Antiviral oral liquid and preparation method thereof

By adopting a stepped dual circulation cooling process and a method of uniform spraying alkali liquid to adjust the pH value in the preparation process of antiviral oral liquid, the problems of low cooling and pH adjustment efficiency are solved, the stability of the product and the stability of Forsythia glycoside content are achieved, and the demand for mass production is met.

CN118557685BActive Publication Date: 2025-03-11BEIJING CHINA RESCOURCES HIGH-TECH NATURAL PHARM CO LTD
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Patent Information

Application Number
CN202410618660.X
Authority / Receiving Office
CN · China
Patent Type
Patents(China)
Current Assignee / Owner
Filing Date
2024-05-17
Publication Date
2025-03-11
Estimated Expiration
2044-05-17

AI Technical Summary

Technical Problem

In the preparation process of existing antiviral oral liquid, the cooling time is long and the pH adjustment efficiency is low, resulting in large differences in product characteristics and Forsythia glycoside content between batches, which cannot meet the needs of batch production.

Method used

The step-by-step dual circulation cooling process is adopted. During the cooling process of the medicinal liquid, the pH value is adjusted by different concentrations of sodium hydroxide solutions, and the alkali liquid is uniformly sprayed by the preparation ring shower device on the upper part of the tank to achieve rapid and effective cooling and pH adjustment.

Benefits of technology

Leave it at 40°C for 6 months, the antiviral oral solution keeps the solution clear, the pH value is stable, and the Forsythiatin content remains stable, solving the problem of batch difference in existing products and improving production efficiency.

✦ Generated by Eureka AI based on patent content.

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Abstract

The present application relates to the technical field of antiviral materials, and specifically discloses an antiviral oral liquid and a preparation method thereof. The preparation method of the antiviral oral liquid disclosed in the present application comprises the following steps in sequence: boiling the raw medicinal materials with water, merging the filtrate, concentrating, and adding auxiliary materials; adjusting the pH value during the cooling of the medicinal liquid, then filtering to clarify, adding water to constant volume and filtering, sterilizing, and obtaining; the specific steps of adjusting the pH value during the cooling of the medicinal liquid are: when the medicinal liquid is cooled to 50-60°C, the pH value of the medicinal liquid is adjusted to 4.0-5.0 using a 5.0-7.5mol / L sodium hydroxide solution; when the medicinal liquid continues to cool to 20-50°C, the pH value of the medicinal liquid is adjusted to 5.5-6.0 using a 1.0-5.0mol / L sodium hydroxide solution. Using the technical solution provided by the present application, the prepared antiviral oral liquid can effectively maintain the clarity of the solution, the pH value, and the stability of the content of forsythiaside.
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Description

Technical Field

[0001] The present application relates to the technical field of antiviral materials, and in particular to an antiviral oral liquid and a preparation method thereof. Background Art

[0002] The existing antiviral oral liquid prescription is mainly composed of nine herbs, including isatis root, gypsum, reed root, rehmannia, curcuma, anemarrhena, calamus, patchouli, and forsythia. The preparation method is generally to add water to the above nine medicinal materials and boil them twice, the first time for 3 hours, collect the volatile oil, and encapsulate it with hydroxypropyl beta-cyclodextrin, or the first time for 1.5 hours (collect the volatile oil and volatile oil emulsion at the same time); the second time for 1 hour and 20 minutes, filter, combine the filtrates, concentrate to an appropriate amount, add more than 85% ethanol to make the alcohol content 70%, let it stand, filter, recover the ethanol from the filtrate and concentrate it to an appropriate amount, add volatile oil inclusion compound and appropriate amount of honey, sucrose, orange essence, sodium cyclamate or add volatile oil, volatile oil emulsion and appropriate amount of honey and sucrose; then cool to below 30°C, adjust the pH value with 10% sodium hydroxide solution, filter; add water to 1000ml, mix well, filter, fill, sterilize, and the product is obtained.

