Preparation method of radix bupleuri and silver oral liquid

Abstract

The invention belongs to the field of traditional Chinese medicine preparations, and particularly relates to a preparation method of a radix bupleuri-honeysuckle flower oral liquid which is prepared from radix bupleuri, honeysuckle flower, radix scutellariae, radix puerariae, herba schizonepetae, herba artemisiae annuae, fructus forsythiae, radix platycodonis, semen armeniacae amarae, herba menthae and herba houttuyniae. The semen armeniacae amarae is subjected to independent ultrasonic extraction, so that the extraction efficiency of the thermally unstable component semen armeniacae amarae is improved, and the effects of relieving cough and asthma, resisting inflammation and easing pain of the medicine are enhanced; and after hydroxypropyl beta-cyclodextrin is added into the extracted concentrated solution, alcohol precipitation is performed, so that the content of baicalin in the components is increased.

Description

Technical Field

[0001] The invention belongs to the technical field of traditional Chinese medicine preparations, and particularly relates to a method for preparing Chaiyin oral liquid. Background Art

[0002] Chaiyin oral liquid is a traditional Chinese medicine oral liquid preparation made from 11 Chinese medicinal materials: Bupleurum, honeysuckle, scutellaria, kudzu root, schizonepeta, artemisia annua, forsythia, platycodon, bitter almond, mint, and houttuynia cordata. It has the effects of clearing away heat and detoxifying, relieving throat and cough. It is used for upper respiratory tract infection with exogenous wind-heat syndrome, with symptoms of fever, aversion to wind, headache, sore throat, sweating, nasal congestion and runny nose, cough, red tip of tongue, and thin yellow fur.

[0003] The preparation process of Chaiyin oral liquid has been disclosed in the 2020 edition of the "Chinese Pharmacopoeia". The preparation steps include: taking bitter almonds and crushing them into coarse particles, soaking them with seven herbs, including bupleurum, honeysuckle, schizonepeta, artemisia annua, forsythia, mint, and houttuynia, adding water for 1 hour, heating and distilling, collecting 2875mL of the effluent, redistilling, collecting 575mL of the redistilled liquid, and storing it in another container; boiling the residue and the other three herbs, including scutellaria, with water for three times, each time for 2 hours, and mixing the decoction with the above distilled liquid Combine and filter, concentrate the filtrate to a clear paste with a relative density of 1.11-1.14 (50°C), add ethanol to make the alcohol content reach 60%, stir well, refrigerate for 24 hours, take the supernatant and reduce the pressure to recover the ethanol, concentrate to a clear paste of 1.13-1.15 (50°C), add the above-mentioned redistilled liquid, 5g of beta-cyclodextrin and 3g of sodium benzoate, stir well, refrigerate for 24 hours, filter, adjust the pH value to 5.5-7.5 with sodium hydroxide solution, fill and sterilize.

[0004] Because the amygdalin contained in the raw material bitter almond has poor thermal stability and is easily hydrolyzed, amygdalin will decompose rapidly when the temperature exceeds 70°C. In the pharmacopoeia process, the temperature during the distillation and collection of the distillate is around 100°C, and the time is relatively long, resulting in a large loss of amygdalin, which reduces the antitussive and antiasthmatic, anti-inflammatory and analgesic effects of the drug. In addition, baicalin has poor solubility in 60% ethanol. When the concentrated liquid is precipitated in the pharmacopoeia process, some baicalin will precipitate, and the transfer rate is only about 50%. The baicalin content of the product produced by this process can barely reach the 3.0 mg / mL required by the pharmacopoeia. The content of baicalin is severely reduced, which further reduces the efficacy of the drug in relieving real fire, removing damp heat, and treating high fever and thirst, lung heat cough, and damp heat diarrhea. Summary of the invention

[0005] In view of the above shortcomings of the prior art, it is necessary to provide a new preparation method for Chaiyin oral liquid, optimize and upgrade the original process, significantly increase the effective ingredients of the product, and further improve the efficacy of Chaiyin preparations.

