Urine toxin clearing liquid preparation and preparation method thereof

Abstract

The invention discloses a uremia clearing liquid preparation and a preparation method thereof, and relates to the technical field of pharmaceutical preparations. The uremia clearing liquid preparation is prepared from the following raw materials: rheum officinale, astragalus membranaceus, white mulberry root-bark, radix sophorae flavescentis, codonopsis pilosula, bighead atractylodes rhizome, poria cocos, radix polygoni multiflori preparata, radix paeoniae alba, salvia miltiorrhiza, ligusticum wallichii, chrysanthemum, ginger processed pinellia, plantain herb, radix bupleuri, liquorice, a disodium hydrogen phosphate-citric acid buffer solution, beta-cyclodextrin, tween-80, xanthan gum, stevioside and water. By improving the preparation process and providing a new auxiliary material system, the stability of the oral liquid preparation is improved, the transfer rate of effective components is increased, the flavor is improved, and the palatability is improved.

Description

Technical Field

[0001] The present invention relates to the technical field of pharmaceutical preparations, and in particular to a urea-clearing liquid preparation and a preparation method thereof. Background Art

[0002] Urea Clearing Granules are pure Chinese medicine preparations for the treatment of chronic renal failure (CRF). Its indications include clearing the bowels and lowering turbidity, strengthening the spleen and removing dampness, and promoting blood circulation and removing blood stasis. It is used for patients with chronic renal failure, azotemia, and early and mid-stage uremia who are diagnosed with spleen dampness and turbidity and spleen deficiency and blood stasis. It can reduce creatinine and urea nitrogen, stabilize renal function, and delay dialysis time. It also has a certain effect on improving renal anemia, increasing blood calcium, and reducing blood phosphorus.

[0003] The basic formula of Urology Clearing Granules is made of rhubarb and astragalus as the main drugs, with mulberry bark, sophora flavescens, codonopsis pilosula, atractylodes macrocephala, poria, processed Polygonum multiflorum, white peony root, salvia miltiorrhiza, chuanxiong, chrysanthemum, ginger pinellia, plantain, bupleurum and licorice as the original drugs. Among them, rhubarb is bitter and cold in nature and has a strong effect. It is used to treat "vomiting after eating" with heat in the stomach. Now it is used to treat water evil, so its amount is reduced and combined with a large amount of sweet and warm qi-invigorating astragalus as the main drug. A large amount of astragalus not only replenishes the qi of the spleen and lungs, but also promotes urination and dredges the blood vessels. The combination of the two drugs can not only promote urination, but also take care of qi deficiency, and eliminate evil without hurting the body. Mulberry bark drains the water of the lung and promotes qi, and sophora flavescens removes the water and dampness of the blood. They are all minister drugs, used to help rhubarb eliminate evil water. Codonopsis pilosula, atractylodes macrocephala and poria are also minister drugs, helping astragalus to invigorate qi and promote water. The liver receives qi from the kidney. Now the kidney has been ill for a long time and the qi and yin are greatly damaged. The liver is also not nourished. The liver governs the tendons. If the liver is not nourished, the tendons will be tense and cause convulsions. The liver wind will move and cause spasms. The second group of adjuvants are combined with processed Polygonum multiflorum, which nourishes the kidney and replenishes essence, white peony root, which astringes yin and nourishes the liver, salvia miltiorrhiza, which promotes blood circulation and nourishes blood, chuanxiong, which promotes blood circulation and qi, and chrysanthemum, which calms the liver and extinguishes wind. Together, they can nourish the kidney and liver, relax the tendons and extinguish wind to stop convulsions and prevent spasms. Plantago is good for urination without hurting yin, and bupleurum can raise the clear yang and benefit the triple burner. The two medicines are adjuvants and concurrently used. Licorice can not only replenish qi and detoxify, but also harmonize the various medicines. It is also used as an adjuvant and concurrently used. Such a combination can eliminate evil and strengthen the body. Together, it can strengthen the spleen and kidney, clear the bowels and reduce turbidity, and promote blood circulation and remove blood stasis, which is in line with the treatment of the disease of evil excess and body deficiency.

