments, the temperature of the third extraction is 95-105° C.; in some embodiments, the temperature of the third extraction is reflux temperature.

[0037] In some embodiments, the ethanol extracted for the first time is 73% to 84% ethanol; in some embodiments, the ethanol extracted for the first time is 74% to 83% ethanol; in some embodiments, the ethanol extracted for the first time is 75% to 82% ethanol.

[0038] In some embodiments, the ethanol extracted for the second time is 33% to 44% ethanol; in some embodiments, the ethanol extracted for the second time is 34% to 43% ethanol; in some embodiments, the ethanol extracted for the second time is 35% to 42% ethanol.

[0039] In some embodiments, the first extraction time is 1.1 to 2.9 hours; in some embodiments, the first extraction time is 1.3 to 2.7 hours; in some embodiments, the first extraction time is 1.5 to 2.5 hours.

[0040] In some embodiments, the second extraction time is 1.1 to 2.9 hours; in some embodiments, the second extraction time is 1.3 to 2.7 hours; in some embodiments, the second extraction time is 1.5 to 2.5 hours.

[0041] In some embodiments, the third extraction time is 1.1 to 2.9 hours; in some embodiments, the third extraction time is 1.3 to 2.7 hours; in some embodiments, the third extraction time is 1.5 to 2.5 hours.

[0042] In some embodiments, during the first extraction process, the steam pressure during boiling is controlled to be 0.01-0.5 MPa, and the steam pressure after boiling is controlled to be 0.01-0.3 MPa.

[0043] In some embodiments, during the second extraction process, the steam pressure during boiling is controlled to be 0.01-0.5 MPa, and the steam pressure after boiling is controlled to be 0.01-0.3 MPa.

[0044] In some embodiments, during the third extraction process, the steam pressure during boiling is controlled to be 0.01-0.5 MPa, and the steam pressure after boiling is controlled to be 0.01-0.3 MPa.

[0045] In some embodiments, the concentration is reduced-pressure concentration; in some embodiments, the steam pressure of the concentration is below 0.4 MPa; the vacuum degree of the concentration is not less than -0.08 MPa; and the temperature of the concentration is below 90°C.

[0046] In some embodiments, the relative density of the concentrated drug solution is 1.05 to 1.12;

[0047] In some embodiments, the drying is performed at 75 to 90°C; in some embodiments, the drying is performed at 80 to 85°C.

[0048] The invention also provides a method for preparing the composition, which is obtained by mixing the prepared Chinese medicinal extract with citric acid according to a formula ratio.

[0049] The pharmaceutical composition of the present invention has good antibacterial effect, has good and stable antibacterial effect on Escherichia coli, Staphylococcus aureus and Salmonella, and can play a better role in treating pharyngitis. It can provide an application for preparing a drug for treating pharyngitis. The application further proposes the application of the above-mentioned pharmaceutical composition in preparing a drug for treating acute and chronic pharyngitis.

[0050] Beneficial effects: The medicine of the present invention has the effects of clearing away heat and detoxifying, reducing swelling and relieving sore throat, and clearing and nourishing the lungs and stomach. It is suitable for acute pharyngitis and acute exacerbation of chronic pharyngitis. Since it treats both the symptoms and the root causes, the therapeutic effect is improved and consolidated, including chlorogenic acid and paeonol with antibacterial and anti-inflammatory effects, as well as various coumarin components with anti-cancer and anti-inflammatory effects, polysaccharides with the ability to enhance human immunity, and amino acid components; among them, chlorogenic acid is an important biologically active substance with the effects of antibacterial, antiviral, increasing white blood cells, protecting the liver and promoting bile secretion, anti-tumor, lowering blood pressure, lowering blood lipids, scavenging free radicals and stimulating the central nervous system. By combining the traditional Chinese medicine extract with citric acid, the inhibitory effect on Escherichia coli, Staphylococcus aureus and Salmonella is unexpectedly improved, and the antibacterial effect of the pharmaceutical composition after being kept at 37°C for 90 days is not significantly different from that before storage, indicating that the antibacterial effect on Escherichia coli, Staphylococcus aureus and Salmonella is stable; at the same time, the present invention selects natural traditional Chinese medicine with bactericidal and antibacterial effect as raw material, extracts effective ingredients to prepare traditional Chinese medicine antibacterial liquid, which is easy to use, has no toxicity to the human body after use, and can be used for inflammatory infection. DETAILED DESCRIPTION

