A cough relieving and phlegm expelling medicine and its preparation method

Abstract

The present application provides a kind of antitussive and expectorant medicine, by adding flurbiprofen to traditional strong loquat, in addition to the anti-inflammatory effect of flurbiprofen, it can also significantly improve the antitussive and expectorant efficacy of traditional strong loquat; Patients do not need to take other expectorant drugs at the same time, such as ambroxol, etc., improve the compliance of cough and phlegm patients for drugs, and show obvious advantages in clinic.

Description

Technical Field

[0001] This invention belongs to the field of pharmaceutical preparations, specifically relating to an antitussive and expectorant drug and its preparation method. Background Technology

[0002] Coughing with phlegm is one of the most common symptoms of respiratory illnesses. Colds, bronchitis, pneumonia, asthma, postnasal drip, smoking, environmental pollution, heart disease, or medication side effects can all cause varying degrees of coughing with phlegm. Bronchitis is one of the most common respiratory diseases, usually caused by infection (viral or bacterial) or irritants (such as smoking or pollutants). Bronchitis can be acute or chronic. While it doesn't directly cause pain, the main symptom is coughing, and a persistent or severe cough may trigger chest pain or a sore throat.

[0003] Flurbiprofen is a nonsteroidal anti-inflammatory drug (NSAID) primarily used to treat rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, post-traumatic pain, and other types of pain. It is effective orally, well-tolerated, and does not promote or inhibit metabolism with long-term use. Flurbiprofen exerts its anti-inflammatory and analgesic effects by inhibiting the activity of prostaglandin synthase cyclooxygenase. Flurbiprofen oral spray is a localized form of the drug, mainly used to relieve inflammation and pain in the throat. It works by directly targeting the inflamed tissues in the throat, quickly relieving symptoms, and is commonly used for pharyngitis or other conditions related to throat pain.

[0004] Strong loquat syrup is a traditional Chinese medicine preparation listed in the pharmacopoeia, possessing the effects of moisturizing the lungs, relieving cough, clearing heat, and detoxifying. CN100500126C discloses a sugar-free version of strong loquat syrup, which replaces the sucrose in traditional strong loquat syrup with a natural flavoring agent to meet the cough treatment needs of diabetic patients. CN106620452A discloses an optimized preparation method for strong loquat syrup to improve the product's taste and increase patient compliance. However, none of these improvements to strong loquat syrup have demonstrated an enhanced cough-suppressing and expectorant effect. With the continuous mutation of viruses and the increasing resistance of bacteria to drugs, the cough-suppressing and expectorant effects of strong loquat syrup have reached a bottleneck, even leading to a situation where the cough worsens and becomes more painful, causing a sharp, stabbing sensation in the throat.

[0005] In reality, for symptoms of cough with phlegm, it is generally necessary to take cough medicine and expectorant at the same time. For more severe cough with phlegm of unknown cause, it may even be necessary to take anti-inflammatory drugs at the same time. This undoubtedly increases the burden of medication for patients, especially young patients, and often leads to problems such as difficulty in taking medication, incorrect dosage, and thus greatly reduced efficacy.

[0006] Therefore, new requirements have been put forward for antitussive and expectorant drugs in clinical practice. It is necessary and urgent to explore a quality-stable antitussive and expectorant drug with stronger antitussive and expectorant effects and better patient compliance. Summary of the Invention

[0007] To overcome the problems of the prior art, the present invention provides an antitussive and expectorant drug that has a stronger antitussive and expectorant effect than traditional strong loquat syrup; moreover, the preparation method of the antitussive and expectorant drug of the present invention is simple and suitable for industrial production.

[0008] To achieve the above objectives, the present invention adopts the following solution:

[0009] An antitussive and expectorant drug, comprising loquat leaf, poppy shell, stemona root, cynanchum root, mulberry bark, platycodon root, menthol, flavoring agent, preservative, flurbiprofen, and purified water.

[0010] In a specific embodiment of the present invention, the antitussive and expectorant drug is a preparation composed of the following raw materials in parts by weight: 67-71 parts loquat leaves, 48-52 parts poppy shells, 14-16 parts stemona root, 8-10 parts cynanchum paniculatum, 5-7 parts mulberry bark, 5-7 parts platycodon root, 0.1-0.2 parts menthol, 0.5-2 parts flavoring agent, 2-4 parts preservative, 1.5-3 parts flurbiprofen, and an appropriate amount of purified water.