[0004] Chinese patent CN1814090A discloses a urinary tract infection drug preparation prepared with 16 Chinese medicines as effective components, including rhubarb, liquorice, bupleurum, astragalus, white mulberry bark, codonopsis, white peony root, chuanxiong, sophora flavescens, ginger pinellia, chrysanthemum, atractylodes, poria, processed polygonum multiflorum, salvia miltiorrhiza, and plantain. The above 16 Chinese medicines are taken and boiled in water for 3 times, the first time for 4 hours, the second time for 3 hours, and the third time for 3 hours. The amount of water added in the first decoction is 4-12 times the weight of the Chinese medicine, the amount of water added in the second decoction is 4-10 times the weight of the Chinese medicine, and the amount of water added in the third decoction is 6-8 times the weight of the Chinese medicine; the filtrate is combined, filtered, and concentrated under reduced pressure to a concentrated solution; the concentrated solution is added with purified water and a flavoring agent to prepare an oral solution. The present invention expands the existing dosage form of urinary tract infection tablets into oral liquid and dispersible tablets. This greatly increases the absorption rate of the drug in the human body, improves the bioavailability, shortens the time to reach the maximum inhibitory concentration, and makes the drug's efficacy more significant.

[0005] Oral liquid preparations have the advantages of being easier to absorb and more suitable for children compared to solid dosage forms. However, on the one hand, the preparation of the extract involves a concentration process, which can easily lead to loss of active ingredients and low transfer rates during the concentration step. On the other hand, urea extracts are prone to precipitate at higher temperatures, and precipitate will also be produced during the filling and high-temperature sterilization processes, affecting product quality. Summary of the invention

[0006] In view of this, the purpose of the present invention is to provide a liquid preparation of Uridine Clearing and a preparation method thereof, targeting 16 raw materials including rhubarb, astragalus, mulberry bark, sophora flavescens, codonopsis pilosula, atractylodes macrocephala, poria, processed Polygonum multiflorum, white peony root, salvia miltiorrhiza, ligusticum chuanxiong, chrysanthemum, pinellia tuber, plantain, bupleurum and licorice, by improving the preparation process and providing a new auxiliary material system, so as to improve the stability of the oral liquid preparation, increase the transfer rate of effective ingredients, improve the flavor and improve the palatability.

[0007] To achieve the above-mentioned object of the invention, the technical solution of the present invention is as follows:

[0008] On the one hand, the present invention provides a liquid preparation of urine poison clearing, the raw materials of which include: rhubarb, astragalus, mulberry bark, sophora flavescens, codonopsis pilosula, atractylodes macrocephala, poria, prepared Polygonum multiflorum, white peony root, salvia miltiorrhiza, chuanxiong, chrysanthemum, ginger pinellia, plantain, bupleurum, liquorice, disodium hydrogen phosphate-citrate buffer, β-cyclodextrin, Tween-80, xanthan gum, steviol glycoside and water.

[0009] Preferably, the mass ratio of rhubarb, astragalus, mulberry bark, sophora flavescens, codonopsis pilosula, atractylodes macrocephala, poria, prepared polygonum multiflorum, white peony root, salvia miltiorrhiza, ligusticum chuanxiong, chrysanthemum, pinellia tuber, plantain, bupleurum and liquorice is 0.5-2:2-6:1-5:0.5-5:1-5:3-8:3-8:3-8:1-5:3-8:1-5:20-50:1-3:1-10:10-20:0.5-3, and more preferably 1:4:3:2:3:5:5:5:3:5:3:25:2:5:15:0.9.

[0010] Preferably, the mass ratio of the sodium hydrogen phosphate-citric acid buffer, β-cyclodextrin, Tween-80, xanthan gum and steviol glycoside is 5-20:1-10:1-5:1-5:5-15, and more preferably 8:5:3:2:8.

[0011] On the other hand, the present invention provides a method for preparing the above-mentioned urea-clearing liquid preparation, comprising the following steps:

[0012] (1) extracting rhubarb, astragalus, mulberry bark, sophora flavescens, codonopsis pilosula, atractylodes macrocephala, poria, prepared shouwu, white peony root, salvia miltiorrhiza, chuanxiong, chrysanthemum, pinellia tuber, plantain, bupleurum, and liquorice together with water for 1-3 times, and combining to obtain a filtrate;

[0013] (2) adding a composite enzyme to the filtrate, filtering, and concentrating to a relative density of 1.3-1.5 to obtain a concentrate;

[0014] (3) adding water to dilute the concentrate, mixing evenly, adding β-cyclodextrin, Tween-80, xanthan gum, and steviol glycoside while stirring, raising the temperature to 45-75° C., adding disodium hydrogen phosphate-citric acid buffer, mixing evenly, and sterilizing to obtain the urea-clearing liquid preparation.