[0006] The technical purpose of the present invention is achieved through the following technical solutions:

[0007] A method for preparing Chaiyin oral liquid, characterized in that it comprises the following steps:

[0008] (1) Bitter almond extraction: weigh the prescribed amount of bitter almonds, crush them into coarse particles, add ethanol, and perform ultrasonic extraction to obtain bitter almond extract, which is set aside; the medicinal residue is set aside;

[0009] (2) Aromatic water extraction: weigh the prescribed amount of seven herbs, namely, honeysuckle, artemisia annua, forsythia, schizonepeta, mint, and houttuynia cordata, soak them in water, and then heat and distill them. Collect the effluent, redistillate, collect the redistilled liquid, and store it in a separate container for later use; store the distilled liquid in a separate container for later use; and store the residue for later use.

[0010] (3) decoction extraction: add water to the drug residue in step (2) and three ingredients, namely, scutellaria baicalensis, kudzu root and platycodon grandiflorum, and decoct to obtain a decoction for later use;

[0011] (4) Concentration and alcohol precipitation: the decoction obtained in step (3) and the distilled medicinal liquid obtained in step (2) are mixed and filtered, the filtrate is concentrated under reduced pressure to a clear paste having a relative density of 1.1-1.2 at 50-65° C., cyclodextrin is added, stirred evenly, bitter almond extract is added, stirred evenly, ethanol is added for alcohol precipitation, the supernatant is decompressed and ethanol is recovered, and concentrated to a clear paste having a relative density of 1.1-1.2 at 50-65° C., to obtain an alcohol precipitation concentrate of Chaiyin oral liquid, which is used for standby use;

[0012] (5) Preparation and filling: Add the alcohol precipitation concentrate obtained in step (4) to the redistilled liquid obtained in step (2), then add appropriate amount of auxiliary materials, add water to the total preparation amount, stir well, refrigerate, filter until the clarity is acceptable, adjust pH to 5.5-7.5, package, and sterilize to obtain the product.

[0013] In step (1), the amount of ethanol added in the ultrasonic extraction of bitter almonds is 4-8 times the amount of an ethanol solution with a concentration of 70%-90%.

[0014] Preferably, the ultrasonic extraction power is 50-70W, and the ultrasonic extraction is performed 1-3 times, each time for 30-60 minutes.

[0015] The optimal ultrasonic extraction power is 60-64W, and ultrasonic extraction is performed twice, each time for 40 minutes.

[0016] The cyclodextrin described in step (4) is hydroxypropyl-β-cyclodextrin or β-cyclodextrin.

[0017] Preferably, the cyclodextrin in step (4) is hydroxypropyl-β-cyclodextrin.

[0018] The amount of cyclodextrin added in step (4) is 1 / 12-1 / 6 of the amount of the Radix Scutellariae Radix. The optimal amount of cyclodextrin added is 1 / 10-1 / 6 of the amount of the Radix Scutellariae Radix.

[0019] Preferably, in step (4), ethanol precipitation is performed by adding ethanol until the ethanol content of the drug solution is 60%-65%.

[0020] The prior art uses water decoction to extract bitter almonds. The decoction temperature is high, which causes the thermally unstable component amygdalin to be hydrolyzed, resulting in reduced antitussive and antiasthmatic, anti-inflammatory and analgesic effects; and the prior art uses the water decoction method, which causes some water-soluble proteins to be extracted and brought into subsequent products, which are not easy to remove, resulting in further reduced product stability. The present invention uses low-temperature ultrasonic extraction of bitter almonds, and uses ethanol solution as the extraction solvent, which can not only significantly improve the extraction rate of amygdalin, but also reduce the extraction of water-soluble proteins, which is beneficial to improving the stability of the product.

[0021] When the prior art extract is precipitated with alcohol, the addition of ethanol will cause a large amount of baicalin to precipitate, reduce the content of baicalin in the preparation, and further reduce the effect of Chaiyin oral liquid on relieving real fire and removing dampness and heat. In this field, sodium hydroxide alkaline cosolvent is often added to improve the solubility of baicalin; however, in the process of drug production, the addition of a large amount of sodium hydroxide will cause changes in the basis of medicinal materials, which has a great impact on the safety, effectiveness and quality stability of the drug. The present invention adds hydroxypropyl-β-cyclodextrin as a cosolvent before the extract is precipitated with alcohol, which can significantly reduce the precipitation of baicalin in the subsequent alcohol precipitation process, improve the transfer rate of baicalin, reduce the loss of baicalin, and increase the bioavailability and stability of the active ingredients in Chaiyin oral liquid. After the hydroxypropyl-β-cyclodextrin of the present invention is complexed with baicalin, its physical and chemical properties can be changed, the toxic and side effects of the drug can be reduced, and the solubility and stability of the drug can be improved. DETAILED DESCRIPTION

[0022] In order to make the purpose, technical scheme and advantages of the embodiments of the present application clearer, the technical scheme in the embodiments of the present application will be fully described below. The reagents or instruments used in the embodiments without indicating the manufacturer can all be conventional products purchased from the market.

