A compound traditional Chinese medicine extract for treating colds and its preparation method

Abstract

The present invention belongs to the technical field of traditional Chinese medicine, and particularly relates to a compound traditional Chinese medicine extract for treating colds and a preparation method thereof. The raw materials of the compound traditional Chinese medicine extract include: mint, schizonepeta spike, arctium fruit, scutellaria baicalensis, platycodon grandiflorum, peucedanum praeruptorum, phragmites australis, angelica dahurica, gardenia jasminoides, bitter apricot kernel, malt, hawthorn, six-herb medicated leaven, honeysuckle flower and forsythia suspensa. The preparation process includes: steam distilling mint and schizonepeta spike to obtain volatile oil; enzymatically extracting, neutralizing and heating for extraction of bitter apricot kernel, arctium fruit, scutellaria baicalensis, platycodon grandiflorum, peucedanum praeruptorum, phragmites australis, angelica dahurica and gardenia jasminoides to obtain extract A; adding malt, hawthorn, six-herb medicated leaven, honeysuckle flower and forsythia suspensa into an ethanol solution for ultrasonic treatment and heating for extraction to obtain extract B; mixing extract A and extract B, purifying and then mixing with a volatile oil inclusion complex to obtain the compound traditional Chinese medicine extract. The compound extract preparation prepared by the preparation method of the present invention has better stability; and has a more significant effect in dissipating heat and reducing temperature.

Description

Technical Field

[0001] The present invention belongs to the technical field of traditional Chinese medicine, and particularly relates to a compound traditional Chinese medicine extract for treating colds and a preparation method thereof. Background Art

[0002] A cold is a common clinical disease that occurs throughout the year, especially in winter and spring, and particularly has a relatively high incidence during the alternation of seasons and sudden climate changes. Among patients with a cold, the mild ones only show symptoms such as nasal congestion, runny nose, and sneezing, while the severe ones will present symptoms such as persistent high fever, headache, and body pain. Even worse, some patients may develop weakness of vital energy after having a cold, which may subsequently cause acute bronchitis, pneumonia, sinusitis, neuritis and other diseases, endangering life, seriously affecting the work and life of patients, and bringing pain to patients.

[0003] Currently, most drugs for treating pediatric colds are non-steroidal anti-inflammatory drugs, antihistamines, and antibiotics. These drugs have relatively common side effects, and some even have serious adverse reactions. For example, although paracetamol has good antipyretic and analgesic effects, it often causes adverse reactions such as gastrointestinal discomfort and allergic dermatitis. Antihistamines such as chlorpheniramine often cause drowsiness. The curative effect of antibiotics in treating colds is uncertain, and it is easy to lead to the generation of drug-resistant strains, dysbacteriosis, allergic reactions, etc. The curative effect of traditional Chinese patent medicines in treating colds has been recognized, but some traditional Chinese patent medicines such as antiviral granules are inconvenient for children to take because they contain a large amount of sugar, have a large dosage per administration (more than 12 g), and poor solubility.