[0003] The above-mentioned preparation process of antiviral oral liquid has the following problems: It takes a long time to cool down the molten sugar liquid in the preparation process: the efficiency of adjusting the pH is slow after the alcohol-removing concentrated liquid is mixed with the auxiliary materials and heated (i.e., molten sugar). The cooling method of only using circulating water in the interlayer of the preparation tank is time-consuming and inefficient, and cannot meet the needs of mass production; and the batch-to-batch difference in the amount of alkali added for pH adjustment is large: when the pH value of the preparation liquid produced by the same batch of raw materials and auxiliary materials is adjusted to the target range required by the process (5.5-6.0), the batch-to-batch difference in the amount of alkali added is large (5-15L), resulting in a long alkali adjustment time, and large differences in product properties and the content of the effective ingredient forsythiaside between batches.

[0004] In view of the problems existing in the above-mentioned preparation process, a more reasonable and efficient new preparation process is developed, which has positive significance for antiviral oral liquid. Summary of the invention

[0005] In order to solve the above technical problems, the present application provides an antiviral oral liquid and a preparation method thereof.

[0006] The present application provides a method for preparing an antiviral oral liquid, which specifically comprises the following steps in sequence:

[0007] The raw medicinal materials are boiled with water, the filtrate is combined, concentrated, and the auxiliary materials are added and mixed; the pH value is adjusted during the cooling of the medicinal solution, and then filtered to clarify, water is added to the fixed volume, filtered, and sterilized to obtain;

[0008] The specific steps of adjusting the pH value during the cooling of the liquid medicine are as follows:

[0009] When the temperature of the liquid medicine is lowered to 50-60°C, the pH value of the liquid medicine is adjusted to 4.0-5.0 using a 5.0-7.5 mol / L sodium hydroxide solution; when the temperature of the liquid medicine is further lowered to 20-50°C, the pH value of the liquid medicine is adjusted to 5.5-6.0 using a 1.0-5.0 mol / L sodium hydroxide solution;

[0010] The raw medicinal materials specifically include the following ingredients: Radix Isatidis, Gypsum, Rhizoma Phragmites, Radix Rehmanniae, Curcuma, Rhizoma Anemarrhenae, Acorus Calamus, Patchouli, and Fructus Forsythiae.

[0011] The present application adopts the above-mentioned technical scheme. In the process of preparing the antiviral oral liquid, after adding the auxiliary materials, the pH is adjusted during the cooling process. By reasonably controlling the concentration of the alkaline solution, the prepared antiviral oral liquid can effectively keep the solution clear and stably maintain the pH value when placed at 40°C for 6 months. At the same time, the stability of the forsythiaside content is also guaranteed, the problems existing in the existing products are solved, and unexpected effects are achieved.

[0012] Preferably, the specific steps of adjusting the pH value during the cooling process are:

[0013] When the temperature of the liquid medicine is lowered to 50-60°C, the pH value of the liquid medicine is adjusted to 4.0-5.0 using a 5.0-7.5 mol / L sodium hydroxide solution;

[0014] While the temperature of the liquid continues to drop to 30-50°C, the pH of the liquid is adjusted to 5.0-5.5 using a 2.5-5.0 mol / L sodium hydroxide solution;

[0015] While the temperature of the liquid medicine continues to drop to 20-30°C, the pH value of the liquid medicine is adjusted to 5.5-6.0 using 1.0-2.5 mol / L sodium hydroxide solution.

[0016] Preferably, the specific steps of adjusting the pH value during the cooling process are:

[0017] When the temperature of the liquid medicine is lowered to 50-60°C, the pH value of the liquid medicine is adjusted to 4.0-5.0 using a 5.5-6.5 mol / L sodium hydroxide solution;

[0018] While the temperature of the liquid continues to drop to 30-50°C, the pH of the liquid is adjusted to 5.0-5.5 using a 3.5-4.5 mol / L sodium hydroxide solution;

[0019] While the temperature of the liquid medicine continues to drop to 20-30°C, the pH value of the liquid medicine is adjusted to 5.5-6.0 using 1.5-2.5 mol / L sodium hydroxide solution.