[0023] The formula of the Chaiyin oral solution prepared in the embodiment is as follows (made into 1000mL):

[0024] Bupleurum 100g Honeysuckle 75g Scutellaria 60g Pueraria lobata 125g Nepeta tenuifolia 125g Artemisia annua 75g

[0025] Forsythia suspensa 75g Platycodon grandiflorum 50g Bitter almond 50g Mint 75g Houttuynia cordata 75g

[0026] The following examples are used to detect the contents of amygdalin and baicalin as follows:

[0027] Amygdalin:

[0028] Chromatographic conditions: Welch Ultimate XB C 18 (250mm×4.6mm, 5μm) chromatographic column; acetonitrile as mobile phase A, 0.2% phosphoric acid solution as mobile phase B, gradient elution (0-11.0min, 9.0%A; 11.0-17.0min, 9.0%A→15.0%A; 17.0-31.0min, 15.0%A→38.0%A; 31.0-45.0min, 38.0%A→62.0%A; 45.0-50.0min, 62.0%A→9.0%A); detection wavelength: 207nm; flow rate: 1.0mL / min; column temperature: 30℃; injection volume: 10μL.

[0029] Preparation of reference solution: Take an appropriate amount of amygdalin reference substance, weigh it accurately, and add methanol to make a solution containing 40 μg per 1 mL.

[0030] Preparation of the test solution: Accurately measure 2 mL of Chaiyin oral solution, accurately add 50% methanol, ultrasonically treat for 15 minutes, cool, filter, and take the filtrate to obtain the test solution.

[0031] Baicalin:

[0032] Chromatographic conditions: Waters C 18 Column (50 mm × 4.6 mm, 2.7 μm); mobile phase: acetonitrile (A)-0.1% phosphoric acid aqueous solution (B), gradient elution (0-30 min 6% A→16% A, 0.4 mL / min; 30-40 min 16% A→28% A, 0.4 mL / min; 40-48 min, 28% A→60% A, 0.4→0.6 mL / min; 48-55 min 60% A, 0.6 mL / min; 55-56 min 60% A→6% A, 0.6→0.4 mL / min); detection wavelength: 230 nm; column temperature: 35°C; injection volume: 2 μL.

[0033] Preparation of reference solution: Take an appropriate amount of baicalin reference substance dried under reduced pressure at 60°C for 4 hours, weigh it accurately, and add methanol to prepare a solution containing 60 μg per 1 mL.

[0034] Preparation of the test solution: Accurately measure 2 mL of Chaiyin oral solution, accurately add 50% methanol, ultrasonically treat for 15 minutes, cool, filter, and take the filtrate to obtain the test solution.

[0035] Example 1 Preparation of Chaiyin Oral Liquid

[0036] (1) Bitter almond extraction: weigh 50 g of bitter almonds, crush them into coarse particles, add 5 times the amount of 80% ethanol, and perform ultrasonic extraction twice, each time for 40 min, with an ultrasonic power of 64 W, to obtain a bitter almond extract for later use;

[0037] (2) Aromatic water extraction: add 100g of bupleurum, 75g of honeysuckle, 75g of artemisia annua, 75g of forsythia, 50g of schizonepeta, 75g of mint and 75g of houttuynia cordata to 10 times the amount of water, soak for 1 hour, heat and distill for 2.5 hours, collect the effluent, redistill, collect the redistilled liquid and store it in a separate container for later use; store the distilled liquid in a separate container for later use; and store the residue for later use;

[0038] (3) decoction: the residues in step (2) are combined with 60 g of Scutellaria baicalensis, 50 g of Pueraria lobata and 50 g of Platycodon grandiflorum, and water is added and decocted three times. The first time, 8 times the amount of water is added and the decoction is performed for 1.5 hours. The second time, 6 times the amount of water is added and the decoction is performed for 1.0 hour. The third time, 6 times the amount of water is added and the decoction is performed for 1.0 hour. The decoctions are combined to obtain the decoction of Chaiyin oral liquid, which is set aside.