[0015] Preferably, in step (1), the number of water extraction is 1-3 times, and the mass of water added is 8-20 times the mass of the substance to be extracted. More preferably, the number of water extraction is 2 times, and the mass of water added is 10-15 times the mass of the substance to be extracted.

[0016] Further preferably, in step (1), the extraction temperature is 70-90° C. and the extraction time is 1-3 hours.

[0017] More preferably, in step (1), the water extraction is specifically as follows: the first time, 15 times the amount of water to be extracted is added, and the extraction is carried out at 80° C. for 2 hours; the second time, 10 times the amount of water to be extracted is added, and the extraction is carried out at 85° C. for 1 hour.

[0018] Preferably, in step (2), the complex enzyme is a mixed enzyme of lipase, xylanase and pectinase, and further preferably, the mass ratio of the lipase, xylanase and pectinase is 1-10:0.1-1:1-5, and further preferably 6:0.5:3.

[0019] Preferably, in step (2), the mass fraction of the complex enzyme in the filtrate is 0.01-1%, more preferably 0.2%.

[0020] Preferably, in step (2), a clarifier or a flocculant is added to the filtrate before the complex enzyme treatment. More preferably, the clarifier is chitosan, and the flocculant is at least one of tannic acid, gelatin, chitosan, and tannin.

[0021] Further preferably, a clarifier is added.

[0022] More preferably, the mass fraction of the chitosan in the filtrate is 0.01-0.5%, and even more preferably 0.1%.

[0023] Preferably, in step (2), the concentration is reverse osmosis concentration; further preferably, the conditions of the reverse osmosis concentration are: temperature 25-35°C, working pressure 2.0-4.0Mpa; further preferably: temperature 32°C, working pressure 3.0Mpa.

[0024] Preferably, in step (3), the temperature is increased to 55°C.

[0025] Preferably, in step (3), the crude drug concentration in the Urea Clear liquid preparation is 0.05-1 g / mL, more preferably 0.5 g / mL.

[0026] The beneficial effects of the present invention are:

[0027] (1) Based on the raw materials of Urea Cleanser, provide an oral liquid preparation with good stability and flavor, improve medication compliance, and improve the dosage form of Urea Cleanser.

[0028] (2) For the first time, a composite enzyme and chitosan synergistic clarification process was introduced into the extract of the urea-clearing preparation, and a specific concentration method was screened to eliminate insoluble substances and reduce the precipitation of precipitates in the liquid preparation, thereby improving stability, while increasing the transfer rate of active ingredients and improving activity.

[0029] (3) The present invention is the first to study the liquid preparation of Urea Clear, screen a specific auxiliary material system, and synergistically improve the flavor and stability through different auxiliary material combinations. DETAILED DESCRIPTION

[0030] In order to make the technical means, creative features, purpose and efficacy of the present invention easy to understand, the present invention is further explained in conjunction with specific embodiments below, but the following embodiments are only preferred embodiments of the present invention, not all. Based on the embodiments in the implementation mode, other embodiments obtained by those skilled in the art without creative work all belong to the protection scope of the present invention. In the following embodiments, unless otherwise specified, the operating methods used are conventional operating methods, the equipment used are conventional equipment, and the equipment materials used in each embodiment are the same.

[0031] In the following embodiments,

[0032] β-cyclodextrin brand: Qinuo; Tween-80 brand: Huazhiyuan; xanthan gum brand: Fufeng; stevioside brand: Mingxi; water is drinking water. Lipase activity is 100,000 u / g, xylanase activity is 30,000 u / g, pectinase activity is 60,000 u / g, and cellulase activity is 50,000 u / g. The above enzymes are all purchased from Xiasheng. The reverse osmosis membrane is Dow Chemical BW30PRO-400IG. The pH value of disodium hydrogen phosphate-citric acid buffer is 4.2-4.3.