[0004] Xiaoganmaoning Syrup for children is designed for wind-heat cold. When wind-heat invades the lung defense, aversion to cold and fever will occur; when wind-heat invades the lung, the lung will be used to promote descending, resulting in nasal congestion, runny nose and cough; when wind-heat disturbs the throat, sore throat will occur. Xiaoganmaoning Syrup for children is a famous prescription for treating colds (wind-heat type) in ancient times, which was adapted from "Yinqiao Powder". The honeysuckle and forsythia in the prescription are fragrant and can dispel wind-heat, clear away heat and detoxify. Honeysuckle is sweet and cold, fragrant and dispersing, and is good at dispersing heat evil in the lung meridian and penetrating heat to the surface; forsythia is bitter and cold, good at clearing heart fire and dispersing wind-heat in the upper part of the body. The two are often used together to treat wind-heat colds, so they are used as the main medicine. Mint and burdock seeds dispersing wind-heat, clearing the head, improving eyesight and relieving sore throat. Mint has a strong pungent and dispersing nature, and is the most effective medicine for dispersing surface evil in the treatment of wind-heat colds; burdock seeds have a clearing and descending nature in the ascending and dispersing nature, and are good at dispersing lungs and removing phlegm, relieving sore throat and swelling, and are commonly used to treat sore throat. Schizonepeta spicata dispels the exterior pathogens and clears the nasal passages. It can treat headaches caused by colds, stuffy noses, and turbid mucus. It is the key medicine for treating "Yangming headaches and headaches caused by sinusitis". The above four medicines can help the main medicine dispel wind-heat and treat sore throats, stuffy noses, and runny noses. Colds are prone to phlegm, so Scutellaria baicalensis, Platycodon grandiflorum, Peucedanum chinense, and Phragmites australis are used to clear the lungs and resolve phlegm, and relieve coughs. Scutellaria baicalensis is injected into the lung meridian, which is good at clearing and draining lung fire, and resolving phlegm and relieving coughs; Platycodon grandiflorum can open and promote lung qi, resolve phlegm and relieve coughs, and can also relieve sore throats and swellings. In ancient times, it was said that "all medicines are boats, carrying medicines to float up" and were lung meridian leading medicines. The above seven medicines can help the main medicine dispel wind-heat, relieve coughs, resolve phlegm, relieve sore throats and swellings, and are collectively ministerial medicines. Colds are prone to stagnation, so the combination of scorched hawthorn, six-spirited koji, and scorched malt can help digestion and eliminate stagnation, stimulate appetite and strengthen the spleen, which can treat children's loss of appetite and enhance appetite, so as to facilitate physical recovery, improve positive energy, and drive away evil spirits. Gardenia can purge fire and relieve restlessness to prevent children from being frightened by colds. It can purge the fire of the three burners, purge the heart fire and relieve restlessness. It is an important medicine for treating fever, restlessness, and restlessness. The above four medicines are combined as adjuvants. All the medicines are used together to play the effect of dispersing wind-heat, clearing heat and relieving cough.

[0005] At present, oral preparations of Chinese herbal extracts are prone to precipitation and their properties are unstable after being stored for a long time. The quality of oral preparations for children's colds needs to be more strictly controlled. Summary of the invention

[0006] The purpose of the present invention is to overcome the deficiencies of the prior art and provide a compound Chinese medicine extract for treating colds and a preparation method thereof. The present invention improves the extraction process, improves the problem of easy precipitation of oral preparations, and further increases the content of effective ingredients, thereby achieving the purpose of quickly treating colds.

[0007] In order to achieve the above-mentioned purpose of the present invention, the specific technical solution adopted by the present invention is:

[0008] A method for preparing a compound Chinese medicine extract for treating colds, wherein the raw materials of the compound Chinese medicine extract include: mint, schizonepeta spicate, burdock fruit, scutellaria baicalensis, platycodon grandiflorum, peucedanum peucedanum, reed root, angelica dahurica, gardenia jasminoides, bitter almond, malt, hawthorn, six-spirit song, honeysuckle and forsythia suspensa;

[0009] The preparation method comprises the following steps:

[0010] (1) crushing mint and schizonepeta spicate, and using steam distillation to obtain volatile oil;

[0011] (2) mixing bitter almond, burdock fruit, scutellaria baicalensis, platycodon grandiflorum, peucedanum peucedanum, reed root, angelica dahurica and gardenia jasmine with water, soaking them, adding enzyme, performing enzymatic hydrolysis and extraction, neutralizing, and heating extraction to obtain extract A;

[0012] (3) pulverizing malt, hawthorn, Liushenqu, honeysuckle and forsythia, adding ethanol solution to ultrasound, and heating for extraction to obtain extract B;

[0013] (4) Mixing the extract A and the extract B, filtering through a filter cloth, and concentrating to obtain a concentrated solution;

[0014] (5) the concentrated solution is ultrafiltered through an ultrafiltration membrane with a molecular weight cutoff of 5000-6000 to obtain a filtrate;

[0015] (6) mixing volatile oil, 2-hydroxypropyl-β-cyclodextrin and water to obtain a volatile oil inclusion complex aqueous solution, then mixing it with the filtrate, boiling it, adding water to the total amount, and refrigerating it to obtain the compound Chinese medicine extract.