[0051] The citric acid used in the examples, also known as citric acid, has a molecular formula of C6H8O7 and meets the current pharmacopoeia standards, wherein the water content is 7.5% to 9.0%.

[0052] All Chinese medicinal materials used in the examples are commercially available and meet the pharmacopoeia standards.

[0053] Fig is the dried immature cryptocarpa of Ficus carica L. of the Moraceae family; Achyranthes bidetata is the dried root and rhizome of Achyranthes bidetata B1 of the Amaranthaceae family; Honeysuckle is the dried flower buds or flowers with initial opening of Lonicerajaponica Thunb. of the Caprifoliaceae family; Peony bark is the dried root bark of Paceniasuffruticosa Andr. of the Ranunculaceae family; Belamcanda is the dried rhizome of Belamcanda chinensis (L.) DC. of the Iridaceae family; Ophiopogon is the dried tuberous root of Ophiopgonjaponicus (Thunb.) Ker-Gawl. of the Liliaceae family; Adenophora stricta is the dried root of Adenophora stricta Miq. of the Campanulaceae family; Licorice is the dried root and rhizome of Glycyrrhiza uralensis Fisch. of the Leguminosae family.

[0054] In the following examples, the content of chlorogenic acid was determined by high performance liquid chromatography (Appendix VID of the 2005 edition of the Chinese Pharmacopoeia). Specifically:

[0055] Chromatographic conditions and system suitability test: Octadecylsilane bonded silica gel was used as the stationary phase, methanol-water-glacial acetic acid-triethylamine (15:85:1:0.3) was used as the mobile phase, the flow rate was 1.0 ml / min, and the detection wavelength was 324 nm. The theoretical plate number was calculated based on the chlorogenic acid peak and should not be less than 1500.

[0056] Preparation of reference solution: Accurately weigh an appropriate amount of chlorogenic acid reference substance, dissolve it in water and prepare a solution containing approximately 0.03 mg of chlorogenic acid per 1 ml.

[0057] Preparation of test solution: Take the Chinese medicine composition, take about 0.2g of fine powder, accurately weigh, put it in a 25ml volumetric flask, add 20ml of water, ultrasonically treat for 15min, take it out, let it cool to room temperature, add water to the scale, shake well, filter, discard the initial filtrate, and use the subsequent filtrate as the test solution.

[0058] Determination method: Accurately pipette 10μl of reference solution and test solution respectively, inject into liquid chromatograph, determine, and calculate according to the external standard method to obtain the result.

[0059] Example 1

[0060] Weigh the following raw materials according to the following weight ratio: 1000g fig, 480g Achyranthes bidentata, 460g honeysuckle, 240g Belamcanda chinensis, 460g Paeonia suffruticosa, 320g Ophiopogon japonicus, 320g Adenophora australis, and 140g Licorice, and set aside.

[0061] 1) extracting paeonol from the peony bark by water distillation with 12 times the amount of distilled water in the weight ratio, and the extraction time is 250 minutes to obtain a distillate and a peony bark residue; refrigerating the obtained distillate, filtering, and obtaining a filter residue of paeonol and a water solution after the peony bark is distilled; blowing the paeonol with cold wind to dry, and drying the peony bark residue at room temperature;

[0062] 2) combining the peony bark residue from step 1) with the remaining medicinal materials and subjecting them to reflux extraction for 3 times, wherein the extraction is performed with 75% ethanol (15 times the mass of the total raw materials) for 2 h, 35% ethanol (15 times the mass of the total raw materials) for 2 h, and water (10 times the mass of the total raw materials) for 2 h to obtain an extract;