[0039] (4) Concentration and alcohol precipitation: the decoction obtained in step (3) is mixed with the medicinal solution distilled in step (2), filtered, and the filtrate is concentrated under reduced pressure to a clear paste with a relative density of 1.12 (50° C.), 10 g of hydroxypropyl-β-cyclodextrin is added, and the mixture is stirred evenly, and the bitter almond extract obtained in step (1) is added, and ethanol is added after stirring until the alcohol content reaches 60%, and the mixture is stirred for 30 min and refrigerated for 24 h. The supernatant is taken and the ethanol is recovered under reduced pressure, and the mixture is concentrated to a clear paste with a relative density of 1.15 (50° C.) to obtain an alcohol-precipitated concentrated solution for standby use;

[0040] (5) Preparation and filling: Take the alcohol precipitation concentrate obtained in step (4), add the redistilled liquid obtained in step (2) and 3 g of sodium benzoate, stir until all are dissolved, add 200 g of sucrose, add water to a total preparation volume of 1000 mL, stir well, refrigerate for 24 hours, filter, adjust the pH to 7.0 with sodium hydroxide solution, fill, and sterilize. HPLC determination of the content of amygdalin is 1.45 mg / mL, and the content of baicalin is 3.68 mg / mL.

[0041] Example 2 Preparation of Chaiyin Oral Liquid

[0042] (1) Bitter almond extraction: weigh 50 g of bitter almonds, crush them into coarse particles, add 8 times the amount of 70% ethanol, and perform ultrasonic extraction twice, each time for 1 hour, with an ultrasonic power of 70 W, to obtain bitter almond extract, which is set aside;

[0043] (2) Aromatic water extraction: add 100g of bupleurum, 75g of honeysuckle, 75g of artemisia annua, 75g of forsythia, 50g of schizonepeta, 75g of mint and 75g of houttuynia cordata to 10 times the amount of water, soak for 1 hour, heat and distill for 2.5 hours, collect the effluent, redistill, collect the redistilled liquid and store it in a separate container for later use; store the distilled liquid in a separate container for later use; and store the residue for later use;

[0044] (3) decoction: the residues in step (2) are combined with 60 g of Scutellaria baicalensis, 50 g of Pueraria lobata and 50 g of Platycodon grandiflorum, and water is added and decocted three times. The first time, 8 times the amount of water is added and the decoction is performed for 1.5 hours. The second time, 6 times the amount of water is added and the decoction is performed for 1.0 hour. The third time, 6 times the amount of water is added and the decoction is performed for 1.0 hour. The decoctions are combined to obtain the decoction of Chaiyin oral liquid, which is set aside.

[0045] (4) Concentration and alcohol precipitation: the decoction obtained in step (3) is mixed with the medicinal solution distilled in step (2), filtered, and the filtrate is concentrated under reduced pressure to a clear paste with a relative density of 1.18 (55° C.), 5 g of hydroxypropyl-β-cyclodextrin is added, and stirred evenly, and the bitter almond extract obtained in step (1) is added, and ethanol is added after stirring to make the alcohol content reach 60%, stirred for 30 minutes, and refrigerated for 24 hours, and the supernatant is taken and the ethanol is recovered under reduced pressure, and concentrated to a clear paste with a relative density of 1.19 (55° C.), to obtain an alcohol-precipitated concentrated solution for standby use;

[0046] (5) Preparation and filling: Take the alcohol precipitation concentrate obtained in step (4), add the redistilled liquid obtained in step (2) and 3 g of sodium benzoate, stir until all are dissolved, add 200 g of sucrose, add water to a total preparation volume of 1000 mL, stir well, refrigerate for 24 hours, filter, adjust the pH to 6.9 with sodium hydroxide solution, fill, and sterilize. HPLC determination of the content of amygdalin is 1.42 mg / mL, and the content of baicalin is 3.52 mg / mL.