[0011] The antitussive and expectorant of the present invention, wherein the flavoring agent is selected from one or more of sucrose, sucralose, xylitol, and steviol glycosides; preferably, the flavoring agent is selected from one or more of sucralose, xylitol, and steviol glycosides.

[0012] The antitussive and expectorant of the present invention uses a preservative selected from one or more of sodium benzoate, benzoic acid, and citric acid.

[0013] The antitussive and expectorant of the present invention further comprises a solubilizer; further, the solubilizer is selected from one or more of ethanol, propylene glycol, and polysorbate 80.

[0014] In a specific embodiment of the present invention, the antitussive and expectorant drug is a preparation composed of the following raw materials in parts by weight: 67-71 parts loquat leaves, 48-52 parts poppy shells, 14-16 parts stemona root, 8-10 parts cynanchum paniculatum, 5-7 parts mulberry bark, 5-7 parts platycodon root, 0.1-0.2 parts menthol, 0.5-2 parts flavoring agent, 2-4 parts preservative, 4-6 parts solubilizer, 1.5-3 parts flurbiprofen, and an appropriate amount of purified water.

[0015] In a specific embodiment of the present invention, the antitussive and expectorant drug is a preparation composed of the following raw materials in the indicated weight ratios: 69.0 parts loquat leaf, 50.0 parts poppy shell, 15.0 parts stemona root, 9.0 parts cynanchum paniculatum, 6.0 parts mulberry bark, 6.0 parts platycodon root, 0.15 parts menthol, 1.0 part flavoring agent, 3 parts preservative, 5.0 parts solubilizer, 2.5 parts flurbiprofen, and an appropriate amount of purified water.

[0016] Furthermore, the flavoring agent is selected from one or more of sucrose, sucralose, xylitol, and steviol glycosides; the preservative is selected from one or more of sodium benzoate, benzoic acid, and citric acid; and the cosolvent is selected from one or more of ethanol, propylene glycol, and polysorbate 80.

[0017] In a preferred embodiment of the present invention, the antitussive and expectorant is a pharmaceutical preparation composed of the following raw materials in the indicated weight ratios: 69.0 parts loquat leaf, 50.0 parts poppy shell, 15.0 parts stemona root, 9.0 parts cynanchum paniculatum, 6.0 parts mulberry bark, 6.0 parts platycodon root, 0.15 parts menthol, 1.0 part sucralose, 2.5 parts sodium benzoate, 0.5 parts citric acid, 5.0 parts ethanol, 2.5 parts flurbiprofen, and an appropriate amount of purified water.

[0018] The antitussive and expectorant drug of the present invention is prepared into a convenient dosage form; preferably, the antitussive and expectorant drug is prepared into an oral solution.

[0019] This invention also provides a method for preparing an antitussive and expectorant drug, the method specifically comprising the following steps:

[0020] 1) Decoction: Loquat leaves, poppy shells, Stemona japonica, Cynanchum paniculatum, mulberry bark, and Platycodon grandiflorus are mixed according to the formula ratio and the extract is obtained through decoction and extraction process for later use;

[0021] 2) Concentration: The extract is concentrated under reduced pressure to obtain a concentrated solution; then it is passed through a vacuum pump in a collection tank to obtain the final Chinese herbal extract.

[0022] 3) Preparation: Extract the Chinese herbal extract from the collection tank to the mixing tank, add the prescribed amount of menthol, flavoring agent, preservative and flurbiprofen, stir evenly, add purified water to the theoretical volume, stir and cool, and the antitussive and expectorant of the present invention is obtained.

[0023] 4) Sterilization and filling: The antitussive and expectorant drugs are filtered and sterilized, then filled into bottles and sealed.

[0024] The method for preparing the antitussive and expectorant of the present invention involves the extraction process in step 1) being carried out in two steps: first, 8 times the weight of purified water is added, and second, 7.5 times the weight of purified water is added, and the extraction is carried out for about 2 hours each time while maintaining a gentle boil; wherein the multiple of purified water is based on the total weight of loquat leaf, poppy shell, stemona root, cynanchum paniculatum, mulberry bark and platycodon root in step 1).

