Oral liquid containing ambroxol hydrochloride and application thereof
By preparing oral liquid containing ambroxol hydrochloride and ligustrazine ligustrazine, the problem of lack of combined use reports in the prior art was solved, and significant therapeutic effect and stability improvement were achieved.
Patent Information
- Application Number
- CN202510288219.4
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Filing Date
- 2025-03-12
- Publication Date
- 2025-06-06
AI Technical Summary
There is a lack of reports on the use of ambroxol hydrochloride and ligustrazine in the prior art for oral treatment of expectorant.
By preparing an oral solution containing components such as ambroxol hydrochloride, ligustrazine and stabilizers, using megluminescent and dextran 40 as stabilizers, L-tryptophan is added to improve stability and taste.
The therapeutic effect of the drug is significantly enhanced, and the respiratory function is improved through the synergistic effect of ambroxol hydrochloride and ligustrazine, and the quality and stability of oral fluid are improved through preferred stabilizers and ingredients.
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Figure CN120093685A_ABST
Abstract
Description
Technical Field
[0001] The invention belongs to the technical field of pharmaceutical preparations, and in particular relates to an oral liquid containing ambroxol hydrochloride and a use thereof. Background Art
[0002] The chemical name of ambroxol hydrochloride is (R, S)-3-bromo-2-hydroxy-N, N-dimethylpropylenediamine hydrochloride. It is a white to off-white crystalline powder, sometimes light yellow. The structural formula is as follows:
[0003]
[0004] Ambroxol hydrochloride is a known active metabolite, which is widely used in the clinic for the adjuvant treatment of acute and chronic bronchitis with abnormal respiratory secretion, bronchial asthma, neonatal respiratory distress syndrome and lung surgery, and has the advantages of low toxicity and definite efficacy. Ambroxol hydrochloride is a very classic and commonly used expectorant in clinical practice. Currently, 16 dosage forms have been approved, including tablets, sustained-release tablets, dispersible tablets, effervescent tablets, chewable tablets, orally disintegrating tablets, capsules, sustained-release capsules, granules, oral solutions, syrups, solutions for inhalation, injections, powder for injection, sodium chloride injection, and glucose injection.
[0005] Ligustrazine is an organic compound with the chemical formula C8H13ClN2. It is a vasodilator used for occlusive cerebrovascular diseases, such as cerebral insufficiency, cerebral thrombosis, cerebral embolism and other ischemic vascular diseases such as coronary heart disease and vasculitis. This product is a white or off-white crystalline powder. This product is easily soluble in water and soluble in ethanol and chloroform. The structural formula is as follows:
[0006]
[0007] There are currently no reports on the combined use of ambroxol hydrochloride and ligustrazine for oral treatment of expectoration. Summary of the invention
[0008] To overcome the deficiencies of the prior art, the present invention provides an oral ambroxol hydrochloride solution with high content, good taste and high stability and a use thereof.
[0009] Specifically, the technical solution of the present invention is as follows:
[0010] An ambroxol hydrochloride oral solution is composed of 3 parts of ambroxol hydrochloride, 0.5-1.7 parts of ligustrazine, 3-11.5 parts of a stabilizer, 10-21 parts of xylitol, 1-5 parts of carboxymethyl cellulose, 1.5-4.5 parts of L-tryptophan, 0.2-0.5 parts of stevioside and an appropriate amount of purified water by weight ratio; the preparation of the ambroxol hydrochloride oral solution comprises the following steps:
[0011] 1) adding a stabilizer to purified water and heating it, adding ambroxol hydrochloride and ligustrazine, and stirring until dissolved;
[0012] 2) adding xylitol, stevioside and L-tryptophan, heating and stirring to dissolve, keeping warm, and cooling;
[0013] 3) Add carboxymethyl cellulose, stir to dissolve, dilute to 1000 mL, adjust pH value, stir evenly; fill to obtain ambroxol hydrochloride oral solution.
[0014] Furthermore, the ambroxol hydrochloride oral solution of the present invention is composed of 3 parts of ambroxol hydrochloride, 1.1 parts of ligustrazine, 8 parts of stabilizer, 15 parts of xylitol, 3 parts of carboxymethyl cellulose, 3 parts of L-tryptophan, 0.35 parts of stevioside and an appropriate amount of purified water.
[0015] Furthermore, in a preferred embodiment of the present invention, the stabilizers are meglumine and dextran 40.
