Cold syrup

Abstract

To provide a cold syrup comprising a herbal medicine along with an antipyretic analgesic, an antihistamine, an antitussive, and an expectorant, which suppresses precipitation from the herbal medicine and also offers favorable taste upon drinking.SOLUTION: A cold syrup containing an antipyretic analgesic, an antihistamine, an antitussive, and an expectorant, characterized by containing a herbal medicine and polyoxyethylene hydrogenated castor oil, wherein the herbal medicine contains at least one selected from the group consisting of Nandina fruit, Ephedra, and Platycodon root.SELECTED DRAWING: None

Description

[Technical Field]

[0001] The present invention relates to a cold syrup containing a herbal medicine, characterized in that it contains polyoxyethylene hydrogenated castor oil. [Background technology]

[0002] Cold syrups (syrup preparations), a form of cold medicine, typically contain a combination of Western (synthetic) active ingredients, such as antipyretics, analgesics, antihistamines, antitussives, expectorants, and bronchodilators, as well as herbal and / or traditional Chinese medicines. Western medicines are generally composed of a single ingredient, acting on specific body parts or symptoms, with effects expressed in varying doses. Herbal medicines, on the other hand, are derived in whole or in part from natural plants, minerals, or animals. A single herbal medicine contains multiple ingredients with various effects, while traditional Chinese medicines, which combine multiple herbal medicines, contain a wide variety of ingredients. Therefore, herbal and / or traditional Chinese medicines have a wide range of effects, from localized to systemic, enhancing the body's natural healing ability. Western medicines, herbal and / or traditional Chinese medicines each have unique advantages, and it is expected that they can be used in optimal combinations. For example, Patent Document 1 proposes an oral liquid (syrup) containing acetaminophen, an antipyretic analgesic, sugars, and licorice extract, while Patent Document 2 proposes an oral liquid containing vitamin B1 and herbal medicines. [Prior art documents] [Patent documents]

[0003] [Patent Document 1] Patent No. 3913795 [Patent Document 2] Patent No. 4403590 Summary of the Invention [Problem to be solved by the invention]

[0004] As mentioned above, herbal medicines and Kampo medicines are essentially "mixtures" containing various ingredients. Therefore, syrups and other liquid preparations containing these ingredients are prone to cloudiness and precipitation during storage. Furthermore, when ingredients that are difficult to ensure stability in aqueous solutions or that tend to crystallize are combined with herbal medicines or Kampo medicines, problems such as the occurrence of precipitation and the like can arise, as well as problems such as a decrease in content due to decomposition or crystallization (precipitation) of the ingredients. To address these problems, various measures have been proposed, such as adding glycols (Patent Document 1) or adjusting the chloride ion concentration in the liquid (Patent Document 2).

[0005] Although the incorporation of solubilizers such as the glycols mentioned above can suppress the occurrence of precipitation in liquid preparations containing herbal medicines, the incorporation of the solubilizers can cause a strong bitter or acrid taste, which can lead to other problems such as making the liquid difficult to drink. So far, no proposal has been made regarding a cold syrup that simultaneously solves the problems of precipitation and unpleasant taste derived from herbal medicines.

[0006] To provide a cold syrup containing a herbal medicine, an antipyretic analgesic, an antihistamine, a cough suppressant and an expectorant, which suppresses precipitation derived from the herbal medicine and has an excellent flavor when drunk. [Means for solving the problem]

[0007] That is, the present invention covers the following [1] to

[14] . [1] A cold syrup containing an antipyretic analgesic, an antihistamine, a cough suppressant, and an expectorant, It is characterized by containing herbal medicine and polyoxyethylene hydrogenated castor oil, A cold syrup, wherein the herbal medicine comprises at least one selected from the group consisting of Nanjingjiang, Ephedra, and Platycodon grandiflorum. [2] The cold syrup according to [1], wherein the herbal medicine and the polyoxyethylene hydrogenated castor oil are contained in a mass ratio of herbal medicine (equivalent to the original herbal medicine):polyoxyethylene hydrogenated castor oil = 1:0.01 to 1:2. [3] The cold syrup according to [1], wherein the herbal medicine is Nantenjitsu and further contains licorice. [4] The cold syrup according to [1], wherein the herbal medicine is Ephedra. [5] The cold syrup according to [1], wherein the herbal medicine is bellflower. [6] The cold syrup according to [1], wherein the herbal medicine is formulated in the form of a herbal medicine containing at least one selected from the group consisting of Nandina palm, Ephedra, and Platycodon grandiflorum. [7] The cold syrup according to [1] further contains a bronchodilator. [8] The cold syrup according to [1], wherein the antipyretic and analgesic is acetaminophen. [9] The cold syrup according to [1], wherein the antihistamine is at least one selected from the group consisting of chlorpheniramine maleate, d-chlorpheniramine maleate, and diphenhydramine hydrochloride.