[0047] Example 3 Preparation of Chaiyin Oral Liquid

[0048] (1) Bitter almond extraction: weigh 50 g of bitter almonds, crush them into coarse particles, add 4 times the amount of 90% ethanol, and perform ultrasonic extraction 3 times, each time for 30 min, with an ultrasonic power of 50 W, to obtain bitter almond extract, which is set aside;

[0049] (2) Aromatic water extraction: add 100g of bupleurum, 75g of honeysuckle, 75g of artemisia annua, 75g of forsythia, 50g of schizonepeta, 75g of mint and 75g of houttuynia cordata to soak for 1 hour, heat and distill for 2.5 hours, collect the effluent, redistill, collect the redistilled liquid, store it in another container for later use; store the distilled liquid in another container for later use; and store the residue for later use;

[0050] (3) decoction: the residues in step (2) are combined with 60 g of Scutellaria baicalensis, 50 g of Pueraria lobata and 50 g of Platycodon grandiflorum, and water is added and decocted three times. The first time, 8 times the amount of water is added and the decoction is performed for 1.5 hours. The second time, 6 times the amount of water is added and the decoction is performed for 1.0 hour. The third time, 6 times the amount of water is added and the decoction is performed for 1.0 hour. The decoctions are combined to obtain the decoction of Chaiyin oral liquid, which is set aside.

[0051] (4) Concentration and alcohol precipitation: the decoction obtained in step (3) is mixed with the medicinal solution distilled in step (2), filtered, and the filtrate is concentrated under reduced pressure to a clear paste with a relative density of 1.15 (65° C.), 6 g of hydroxypropyl-β-cyclodextrin is added, and stirred evenly, and the bitter almond extract obtained in step (1) is added, and ethanol is added after stirring until the alcohol content reaches 65%, stirred for 30 minutes, and refrigerated for 24 hours, and the supernatant is taken and the ethanol is recovered under reduced pressure, and concentrated to a clear paste with a relative density of 1.18 (65° C.), to obtain an alcohol precipitation concentrate for standby use;

[0052] (5) Preparation and filling: Take the alcohol precipitation concentrate obtained in step (4), add the redistilled liquid obtained in step (2) and 3 g of sodium benzoate, stir until all are dissolved, add 200 g of sucrose, add water to a total preparation volume of 1000 mL, stir well, refrigerate for 24 hours, filter, adjust the pH to 7.1 with sodium hydroxide solution, fill, and sterilize. HPLC determination of the content of amygdalin is 1.39 mg / mL, and the content of baicalin is 3.59 mg / mL.

[0053] Example 4 Preparation of Chaiyin Oral Liquid

[0054] (1) Bitter almond extraction: weigh 50 g of bitter almonds, crush them into coarse particles, add 5 times the amount of 80% ethanol, and perform ultrasonic extraction twice, each time for 40 min, with an ultrasonic power of 60 W, to obtain a bitter almond extract for later use;

[0055] (2) Aromatic water extraction: add 100g of bupleurum, 75g of honeysuckle, 75g of artemisia annua, 75g of forsythia, 50g of schizonepeta, 75g of mint and 75g of houttuynia cordata to soak for 1 hour, heat and distill for 2.5 hours, collect the effluent, redistill, collect the redistilled liquid, store it in another container for later use; store the distilled liquid in another container for later use; and store the residue for later use;

[0056] (3) decoction: the residues in step (2) are combined with 60 g of Scutellaria baicalensis, 50 g of Pueraria lobata and 50 g of Platycodon grandiflorum, and water is added and decocted three times. The first time, 8 times the amount of water is added and the decoction is performed for 1.5 hours. The second time, 6 times the amount of water is added and the decoction is performed for 1.0 hour. The third time, 6 times the amount of water is added and the decoction is performed for 1.0 hour. The decoctions are combined to obtain the decoction of Chaiyin oral liquid, which is set aside.

[0057] (4) Concentration and alcohol precipitation: the decoction obtained in step (3) is mixed with the medicinal solution distilled in step (2), filtered, and the filtrate is concentrated under reduced pressure to a clear paste with a relative density of 1.13 (55° C.), 10 g of β-cyclodextrin is added, and the mixture is stirred evenly, and the bitter almond extract obtained in step (1) is added, and ethanol is added to make the alcohol content reach 60%, stirred for 30 minutes, and then refrigerated for 24 hours, and the supernatant is taken out and the ethanol is recovered under reduced pressure, and concentrated to a clear paste with a relative density of 1.20 (55° C.), and the alcohol precipitation concentrate is obtained for standby use;

[0058] (5) Preparation and filling: Take the alcohol precipitation concentrate obtained in step (4), add the redistilled liquid obtained in step (2) and 3 g of sodium benzoate, stir until all are dissolved, add 200 g of sucrose, add water to a total preparation volume of 1000 mL, stir well, refrigerate for 24 hours, filter, adjust the pH to 7.2 with sodium hydroxide solution, fill, and sterilize. HPLC determination of the content of amygdalin is 1.51 mg / mL, and the content of baicalin is 3.44 mg / mL.