[0020] Preferably, the step of cooling the liquid medicine is carried out by adopting a stepped double-circulation cooling method; the step of adjusting the pH value is to use a circular sprinkler device on the upper part of the preparation tank to evenly spray the alkali solution into the liquid medicine.

[0021] This application adopts Figure 1 The double-circulation cooling equipment shown adopts a step-by-step double-circulation cooling method to shorten the cooling time, improve the mixing degree of the liquid medicine, and realize batch production. Step-by-step double-circulation cooling means that after adding auxiliary materials to prepare the molten sugar liquid medicine, it is first cooled to 50-60°C through the interlayer of the preparation tank body through circulating water. The purpose is to prevent the liquid medicine temperature from dropping suddenly, and the effective ingredients and auxiliary materials from crystallizing and precipitating, which affects the uniformity of the liquid medicine. Then it flows into the external refrigerant device through the liquid outlet of the preparation tank for circulation cooling to 20-30°C. While increasing the cooling rate, it promotes the effective mixing of the prepared liquid medicine and the synergistic compatibility of the effective ingredients, providing a uniform and stable liquid medicine environment for adjusting the pH.

[0022] In order to solve the problem of large batch differences in the amount of alkali added for adjusting pH during the preparation process: based on the optimization method of cooling down the sugar in the preparation process with a step-by-step cycle, a peristaltic pump is used to add sodium hydroxide solutions of different concentrations to adjust the pH value to the target range (5.5-6.0) according to the pH range of the solution, and the solution is evenly sprayed into the solution through the circular sprinkler device on the top of the preparation tank.

[0023] Preferably, the temperature of the drug solution is cooled to 50-60°C at a rate of 2-8°C / min.

[0024] Preferably, the temperature of the drug solution is cooled to 20-50°C at a rate of 0.5-2°C / min.

[0025] Preferably, during the process of adding the auxiliary materials, the temperature of the drug solution is 60-100° C., and the pH of the drug solution is 3.0-4.0.

[0026] Preferably, after the step of adding auxiliary materials, the temperature of the drug solution is 60-70° C., and the pH of the drug solution is 3.0-4.0.

[0027] Preferably, the raw medicinal materials specifically include the following components in parts by weight: 126-130 parts of indigo root, 55-59 parts of gypsum, 58-62 parts of rehmannia root, 30-34 parts of rehmannia root, 23-27 parts of curcuma, 23-27 parts of anemarrhena, 23-27 parts of calamus, 26-30 parts of patchouli, and 44-49 parts of forsythia.

[0028] In a second aspect, the present application provides an antiviral oral liquid prepared using the above-mentioned method for preparing the antiviral oral liquid.

[0029] In summary, the technical solution of this application has the following effects:

[0030] In the process of preparing the antiviral oral liquid, the present application adjusts the pH value simultaneously during the cooling process after adding the auxiliary materials. By reasonably controlling the concentration of the alkaline solution, the prepared antiviral oral liquid can effectively keep the solution clear and stably maintain the pH value when placed at 40°C for 6 months. At the same time, the stability of the forsythiaside content is also ensured, solving the problems existing in existing products and achieving unexpected results. BRIEF DESCRIPTION OF THE DRAWINGS

[0031] Figure 1 This is a schematic diagram of the dual-circulation cooling equipment used in Example 1 of the present application. DETAILED DESCRIPTION

[0032] The raw materials and reagents used in this application can be obtained commercially.

[0033] The present application is further described in detail below in conjunction with examples, comparative examples and performance testing experiments. These examples should not be construed as limiting the scope of protection claimed in the present application.

[0034] Example

[0035] Example 1

[0036] Example 1 provides an antiviral oral liquid.