[0016] Furthermore, calculated by weight ratio, meglumine: dextran 40 = 5-20: 1-3, and more preferably meglumine: dextran 40 = 12.5:2.
[0017] Furthermore, the ambroxol hydrochloride oral solution is composed of 3 parts of ambroxol hydrochloride, 0.5-1.7 parts of ligustrazine, 0.5-1.5 parts of dextran 40, 2.5-10 parts of meglumine, 10-21 parts of xylitol, 1-5 parts of carboxymethyl cellulose, 1.5-4.5 parts of L-tryptophan, 0.2-0.5 parts of stevioside and an appropriate amount of purified water.
[0018] Furthermore, the ambroxol hydrochloride oral solution is composed of 3 parts of ambroxol hydrochloride, 1.1 parts of ligustrazine, 401 parts of dextran, 7 parts of meglumine, 15 parts of xylitol, 3 parts of carboxymethyl cellulose, 3 parts of L-tryptophan, 0.35 parts of stevioside and an appropriate amount of purified water.
[0019] Further, the method of the ambroxol hydrochloride oral solution comprises the following steps:
[0020] 1) Add meglumine and dextran 40 to purified water and heat to 75-85°C, add ambroxol hydrochloride and ligustrazine, and stir until dissolved;
[0021] 2) adding xylitol, stevioside and L-tryptophan to step 1) and stirring to dissolve, keeping at 60-70° C. for 0.5-1.5 h, and then cooling to 42-52° C.;
[0022] 3) Add carboxymethyl cellulose, stir to dissolve, cool to room temperature, adjust pH value with a regulator after volume adjustment, stir evenly; fill to obtain ambroxol hydrochloride oral solution.
[0023] Furthermore, in a preferred embodiment of the present invention, the pH value of step 3) is 5.5-6.5.
[0024] The regulator in step 3) is one or more of citric acid, ferulic acid or glutamic acid; preferably, the regulator is citric acid.
[0025] Further, the method of the ambroxol hydrochloride oral solution comprises the following steps:
[0026] 1) Add meglumine and dextran 40 to purified water and heat to 80°C, add ambroxol hydrochloride and ligustrazine, and stir until dissolved;
[0027] 2) adding xylitol, stevioside and L-tryptophan to step 1) and stirring to dissolve, keeping at 65° C. for 0.5-1.5 h, and then cooling to 42-52° C.;
[0028] 3) Add carboxymethyl cellulose, stir to dissolve, and then cool to room temperature. After diluting to volume, add citric acid to adjust the pH value to 6.0, stir evenly, and fill to obtain ambroxol hydrochloride oral solution.
[0029] Compared with the prior art, the present invention has achieved unexpected technical effects:
[0030] 1) The present invention uses ambroxol hydrochloride and ligustrazine in combination, and the synergistic effect of the two significantly enhances the therapeutic effect of the drug. Ambroxol hydrochloride is a mucolytic agent that can promote the discharge of respiratory mucus and relieve cough symptoms; ligustrazine has anti-inflammatory, antioxidant and microcirculation-improving effects, can reduce respiratory inflammation and promote tissue repair.
[0031] 2) The present invention uses meglumine and dextran 40 as stabilizers, which significantly improves the quality and stability of the oral solution. Meglumine can enhance the solubility and stability of the drug, and dextran 40 forms a protective layer through its polymer properties to prevent the degradation of the drug components.
[0032] 3) The present invention further adds L-tryptophan oxidant component to the oral liquid, and through its antioxidant effect, effectively prevents the drug components from oxidative degradation during storage, thereby further improving the stability of the product, which is suitable for further industrial large-scale production. BRIEF DESCRIPTION OF THE DRAWINGS
[0033] Figure 1 : Comparative analysis of the respiratory rates of the relevant embodiments of the present invention in the pharmacological experiments; a: the respiratory rate of the model group was significantly higher than that of the normal group (P < 0.05); b: the respiratory rate of the embodiment 1-3 groups was better than that of the model group (P < 0.05); there was no significant difference between the comparative example 1 group and the model group (P > 0.05).
[0034] Figure 2 : Comparative analysis of ventilation volume of the relevant embodiments of the present invention in pharmacological experiments; a: the ventilation volume of the model group was significantly lower than that of the normal group (P < 0.05); b: the ventilation volume of the embodiment 1-3 group was better than that of the model group (P < 0.05); c: the difference between the comparative example 1 group and the model group was statistically significant (P < 0.05); d: the difference between the ventilation volume of the embodiment 1-3 group and the comparative example 1 group was statistically significant (P < 0.05).