[0016] Preferably, the raw materials of the compound Chinese medicine extract include, by weight: 5-15 parts of mint, 5-15 parts of schizonepeta spicate, 6-15 parts of burdock seeds, 6-15 parts of scutellaria baicalensis, 5-15 parts of platycodon, 6-15 parts of peucedanum, 10-15 parts of reed rhizomes, 1-5 parts of angelica dahurica, 1-10 parts of gardenia, 6-15 parts of bitter almonds, 1-5 parts of malt, 1-5 parts of hawthorn, 1-5 parts of liushenqu, 10-15 parts of honeysuckle and 1-10 parts of forsythia.

[0017] Preferably, in step (1), 3-6 times the volume of water is added to the mint and schizonepeta spicate for distillation, the distillation temperature is 80-90° C., and the distillation time is 1-3 h.

[0018] Preferably, in step (2), the total mass of bitter almond, burdock fruit, scutellaria baicalensis, platycodon grandiflorum, peucedanum chinense, reed root, angelica dahurica and gardenia jasmine to water is 1 g: 5-15 mL; and the soaking time is 1-2 h.

[0019] Preferably, the enzymes described in step (2) are cellulase and papain, and the mass ratio of cellulase to papain is 3-5:1; the dosage of the enzyme is 80-100 U / g, the enzymolysis temperature is 50-60°C, the enzymolysis pH is 4-5, and the enzymolysis time is 80-100 min; the heating temperature is 80-90°C, and the heating extraction time is 80-100 min.

[0020] Preferably, in step (3), the total mass of malt, hawthorn, six - flavor medicated leaven, honeysuckle and forsythia and the mass - to - volume ratio of the ethanol solution is 1 g: 5 - 15 mL, and the mass concentration of the ethanol solution is 50% - 70%; the power of the ultrasonic wave is 200 - 250 W, and the ultrasonic time is 30 - 60 min; the heating temperature is 80 - 90 °C, and the heating extraction time is 30 - 50 min.

[0021] Preferably, in step (4), the aperture of the filter cloth is 200 - 400 mesh, and it is concentrated until there is no ethanol smell.

[0022] Preferably, in step (6), the mass ratio of the volatile oil, 2 - hydroxypropyl - β - cyclodextrin and water is 1: 3 - 5: 10 - 20; the preparation method of the aqueous solution of the volatile oil inclusion complex includes: heating and mixing 2 - hydroxypropyl - β - cyclodextrin and water at 80 - 90 °C, and then adding the volatile oil and stirring for 30 - 50 min.

[0023] The present invention also relates to the compound traditional Chinese medicine extract prepared by the above - mentioned preparation method, and the dosage form of the compound traditional Chinese medicine extract is selected from any one of oral liquid, mixture and syrup.

[0024] Preferably, the oral liquid, mixture and syrup also include medical adjuvants, and the medical adjuvants are sucrose, stevioside and sodium benzoate. The addition amounts of sucrose, stevioside and sodium benzoate are 18% - 22%, 0.15% - 0.25% and 0.4% - 0.6% of the total mass of the compound traditional Chinese medicine extract, respectively.

[0025] Compared with the prior art, the present invention has the following beneficial effects:

[0026] (1) The compound traditional Chinese medicine extract prepared by the present invention has better stability;

[0027] (2) The compound traditional Chinese medicine extract prepared by the present invention has a higher content of active ingredients and has a more significant effect in dissipating heat and reducing temperature. Detailed implementation manners

[0028] The technical solutions in the embodiments of the present invention are further clearly described. The described embodiments are only a part of the present invention, which is used to explain the present invention but not to limit the present invention. Therefore, other embodiments obtained by other technicians in the art without creative labor belong to the protection scope of the present invention.