[0037] The specific preparation process of the antiviral oral liquid in this embodiment is as follows:

[0038] (1) Weigh 128.57 g of Radix Isatidis, 57.14 g of Gypsum, 60.71 g of Rhizoma Phragmites, 32.14 g of Radix Rehmanniae, 25 g of Radix Curcumae, 25 g of Rhizoma Anemarrhenae, 25 g of Rhizoma Acorus Tatarinowii, 28.57 g of Pogostemon Cablin, and 46.43 g of Fructus Forsythiae respectively, add 8 times the amount of water, and boil for 1.5 hours. Collect the volatile oil through an oil-water separator to obtain 3.5 ml of volatile oil and 285 ml of aromatic water. Add 6 times the amount of water to the residue and boil for 1 hour and 20 minutes. Filter and collect the filtrate. Combine the filtrates and discard the residue.

[0039] (2) The combined filtrate is concentrated in vacuo at a temperature below 65°C to a relative density of 1.12 (measured hot at 60°C), cooled to room temperature, and 85% ethanol is slowly added while stirring to a concentration of 70±2% ethanol. The mixture is allowed to stand for 24 hours, filtered, and the supernatant is taken to recover ethanol and concentrated to a relative density of 1.09 (measured at 20°C) to obtain a concentrated solution for later use.

[0040] (3) Take 15 g of hydroxypropyl-β-cyclodextrin and prepare a saturated aqueous solution, add 2 ml of volatile oil dehydrated with anhydrous sodium sulfate, control the temperature at 40-60° C. and stir for 5 hours at a stirring speed of 300 r / min to obtain a hydroxypropyl-β-cyclodextrin inclusion solution.

[0041] (4) At a temperature of 65°C, 300 ml of the antiviral concentrate was filtered, and then 100 g of honey, 125 g of sucrose, and 12.5 g of hydroxypropyl-β-cyclodextrin inclusion complex were added. The pH value of the mixed solution was 3.5. The pH value was then adjusted during the cooling process of the solution. The solution was filtered until clear, and water was added to make the volume to 1000 ml. The fixed volume solution was filtered and sterilized.

[0042] Among them, the specific steps of adjusting the pH value during the cooling of the liquid medicine are:

[0043] The equipment used is as follows Figure 1 As shown, the step of cooling the liquid medicine is to adopt a step-by-step double-circulation cooling method; the step of adjusting the pH value is to use the circular sprinkler device on the upper part of the preparation tank to evenly spray the alkali solution into the liquid medicine;

[0044] When the temperature of the liquid medicine was lowered to 50°C, the temperature reduction rate was controlled at 5°C / min, and the pH value of the liquid medicine was adjusted to 4.5 using a 6.0 mol / L sodium hydroxide solution;

[0045] When the temperature of the liquid medicine was cooled to 30°C, the cooling rate was controlled at 1°C / min, and the pH value of the liquid medicine was adjusted to 5.2 using 4.0 mol / L sodium hydroxide solution;

[0046] When the temperature of the drug solution was cooled to 25°C, the cooling rate was controlled at 1°C / min, and the pH value of the drug solution was adjusted to 5.8 using 2.0 mol / L sodium hydroxide solution.

[0047] Example 2

[0048] Example 2 provides an antiviral oral liquid.

[0049] The specific preparation process of the antiviral oral liquid in this embodiment is different from that in Example 1 in that the specific steps for adjusting the pH value during the cooling of the liquid are different, as shown below.

[0050] Among them, the specific steps of adjusting the pH value during the cooling of the liquid medicine are:

[0051] When the temperature of the liquid medicine was lowered to 50°C, the temperature reduction rate was controlled at 5°C / min, and the pH value of the liquid medicine was adjusted to 4.5 using a 6.0 mol / L sodium hydroxide solution;

[0052] When the temperature of the drug solution was cooled to 25°C, the cooling rate was controlled at 1°C / min, and the pH value of the drug solution was adjusted to 5.8 using 4.0 mol / L sodium hydroxide solution.

[0053] The specific preparation process of the antiviral oral liquid in this embodiment is the same as the remaining steps of Example 1.

[0054] Example 3

[0055] Example 3 provides an antiviral oral liquid.

[0056] The specific preparation process of the antiviral oral liquid in this embodiment is different from that in Example 1 in that the specific steps for adjusting the pH value during the cooling of the liquid are different, as shown below.