[0025] The method for preparing the antitussive and expectorant drug of the present invention further includes a centrifugal filtration step in the extraction process of step 1), wherein the centrifuge is preferably a tubular centrifuge or a disc centrifuge; and the centrifugal speed of the centrifuge is selected from 10,000-20,000 rpm.

[0026] The method for preparing the antitussive and expectorant drug of the present invention further includes the addition of a solubilizer in step 3).

[0027] In the preparation method of the antitussive and expectorant drug of the present invention, there is no specific order of addition of menthol, flavoring agent, preservative and flurbiprofen in step 3). Those skilled in the art can select a suitable order or method of addition according to the types of flavoring agent and preservative.

[0028] The beneficial effects of this invention are:

[0029] 1) The antitussive and expectorant of this invention comprises loquat leaf, poppy shell, stemona root, cynanchum paniculatum, mulberry bark, platycodon root, menthol, flavoring agent, preservative, flurbiprofen, and purified water. Loquat leaf, poppy shell, stemona root, cynanchum paniculatum, mulberry bark, platycodon root, and menthol are components of a potent loquat syrup. Therefore, this invention combines flurbiprofen with a potent loquat syrup to form an antitussive and expectorant. The applicant has discovered that, in addition to flurbiprofen's anti-inflammatory effect, the antitussive and expectorant of this invention has a stronger antitussive and expectorant effect than a potent loquat syrup. Patients no longer need to take other expectorants, such as ambroxol, thus improving medication adherence in patients with cough and excessive phlegm, demonstrating significant advantages in clinical practice.

[0030] 2) Compared with the strong loquat syrup, the antitussive and expectorant drug of the present invention can significantly reduce the number of coughs in guinea pigs and significantly increase the absorbance of tracheal secretions in guinea pigs when administered at the same dose, indicating that the antitussive and expectorant drug of the present invention has a stronger antitussive and expectorant effect than the commercially available strong loquat syrup. Detailed Implementation

[0031] The technical solution of the present invention will be further described below with reference to specific embodiments, but the present invention is not limited thereto.

[0032] Example 1

[0033] composition Dosage loquat leaves 69.0 copies poppy shells 50.0 copies Hundreds of books 15.0 copies Bai Qian 9.0 copies Mulberry bark 6.0 copies Platycodon grandiflorus 6.0 copies Menthol 0.15 copies Sucralose 1.0 copy Sodium benzoate 3.0 copies Flurbiprofen 2.5 portions Purified water Add to 1000L

[0034] Preparation method:

[0035] 1) Decoction: Mix loquat leaves, poppy shells, stemona root, cynanchum root, mulberry bark, and platycodon root according to the formula ratio. First, add about 8 times the weight of purified water and decoct at a simmer for about 2 hours. Filter the extract through a centrifuge into an extraction tank for later use. Then add about 7.5 times the weight of purified water and decoct at a simmer for about 2 hours. Filter the extract through a centrifuge into an extraction tank. Combine the extracts and set aside for later use.

[0036] 2) Concentration: The extract is concentrated under reduced pressure using a double-effect energy-saving concentrator until the relative density is above 1.03, thus obtaining a concentrated liquid; a vacuum pump in a collection tank is used to obtain the final Chinese herbal extract.

[0037] 3) Preparation: Draw the herbal extract from the collection tank into the mixing tank, weigh the prescribed amount of sodium benzoate and add it to the mixing tank, stir to dissolve, add the prescribed amount of sucralose and heat to boiling, keep it simmering for 20 minutes, and let it stand; then add the prescribed amounts of menthol and flurbiprofen, stir, mix well, let it stand, add purified water to the theoretical volume, and continue stirring and cooling.

[0038] 4) Sterilization and filling: The prepared antitussive and expectorant drugs are filtered and sterilized, then filled into clean bottles, sealed and stored to obtain the antitussive and expectorant drugs of Example 1.