[10] The cold syrup according to [1], wherein the antitussive agent is at least one selected from the group consisting of dihydrocodeine phosphate, tipepidine citrate, and dextromethorphan hydrobromide hydrate.

[11] The cold syrup according to [1], wherein the expectorant is at least one selected from the group consisting of guaifenesin and potassium guaiacolsulfonate.

[12] The cold syrup according to [7], wherein the bronchodilator is dl-methylephedrine hydrochloride.

[13]

[10] The cold syrup according to any one of [1] to

[12] , further comprising, as other ingredients, at least one selected from the group consisting of alloclamide hydrochloride, cloperastine hydrochloride, cloperastine fendizoate, codeine phosphate hydrate, dibunate sodium, tipepidine hibenzate, dextromethorphan phenolphthalin salt, pentoxyverine citrate, dimemorfan phosphate, noscapine, noscapine hydrochloride hydrate, dl-methylephedrine saccharin salt, potassium cresolsulfonate, bromhexine hydrochloride, L-carbocysteine, L-ethylcysteine ​​hydrochloride, belladonna total alkaloids, isopropamide iodide, senega, ginger, zhiyu, ginseng, and Chinese laurel.

[14] The cold syrup according to claim [1], wherein the polyoxyethylene hydrogenated castor oil is contained in an amount of 60 mg to 1000 mg per 120 mL of the total amount of cold syrup. [Effects of the Invention]

[0008] According to the present invention, by blending polyoxyethylene hydrogenated castor oil in a cold syrup containing herbal medicines, etc., it is possible to suppress turbidity, precipitates, sedimentation, etc., and also to reduce bitterness and unpleasant taste when drinking. It is possible to provide a cold syrup in which unpleasant flavors such as mucilage are suppressed, and which is stable during storage and easy to drink. DETAILED DESCRIPTION OF THE INVENTION

[0009] [Cold syrup] The cold syrup of the present invention contains an antipyretic analgesic, an antihistamine, a cough suppressant, and an expectorant, and is characterized by containing herbal medicines and polyoxyethylene hydrogenated castor oil. Furthermore, since cold syrups are usually formulated for children, it is desirable to use ingredients that are as safe as possible, and it is undesirable to use ingredients that are generally contraindicated for use by people under the age of 15.

[0010] <Herbal medicine> The cold syrup of the present invention contains at least one or more herbal medicines selected from the group consisting of Nantenji (Nandina fruit), Ephedra (Ma Huang), and Platycodon grandiflorum (Platycodon grandiflorum). These herbal medicines have antitussive and expectorant effects in suppressing cough and phlegm. In addition to the above herbal medicines, other herbal medicines that have a proven track record of use in cold medicines, such as licorice (liquorice), senega, ginger, earth dragon, ginseng, and cherry bark, which have antitussive and expectorant effects, promote blood circulation (warm the body), reduce fever, and have a tonic effect, may also be used in combination. For example, a combination of Nanjing and Glycyrrhiza, Ephedra alone, or Platycodon grandiflorum alone can be used, but is not limited to these. Furthermore, the cold syrup of the present invention can contain at least one of the above-mentioned Nantenjitsu, Ephedra Root, and Platycodon grandiflorum in the form of a herbal medicine (a combination of multiple herbal medicines). Examples of such herbal medicines include, but are not limited to, Kakkonto (herbal medicine composition: Kakkon, Ephedra Root, Taiso, Cinnamon Bark or Cinnamon Bark, Peony Root, Licorice Root, Ginger Root or Sheng Ginger Root), Kakkonto Ka Platycodon Grandiflorum (herbal medicine composition: Kakkonto with Platycodon grandiflorum), Shoseiryuto (herbal medicine composition: Ephedra Root, Peony Root, Ginger Root or Ginger Root, Licorice Root, Cinnamon Bark, Saishin, Gomishi, and Pinellia Root), and Mao Tang (herbal medicine composition: Ephedra Root, Cinnamon Bark, Apricot Nin, and Licorice).