[0059] Comparative Example 1 Preparation of Chaiyin Oral Liquid

[0060] (1) Extraction and concentration process:

[0061] 50g of bitter almonds were roughly chopped and mixed with 100g of bupleurum, 75g of honeysuckle, 50g of schizonepeta, 75g of artemisia annua, 75g of forsythia, 75g of mint and 75g of houttuynia cordata, soaked in 10 times the amount of water for 1 hour, heated and distilled for 2.5 hours, and 450mL of distillate was collected; the leaching liquid after distillation was released; the residues were boiled and extracted three times with water together with 60g of scutellaria, 50g of platycodon and 50g of kudzu root, the first time 8 times the amount of water was added, boiled for 1.5 hours, the second time 6 times the amount of water was added, boiled for 1.0 hour, and the third time 6 times the amount of water was added, boiled for 1.0 hour; the decoction and the leaching liquid after distillation were combined, filtered, and the filtrate was concentrated under reduced pressure to a relative density of 1.14 (55°C), and 2 times the amount of extract was added at a uniform speed. 8.0% alkaline ethanol (alcohol content 60%) was used for pre-alcohol precipitation. After stirring evenly, 85% ethanol was added until the alcohol content reached 60%. After stirring for 30 minutes, cold precipitation was carried out for 24 hours, and the filtrate was concentrated under reduced pressure to a relative density of 1.20 (55°C). Distillate and purified water were added to 750mL to obtain a solution for preparation;

[0062] (2) Preparation process

[0063] Add 200g sucrose and 3g sodium benzoate to the prepared solution, stir and dissolve, refrigerate for 24h, filter, adjust the pH to 7.1 with sodium hydroxide solution, add purified water to 1000mL, filter until the clarity is qualified, fill, sterilize, and obtain. The content of amygdalin determined by HPLC is 1.02mg / mL, and the content of baicalin is 3.11mg / mL.

[0064] Preparation of Comparative Example 2 Chaiyin Oral Liquid

[0065] (1) Extraction and concentration process:

[0066] Crush 50g of bitter almonds and add 100g of bupleurum, 75g of honeysuckle, 50g of schizonepeta, 75g of artemisia annua, 75g of forsythia, 75g of mint and 75g of houttuynia cordata to soak for 1 hour, heat and distill for 2.5 hours, collect 450mL of distillate; release the extracted liquid after distillation; add dregs of the medicine together with 60g of scutellaria, 50g of platycodon and 50g of kudzu root, decoct for three times, add 8 times of water for the first time, decoct for 1. 5 hours, add 6 times the amount of water for the second time, decoct for 1.0 hour, add 6 times the amount of water for the third time, decoct for 1.0 hour; combine the decoction and the leaching liquid after distillation, filter, decompress the filtrate to a relative density of 1.11 (65°C), add 95% ethanol to an alcohol content of 65%, dissolve the refined precipitate, filter, decompress the filtrate to a relative density of 1.11 (65°C), add distillate and purified water to 750mL, and precipitate for preparation;

[0067] (2) Preparation process

[0068] Adjust the pH of the prepared solution to 7.0, add 15g of β-cyclodextrin, control the inclusion temperature to 20-30°C, stir and include for 60 minutes, filter, add 200g of sucrose and 3g of sodium benzoate to the filtrate, stir and dissolve, add purified water to 1000mL, filter until the clarity is qualified, fill, sterilize, and obtain. The content of amygdalin determined by HPLC is 1.05mg / mL, and the content of baicalin is 3.06mg / mL.