[0039] Example 2

[0040] composition Dosage loquat leaves 69.0 copies poppy shells 50.0 copies Hundreds of books 15.0 copies Bai Qian 9.0 copies Mulberry bark 6.0 copies Platycodon grandiflorus 6.0 copies Menthol 0.1 copies Xylitol 1.0 copy benzoic acid 3.0 copies ethanol 5.0 copies Flurbiprofen 1.5 copies Purified water Add to 1000L

[0041] Preparation method:

[0042] 1) Decoction: Mix loquat leaves, poppy shells, stemona root, cynanchum root, mulberry bark, and platycodon root according to the formula ratio. First, add about 8 times the weight of purified water and decoct at a simmer for about 2 hours. Filter the extract through a centrifuge into an extraction tank for later use. Then add about 7.5 times the weight of purified water and decoct at a simmer for about 2 hours. Filter the extract through a centrifuge into an extraction tank. Combine the extracts and set aside for later use.

[0043] 2) Concentration: The extract is concentrated under reduced pressure using a double-effect energy-saving concentrator until its relative density reaches above 1.03, yielding a concentrated solution. A vacuum pump in a collection tank is then used to obtain the final herbal extract.

[0044] 3) Preparation: Draw the herbal extract from the collection tank into the mixing tank. Weigh the prescribed amount of benzoic acid and add it to the mixing tank. Stir to dissolve. Add the prescribed amount of xylitol and heat to boiling. Maintain a gentle boil for 20 minutes and let stand. Weigh the prescribed amount of menthol and ethanol and stir to dissolve. Add the prescribed amount of flurbiprofen and the dissolved menthol. Stir, mix well, and let stand. Add purified water to the theoretical volume and continue stirring and cooling.

[0045] 4) Sterilization and filling: The prepared antitussive and expectorant drugs are filtered and sterilized, then filled into clean bottles, sealed and stored to obtain the antitussive and expectorant drugs of Example 2.

[0046] Example 3

[0047] composition Dosage loquat leaves 71.0 copies poppy shells 52.0 copies Hundreds of books 14.0 copies Bai Qian 8.0 copies Mulberry bark 7.0 copies Platycodon grandiflorus 5.0 copies Menthol 0.15 copies Steviosides 2.0 copies Citric acid 2.0 copies Propylene glycol 6.0 copies Flurbiprofen 3.0 copies Purified water Add to 1000L

[0048] Preparation method:

[0049] 1) Decoction: Mix loquat leaves, poppy shells, stemona root, cynanchum root, mulberry bark, and platycodon root according to the formula ratio. First, add about 8 times the weight of purified water and decoct at a simmer for about 2 hours. Filter the extract through a centrifuge into an extraction tank for later use. Then add about 7.5 times the weight of purified water and decoct at a simmer for about 2 hours. Filter the extract through a centrifuge into an extraction tank. Combine the extracts and set aside for later use.

[0050] 2) Concentration: The extract is concentrated under reduced pressure using a double-effect energy-saving concentrator until its relative density reaches above 1.03, yielding a concentrated solution. A vacuum pump in a collection tank is then used to obtain the final herbal extract.

[0051] 3) Preparation: Draw the herbal extract from the collection tank into the mixing tank, weigh the prescribed amount of steviol glycosides, heat to boiling, maintain a gentle boil for 20 minutes, and let stand; weigh the prescribed amount of menthol and propylene glycol, stir and dissolve thoroughly, add the prescribed amount of citric acid, flurbiprofen and the dissolved menthol, stir, mix well, let stand, add purified water to the theoretical volume, and continue stirring and cooling;

[0052] 4) Sterilization and filling: The prepared antitussive and expectorant drug is filtered and sterilized, then filled into clean bottles, sealed and stored to obtain the antitussive and expectorant drug of Example 3.

[0053] Example 4

[0054]

[0055]

[0056] Preparation method:

[0057] 1) Decoction: Mix loquat leaves, poppy shells, stemona root, cynanchum root, mulberry bark, and platycodon root according to the formula ratio. First, add about 8 times the weight of purified water and decoct at a simmer for about 2 hours. Filter the extract through a centrifuge into an extraction tank for later use. Then add about 7.5 times the weight of purified water and decoct at a simmer for about 2 hours. Filter the extract through a centrifuge into an extraction tank. Combine the extracts and set aside for later use.

[0058] 2) Concentration: The extract is concentrated under reduced pressure using a double-effect energy-saving concentrator until its relative density reaches above 1.03, yielding a concentrated solution. A vacuum pump in a collection tank is then used to obtain the final herbal extract.