[0033] Example 1

[0034] (1) Wash and dry rhubarb, astragalus, mulberry bark, sophora flavescens, codonopsis pilosula, atractylodes macrocephala, poria, prepared shouwu, white peony root, salvia miltiorrhiza, chuanxiong, chrysanthemum, pinellia tuber, plantain, bupleurum, and liquorice according to a mass ratio of 0.5:6:1:0.5:1:3:3:3:5:8:5:50:3:10:10:0.5, crush, and extract with water. For the first time, add 15 times the amount of water to be extracted, and extract at 70°C for 3 hours; for the second time, add 10 times the amount of water to be extracted, and extract at 90°C for 1 hour, and combine to obtain a filtrate;

[0035] (2) adding a composite enzyme to the filtrate, wherein the composite enzyme is a mixed enzyme of lipase, xylanase and pectinase in a mass ratio of 1:0.1:5, adjusting the mass fraction of the composite enzyme in the filtrate to 0.2%, performing enzymolysis at 45° C. for 15 min, heating to 70° C. to inactivate the enzyme, cooling to room temperature and filtering, and performing reverse osmosis concentration at a temperature of 32° C. and a working pressure of 3.0 MPa to concentrate to a relative density of 1.3-1.5 to obtain a concentrate;

[0036] (3) adding a small amount of water to the concentrate (according to mass, concentrate: water = 1:1) to dilute, stirring until mixed evenly, then adding β-cyclodextrin, Tween-80, xanthan gum, and steviol glycoside while stirring, heating to 55° C., adding disodium hydrogen phosphate-citric acid buffer, stirring at 500 rpm for 15 min, mixing evenly, adding water to adjust the crude drug concentration to 0.5 g / mL, sterilizing, and obtaining the Urea Clear liquid preparation;

[0037] The mass ratio of disodium hydrogen phosphate-citric acid buffer, β-cyclodextrin, Tween-80, xanthan gum and steviol glycoside is 5:1:1:5:15, and the mass ratio of the total amount of excipients (the total mass of disodium hydrogen phosphate-citric acid buffer, β-cyclodextrin, Tween-80, xanthan gum and steviol glycoside) and the crude drug is 1:9.

[0038] Example 2

[0039] (1) Wash and dry rhubarb, astragalus, mulberry bark, sophora flavescens, codonopsis pilosula, atractylodes macrocephala, poria, prepared shouwu, white peony root, salvia miltiorrhiza, chuanxiong, chrysanthemum, pinellia tuber, plantain, bupleurum, and liquorice in a mass ratio of 1:4:3:2:3:5:5:5:3:5:3:25:2:5:15:0.9, crush, and extract with water, adding 15 times the amount of water to be extracted for the first time, extracting at 80°C for 2 hours; adding 10 times the amount of water to be extracted for the second time, extracting at 85°C for 1 hour, and combining to obtain a filtrate;

[0040] (2) adding a composite enzyme to the filtrate, wherein the composite enzyme is a mixed enzyme of lipase, xylanase and pectinase in a mass ratio of 6:0.5:3, adjusting the mass fraction of the composite enzyme in the filtrate to 0.2%, performing enzymolysis at 45° C. for 15 min, heating to 70° C. to inactivate the enzyme, cooling to room temperature and filtering, and performing reverse osmosis concentration at a temperature of 32° C. and a working pressure of 3.0 MPa to concentrate to a relative density of 1.3-1.5 to obtain a concentrate;

[0041] (3) adding a small amount of water to the concentrate (according to the mass, the concentrate: water = 1:1) to dilute, stirring until the mixture is uniformly mixed, then adding β-cyclodextrin, Tween-80, xanthan gum, and steviol glycoside while stirring, heating to 55° C., adding disodium hydrogen phosphate-citric acid buffer, stirring at 500 rpm for 15 min, mixing, sterilizing, and adding water to adjust the crude drug concentration to 0.5 g / mL to obtain the Urea Clear liquid preparation;

[0042] The mass ratio of disodium hydrogen phosphate-citric acid buffer, β-cyclodextrin, Tween-80, xanthan gum and steviol glycoside is 8:5:3:2:8, and the mass ratio of the total amount of excipients (the total mass of disodium hydrogen phosphate-citric acid buffer, β-cyclodextrin, Tween-80, xanthan gum and steviol glycoside) and crude drug is 1:9.