[0063] 3) filtering the extract of step 2) and the water solution after distillation of the peony bark of step 1) while hot, recovering the solvent, and concentrating under reduced pressure to a relative density of 1.12 (50-60° C.) to obtain an extract;

[0064] 4) drying the extract obtained in step 3) under reduced pressure, controlling the oven to 85° C., to obtain extract powder;

[0065] 5) adding the extract powder to the paeonol prepared in step 1) and mixing to obtain a compound fig Chinese medicine extract. The content of chlorogenic acid in each gram of the Chinese medicine extract was determined to be 3.51 mg chlorogenic acid;

[0066] 6) taking an appropriate amount of the compound fig Chinese medicinal extract, adding citric acid at a weight ratio of the extract to citric acid of 130:1, and mixing to prepare a pharmaceutical composition containing the compound fig Chinese medicinal extract.

[0067] Example 2

[0068] Weigh the following raw materials according to the following weight ratio: 1000g fig, 480g Achyranthes bidentata, 460g honeysuckle, 240g Belamcanda chinensis, 460g Paeonia suffruticosa, 320g Ophiopogon japonicus, 320g Adenophora australis, and 140g Licorice, and set aside.

[0069] 1) extracting paeonol from the peony bark by water distillation with 10 times distilled water in the weight ratio, and the extraction time is 250 minutes to obtain a distillate and a peony bark residue; refrigerating the obtained distillate, filtering, obtaining paeonol and a water solution after distillation of the peony bark, and blowing the paeonol to dryness with cold wind; and drying the peony bark residue at room temperature;

[0070] 2) The peony bark residue from step 1) was combined with the remaining medicinal materials and refluxed for extraction three times, wherein 12 times the mass of the total raw material was used for extraction for 2 h with 75% ethanol, 12 times the mass of the total raw material was used for extraction for 2 h with 35% ethanol, and 18 times the mass of the total raw material was used for extraction for 2 h with water to obtain an extract.

[0071] 3) filtering the extract of step 2) and the water solution after distillation of the peony bark of step 1) while hot, recovering the solvent, and concentrating under reduced pressure to a relative density of 1.12 (50-60° C.) to obtain an extract;

[0072] 4) spray drying the extract obtained in step 3) at a drying temperature of 80° C. to obtain extract powder;

[0073] 5) adding the extract powder to the paeonol prepared in step 1) and mixing to obtain a compound fig Chinese medicine extract. The content of chlorogenic acid in each gram of the Chinese medicine extract was determined to be 3.61 mg chlorogenic acid;

[0074] 6) taking an appropriate amount of the compound fig Chinese medicine extract, adding citric acid at a weight ratio of the extract to citric acid of 100:1, and mixing, to prepare a pharmaceutical composition containing the compound fig Chinese medicine extract.

[0075] Example 3

[0076] Weigh the following raw materials according to the following weight ratio: 1000g fig, 520g Achyranthes bidentata, 520g honeysuckle, 220g Belamcanda chinensis, 480g Paeonia suffruticosa, 330g Ophiopogon japonicus, 330g Adenophora australis, and 130g Licorice, and set aside.

[0077] 1) extracting paeonol from the peony bark with the weight ratio by water distillation, and the distillation conditions are the same as those in Example 2 to obtain a distillate and a peony bark residue; refrigerating the obtained distillate, filtering to obtain paeonol and a water solution after distillation of the peony bark, and blowing the paeonol to dryness with cold wind.