[0035] Figure 3 : Comparative analysis of tidal volume in relevant embodiments of the present invention in pharmacological experiments; a: the tidal volume of the model group was significantly lower than that of the normal group (P < 0.05); b: the tidal volume of the embodiments 1-3 groups was better than that of the model group (P < 0.05); c: the difference between the comparative example 1 group and the model group was statistically significant (P < 0.05); d: the tidal volume of the embodiment 3 group was statistically significant compared with the comparative example 1 group (P < 0.05).
[0036] Figure 4 : The pH value of the relevant embodiment of the present invention is detected, and the detection is carried out at the 0th month, the 1st month, the 2nd month, the 3rd month, and the 6th month. Figure 5 : Detection of total impurity content in the relevant embodiments of the present invention, and detection at the 0th month, 1st month, 2nd month, 3rd month, and 6th month. DETAILED DESCRIPTION
[0037] The above are only preferred embodiments of the present invention and are not intended to limit the present invention. Although the present invention has been described in detail with reference to the aforementioned embodiments, those skilled in the art can still modify the technical solutions described in the aforementioned embodiments or replace some of the technical features therein by equivalents. Any modification, equivalent replacement, improvement, etc. made within the spirit and principle of the present invention shall be included in the protection scope of the present invention.
[0038] Embodiment 1: an oral solution containing ambroxol hydrochloride, specifically as follows:
[0039]
[0040] The preparation process is as follows:
[0041] 1) Add meglumine and dextran 40 to purified water and heat to 75°C, add ambroxol hydrochloride and ligustrazine, and stir until dissolved;
[0042] 2) adding xylitol, stevioside and L-tryptophan to step 1) and stirring to dissolve, keeping at 60° C. for 1.5 h, and then cooling to 42° C.;
[0043] 3) Add carboxymethyl cellulose, stir to dissolve, cool to room temperature, dilute to 1000 mL, adjust pH to 5.5 with glutamic acid, stir evenly; fill to obtain ambroxol hydrochloride oral solution.
[0044] Embodiment 2: an oral solution containing ambroxol hydrochloride, specifically as follows:
[0045]
[0046] The preparation process is as follows:
[0047] 1) Add meglumine and dextran 40 to purified water and heat to 85°C, add ambroxol hydrochloride and ligustrazine, and stir until dissolved;
[0048] 2) adding xylitol, stevioside and L-tryptophan to step 1) and stirring to dissolve, keeping at 70° C. for 0.5 h, and then cooling to 52° C.;
[0049] 3) Add carboxymethyl cellulose, stir to dissolve, cool to room temperature, dilute to 1000 mL, adjust pH to 6.5 with ferulic acid, stir evenly; fill to obtain ambroxol hydrochloride oral solution.
[0050] Embodiment 3: An oral solution containing ambroxol hydrochloride, specifically as follows:
[0051]
[0052]
[0053] The preparation process is as follows:
[0054] 1) Add meglumine and dextran 40 to purified water and heat to 80°C, add ambroxol hydrochloride and ligustrazine, and stir until dissolved;
[0055] 2) adding xylitol, stevioside and L-tryptophan to step 1) and stirring to dissolve, keeping at 65° C. for 0.5-1.5 h, and then cooling to 42-52° C.;
[0056] 3) Add carboxymethyl cellulose, stir to dissolve, cool to room temperature, dilute to 1000 mL, adjust pH to 6.0 with citric acid, stir evenly, and fill to obtain ambroxol hydrochloride oral solution.
[0057] Comparative Example 1: An oral solution containing ambroxol hydrochloride, specifically as follows:
[0058]
[0059] The preparation process is the same as that of Example 3.
[0060] Comparative Example 2: An oral solution containing ambroxol hydrochloride, specifically as follows:
[0061]
[0062] The preparation process is the same as that of Example 3.
[0063] Comparative Example 3: An oral solution containing ambroxol hydrochloride, specifically as follows:
[0064]
[0065] The preparation process is the same as that of Example 3.
[0066] Comparative Example 4: An oral solution containing ambroxol hydrochloride, specifically as follows:
[0067]
[0068] The preparation process is the same as that of Example 3.