[0029] Example 1

[0030] A compound traditional Chinese medicine extract for treating colds, with the raw materials being: 80 g of mint, 67 g of Schizonepeta spike, 80 g of great burdock achene, 80 g of skullcap root, 67 g of platycodon root, 80 g of purpleflower hogfennel root, 120 g of reed rhizome, 27 g of dahurian angelica root, 40 g of stir-fried gardenia fruit, 80 g of bitter apricot kernel, 27 g of stir-fried malt, 27 g of stir-fried hawthorn fruit, 27 g of six-fermented medicinals (stir-fried), 120 g of honeysuckle flower and 80 g of forsythia fruit;

[0031] Preparation method:

[0032] (1) Crush mint and Schizonepeta spike, add 5 times the volume of water, distill at 90 °C for 2 h to obtain volatile oil;

[0033] (2) Mix bitter apricot kernel, great burdock achene, skullcap root, platycodon root, purpleflower hogfennel root, reed rhizome, dahurian angelica root and gardenia fruit with 5 L of water and soak for 1.5 h, then add cellulase and papain with a mass ratio of 5:1 at 90 U / g, enzymatically hydrolyze at 50 °C and pH = 4 for 90 min; then neutralize with sodium hydroxide and heat to 90 °C for extraction for 90 min to obtain extract A;

[0034] (3) Crush malt, hawthorn fruit, six-fermented medicinals, honeysuckle flower and forsythia fruit, add 2 L of ethanol solution with a mass concentration of 60% and ultrasonicate for 40 min with a power of 220 W, then heat to 90 °C for extraction for 30 min to obtain extract B;

[0035] (4) Mix extract A and extract B, filter through a 300-mesh filter cloth, and concentrate until the ethanol smell disappears to obtain a concentrated solution;

[0036] (5) Ultrafilter the concentrated solution through an ultrafiltration membrane with a molecular weight cut-off of 5000 to obtain a filtrate;

[0037] (6) Mix the volatile oil, 2-hydroxypropyl-β-cyclodextrin and water in a mass ratio of 1:5:15. First, mix 2-hydroxypropyl-β-cyclodextrin and water evenly at 90 °C, then add the volatile oil and stir for 40 min to obtain an aqueous solution of volatile oil inclusion compound; then mix it with the filtrate, 200 g of sucrose, 2 g of stevioside and 5 g of sodium benzoate, boil, add water to 1 L, and refrigerate.

[0038] Example 2

[0039] A compound traditional Chinese medicine extract for treating colds, with the raw materials being: 100 g of mint, 80 g of Schizonepeta spike, 100 g of great burdock achene, 100 g of skullcap root, 80 g of platycodon root, 100 g of purpleflower hogfennel root, 150 g of reed rhizome, 40 g of dahurian angelica root, 50 g of stir-fried gardenia fruit, 100 g of bitter apricot kernel, 40 g of stir-fried malt, 40 g of stir-fried hawthorn fruit, 40 g of six-fermented medicinals (stir-fried), 150 g of honeysuckle flower and 100 g of forsythia fruit;

[0040] Preparation method:

[0041] (1) Crush mint and Schizonepeta spike, add water with a volume 5 times that of the raw materials, and distill at 90 °C for 2 h to obtain volatile oil;

[0042] (2) Mix bitter apricot kernels, great burdock fruits, Scutellaria baicalensis, platycodon roots, Peucedanum praeruptorum, phragmites rhizomes, angelica dahurica and gardenia fruits with 5 L of water and soak for 2 h. Then add cellulase and papain with a mass ratio of 4:1 at 100 U / g, and carry out enzymatic hydrolysis at 55 °C and pH = 4 for 80 min. Then neutralize with sodium hydroxide and heat to 80 °C for extraction for 80 min to obtain extract A;