[0078] 2) combining the peony bark residue from step 1) with the remaining medicinal materials and extracting them by reflux for 3 times, wherein the extraction is performed with 75% ethanol (12 times the mass of the total raw materials) for 2 h, 40% ethanol (12 times the mass of the total raw materials) for 2 h, and water (16 times the mass of the total raw materials) for 2 h to obtain an extract;

[0079] 3) filtering the extract of step 2) and the water solution after distillation of the peony bark of step 1) while hot, recovering the solvent, and concentrating the solution to a relative density of 1.16 (50-60° C.) to obtain an extract;

[0080] 4) spray drying the extract obtained in step 3) at a drying temperature of 85° C. to obtain extract powder;

[0081] 5) adding the extract powder to the paeonol prepared in step 1) and mixing to obtain a compound fig Chinese medicine extract. The content of chlorogenic acid in each gram of the Chinese medicine extract was determined to be 3.54 mg chlorogenic acid;

[0082] 6) taking an appropriate amount of the compound fig Chinese medicine extract, adding citric acid at a weight ratio of the extract to citric acid of 160:1, and mixing to prepare a pharmaceutical composition containing the compound fig Chinese medicine extract.

[0083] Example 4

[0084] Weigh the following raw materials according to the following weight ratio: 1000g fig, 500g Achyranthes bidentata, 500g honeysuckle, 250g Belamcanda chinensis, 500g Paeonia suffruticosa, 330g Ophiopogon japonicus, 330g Adenophora australis, and 130g Licorice, and set aside.

[0085] 1) extracting paeonol from the peony bark by water distillation with 9 times the amount of distilled water in the weight ratio, and the extraction time is 230 minutes to obtain a distillate and a peony bark residue; refrigerating the obtained distillate, filtering, and obtaining paeonol and a water solution after distillation of the peony bark.

[0086] 2) combining the peony bark residue from step 1) with the remaining medicinal materials and subjecting them to reflux extraction for 3 times, wherein the extraction is performed with 75% ethanol (15 times the mass of the total raw materials) for 2 h, 35% ethanol (15 times the mass of the total raw materials) for 2 h, and water (10 times the mass of the total raw materials) for 2 h to obtain an extract;

[0087] 3) filtering the extract of step 2) and the water solution after distillation of the peony bark of step 1) while hot, recovering the solvent, and concentrating under reduced pressure to a relative density of 1.12 (50-60° C.) to obtain an extract;

[0088] 4) drying the extract obtained in step 3) under reduced pressure, controlling the oven to 85° C., to obtain extract powder;

[0089] 5) adding the extract powder to the paeonol prepared in step 1) and mixing to obtain a compound fig Chinese medicine extract. The content of chlorogenic acid in each gram of the Chinese medicine extract was determined to be 3.49 mg chlorogenic acid;

[0090] 6) taking an appropriate amount of the compound fig Chinese medicine extract, adding citric acid at a weight ratio of the extract to citric acid of 120:1, and mixing to prepare a pharmaceutical composition containing the compound fig Chinese medicine extract.

[0091] Example 5 Experiment on the antibacterial effect of the compound fig Chinese medicine extract.

[0092] 5.1 Experimental drugs

[0093] The compound fig Chinese medicine extract prepared by the method of Example 2 and Example 3 was ground into fine powder, added with appropriate amount of water, dissolved by ultrasonic, and prepared into dosing solutions with the concentrations of the dosing experiments.

[0094] Experimental group 1: 75 mg / ml dosing solution prepared and treated according to the method of Example 2.

[0095] Experimental Group 2: 150 mg / ml dosing solution prepared and treated according to the method of Example 2.

[0096] Experimental Group 3: A 225 mg / ml dosing solution prepared and treated according to the method of Example 2.

[0097] Experimental group 4: 150 mg / ml dosing solution prepared and treated according to the method of Example 3.

[0098] Experimental group 5: the dosing solution of experimental group 2 was treated with citric acid added at a weight ratio of extract to citric acid of 150:1.

[0099] Experimental group 6: the dosing solution of experimental group 2 was treated with citric acid added at a weight ratio of extract to citric acid of 100:1.

[0100] Experimental group 7: Citric acid was prepared with water to form a dosing solution with a concentration of 1.5 mg / ml.