[0057] Among them, the specific steps of adjusting the pH value during the cooling of the liquid medicine are:

[0058] The specific steps for adjusting the pH value during the cooling of the liquid medicine are as follows:

[0059] When the temperature of the liquid medicine was lowered to 50°C, the temperature reduction rate was controlled at 5°C / min, and the pH value of the liquid medicine was adjusted to 4.5 using a 6.0 mol / L sodium hydroxide solution;

[0060] When the temperature of the liquid medicine was cooled to 30°C, the cooling rate was controlled at 1°C / min, and the pH value of the liquid medicine was adjusted to 5.2 using 2.0 mol / L sodium hydroxide solution;

[0061] When the temperature of the drug solution was cooled to 25°C, the cooling rate was controlled at 1°C / min, and the pH value of the drug solution was adjusted to 5.8 using 4.0 mol / L sodium hydroxide solution.

[0062] The specific preparation process of the antiviral oral liquid in this embodiment is the same as the remaining steps of Example 1.

[0063] Example 4

[0064] Example 4 provides an antiviral oral liquid.

[0065] The specific preparation process of the antiviral oral liquid in this embodiment is different from that in Example 1 in that the specific steps for adjusting the pH value during the cooling of the liquid are different, as shown below.

[0066] Among them, the specific steps of adjusting the pH value during the cooling of the liquid medicine are:

[0067] The specific steps for adjusting the pH value during the cooling of the liquid medicine are as follows:

[0068] When the temperature of the liquid medicine was lowered to 50°C, the cooling rate was controlled at 5°C / min, and the pH value of the liquid medicine was adjusted to 4.5 using 5.0 mol / L sodium hydroxide solution;

[0069] When the temperature of the liquid medicine was cooled to 30°C, the cooling rate was controlled at 1°C / min, and the pH value of the liquid medicine was adjusted to 5.2 using 4.0 mol / L sodium hydroxide solution;

[0070] When the temperature of the drug solution was cooled to 25°C, the cooling rate was controlled at 1°C / min, and the pH value of the drug solution was adjusted to 5.8 using 2.0 mol / L sodium hydroxide solution.

[0071] The specific preparation process of the antiviral oral liquid in this embodiment is the same as the remaining steps of Example 1.

[0072] Example 5

[0073] Example 5 provides an antiviral oral liquid.

[0074] The specific preparation process of the antiviral oral liquid in this embodiment is different from that in Example 1 in that the specific steps for adjusting the pH value during the cooling of the liquid are different, as shown below.

[0075] Among them, the specific steps of adjusting the pH value during the cooling of the liquid medicine are:

[0076] The specific steps for adjusting the pH value during the cooling of the liquid medicine are as follows:

[0077] When the temperature of the liquid medicine was lowered to 50°C, the cooling rate was controlled at 1°C / min, and the pH value of the liquid medicine was adjusted to 4.5 using 6.0 mol / L sodium hydroxide solution;

[0078] When the temperature of the liquid medicine was cooled to 30°C, the cooling rate was controlled at 5°C / min, and the pH value of the liquid medicine was adjusted to 5.2 using 4.0 mol / L sodium hydroxide solution;

[0079] When the temperature of the drug solution was cooled to 25°C, the cooling rate was controlled at 5°C / min, and the pH value of the drug solution was adjusted to 5.8 using 2.0 mol / L sodium hydroxide solution.

[0080] The specific preparation process of the antiviral oral liquid in this embodiment is the same as the remaining steps of Example 1.

[0081] Example 6

[0082] Example 6 provides an antiviral oral liquid.

[0083] The specific preparation process of the antiviral oral liquid in this embodiment is different from that in Example 1 in that the specific steps for adjusting the pH value during the cooling of the liquid are different, as shown below.