[0059] 3) Preparation: Transfer the herbal extract from the collection tank to the mixing tank. Weigh the prescribed amount of sodium benzoate and add it to the mixing tank. Stir to dissolve. Add the prescribed amount of sucralose and heat to boiling. Maintain a gentle boil for 20 minutes and let stand. Weigh the prescribed amount of menthol, and thoroughly stir to dissolve it with polysorbate 80 and ethanol. Add the prescribed amounts of citric acid, flurbiprofen, and the dissolved menthol. Stir, mix well, and let stand. Add purified water to the theoretical volume and continue stirring and cooling.

[0060] 4) Sterilization and filling: The prepared antitussive and expectorant drug is filtered and sterilized, then filled into clean bottles, sealed and stored to obtain the antitussive and expectorant drug of Example 4.

[0061] Comparative Example

[0062] composition Dosage Sucralose 1.0 copy Sodium benzoate 2.5 portions Citric acid 0.5 copies ethanol 5.0 copies Flurbiprofen 2.5 portions Purified water Add to 1000L

[0063] Preparation method:

[0064] 1) Preparation: Weigh the prescribed amount of sodium benzoate and add it to the mixing container. Stir to dissolve. Add the prescribed amount of sucralose and heat to boiling. Maintain a gentle boil for 20 minutes and let stand. Add the prescribed amounts of ethanol, citric acid and flurbiprofen, stir, mix well and let stand. Add purified water to the theoretical volume and continue stirring and cooling.

[0065] 2) Sterilization and filling: The prepared drug solution is filtered and sterilized, then filled into clean bottles, sealed and stored to obtain a proportional flurbiprofen oral solution.

[0066] Stability test

[0067] Accelerated stability testing was conducted in accordance with the guidelines for stability testing (General Chapter 9001, Part IV, Chinese Pharmacopoeia 2020 Edition) and the technical guidelines for stability studies of chemical drugs (active pharmaceutical ingredients and preparations). The samples examined were the antitussive and expectorant drugs of Examples 1-4, the comparative example of flurbiprofen oral solution, and a commercially available product (Strong Loquat Syrup).

[0068] Table 1. Results of accelerated (40℃) test

[0069]

[0070] In the table, NA indicates that it was not detected.

[0071] As shown in Table 1, the antitussive and expectorant drugs of Examples 1-4 of the present invention met the requirements of the Chinese Pharmacopoeia in the stability test, and had good clarity; the flurbiprofen content was stable, and no incompatibility was found, indicating that the antitussive and expectorant drugs of the present invention are of stable quality.

[0072] Pharmacological experiment investigation

[0073] Pharmacological studies were conducted on the effects of the antitussive and expectorant drugs of Examples 1-4 of this invention, the comparative flurbiprofen oral solution, and a commercially available product (Strong Loquat Syrup) on citrate-induced cough in guinea pigs. The test methods are as follows:

[0074] 1. Eighty guinea pigs, half male and half female, were randomly divided into a negative control group (distilled water group), a drug control group (comparative example and commercially available products of this application), and an experimental group (Examples 1-4 of this invention), with 10 guinea pigs in each group. Before the experiment, the guinea pigs were fasted but allowed free access to water for 12 hours. Then, they were administered the drug by gavage at a dose of 6 mL / k of body weight. The negative control group received the same volume of distilled water. The drug was administered once daily for three consecutive days. One hour before the experiment, each guinea pig was placed in a 2L-4L sealed container, and a 17.5% citric acid solution was sprayed into them using an ultrasonic nebulizer for 5-10 seconds. The number of coughs within 5 minutes of the spray was recorded.

[0075] The test results are shown in Tables 2 and 3 below.

[0076] Table 2. Number of coughs in female guinea pigs within 5 minutes of spraying.

[0077] Group 1 2 3 4 5 6 7 8 9 10 negative control group 32 21 20 25 19 20 23 24 26 22 Commercially available products 18 20 17 19 21 16 16 17 16 18 Example 1 12 15 14 11 10 14 13 15 14 12 Example 2 14 12 15 12 13 12 14 12 13 11 Example 3 11 12 12 10 15 12 14 11 11 14 Example 4 14 12 11 13 11 12 13 12 14 13 Comparative Example 31 21 19 24 20 20 24 26 27 23

[0078] Table 3. Number of coughs in male guinea pigs within 5 minutes of spraying.