[0101] 5.2 Antibacterial ability test method

[0102] According to the antibacterial test of item 2.1.7 of the Technical Specification for Disinfection (2002 edition), the antibacterial property of the compound fig Chinese medicine extract of the present invention is tested. The specific method and test results are as follows:

[0103] 5.2.1 Principle

[0104] The antibacterial agent is continuously dissolved and diffused through agar to form different concentration gradients to show its antibacterial effect. The size of the antibacterial ring is used to determine whether it has antibacterial ability.

[0105] 5.3 Test equipment

[0106] (1) Bacterial suspensions of Escherichia coli (ATCC25922), Staphylococcus aureus (ATCC25923), and Salmonella (ATCC50760).

[0107] (2) Antibacterial agent carrier (Oxford cup, sterilized by pressure steam, dried at 120°C for 2 h, and stored for future use).

[0108] (3) Equipment required for viable bacterial culture counting and sterile distilled water as a negative control.

[0109] (4) Micropipette (5 μl to 50 μl, adjustable).

[0110] (5) Vernier caliper.

[0111] (6) Nutrient agar, tryptic soy agar, and Sabouraud dextrose agar.

[0112] 5.4 Operating procedures

[0113] (1) Inoculation of test bacteria: Use a sterile cotton swab to inoculate a 5×10 5cfu / ml~5×10 6 CFU / ml test bacteria suspension is evenly applied on the surface of the nutrient agar medium plate for 3 times. Each time the plate is applied, the plate should be rotated 60°, and finally the cotton swab is applied around the edge of the plate for one circle. Cover the plate and dry it at room temperature for 5 minutes.

[0114] (2) Addition of antibacterial agent: Place one infected plate in each Oxford cup experiment, with four Oxford cups as samples and one Oxford cup as a negative control sample on each plate, for a total of five. Use sterile tweezers to take the Oxford cup and place it on the surface of the plate. The centers of each Oxford cup should be at least 25 mm apart and at least 15 mm away from the edge of the plate. After placing it, use sterile tweezers to gently press the Oxford cup to make it fit tightly against the surface of the plate. Use a sterile pipette to add the sample and control sample to the Oxford cup to fill it up, cover the plate, place it in a 37°C incubator, incubate for 24 hours, and observe the results. Use a vernier caliper to measure the diameter of the antibacterial ring and record it. Repeat the experiment three times.

[0115] When measuring the antibacterial ring, you should choose a uniform and completely sterile antibacterial ring. The diameter should be measured with the outer edge of the antibacterial ring as the boundary.

[0116] 5.5 Evaluation Regulations

[0117] (1) Determination of antibacterial effect:

[0118] The criteria for judging the test results of the Oxford cup method are: the diameter of the inhibition zone is greater than 20mm, which is very sensitive; between 15 and 20mm, which is highly sensitive; between 10 and 15mm, which is moderately sensitive; and less than 10mm, which is lowly sensitive. The diameter of the inhibition zone is proportional to the antibacterial activity.

[0119] (2) If the three repeated tests show antibacterial effects, the samples are considered qualified.

[0120] (3) There should be no inhibition zone in the negative control group (water used for extraction and dilution). Otherwise, the test is invalid.

[0121] 5.6 Test results

[0122] The diameter of the inhibition zone (mm) of each test group is shown in Table 1 below

[0123] Table 1 Diameter of inhibition zone of each test group (mm)

[0124]

[0125] The negative control group met the requirements, and none of the above bacterial species produced an inhibition ring, and the diameter of the inhibition ring was 0.

[0126] According to the above experimental results, the following conclusions are drawn: the Chinese medicine extract of the present invention is used in combination with citric acid, at a certain concentration, to improve the antibacterial effect of the product of the present invention, especially the antibacterial effect on Salmonella. The present invention selects natural Chinese medicine with bactericidal and antibacterial effects as raw materials, extracts effective ingredients to prepare Chinese medicine antibacterial liquid, which is easy to use, has no toxicity to the human body after use, and can be used for inflammatory infections.