[0084] Among them, the specific steps of adjusting the pH value during the cooling of the liquid medicine are:

[0085] The specific steps for adjusting the pH value during the cooling of the liquid medicine are as follows:

[0086] When the temperature of the liquid medicine was lowered to 50°C, the cooling rate was controlled at 8°C / min, and the pH value of the liquid medicine was adjusted to 4.5 using 6.0 mol / L sodium hydroxide solution;

[0087] When the temperature of the liquid medicine was lowered to 30°C, the cooling rate was controlled at 0.5°C / min, and the pH value of the liquid medicine was adjusted to 5.2 using 4.0 mol / L sodium hydroxide solution;

[0088] When the temperature of the drug solution was cooled to 25°C, the cooling rate was controlled at 0.5°C / min, and the pH value of the drug solution was adjusted to 5.8 using 2.0 mol / L sodium hydroxide solution.

[0089] The specific preparation process of the antiviral oral liquid in this embodiment is the same as the remaining steps of Example 1.

[0090] Example 7

[0091] Example 7 provides an antiviral oral liquid.

[0092] The specific preparation process of the antiviral oral liquid in this embodiment is different from that in Example 1 in that the specific steps for adjusting the pH value during the cooling of the liquid are different, as shown below.

[0093] Among them, the specific steps of adjusting the pH value during the cooling of the liquid medicine are:

[0094] The specific steps for adjusting the pH value during the cooling of the liquid medicine are as follows:

[0095] When the temperature of the liquid medicine was lowered to 50°C, the cooling rate was controlled at 2°C / min, and the pH value of the liquid medicine was adjusted to 4.5 using 6.0 mol / L sodium hydroxide solution;

[0096] When the temperature of the liquid medicine was cooled to 30°C, the cooling rate was controlled at 2°C / min, and the pH value of the liquid medicine was adjusted to 5.2 using 4.0 mol / L sodium hydroxide solution;

[0097] When the temperature of the drug solution was cooled to 25°C, the cooling rate was controlled at 2°C / min, and the pH value of the drug solution was adjusted to 5.8 using 2.0 mol / L sodium hydroxide solution.

[0098] The specific preparation process of the antiviral oral liquid in this embodiment is the same as the remaining steps of Example 1.

[0099] Examples 8-10

[0100] Examples 8-10 provide an antiviral oral liquid.

[0101] The specific preparation process of the antiviral oral liquid in this embodiment is different from that in Example 1 in that: during the process of adding auxiliary materials in step (4), the temperature of the liquid is different, as shown below.

[0102] In Example 8: During the process of adding auxiliary materials in step (4), the temperature of the drug solution was 75°C.

[0103] In Example 9: During the process of adding auxiliary materials in step (4), the temperature of the drug solution was 85°C.

[0104] In Example 10: During the process of adding auxiliary materials in step (4), the temperature of the drug solution is 95°C.

[0105] The specific preparation process of the antiviral oral liquid in the above embodiment is the same as the remaining steps in Example 1.

[0106] Comparative Example

[0107] Comparative Example 1

[0108] This comparative example provides an antiviral oral liquid.

[0109] The preparation method of the antiviral oral liquid in this comparative example is specifically as follows.

[0110] (1) Weigh 128.57 g of Radix Isatidis, 57.14 g of Gypsum, 60.71 g of Rhizoma Phragmites, 32.14 g of Radix Rehmanniae, 25 g of Curcuma, 25 g of Rhizoma Anemarrhenae, 25 g of Rhizoma Acorus Calamus, 28.57 g of Pogostemon Cablin, and 46.43 g of Fructus Forsythiae respectively, add 8 times the amount of water, and boil for 3 hours. Collect the volatile oil through an oil-water separator to obtain 3.5 ml of volatile oil and 285 ml of aromatic water; add 6 times the amount of water to the residue and boil for 1 hour and 20 minutes, collect the filtrate by filtration, combine the filtrates, and discard the residue.

[0111] (2) The combined filtrate is concentrated in vacuo at a temperature below 65°C to a relative density of 1.12 (measured hot at 60°C), cooled to room temperature, and 85% ethanol is slowly added while stirring to a concentration of 70±2% ethanol. The mixture is allowed to stand for 24 hours, filtered, and the supernatant is taken to recover ethanol and concentrated to a relative density of 1.09 (measured at 20°C) to obtain an antiviral concentrate for later use.