[0043] (3) Crush malt, hawthorn, medicated leaven, honeysuckle and forsythia suspense, add 2 L of ethanol solution with a mass concentration of 50%, and carry out ultrasonic treatment for 60 min at a power of 200 W. Then heat to 80 °C for extraction for 50 min to obtain extract B;

[0044] (4) Mix extract A and extract B, filter through a filter cloth with a mesh size of 400, and concentrate until the ethanol smell disappears to obtain a concentrated solution;

[0045] (5) Ultrafilter the concentrated solution through an ultrafiltration membrane with a molecular weight cut-off of 6000 to obtain a filtrate;

[0046] (6) Mix the volatile oil, 2-hydroxypropyl-β-cyclodextrin and water according to a mass ratio of 1:3:10. First, mix 2-hydroxypropyl-β-cyclodextrin and water evenly at 80 °C, then add the volatile oil and stir for 50 min to obtain an aqueous solution of volatile oil inclusion compound. Then mix it with the filtrate, 240 g of sucrose, 2.4 g of stevioside and 6 g of sodium benzoate, boil, add water to 1.2 L, and refrigerate.

[0047] Example 3

[0048] A compound traditional Chinese medicine extract for treating colds, with the following raw materials: 50 g of mint, 50 g of Schizonepeta spike, 60 g of great burdock fruits, 60 g of Scutellaria baicalensis, 50 g of platycodon roots, 60 g of Peucedanum praeruptorum, 100 g of phragmites rhizomes, 20 g of angelica dahurica, 30 g of gardenia fruits (fried), 60 g of bitter apricot kernels, 20 g of malt (charred), 20 g of hawthorn (charred), 20 g of medicated leaven (charred), 100 g of honeysuckle and 60 g of forsythia suspense;

[0049] Preparation method:

[0050] (1) Crush mint and Schizonepeta spike, add water with a volume 3 times that of the raw materials, and distill at 80 °C for 3 h to obtain volatile oil;

[0051] (2) Mix bitter apricot kernels, great burdock fruits, skullcap roots, platycodon roots, hogfennel roots, reed rhizomes, dahurian angelica roots, and gardenia fruits with 5 L of water, soak for 1 h, add cellulase and papain with a mass ratio of 4:1 at 80 U / g, and carry out enzymatic hydrolysis at 60 °C and pH = 5 for 85 min; then neutralize with sodium hydroxide, heat to 85 °C, and extract for 85 min to obtain extract A;

[0052] (3) Crush malt, hawthorn fruits, medicated leaven, honeysuckle flowers, and forsythia fruits, add 3 L of an ethanol solution with a mass concentration of 70%, carry out ultrasonic treatment for 30 min with a power of 250 W; then heat to 85 °C and extract for 40 min to obtain extract B;

[0053] (4) Mix extract A and extract B, filter through a filter cloth with a mesh size of 500, and concentrate until there is no ethanol smell to obtain a concentrated solution;

[0054] (5) Ultrafilter the concentrated solution through an ultrafiltration membrane with a molecular weight cut-off of 5000 to obtain a filtrate;

[0055] (6) Mix volatile oil, 2-hydroxypropyl-β-cyclodextrin, and water in a mass ratio of 1:4:20. First, mix 2-hydroxypropyl-β-cyclodextrin and water evenly at 85 °C, then add the volatile oil and stir for 40 min to obtain an aqueous solution of volatile oil inclusion compound; then mix it with the filtrate, 120 g of sucrose, 1.2 g of stevioside, and 3 g of sodium benzoate, boil, add water to 600 mL, and refrigerate.