[0011] The herbal medicines to be incorporated into the cold syrup of the present invention are preferably incorporated in the form of an extract. The extract is produced by conventional methods, such as extracting the herbal raw materials using an extraction solvent at an appropriate temperature (low temperature or high temperature). The extraction solvent can be selected appropriately depending on the herbal medicine, but water, hydrophilic solvents (especially ethanol), and mixtures thereof are preferably used. In this specification, the term "extract" refers to a liquid extract that can be used as is, or a liquid extract diluted with water, a liquid extract concentrate, or a liquid extract dried. In other words, the extract used in the present invention may be a dry extract, soft extract, liquid extract, tincture, or the like.

[0012] <Polyoxyethylene hydrogenated castor oil> The cold syrup of the present invention is characterized by the use of polyoxyethylene hydrogenated castor oil together with the above-mentioned herbal medicines. Polyoxyethylene hydrogenated castor oil acts as a solubilizer, dispersant, and stabilizer, and not only can it suppress precipitation in the cold syrup containing the herbal medicines of the present invention, but also can suppress unpleasant tastes such as bitterness and astringency. Examples of polyoxyethylene hydrogenated castor oils that can be blended into the cold syrup of the present invention include polyoxyethylene hydrogenated castor oil 40, polyoxyethylene hydrogenated castor oil 50, and polyoxyethylene hydrogenated castor oil 60, which can be blended either alone or in combination. Polyoxyethylene hydrogenated castor oil can be blended in an amount of 60 mg to 1000 mg in a total volume of 120 mL of cold syrup, for example. Furthermore, polyoxyethylene hydrogenated castor oil can be blended in a ratio of, for example, the amount of the herbal medicine (equivalent to the amount of the herbal medicine):polyoxyethylene hydrogenated castor oil = 1:0.01 to 1:2 (mass ratio) relative to the amount of the herbal medicine blended in terms of the raw herbal medicine. The term "equivalent to crude drug" means expressing the amount of crude drug that may be contained in various forms in terms of the dry weight of the plant material required to obtain it (for example, the dry weight of parts of the plant such as bark, branches, or fruit, or the dry weight of processed products that have been subjected to only physical processing such as fine pieces or powder of said parts). For example, if 10 parts by mass of cinnamon bark extract powder is obtained from 100 parts by mass of dried cinnamon bark, 10 mg of said extract powder is expressed as 100 mg of crude drug equivalent.

[0013] <Antipyretics and analgesics> As mentioned above, when it comes to cold syrups for children, it is advisable to avoid the use of certain nonsteroidal anti-inflammatory drugs (NSAIDs), which have been shown to increase the risk of causing influenza encephalopathy, which is accompanied by high fever, loss of consciousness, and convulsions, when used to reduce fever from influenza or chickenpox. For these reasons, it is desirable to use acetaminophen as the antipyretic and analgesic agent in the cold syrup of the present invention.

[0014] <Antihistamines> The antihistamine used in the cold syrup of the present invention is preferably at least one selected from the group consisting of chlorpheniramine maleate, d-chlorpheniramine maleate, and diphenhydramine hydrochloride, which may be used alone or in combination.

[0015] <Cough suppressants> The antitussive agent used in the cold syrup of the present invention is preferably at least one selected from the group consisting of dihydrocodeine phosphate, tipepidine citrate, and dextromethorphan hydrobromide hydrate, which may be used alone or in combination.

[0016] <Expectorant> The expectorant used in the cold syrup of the present invention may be at least one selected from the group consisting of guaifenesin and potassium guaiacolsulfonate, which may be formulated either alone or in combination.

[0017] <Bronchodilators> The cold syrup of the present invention may also contain a bronchodilator, such as dl-methylephedrine hydrochloride.

[0018] <Other ingredients> The cold syrup of the present invention may contain other ingredients as long as the effects of the present invention are not impaired. For example, antitussives such as alloclamide hydrochloride, cloperastine hydrochloride, cloperastine fendizoate, codeine phosphate hydrate, dibunate sodium, tipepidine hibenzate, dextromethorphan phenolphthalin salt, pentoxyverine citrate, dimemorfan phosphate, noscapine, and noscapine hydrochloride hydrate; bronchodilators such as dl-methylephedrine saccharin salt; expectorants such as airway mucosal secretion promoters such as potassium cresol sulfonate and bromhexine hydrochloride, and airway mucolytics such as L-carbocysteine ​​and L-ethylcysteine ​​hydrochloride; parasympathetic nervous system agents such as belladonna total alkaloids and isopropamide iodide. Examples of the active ingredient include a mucus-blocking component (which relieves runny nose), etc. These can be formulated either alone or in combination.