[0112] (3) Take 15 g of hydroxypropyl-β-cyclodextrin and prepare a saturated aqueous solution, add 2 ml of volatile oil dehydrated with anhydrous sodium sulfate, control the temperature at 40-60° C. and stir for 5 hours at a stirring speed of 300 r / min to obtain a hydroxypropyl-β-cyclodextrin inclusion solution.

[0113] (4) At a temperature of 65°C, take 300 ml of the antiviral concentrate and filter it, then add 100 g of honey, 125 g of sucrose, and 12.5 g of hydroxypropyl-β-cyclodextrin inclusion complex. The pH of the mixed solution is 3.5. The solution is then cooled to 25°C, and the pH of the solution is adjusted to 5.8 using a 6.0 mol / L sodium hydroxide solution. The solution is filtered until clear, and water is added to make the volume to 1000 ml. The fixed volume solution is filtered and sterilized.

[0114] Comparative Example 2

[0115] This comparative example provides an antiviral oral liquid.

[0116] The specific preparation process of the antiviral oral liquid in this comparative example is different from that in Example 1 in that the specific steps for adjusting the pH value during the cooling of the liquid are different, as shown below.

[0117] Among them, the specific steps of adjusting the pH value during the cooling of the liquid medicine are:

[0118] The equipment used is as follows Figure 1 As shown, the step of cooling the liquid medicine is to adopt a step-by-step double-circulation cooling method; the step of adjusting the pH value is to use the circular sprinkler device on the upper part of the preparation tank to evenly spray the alkali solution into the liquid medicine;

[0119] When the temperature of the liquid medicine was lowered to 50°C, the temperature reduction rate was controlled at 5°C / min, and the pH value of the liquid medicine was adjusted to 4.5 using 8.0 mol / L sodium hydroxide solution;

[0120] When the temperature of the liquid medicine was cooled to 30°C, the cooling rate was controlled at 1°C / min, and the pH value of the liquid medicine was adjusted to 5.2 using 6.0 mol / L sodium hydroxide solution;

[0121] When the temperature of the drug solution was cooled to 25°C, the cooling rate was controlled at 1°C / min, and the pH value of the drug solution was adjusted to 5.8 using 6.0 mol / L sodium hydroxide solution.

[0122] The specific preparation process of the antiviral oral liquid in this comparative example is the same as the remaining steps of Example 1.

[0123] Performance testing

[0124] Stability test method: The antiviral oral liquid samples were placed in a constant temperature and humidity chamber at the same time, and the temperature was controlled at 40±2°C and the relative humidity was controlled at 75±5%. The pH and forsythiaside content of the antiviral oral liquid were tested at 0, 3, and 6 months.

[0125] The specific method for detecting the content of Forsythiaside is as follows: refer to the Forsythiaside quality detection standard in Part 1 of the 2020 edition of the "Chinese Pharmacopoeia", use the HPLC detection method, use octadecylsilane bonded silica gel as the filler; use acetonitrile-water solution with a volume ratio of 25:75 as the mobile phase; and the detection wavelength is 277nm.

[0126] Test results: as shown in Table 1.

[0127] Table 1 Performance test results of antiviral oral liquid in Examples 1-10 and Comparative Examples 1-2

[0128]

[0129] Combined with Table 1, by comparing the test results of Examples 1-10 with those of Comparative Examples 1-2, in the process of preparing the antiviral oral liquid, the present application simultaneously adjusts the pH during the cooling process after adding the auxiliary materials, and by reasonably controlling the concentration of the alkali solution, the prepared antiviral oral liquid can be placed at 40°C for 6 months to effectively keep the solution clear and stably maintain the pH value, while also ensuring the stability of the forsythin content, solving the problems existing in the existing products and achieving unexpected results.

[0130] Although the present invention has been described in detail above with general descriptions and specific embodiments, it is obvious to those skilled in the art that some modifications or improvements may be made thereto based on the present invention. Therefore, these modifications or improvements made without departing from the spirit of the present invention all fall within the scope of protection claimed by the present invention.