[0069] Comparative Example 5: An oral solution containing ambroxol hydrochloride, specifically as follows:
[0070]
[0071] The preparation process is the same as that of Example 3.
[0072] Comparative Example 6: An oral solution containing ambroxol hydrochloride, specifically as follows:
[0073]
[0074] The preparation process is the same as that of Example 3.
[0075] Comparative Example 7: An oral solution containing ambroxol hydrochloride, specifically as follows:
[0076]
[0077] The preparation process is as follows: add meglumine, dextran 40, xylitol, stevioside and L-tryptophan into purified water, heat it to 50°C, add ambroxol hydrochloride and ligustrazine, and stir until dissolved; add carboxymethyl cellulose, stir and dissolve, then cool to room temperature, dilute to 1000 mL, adjust the pH value to 6.0 with hydrochloric acid, and stir evenly; fill to obtain ambroxol hydrochloride oral solution.
[0078] 1. Investigation of the effect of combined use of ambroxol hydrochloride and ligustrazine
[0079] 1.1 Establishment of lipopolysaccharide (LPS)-induced acute lung injury (ALI) rat model
[0080] After 7 days of conventional feeding, the rats were randomly divided into a normal group, a model group, an example 1 group, an example 2 group, an example 3 group, and a comparative example 1 group. Except for the normal group, 5 mg / kg of LPS was injected into the tail vein of the other groups to construct an ALI model, with an injection dose of 0.5 mL, and the normal group was given an equal volume of normal saline; after the rat model was completed, 75.5 mg / kg was administered orally to the experimental group every day for 28 consecutive days, and the normal group and the model group were given an equal amount of normal saline. After completion, the rats were free to eat without restriction.
[0081] 1.2 Detection indicators
[0082] Testing the respiratory function of each group: On the second day after the end of drug administration, the tidal volume, respiratory rate and minute ventilation were measured using an animal pulmonary function tester in the coma and awake states of the rats in a specific recording box.
[0083] 1.3 Statistical analysis
[0084] GraphPad Prism software was used to analyze the data. P<0.05 was considered statistically significant.
[0085] 1.4 Results
[0086] From the data, it can be seen that the respiratory rate of the model group increased significantly, while the ventilation and tidal volume decreased significantly, indicating that the model group had abnormal respiratory function. The respiratory rate, ventilation and tidal volume of the Example 1-3 group were better than those of the model group and close to those of the normal group, indicating that Examples 1-3 had a significant improvement on respiratory function.
[0087] Figure 1 : a: The respiratory rate of the model group was significantly higher than that of the normal group (P < 0.05); b: The respiratory rate of the Example 1-3 group was better than that of the model group (P < 0.05); There was no significant difference between the comparative example 1 group and the model group (P > 0.05).
[0088] Figure 2 : a: The ventilation volume of the model group was significantly lower than that of the normal group (P < 0.05); b: The ventilation volume of the Example 1-3 group was better than that of the model group (P < 0.05); c: The difference between the comparative example 1 group and the model group was statistically significant (P < 0.05); d: The difference between the ventilation volume of the Example 1-3 group and the comparative example 1 group was statistically significant (P < 0.05).
[0089] Figure 3: a: The tidal volume of the model group was significantly lower than that of the normal group (P < 0.05); b: The tidal volume of the Example 1-3 groups was better than that of the model group (P < 0.05); c: The difference between the comparative example 1 group and the model group was statistically significant (P < 0.05); d: The tidal volume of the Example 3 group was statistically significant compared with that of the comparative example 1 group (P < 0.05).
[0090] In summary, comparative example 1 does not add ligustrazine, resulting in the lack of its anti-inflammatory and microcirculation improving effects, so its respiratory function improvement effects are not as good as those of examples 1-3.
[0091] 2. Physical properties of oral liquid prepared in the embodiment of the invention
[0092] 2.1 pH value detection
[0093] Take 5 mL of the solution of Example 3 and Comparative Examples 2-7, add water to 20 mL and measure according to the law (General Rule 0631), and test under accelerated experimental conditions (test at the 0th month, 1st month, 2nd month, 3rd month, and 6th month under the conditions of temperature 40°C ± 2°C and relative humidity 75% ± 5%). See details Figure 4 .