[0079] Group 1 2 3 4 5 6 7 8 9 10 negative control group 25 18 28 29 31 25 26 28 29 19 Commercially available products 15 16 18 17 16 18 15 18 14 13 Example 1 10 10 9 8 12 11 10 9 12 9 Example 2 12 11 12 11 10 12 11 10 12 8 Example 3 12 12 11 11 13 12 10 7 11 10 Example 4 12 11 13 8 11 10 13 12 13 11 Comparative Example 24 18 27 28 30 26 24 29 28 20

[0080] From the data in Tables 2 and 3, we can see that:

[0081] (1) Under the same dosage, there was no significant difference in the number of coughs in guinea pigs after administration of flurbiprofen oral solution in the comparative ratio and the negative control group, indicating that flurbiprofen oral solution did not improve cough, that is, flurbiprofen has no antitussive effect.

[0082] (2) Compared with the negative control group, the antitussive and expectorant drugs of Examples 1-4 of this invention significantly reduced the number of coughs in guinea pigs within 5 minutes, and the reduction was significantly better than that of commercially available products. This indicates that the antitussive and expectorant drugs obtained by combining flurbiprofen and strong loquat syrup in this application have a better antitussive effect than commercially available strong loquat syrup, that is, flurbiprofen enhances the antitussive effect of strong loquat syrup.

[0083] 2. In the above experiment, inject 25 ml / k of 0.5% phenol red saline solution into the guinea pigs intraperitoneally. The phenol red dosage was 125 ml / k. Thirty minutes after the injection, anesthetize the mice, dislocate them, fix them in a dorsal position, and separate the trachea. Cut off a section of the trachea from the thyroid cartilage to the lower bifurcation point and place it in a test tube containing 4 ml of saline solution. Shake for 10 minutes. Remove the trachea from the test tube and remove suspended solids by centrifugation. Take 3.5 ml of the obtained supernatant, add 0.1 ml of 1 mol / L sodium hydroxide solution, and after color development, take 100 μl and read the absorbance at 546 nm using a microplate reader.

[0084] The test results are shown in Tables 4 and 5 below.

[0085] Table 4 Absorbance of female guinea pigs

[0086]

[0087]

[0088] Table 5 Absorbance of Male Guinea Pigs

[0089] Group 1 2 3 4 5 6 7 8 9 10 negative control group 0.0635 0.0712 0.0582 0.0416 0.0558 0.0715 0.0456 0.0556 0.0451 0.0658 Commercially available products 0.2514 0.2915 0.3028 0.2752 0.2415 0.2403 0.2715 0.2105 0.2650 0.2381 Example 1 0.3446 0.3675 0.3862 0.3754 0.3816 0.3656 0.3721 0.3545 0.3738 0.3675 Example 2 0.3518 0.3733 0.3816 0.3548 0.3658 0.3614 0.3819 0.3727 0.3515 0.3815 Example 3 0.3628 0.3595 0.3617 0.3781 0.3714 0.3615 0.3525 0.3536 0.3526 0.3612 Example 4 0.3625 0.3514 0.3588 0.3836 0.3630 0.3540 0.3718 0.3632 0.3754 0.3654 Comparative Example 0.1157 0.1314 0.1175 0.0941 0.1082 0.1414 0.1005 0.0942 0.1057 0.1156

[0090] From the data in Tables 4 and 5, we can see that:

[0091] By administering the same dose to guinea pigs, it can be seen that, compared with the comparative and negative control groups, the absorbance value of the tracheal secretions of guinea pigs after administration of the antitussive and expectorant drugs of Examples 1-4 of this invention is significantly larger and greater than that of commercially available products. The absorbance value of tracheal secretions reflects the expectorant effect of the drug, indicating that the antitussive and expectorant drug obtained by combining flurbiprofen and strong loquat syrup in this application has a better expectorant effect than commercially available strong loquat syrup, that is, flurbiprofen enhances the expectorant effect of strong loquat syrup.

[0092] In summary, the antitussive and expectorant drug of the present invention has significant advantages in relieving cough and expectoration.

[0093] It should be understood that the specific embodiments described above are merely illustrative or explanatory of the principles of the invention and do not constitute a limitation thereof. Therefore, any modifications, equivalent substitutions, improvements, etc., made without departing from the spirit and scope of the invention should be included within the protection scope of the invention. Furthermore, the appended claims are intended to cover all variations and modifications falling within the scope and boundaries of the appended claims, or equivalent forms of such scope and boundaries.