[0043] Example 3

[0044] (1) Wash and dry rhubarb, astragalus, mulberry bark, sophora flavescens, codonopsis pilosula, atractylodes macrocephala, poria, prepared shouwu, white peony root, salvia miltiorrhiza, chuanxiong, chrysanthemum, pinellia tuber, plantain, bupleurum, and liquorice in a mass ratio of 2:2:5:5:5:8:8:8:1:3:1:20:1:1:20:3, grind, and extract with water. For the first time, add 15 times the amount of water to be extracted and extract at 80° C. for 2 hours; for the second time, add 10 times the amount of water to be extracted and extract at 85° C. for 1 hour, and combine to obtain a filtrate;

[0045] (2) adding a composite enzyme to the filtrate, wherein the composite enzyme is a mixed enzyme of lipase, xylanase and pectinase in a mass ratio of 10:1:1, adjusting the mass fraction of the composite enzyme in the filtrate to 0.2%, performing enzymolysis at 45° C. for 15 min, heating to 70° C. to inactivate the enzyme, cooling to room temperature and filtering, and performing reverse osmosis concentration at a temperature of 32° C. and a working pressure of 3.0 MPa to concentrate to a relative density of 1.3-1.5 to obtain a concentrate;

[0046] (3) adding a small amount of water to the concentrate (according to the mass, the concentrate: water = 1:1) to dilute, stirring until the mixture is uniformly mixed, then adding β-cyclodextrin, Tween-80, xanthan gum, and steviol glycoside while stirring, heating to 55° C., adding disodium hydrogen phosphate-citric acid buffer, stirring at 500 rpm for 15 min, mixing, sterilizing, and adding water to adjust the crude drug concentration to 0.5 g / mL to obtain the Urea Clear liquid preparation;

[0047] The mass ratio of disodium hydrogen phosphate-citric acid buffer, β-cyclodextrin, Tween-80, xanthan gum and steviol glycoside is 20:10:5:1:5, and the mass ratio of the total amount of excipients (the total mass of disodium hydrogen phosphate-citric acid buffer, β-cyclodextrin, Tween-80, xanthan gum and steviol glycoside) and crude drug is 1:9.

[0048] Embodiment 4-10

[0049] The difference from Example 2 is that the type and amount of the complex enzyme were screened, and the other conditions were the same as in Example 2. The specific parameters are as follows:

[0050] Complex enzyme type Addition amount Example 4 Lipase + xylanase + pectinase (6:0.5:3) 0.1％ Example 5 Lipase + xylanase + pectinase (6:0.5:3) 0.5％ Example 6 Lipase + xylanase + pectinase (6:0.5:3) 1％ Example 7 Lipase + xylanase + pectinase (6:0.5:3) 1.5％ Example 8 Lipase + Cellulase + Pectinase (6:0.5:3) 0.2％ Example 9 Cellulase + xylanase + pectinase (6:0.5:3) 0.2％ Example 10 Lipase + xylanase + cellulase (6:0.5:3) 0.2％

[0051] Embodiment 11

[0052] (1) Wash and dry rhubarb, astragalus, mulberry bark, sophora flavescens, codonopsis pilosula, atractylodes macrocephala, poria, prepared shouwu, white peony root, salvia miltiorrhiza, chuanxiong, chrysanthemum, pinellia tuber, plantain, bupleurum, and liquorice in a mass ratio of 1:4:3:2:3:5:5:5:3:5:3:25:2:5:15:0.9, crush, and extract with water, adding 15 times the amount of water to be extracted for the first time, extracting at 80°C for 2 hours; adding 10 times the amount of water to be extracted for the second time, extracting at 85°C for 1 hour, and combining to obtain a filtrate;

[0053] (2) adding chitosan to the filtrate, wherein the mass fraction of chitosan in the filtrate is 0.1%, and then adding a composite enzyme treatment, wherein the composite enzyme is a mixed enzyme of lipase, xylanase and pectinase in a mass ratio of 6:0.5:3, and adjusting the mass fraction of the composite enzyme in the filtrate to 0.2%, performing enzymolysis at 45° C. for 10 min, heating to 70° C. to inactivate the enzyme, cooling to room temperature and filtering, and performing reverse osmosis concentration at a temperature of 32° C. and a working pressure of 3.0 MPa to concentrate to a relative density of 1.3-1.5 to obtain a concentrate;

[0054] (3) adding a small amount of water to the concentrate (according to the mass, the concentrate: water = 1:1) to dilute, stirring until the mixture is uniformly mixed, then adding β-cyclodextrin, Tween-80, xanthan gum, and steviol glycoside while stirring, heating to 55° C., adding disodium hydrogen phosphate-citric acid buffer, stirring at 500 rpm for 15 min, mixing, sterilizing, and adding water to adjust the crude drug concentration to 0.5 g / mL to obtain the Urea Clear liquid preparation;

[0055] The mass ratio of disodium hydrogen phosphate-citric acid buffer, β-cyclodextrin, Tween-80, xanthan gum and steviol glycoside is 15:5:3:2:2, and the mass ratio of the total amount of excipients (the total mass of disodium hydrogen phosphate-citric acid buffer, β-cyclodextrin, Tween-80, xanthan gum and steviol glycoside) and the crude drug is 1:9.