[0094] Figure 4 :It can be seen that in Example 3, the pH value slowly dropped from 6.0 to 5.7, with a small range of change, indicating that its stability is good. Comparative Examples 2-7: The pH value dropped significantly from 6.0 to 4.5-5.3, with a large range of change, indicating that its stability is poor. Example 3 significantly improved the stability of the preparation through reasonable formula design (addition of ligustrazine, dextran 40, and L-tryptophan) and process optimization (control of temperature and pH value), and the pH value changed slightly. The inventor believes that it may be that Example 3 uses citric acid to adjust the pH value, which has good buffering capacity and can effectively maintain the stability of the pH value. However, due to improper selection of excipients or process defects, Comparative Examples 2-7 resulted in decreased drug stability and a significantly reduced pH value. This shows that the formula design of Example 3 has a significant synergistic effect and can effectively maintain the stability of the pH value of the preparation.
[0095] 2.2.2 Comparison of clarity and color See Table 1 for details
[0096] Table 1 Comparison of clarity and color of each embodiment
[0097]
[0098]
[0099]
[0100] Examples 1-3 are significantly better than Comparative Examples 2-7 in terms of stability. It can be seen from Table 1 that the differences in the main formulation design and process optimization lead to turbidity, discoloration and visible foreign matter. This shows that the formulation design of Examples 1-3 has a significant synergistic effect and can effectively improve the stability of the preparation.
[0101] 2.2 [Related substances] According to the high performance liquid chromatography method in accordance with the Chinese Pharmacopoeia 2020 edition (General Chapter 0512)
[0102] Mobile phase: 0.01 mol / L diammonium hydrogen phosphate solution (pH adjusted to 7.0 with phosphoric acid)-acetonitrile (50:50).
[0103] Test solution: Take an appropriate amount of the product, dissolve it in the mobile phase and dilute it to make a solution containing about 1 mg per 1 mL.
[0104] Control solution: Accurately measure 1 mL of the test solution, place it in a 100 mL volumetric flask, dilute to the mark with mobile phase, and shake well.
[0105] System suitability: Solution: Take about 5 mg of ambroxol hydrochloride, add 0.2 mL of methanol to dissolve, then add 40 μl of formaldehyde solution (1→100), shake well, heat in a 60°C water bath for 5 minutes, and blow dry with nitrogen. Dissolve the residue in 5 mL of water, dilute to 20 mL with mobile phase, and shake well.
[0106] Chromatographic conditions: octadecylsilane bonded silica gel was used as filler; 0.01 mol / L diammonium hydrogen phosphate solution (pH adjusted to 7.0 with phosphoric acid)-acetonitrile (50:50) was used as mobile phase; detection wavelength was 248 nm; injection volume was 20 mL.
[0107] System suitability requirements: In the system suitability solution chromatogram, the separation between the ambroxol peak and the impurity I peak (relative retention time of approximately 0.8) should be greater than 4.0.
[0108] Determination method: Accurately measure the test solution and the control solution, inject them into the liquid chromatograph respectively, and record the chromatogram to twice the retention time of the main component peak. Limit: If there are impurity peaks in the chromatogram of the test solution, the sum of the areas of the impurity peaks shall not be greater than 0.3 times (0.3%) the main peak area of the control solution.
[0109] For specific results, see Figure 5: As can be seen from Table 1, the impurity content of Comparative Example 1 (without ligustrazine) is relatively high. Comparative Example 2 (polyethylene glycol 400 replaces dextran 40) The inventor believes that polyethylene glycol 400 may not provide the same stabilizing effect as dextran 40, resulting in a higher impurity content. The poloxamer in Comparative Example 3 (poloxamer replaces meglumine) may have poor compatibility with other ingredients, resulting in decreased drug stability. The L-cysteine in Comparative Example 4 (L-cysteine replaces L-tryptophan) may not be as stable as L-tryptophan, or may promote drug degradation under certain conditions. The excessive or low dosage of dextran 40 in Comparative Examples 5-6 (excess or insufficient dextran 40) may affect drug stability and increase impurity content.
[0110] The low temperature (50°C) in Comparative Example 7 (low temperature preparation process) may lead to insufficient dissolution of the drug ingredients, affecting stability and resulting in a high impurity content. In summary, Examples 1-3 are superior to Comparative Examples 1-7 in terms of the content of related substances and appearance, mainly due to reasonable formula design (the addition of ligustrazine, dextran 40, and L-tryptophan) and process optimization (control of temperature and pH value). In the comparative examples, due to improper selection of excipients or process defects, the drug stability decreased and the impurity content increased.