[0127] In addition, after the experimental samples were kept at 37° C. for 90 days, the antibacterial effects of the experimental groups of the present invention on Escherichia coli, Staphylococcus aureus, and Salmonella were not significantly different from those before storage, indicating that the antibacterial effects on Escherichia coli, Staphylococcus aureus, and Salmonella were stable.

[0128] The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. Any modifications, equivalent substitutions, improvements, etc. made within the spirit and principle of the present invention should be included in the protection scope of the present invention.

Claims

1. A pharmaceutical composition, characterized in that The pharmaceutical composition comprises a Chinese herbal medicine extract and citric acid. The Chinese herbal medicine extract is prepared from the following raw materials in parts by weight, wherein the raw materials comprise: 5-20 parts of figs, 1-30 parts of rhizoma achyranthis Bidentatae, 1-30 parts of flos lonicerae, 1-30 parts of peony bark, 1-20 parts of belamcanda chinensis, 1-20 parts of ophiopogon japonicus, 1-20 parts of adenophora australis, and 1-20 parts of licorice.

2. The pharmaceutical composition according to claim 1, characterized in that The manufacturing process comprises the following steps: 1) Distilling and extracting the peony bark with water according to the formula ratio, and collecting the distillate and the peony bark residue; 2) cooling and filtering the distillate from step 1), collecting the filtrate and the filter residue, and drying the filter residue; 3) combining the peony bark residue obtained in step 1) with the remaining components in the formula to obtain a residue mixture, and extracting the obtained residue mixture with 73%-84% ethanol aqueous solution, 33%-44% ethanol aqueous solution, and water in sequence for the first extraction, the second extraction, and the third extraction; combining the extracts from each extraction with the filtrate obtained in step 2), concentrating the extract to a relative density of 1.04-1.17, and drying to obtain an extract powder; 4) Mixing the extract powder with the filter residue after drying in step 2) to obtain a Chinese medicine extract.

3. The pharmaceutical composition according to claim 1, characterized in that The Chinese medicine extract is prepared from the following raw materials in parts by weight: 5-15 parts of figs, 2-10 parts of radix achyranthis Bidentatae, 2-10 parts of honeysuckle, 2-10 parts of peony bark, 1-6 parts of rhizoma iris, 1-8 parts of ophiopogon japonicus, 1-8 parts of adenophora australis, and 1-4 parts of licorice; further comprising: 9-13 parts of figs, 4-8 parts of radix achyranthis Bidentatae, 4-8 parts of honeysuckle, 2-4 parts of rhizoma iris, 4-8 parts of peony bark, 3-6 parts of ophiopogon japonicus, and 1-4 parts of licorice. 3-6 parts of ginseng, 1-3 parts of liquorice; further: 9.6-12 parts of figs, 4-6 parts of radix achyranthis Bidentatae, 4-6 parts of honeysuckle, 2-3 parts of rhizoma suffruticosae, 4-6 parts of peony bark, 3-4 parts of ophiopogon japonicus, 3-4 parts of adenophora australis, 1-2 parts of liquorice; further: 9.6-10 parts of figs, 4.8-6 parts of rhizoma suffruticosae, 4.6-6 parts of honeysuckle, 2.4-3 parts of rhizoma suffruticosae, 4.6-6 parts of peony bark, 3.2-4 parts of Radix Ophiopogonis, 3.2-4 parts of Radix Adenophorae, 1.4-2 parts of Radix Glycyrrhizae; or the Chinese medicine extract is made of the following raw materials in parts by weight: 10 parts of figs, 4.8 parts of Radix Cynoglossi, 4.6 parts of Flos Lonicerae, 2.4 parts of Radix Belamcandae, 4.6 parts of Cortex Moutan, 3.2 parts of Radix Ophiopogonis, 3.2 parts of Radix Adenophorae, 1.4 parts of Radix Glycyrrhizae; or: 10 parts of figs, 5 parts of Radix Cynoglossi, 5 parts of Flos Lonicerae, 2.5 parts of Radix Belamcandae, 5 parts of peony bark, 3.3 parts of ophiopogon, 3.3 parts of adenophora australis, and 1.3 parts of liquorice; or: 10 parts of figs, 6 parts of rhizoma achyranthis Bidentatae, 6 parts of honeysuckle, 3 parts of rhizoma belamcandae, 6 parts of peony bark, 4 parts of ophiopogon, 4 parts of adenophora australis, and 2 parts of liquorice; or 10 parts of figs, 5.2 parts of rhizoma achyranthis Bidentatae, 5.2 parts of honeysuckle, 2.2 parts of rhizoma belamcandae, 4.8 parts of peony bark, 3.3 parts of ophiopogon, 3.3 parts of adenophora australis, and 1.3 parts of liquorice.