[0056] Comparative Example 1

[0057] The difference from Example 2 is that the concentration method is evaporation concentration to a relative density of 1.3-1.5, and the rest is the same.

[0058] Comparative Example 2

[0059] Unlike Example 11, no complex enzyme treatment was added, and step (2) was: chitosan was added to the filtrate, the mass fraction of chitosan in the filtrate was 0.1%, stirring was carried out for 30 minutes, filtering, and reverse osmosis concentration was performed at a temperature of 32° C. and a working pressure of 3.0 MPa to concentrate to a relative density of 1.3-1.5 to obtain a concentrate.

[0060] Comparative Example 3

[0061] The difference from Example 2 is that the mass ratio of the sodium hydrogen phosphate-citric acid buffer, β-cyclodextrin, Tween-80, xanthan gum, and steviol glycoside is 30:12:0.5:0.5:2, and the rest are the same.

[0062] Comparative Example 4

[0063] The difference from Example 2 is that xanthan gum is not added to the auxiliary materials, and the rest are the same.

[0064] Comparative Example 5

[0065] The difference from Example 2 is that no disodium hydrogen phosphate-citric acid buffer solution is added to the auxiliary materials, and the rest are the same.

[0066] Results

[0067] 1. Transfer rate

[0068] The transfer rate is the mass ratio of the total flavonoids in the concentrate in step (2) to the total flavonoids in the filtrate in step (1), and the total flavonoid content is determined by spectrophotometry (using rutin as a reference and measuring the absorbance at 500 nm).

[0069] The results are as follows:

[0070] Total flavonoid transfer rate during concentration Example 1 58-62％ Example 2 69-71％ Example 3 63-66％ Example 4 60-63％ Example 5 68-71％ Example 6 57-60％ Example 7 51-54％ Example 8 54-57％ Example 9 51-55％ Example 10 54-58％ Embodiment 11 62-64％ Comparative Example 1 37-41％ Comparative Example 2 27-34％

[0071] During the concentration process, the solvent removal method, other ingredients in the compound, etc., will affect the transfer rate of effective ingredients such as total flavonoids. The results of comparative example 1 show that evaporation concentration treatment will cause a large loss of active ingredients. The results of comparative example 2 show that the composite enzyme clarification treatment can effectively improve the transfer rate of total flavonoids. In Examples 1-6, most of the insoluble substances in the filtrate and their effects on total flavonoids are removed by combining composite enzyme hydrolysis and reverse osmosis concentration, and the total flavonoid transfer rate can be increased to 60% and above. In Example 7, too much composite enzyme is added in the clarification stage, resulting in excessive enzymatic hydrolysis, which in turn causes the transfer rate to show a downward trend. Examples 8-10 use different composite enzyme treatments to improve the transfer rate during the concentration process, but compared with the composite enzyme in Example 2, the transfer rate is significantly different. Considering the cost issue comprehensively, the enzyme combination in Example 2 is selected. Example 11 adds chitosan treatment, which reduces the transfer rate to a certain extent.

[0072] 2. Stability

[0073] The oral liquids of Examples 1-11 and Comparative Examples 1-5 were placed at 50±2° C. and a relative humidity of 75±5% to perform an accelerated test and observe the precipitation, stratification and color.

[0074] The preparations prepared in the examples and comparative examples are transparent brown-yellow liquids. The number of precipitated particles is less than 5, which is recorded as a small amount; 5-20, which is recorded as a large amount; and >20, which is recorded as a large amount.

[0075] The results are as follows:

[0076]

[0077]

[0078] 3. Flavor testing

[0079] With reference to GB / T16291.1-2012, 10 volunteers were selected, five males and five females, with no history of severe allergies, genetic diseases, or recent diseases. 10 mL of the sample of Example 2 was placed in the mouth, rinsed for 15 seconds, and the sample was spit out, repeated 5 times, and then scored.