Claims
1. An ambroxol hydrochloride oral solution, characterized in that, Calculated by weight ratio, the ambroxol hydrochloride oral solution is composed of 3 parts of ambroxol hydrochloride, 0.5-1.7 parts of ligustrazine, 3-11.5 parts of stabilizer, 10-21 parts of xylitol, 1-5 parts of carboxymethyl cellulose, 1.5-4.5 parts of L-tryptophan, 0.2-0.5 parts of stevioside and an appropriate amount of purified water; the preparation of the ambroxol hydrochloride oral solution comprises the following steps: 1) adding a stabilizer to purified water and heating it, adding ambroxol hydrochloride and ligustrazine, and stirring until dissolved; 2) adding xylitol, stevioside and L-tryptophan, heating and stirring to dissolve, keeping warm, and cooling; 3) Add carboxymethyl cellulose, stir to dissolve, dilute to 1000 mL, adjust pH value, stir evenly; fill to obtain ambroxol hydrochloride oral solution.
2. Ambroxol hydrochloride oral solution according to claim 1, characterized in that, The ambroxol hydrochloride oral solution is composed of 3 parts of ambroxol hydrochloride, 1.1 parts of ligustrazine, 8 parts of stabilizer, 15 parts of xylitol, 3 parts of carboxymethyl cellulose, 3 parts of L-tryptophan, 0.35 parts of stevioside and an appropriate amount of purified water.
3. The ambroxol hydrochloride oral solution according to any one of claims 1-2, characterized in that The stabilizers are meglumine and dextran 40.
4. Ambroxol hydrochloride oral solution according to claim 3, characterized in that, Calculated by weight ratio, meglumine: dextran 40 = 5-20: 1-3, and more preferably meglumine: dextran 40 = 12.5:
2.
5. The ambroxol hydrochloride oral solution according to claim 3, characterized in that The ambroxol hydrochloride oral solution is composed of 3 parts of ambroxol hydrochloride, 0.5-1.7 parts of ligustrazine, 0.5-1.5 parts of dextran 40, 2.5-10 parts of meglumine, 10-21 parts of xylitol, 1-5 parts of carboxymethyl cellulose, 1.5-4.5 parts of L-tryptophan, 0.2-0.5 parts of stevioside and an appropriate amount of purified water.
6. The ambroxol hydrochloride oral solution according to claim 5, characterized in that The ambroxol hydrochloride oral solution is composed of 3 parts of ambroxol hydrochloride, 1.1 parts of ligustrazine, 1 part of dextran 40, 7 parts of meglumine, 15 parts of xylitol, 3 parts of carboxymethyl cellulose, 3 parts of L-tryptophan, 0.35 parts of stevioside and an appropriate amount of purified water.
7. A method for preparing the ambroxol hydrochloride oral solution according to any one of claims 1 to 6, characterized in that: The method comprises the following steps: 1) Add meglumine and dextran 40 to purified water and heat to 75-85°C, add ambroxol hydrochloride and ligustrazine, and stir until dissolved; 2) adding xylitol, stevioside and L-tryptophan to step 1) and stirring to dissolve, keeping at 60-70° C. for 0.5-1.5 h, and then cooling to 42-52° C.; 3) Add carboxymethyl cellulose, stir to dissolve, cool to room temperature, adjust pH value with a regulator after volume adjustment, stir evenly; fill to obtain ambroxol hydrochloride oral solution.
8. The method according to claim 7, characterized in that The pH value of step 3) is 5.5-6.
5.
9. The method according to claim 7, characterized in that: The regulator in step 3) is one or more of citric acid, ferulic acid or glutamic acid; preferably, the regulator is citric acid.
10. The method according to claim 7, characterized in that The method comprises the following steps: 1) Add meglumine and dextran 40 to purified water and heat to 80°C, add ambroxol hydrochloride and ligustrazine, and stir until dissolved; 2) adding xylitol, stevioside and L-tryptophan to step 1) and stirring to dissolve, keeping at 65° C. for 0.5-1.5 h, and then cooling to 42-52° C.; 3) Add carboxymethyl cellulose, stir to dissolve, and then cool to room temperature. After diluting to volume, add citric acid to adjust the pH value to 6.0, stir evenly, and fill to obtain ambroxol hydrochloride oral solution.