Claims

1. A method for preparing an antiviral oral liquid, characterized in that: Specifically, the following steps are included: The raw medicinal materials are boiled with water, the filtrates are combined, concentrated, and the auxiliary materials are added and mixed; the pH value is adjusted during the cooling of the medicinal solution, and then filtered to clarify, water is added to the fixed volume, filtered, and sterilized to obtain the product; The specific steps of adjusting the pH value during the cooling of the liquid medicine are as follows: When the temperature of the liquid medicine is lowered to 50-60°C, the pH value of the liquid medicine is adjusted to 4.0-5.0 using a 5.0-7.5 mol / L sodium hydroxide solution; While the temperature of the liquid continues to drop to 20-50°C, the pH of the liquid is adjusted to 5.5-6.0 using a 1.0-5.0 mol / L sodium hydroxide solution; The raw medicinal materials are composed of the following components in parts by weight: 126-130 parts of isatis root, 55-59g parts of gypsum, 58-62 parts of rehmannia root, 30-34 parts of rehmannia root, 23-27 parts of curcuma, 23-27 parts of anemarrhena, 23-27 parts of calamus, 26-30 parts of patchouli, and 44-49 parts of forsythia.

2. The method for preparing the antiviral oral liquid according to claim 1, characterized in that: The specific steps of adjusting the pH value during the cooling process are: When the temperature of the liquid medicine is lowered to 50-60°C, the pH value of the liquid medicine is adjusted to 4.0-5.0 using a 5.0-7.5 mol / L sodium hydroxide solution; While the temperature of the liquid continues to drop to 30-50°C, the pH of the liquid is adjusted to 5.0-5.5 using a 2.5-5.0 mol / L sodium hydroxide solution; While the temperature of the liquid medicine continues to drop to 20-30°C, the pH value of the liquid medicine is adjusted to 5.5-6.0 using 1.0-2.5 mol / L sodium hydroxide solution.

3. The method for preparing the antiviral oral liquid according to claim 2, characterized in that: The specific steps of adjusting the pH value during the cooling process are: When the temperature of the liquid medicine is lowered to 50-60°C, the pH value of the liquid medicine is adjusted to 4.0-5.0 using a 5.5-6.5 mol / L sodium hydroxide solution; While the temperature of the liquid continues to drop to 30-50°C, the pH of the liquid is adjusted to 5.0-5.5 using a 3.5-4.5 mol / L sodium hydroxide solution; While the temperature of the liquid medicine continues to drop to 20-30°C, the pH value of the liquid medicine is adjusted to 5.5-6.0 using 1.5-2.5 mol / L sodium hydroxide solution.

4. The method for preparing the antiviral oral liquid according to claim 1, characterized in that: The step of cooling the liquid medicine is carried out by adopting a stepped double-circulation cooling method; the step of adjusting the pH value is to use a circular sprinkler device on the upper part of the preparation tank to evenly spray the alkali solution into the liquid medicine.

5. The method for preparing the antiviral oral liquid according to claim 1, characterized in that: The temperature of the drug solution is cooled to 50-60°C at a rate of 2-8°C / min.

6. The method for preparing the antiviral oral liquid according to claim 1, characterized in that: The temperature of the drug solution is cooled to 20-50°C at a rate of 0.5-2°C / min.

7. The method for preparing the antiviral oral liquid according to claim 1, characterized in that: During the process of adding the auxiliary materials, the temperature of the drug solution is 60-100° C., and the pH value of the drug solution is 3.0-4.

0.

8. The method for preparing the antiviral oral liquid according to claim 7, characterized in that: After the step of adding auxiliary materials, the temperature of the drug solution is 60-70° C., and the pH value of the drug solution is 3.0-4.

0.

9. An antiviral oral liquid, characterized in that: The antiviral oral liquid is prepared by the preparation method of any one of claims 1 to 8.

Citation Information

Patent Citations

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    CN102940856A

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