[0056] Comparative Example 1

[0057] A compound traditional Chinese medicine extract for treating colds, with the raw materials being: 80 g of mint, 67 g of schizonepeta spikes, 80 g of great burdock fruits, 80 g of skullcap roots, 67 g of platycodon roots, 80 g of hogfennel roots, 120 g of reed rhizomes, 27 g of dahurian angelica roots, 40 g of stir-fried gardenia fruits, 80 g of bitter apricot kernels, 27 g of stir-fried malt, 27 g of stir-fried hawthorn fruits, 27 g of stir-fried medicated leaven, 120 g of honeysuckle flowers, and 80 g of forsythia fruits;

[0058] Preparation method:

[0059] (1) Crush mint and schizonepeta spikes, add 5 times the volume of water, and distill at 90 °C for 2 h to obtain volatile oil;

[0060] (2) Carry out steam distillation on bitter apricot kernels to obtain apricot kernel water;

[0061] (3) Mix great burdock fruits, skullcap roots, platycodon roots, hogfennel roots, dahurian angelica roots, gardenia fruits, hawthorn fruits, medicated leaven, malt, reed rhizomes, honeysuckle flowers, and forsythia fruits, add 5 L of water and decoct together. After filtering the obtained decoction, combine and concentrate to a relative density of 1.05 to obtain a water extract concentrated solution;

[0062] (4) Filter the water extract concentrated solution through a filter cloth with a mesh size of 300, and concentrate to obtain a concentrated solution;

[0063] (5) The concentrated solution is ultrafiltered through an ultrafiltration membrane with a molecular weight cut-off of 5000 to obtain a filtrate;

[0064] (6) The volatile oil, 2-hydroxypropyl-β-cyclodextrin, and water are mixed at a mass ratio of 1:5:15. First, 2-hydroxypropyl-β-cyclodextrin and water are mixed evenly at 90 °C, and then the volatile oil is added and stirred for 40 min to obtain an aqueous solution of the volatile oil inclusion compound; then it is mixed with the filtrate, 200 g of sucrose, 2 g of stevioside, and 5 g of sodium benzoate, boiled, water is added to 1 L, and refrigerated.

[0065] Comparative Example 2

[0066] A compound traditional Chinese medicine extract for treating colds, with the raw materials being the same as those in Example 1.

[0067] The preparation method is the same as that in Example 1, with the only difference being that: in step (2), only 100 U / g of cellulase (without papain) is added for enzymatic hydrolysis.

[0068] Comparative Example 3

[0069] A compound traditional Chinese medicine extract for treating colds, with the raw materials being the same as those in Example 1.

[0070] The preparation method is the same as that in Example 1, with the only difference being that: in step (2), 100 U / g of cellulase and amylase with a mass ratio of 5:1 are added for enzymatic hydrolysis.

[0071] Comparative Example 4

[0072] A compound traditional Chinese medicine extract for treating colds, with the raw materials being the same as those in Example 1.

[0073] The preparation method is the same as that in Example 1, with the only difference being that: in step (3), malt, hawthorn, six-herb powder, honeysuckle, and forsythia are crushed, 2 L of water is added for decoction, and the decoction liquid is filtered and then concentrated to a relative density of 1.05 to obtain extract B.

[0074] Comparative Example 5

[0075] A compound traditional Chinese medicine extract for treating colds, with the raw materials being the same as those in Example 1.

[0076] The preparation method is the same as that in Example 1, with the only difference being that: in step (3), the ethanol solution is absolute ethanol.

[0077] Effect test

[0078] Test Example 1 Stability test

[0079] The detection was carried out according to the standards of the General Rules for the Inspection of Mixtures (Oral Liquid) (2020 Edition Pharmacopoeia). It was placed in a comprehensive drug stability test chamber (equipment model: LHH-80SD) for accelerated testing at 40±2°C and relative humidity of 75±5%. The clarity of each batch of products was observed under a clarity detector after 1 month, 2 months, 3 months, 6 months, and 12 months of accelerated testing. The test results are shown in Table 1.