[0080] Scoring criteria:

[0081] 4 points: good flavor, acceptable;

[0082] 3 points: bitter taste, acceptable;

[0083] 2 points: There is a noticeable bitter taste, barely acceptable;

[0084] 1 point: Strong bitter taste, unacceptable.

[0085] The statistical results are as follows:

[0086] Points 1 2 3 4 Number of people 0 0 4 6

[0087] The results show that the oral liquid prepared by the formula of the present invention has good flavor and high acceptance.

[0088] 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 liquid preparation for removing urine poison, characterized in that: The raw materials of the urine-clearing liquid preparation include: rhubarb, astragalus, mulberry bark, sophora flavescens, codonopsis pilosula, atractylodes macrocephala, tuckahoe, prepared radix polygoni multiflori, white peony root, salvia miltiorrhiza, ligusticum chuanxiong, chrysanthemum, ginger pinellia, plantain, bupleurum, liquorice, disodium hydrogen phosphate-citrate buffer, β-cyclodextrin, Tween-80, xanthan gum, steviol glycoside and water.

2. The liquid preparation of urine poisoning according to claim 1, characterized in that: The mass ratio of rhubarb, astragalus, mulberry bark, sophora flavescens, codonopsis pilosula, atractylodes macrocephala, tuckahoe, prepared radix polygoni multiflori, white peony root, salvia miltiorrhiza, ligusticum chuanxiong, chrysanthemum, pinellia tuber, plantain, bupleurum and liquorice is 0.5-2:2-6:1-5:0.5-5:1-5:3-8:3-8:3-8:1-5:3-8:1-5:20-50:1-3:1-10:10-20:0.5-3; The mass ratio of the disodium hydrogen phosphate-citric acid buffer, beta-cyclodextrin, Tween-80, xanthan gum and steviol glycoside is 5-20:1-10:1-5:1-5:5-15.

3. The method for preparing the liquid preparation of urea extract according to claim 1 or 2, characterized in that: The following steps are involved: (1) extracting rhubarb, astragalus, mulberry bark, sophora flavescens, codonopsis pilosula, atractylodes macrocephala, poria, prepared shouwu, white peony root, salvia miltiorrhiza, chuanxiong, chrysanthemum, pinellia tuber, plantain, bupleurum, and liquorice together with water for 1-3 times, and combining to obtain a filtrate; (2) adding a composite enzyme to the filtrate, filtering, and concentrating to a relative density of 1.3-1.5 to obtain a concentrate; (3) adding water to dilute the concentrate, mixing evenly, adding β-cyclodextrin, Tween-80, xanthan gum, and steviol glycoside while stirring, raising the temperature to 45-75° C., adding disodium hydrogen phosphate-citric acid buffer, mixing evenly, and sterilizing to obtain the urea-clearing liquid preparation.

4. The preparation method according to claim 3, characterized in that: In step (1), the number of times of water extraction is 1-3 times, and the mass of water added is 8-20 times the mass of the substance to be extracted; the extraction temperature each time is 70-90° C., and the extraction time is 1-3 hours.

5. The preparation method according to claim 3, characterized in that: In step (2), the complex enzyme is a mixed enzyme of lipase, xylanase and pectinase, and the mass fraction of the complex enzyme in the filtrate is 0.01-1%.

6. The preparation method according to any one of claims 3 to 5, characterized in that: In step (2), the mass ratio of the lipase, xylanase and pectinase is 1-10:0.1-1:1-5.

7. The preparation method according to claim 5, characterized in that: In step (2), the mass fraction of the complex enzyme in the filtrate is 0.2%.

8. The preparation method according to claim 3, characterized in that: In step (2), before the complex enzyme treatment, a clarifier or a flocculant is added to the filtrate; the clarifier is chitosan, and the flocculant is at least one of tannic acid, gelatin, chitin, and tannin.

9. The preparation method according to claim 3, characterized in that: In step (2), the concentration is reverse osmosis concentration; the conditions of the reverse osmosis concentration are: temperature 25-35°C, working pressure 2.0-4.0Mpa.

10. The preparation method according to claim 3, characterized in that: In step (3), the crude drug concentration in the Urea Clear liquid preparation is 0.05-1 g / mL.

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