4. The pharmaceutical composition according to claim 1, characterized in that The mass ratio of the Chinese herbal extract to citric acid is 60-200:1, preferably 70-190:1, preferably 80-180:1, more preferably 90-180:1, further preferably 90-160:1; and further preferably 100-150:

1.

5. The pharmaceutical composition according to any one of claims 1 to 4, characterized in that The citric acid is citric acid monohydrate or anhydrous citric acid.

6. The pharmaceutical composition according to claim 2, characterized in that In step 1), the solid-liquid ratio of peony bark to water is 1g:(5-15)mL; further, the solid-liquid ratio of peony bark to water is 1g:(8-12)mL, and further, the solid-liquid ratio of peony bark to water is 1g:10mL; the water distillation extraction, the steam pressure during boiling is 0.01-0.5MPa, and the steam pressure during distillation is below 0.15MPa; the extraction temperature is 70-130°C; further, the extraction temperature is 90-110°C; further, the extraction temperature is 100°C; the extraction time is 200-300min; further, the extraction time is 225-275min; further, the extraction time is 250min.

7. The pharmaceutical composition according to claim 2, characterized in that In step 2), the dried filter residue is dried below 50°C; preferably, the dried filter residue is dried at 20-50°C; further preferably, the dried filter residue is dried at 20-40°C; further, the dried filter residue is dried at room temperature.

8. The pharmaceutical composition according to claim 2, characterized in that In step 3), each time when ethanol-water solution is used for extraction, the amount of ethanol-water solution is 10 to 15 times the mass of the total raw materials, and when water is used for extraction, the amount of water is 8 to 22 times the mass of the total raw materials, preferably 10 to 20 times, and reflux extraction is adopted; each extraction time is 1.1 to 2.9 hours, further 13.-2.7 hours, and further 1.5 to 2.5 hours; during each extraction process, the steam pressure during boiling is controlled to be 0.01 to 0.5 MPa, and the steam pressure after boiling is controlled to be 0.01 to 0.3 MPa; Further, the temperature of the first extraction is 75-95°C, further 80-90°C, and further reflux temperature; the ethanol aqueous solution used in the first extraction is 74%-83% ethanol aqueous solution; further 75%-82% ethanol aqueous solution; The second extraction temperature is 90-110°C, further 95-105°C, further reflux temperature, and the ethanol aqueous solution used in the second extraction is 34%-43% ethanol aqueous solution, further 5%-42% ethanol aqueous solution; The third extraction temperature is an extraction temperature of 90-110°C, further 95-105°C, further reflux temperature; The concentration is reduced pressure concentration, the steam pressure of the reduced pressure concentration is below 0.4MPa; the vacuum degree of the concentration is not less than -0.08MPa; the temperature of the concentration is below 90°C; Concentrate to a relative density of 1.05~1.12; The drying is performed at 75-90°C, and further at 80-85°C.

9. The method for preparing the pharmaceutical composition according to any one of claims 1 to 8, characterized in that: The Chinese herbal medicine extract and citric acid are mixed according to a formula ratio to obtain the product.

10. Use of the pharmaceutical composition according to any one of claims 1 to 8 for inhibiting at least one of Escherichia coli, Staphylococcus aureus and Salmonella, or for preparing a medicament for treating acute and / or chronic pharyngitis.

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