[0080] Table 1 Clarity Test Results

[0081]

[0082] Test Example 2 Pharmacodynamic Test

[0083] 1. Establish a model: Take 50 healthy mice with the same body weight, measure their body temperature (recorded as T0); then subcutaneously inject 10 mL / kg of yeast suspension with a mass concentration of 20% on the back. After 6 hours of modeling, the body temperature rises by more than 0.8°C.

[0084] 2. Grouping and drug administration: Randomly divide into 5 groups, namely the blank group, the model group, the control group, and the experimental group; among them, the experimental group was fed the preparations prepared in Example 1 and Comparative Example 1, both at 300 mg / kg; the control group was fed the same amount of Xiao'er Ganmaoning Mixture purchased on the market, and the model group was fed the same volume of distilled water.

[0085] Measure the body temperature of each group of rats 6 hours after modeling and 1 hour and 4 hours after drug administration, and calculate the body temperature change value of the rats at each body temperature monitoring point (△T = measured body temperature - T0). Perform an inter-group t-test using the statistical software SPSS13.0. The results are shown in Table 2.

[0086] Table 2 Heat Dissipation Effect Test

[0087]

[0088] Compared with the model group, the control group (whose composition and dosage are the same as those in Example 1 of the present invention) and the oral liquid group of Comparative Example 1 can significantly reduce the increase in body temperature of rats caused by dry yeast (P < 0.05). Among the three groups, the compound traditional Chinese medicine extract preparation (Example 1) of the present invention has a more obvious effect in reducing the increase in body temperature of rats than the control group and the group of Comparative Example 1.

[0089] Test Example 3 Active Ingredient Content

[0090] Test method: Use octadecylsilane chemically bonded silica gel as the filler; use methanol-water-phosphoric acid (50:50:0.2) as the mobile phase; the detection wavelength is 315 nm. The number of theoretical plates calculated by the baicalin peak should not be less than 3000.

[0091] Preparation of reference substance solution: Weigh an appropriate amount of baicalin reference substance accurately, dissolve it in methanol to prepare a solution containing 10 μg per 1 ml, and that's it.

[0092] Preparation of test solution: Take 6 g of this product, weigh it accurately, place it in a 100 ml volumetric flask, slowly add 50 ml of methanol while shaking, perform ultrasonic treatment (power 150 W, frequency 50 kHz) for 20 minutes, add methanol to the scale, shake well, let it stand, take the supernatant, centrifuge (rotation speed 5000 revolutions per minute), accurately measure 2 ml of the supernatant, place it in a 25 ml volumetric flask, add methanol to the scale, shake well, and that's it.

[0093] Determination method: Accurately pipette 10 μl of the reference substance solution and the test solution respectively, inject them into the liquid chromatograph for determination, and that's it.

[0094] The baicalin contents in Examples 1 - 3 and Comparative Examples 1 - 3 were measured respectively, as shown in Table 3.

[0095] Table 3 Baicalin content (mg / mL)

[0096]

[0097]

[0098] The above detailed description is a specific description of one feasible embodiment of the present invention. This embodiment is not intended to limit the patent scope of the present invention. Any equivalent implementation or modification without departing from the present invention should be included within the scope of the technical solution of the present invention.