[0069] Comparative Example 3 Preparation of Chaiyin Oral Liquid

[0070] (1) Extraction and concentration process:

[0071] 50g of bitter almonds were roughly chopped and soaked with 100g of bupleurum, 75g of honeysuckle, 50g of schizonepeta, 75g of artemisia annua, 75g of forsythia, 75g of mint and 75g of houttuynia cordata, heated and distilled for 2.5 hours, and 450mL of distillate was collected; the leached medicinal liquid after distillation was released; the medicinal residues were boiled and extracted three times with 60g of scutellaria, 50g of platycodon and 50g of kudzu root, 8 times of water was added for the first time, boiled for 1.5 hours, 6 times of water was added for the second time, boiled for 1.0 hour, and 6 times of water was added for the third time, boiled for 1.0 hour; the decoction and the leached medicinal liquid after distillation were combined, filtered, the filtrate was concentrated under reduced pressure to a relative density of 1.08 (65°C), ethanol was added to an alcohol content of 65%, the refined extract precipitate was transferred to a solution, filtered, the filtrate was concentrated under reduced pressure to a relative density of 1.11 (65°C), distillate and purified water were added to 750mL, and the mixture was prepared after cold precipitation;

[0072] (2) Preparation process

[0073] Adjust the pH of the prepared solution to 7.2, add 15g of hydroxypropyl-β-cyclodextrin, control the inclusion temperature to 20-30°C, stir and include for 60min, filter, add 200g of sucrose and 3g of sodium benzoate to the filtrate, stir and dissolve, add purified water to 1000mL, filter until the clarity is qualified, fill, sterilize, and obtain. The content of amygdalin determined by HPLC is 1.03mg / mL, and the content of baicalin is 2.97mg / mL.

Claims

1. A method for preparing Chaiyin oral liquid, characterized in that: The steps include: (1) Bitter almond extraction: weigh the prescribed amount of bitter almonds, crush them into coarse particles, add ethanol, and perform ultrasonic extraction to obtain bitter almond extract, which is set aside; the medicinal residue is set aside; (2) Aromatic water extraction: weigh the prescribed amount of seven herbs, namely, honeysuckle, artemisia annua, forsythia, schizonepeta, mint, and houttuynia cordata, soak them in water, and then heat and distill them. Collect the effluent, redistillate, collect the redistilled liquid, and store it in a separate container for later use; store the distilled liquid in a separate container for later use; and store the residue for later use. (3) decoction extraction: add water to the drug residue in step (2) and three ingredients, namely, scutellaria baicalensis, kudzu root and platycodon grandiflorum, and decoct to obtain a decoction for later use; (4) Concentration and alcohol precipitation: the decoction obtained in step (3) and the distilled medicinal liquid obtained in step (2) are mixed and filtered, the filtrate is concentrated under reduced pressure to a clear paste having a relative density of 1.1-1.2 at 50-65° C., cyclodextrin is added, stirred evenly, bitter almond extract is added, stirred evenly, ethanol is added for alcohol precipitation, the supernatant is decompressed and ethanol is recovered, and concentrated to a clear paste having a relative density of 1.1-1.2 at 50-65° C., to obtain an alcohol precipitation concentrate of Chaiyin oral liquid, which is used for standby use; (5) Preparation and filling: Add the alcohol precipitation concentrate obtained in step (4) to the redistilled liquid obtained in step (2), then add appropriate amount of auxiliary materials, add water to the total preparation amount, stir well, refrigerate, filter until the clarity is acceptable, adjust pH to 5.5-7.5, package, and sterilize to obtain the product.

2. The preparation method according to claim 1, characterized in that: In step (1), the amount of ethanol added in the ultrasonic extraction of bitter almonds is 4-8 times the amount of an ethanol solution with a concentration of 70%-90%.

3. The preparation method according to claim 2, characterized in that: The ultrasonic extraction power is 50-70W, and the ultrasonic extraction is performed 1-3 times, each time for 30-60 minutes.

4. The preparation method according to claim 3, characterized in that: The ultrasonic extraction power is 60-64W, and the ultrasonic extraction is performed twice, each time for 40 minutes.

5. The preparation method according to claim 1, characterized in that: The cyclodextrin described in step (4) is hydroxypropyl-β-cyclodextrin or β-cyclodextrin.

6. The preparation method according to claim 5, characterized in that: The cyclodextrin described in step (4) is hydroxypropyl-β-cyclodextrin.

7. The preparation method according to claim 1, characterized in that: The amount of cyclodextrin added in step (4) is 1 / 12-1 / 6 of the amount of the Radix Scutellariae medicinal material.

8. The preparation method according to claim 7, characterized in that: The amount of cyclodextrin added is 1 / 10-1 / 6 of the amount of Scutellaria baicalensis medicinal material.

9. The preparation method according to claim 1, characterized in that: In step (4), ethanol precipitation is performed by adding ethanol until the ethanol content of the drug solution is 60%-65%.