Claims

1. A cough suppressant and expectorant, characterized in that, The antitussive and expectorant drugs include: loquat leaf, poppy shell, stemona root, cynanchum root, mulberry bark, platycodon root, menthol, flavoring agent, preservative, flurbiprofen, and purified water.

2. The antitussive and expectorant drug according to claim 1, characterized in that, The antitussive and expectorant medicine is a preparation composed of the following raw materials in parts by weight: 67-71 parts loquat leaves, 48-52 parts poppy shells, 14-16 parts stemona root, 8-10 parts cynanchum paniculatum, 5-7 parts mulberry bark, 5-7 parts platycodon root, 0.1-0.2 parts menthol, 0.5-2 parts flavoring agent, 2-4 parts preservative, 1.5-3 parts flurbiprofen, and an appropriate amount of purified water.

3. The antitussive and expectorant drug according to claim 1, characterized in that, The flavoring agent is selected from one or more of sucrose, sucralose, xylitol, and steviol glycosides; preferably, the flavoring agent is selected from one or more of sucralose, xylitol, and steviol glycosides; the preservative is selected from one or more of sodium benzoate, benzoic acid, and citric acid.

4. The antitussive and expectorant drug according to claim 1, characterized in that, The antitussive and expectorant drug further includes a solubilizer.

5. The antitussive and expectorant drug according to claim 4, characterized in that, The antitussive and expectorant drug is a preparation composed of the following raw materials in parts by weight: 67-71 parts loquat leaves, 48-52 parts poppy shells, 14-16 parts stemona root, 8-10 parts cynanchum paniculatum, 5-7 parts mulberry bark, 5-7 parts platycodon root, 0.1-0.2 parts menthol, 0.5-2 parts flavoring agent, 2-4 parts preservative, 4-6 parts solubilizer, 1.5-3 parts flurbiprofen, and an appropriate amount of purified water.

6. The antitussive and expectorant drug according to claim 4 or 5, characterized in that, The co-solvent is selected from one or more of ethanol, propylene glycol, and polysorbate 80.

7. The antitussive and expectorant drug according to any one of claims 1-6, characterized in that, The antitussive and expectorant drug is prepared as an oral solution.

8. The method for preparing the antitussive and expectorant drug according to claim 7, characterized in that, The preparation method specifically includes the following steps: 1) Decoction: Loquat leaves, poppy shells, Stemona japonica, Cynanchum paniculatum, mulberry bark, and Platycodon grandiflorus are mixed according to the formula ratio and the extract is obtained through decoction and extraction process for later use; 2) Concentration: The extract is concentrated under reduced pressure to obtain a concentrated solution; then it is passed through a vacuum pump in a collection tank to obtain the final Chinese herbal extract. 3) Preparation: Extract the herbal extract from the collection tank to the mixing tank, add the prescribed amounts of menthol, flavoring agent, preservative and flurbiprofen, and stir evenly; then add purified water to the theoretical volume, stir and cool to obtain the antitussive and expectorant drug of the present invention; 4) Sterilization and filling: The antitussive and expectorant drugs are filtered and sterilized, then filled into bottles and sealed.

9. The method for preparing the antitussive and expectorant drug according to claim 8, characterized in that, The extraction process in step 1) is carried out in two steps: the first step involves adding 8 times the weight of purified water, and the second step involves adding 7.5 times the weight of purified water. The extraction is carried out for about 2 hours each time while maintaining a gentle boil. The multiple of purified water is based on the total weight of loquat leaves, poppy shells, stemona root, cynanchum paniculatum, mulberry bark, and platycodon root in step 1).

10. The method for preparing the antitussive and expectorant drug according to claim 8, characterized in that, The extraction process in step 1) further includes a centrifugal filtration step; the centrifuge in the centrifugal filtration step is selected from a tubular centrifuge or a disc centrifuge; the centrifugal speed of the centrifuge is selected from 10000-20000 rpm.

11. The method for preparing the antitussive and expectorant drug according to claim 8, characterized in that, Step 3) further includes the process of adding a co-solvent; the co-solvent is selected from one or more of ethanol, propylene glycol, and polysorbate 80.

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