Claims

1. A preparation method of a compound traditional Chinese medicine extract for treating colds, characterized in that, By weight parts, the raw materials of the compound traditional Chinese medicine extract are composed of 5 - 15 parts of mint, 5 - 15 parts of schizonepeta spike, 6 - 15 parts of great burdock achene, 6 - 15 parts of scutellaria baicalensis, 5 - 15 parts of platycodon grandiflorum, 6 - 15 parts of peucedanum praeruptorum, 10 - 15 parts of reed rhizome, 1 - 5 parts of dahurian angelica root, 1 - 10 parts of cape jasmine fruit, 6 - 15 parts of bitter apricot kernel, 1 - 5 parts of malt, 1 - 5 parts of hawthorn, 1 - 5 parts of medicated leaven, 10 - 15 parts of honeysuckle flower and 1 - 10 parts of forsythia suspensa; The preparation method comprises the following steps: (1) Crush mint and schizonepeta spike, and carry out steam distillation to obtain volatile oil; (2) Mix bitter apricot kernel, great burdock achene, scutellaria baicalensis, platycodon grandiflorum, peucedanum praeruptorum, reed rhizome, dahurian angelica root and cape jasmine fruit with water for soaking, then add enzymes for enzymatic hydrolysis extraction, neutralize, and heat for extraction to obtain extract A; (3) Crush malt, hawthorn, medicated leaven, honeysuckle flower and forsythia suspensa, add ethanol solution for ultrasonic treatment, and heat for extraction to obtain extract B; (4) Mix extract A and extract B, filter with filter cloth, and concentrate to obtain concentrated solution; (5) Ultrafilter the concentrated solution through an ultrafiltration membrane with a molecular weight cut-off of 5000 - 6000 to obtain filtrate; (6) Mix the volatile oil, 2-hydroxypropyl-β-cyclodextrin and water to obtain an aqueous solution of volatile oil inclusion compound, then mix it with the filtrate, boil, and refrigerate to obtain the compound traditional Chinese medicine extract, wherein, the enzymes in step (2) are cellulase and papain, and the mass ratio of cellulase to papain is 3 - 5:1; the mass concentration of the ethanol solution in step (3) is 50% - 70%; the power of the ultrasonic treatment is 200 - 250W, and the time of the ultrasonic treatment is 30 - 60min.

2. The preparation method according to claim 1, wherein In step (1), 3 - 6 times the volume of water is added to mint and schizonepeta spike for distillation, the distillation temperature is 80 - 90°C, and the distillation time is 1 - 3h.

3. The preparation method according to claim 1, wherein In step (2), the mass volume ratio of the total mass of bitter apricot kernel, great burdock achene, scutellaria baicalensis, platycodon grandiflorum, peucedanum praeruptorum, reed rhizome, dahurian angelica root and cape jasmine fruit to water is 1g:5 - 15mL; the soaking time is 1 - 2h.

4. The preparation method according to claim 1, characterized in that, In step (2), the dosage of the enzymes is 80 - 100U / g, the enzymatic hydrolysis temperature is 50 - 60°C, the enzymatic hydrolysis pH is 4 - 5, and the enzymatic hydrolysis time is 80 - 100min; the heating temperature is 80 - 90°C, and the heating extraction time is 80 - 100min.

5. The preparation method according to any one of claims 1-4, characterized in that, In step (3), the mass volume ratio of the total mass of malt, hawthorn, medicated leaven, honeysuckle flower and forsythia suspensa to the ethanol solution is 1g:5 - 15mL; the heating temperature is 60 - 80°C, and the heating extraction time is 30 - 50min.

6. The preparation method according to claim 1, characterized in that, In step (4), the aperture of the filter cloth is 200 - 400 mesh, and it is concentrated until there is no ethanol smell.

7. The preparation method according to claim 1, characterized in that, In step (6), the mass ratio of the volatile oil, 2-hydroxypropyl-β-cyclodextrin and water is 1:3 - 5:10 - 20; the preparation method of the aqueous solution of volatile oil inclusion compound comprises: heating and mixing 2-hydroxypropyl-β-cyclodextrin and water at 80 - 90°C, and then adding the volatile oil and stirring for 30 - 50min.

8. A compound traditional Chinese medicine extract prepared by the preparation method according to any one of claims 1-7, characterized in that, The dosage form of the compound traditional Chinese medicine extract is selected from any one of oral liquid and syrup.

9. The compound traditional Chinese medicine extract according to claim 8, wherein, The oral liquid and syrup also include medical adjuvants, and the medical adjuvants are sucrose, stevioside and sodium benzoate. The addition amounts of sucrose, stevioside and sodium benzoate are respectively 18%-22%, 0.15%-0.25% and 0.4%-0.6% of the total mass of the compound traditional Chinese medicine extract.

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