[0019] In addition, optional ingredients such as conventional ingredients normally added to liquids and syrups, for example, pH adjusters and buffers such as citric acid, sodium citrate, hydrochloric acid, sodium chloride, and sodium hydroxide; solubilizers such as ethanol and propylene glycol; stabilizers and preservatives such as sodium benzoate, alkylparabens, ethyl parahydroxybenzoate, and butyl parahydroxybenzoate; sweeteners such as sucrose and sorbitol; colorants such as caramel; and flavorings may also be added. Polysorbates, which are generally used as solubilizers or emulsifiers in liquid preparations, are effective in preventing precipitation, but they can worsen the flavor of cold syrups, so they should be used with caution and it is preferable not to use them at all.

[0020] The cold syrup of the present invention can be produced by dissolving the above-mentioned essential ingredients and necessary optional ingredients in purified water under heating and / or stirring as necessary. As mentioned above, the herbal medicines may be dissolved in the form of a herbal medicine containing multiple types of herbal medicines. Alternatively, the cold syrup may be prepared by preparing multiple mixtures containing several ingredients and combining these mixtures.

[0021] In the cold syrup of the present invention, the amount of each ingredient to be blended is not particularly limited as long as it is within a blending amount range that can achieve the desired effect, and can be, for example, as follows relative to the total amount of cold syrup (100% by mass): Herbal medicine: 0.5 to 5.0% by mass Polyoxyethylene hydrogenated castor oil: 0.05 to 0.83% by mass Antipyretic analgesic: 0.25 to 0.50% by mass Antihistamine: 0.001 to 0.042% by mass Cough suppressant: 0.007 to 0.033% by mass Expectorant: 0.05 to 0.14% by mass Other ingredients: Residue The other ingredients may be, for example, 10 to 60% by mass of sweeteners such as sucrose or sorbitol (amount added if blended, same below), 1 to 10% by mass of solubilizers such as ethanol or propylene glycol, 10 to 80% by mass of purified water, and 0.1 to 5% by mass of flavorings, colorants, pH adjusters, stabilizers, etc. The other ingredients are not limited to these, and ingredients normally added to liquid preparations such as cold syrup can be blended as appropriate, and the inclusion of other ingredients is not essential. [Example]

[0022] The present invention will be described in more detail below with reference to examples, although the present invention is not limited to these examples.

[0023] [Preparation of cold syrup] Example 1 An appropriate amount of purified water was added to 550 mg of licorice extract and pretreated with a filter aid. After pretreatment, 200 mg of polyoxyethylene hydrogenated castor oil 60, 8 g of D-sorbitol solution (70%), 600 mg of acetaminophen, and 36 g of sucrose were added and dissolved. To this solution, 1.8 mL of Nandina fruit juice extract, 40 mg of dl-methylephedrine hydrochloride, 30 mg of dextromethorphan hydrobromide, 50 mg of diphenhydramine hydrochloride, 160 mg of potassium guaiacolsulfonate, and 70 mg of sodium benzoate were added and dissolved. 0.12 mL of flavoring and 1.6 mg of colorant were added and dissolved. The pH was adjusted to 5.5 with appropriate amounts of sodium citrate hydrate and citric acid hydrate, and purified water was added to a total volume of 120 mL to obtain the cold syrup of Example 1.

[0024] Example 2 A cold syrup of Example 2 was obtained in the same manner as in Example 1, except that dl-methylephedrine hydrochloride was not added.

[0025] Example 3 The cold syrup of Example 3 was obtained in the same manner as in Example 1, except that 100 mg of ephedra extract was added instead of dl-methylephedrine hydrochloride, Nandina fruit fluid extract, and licorice extract in Example 1, and the amount of polyoxyethylene hydrogenated castor oil 60 was changed to 1000 mg.

[0026] Example 4 A cold syrup of Example 4 was obtained in the same manner as in Example 1, except that 200 mg of polyoxyethylene hydrogenated castor oil 50 was added instead of polyoxyethylene hydrogenated castor oil 60.

[0027] Example 5 The cold syrup of Example 5 was obtained in the same manner as Example 1, except that 6000 mg of Platycodon grandiflorum liquid extract was added instead of the Nandina oleracea liquid extract and licorice extract in Example 1, and the amount of polyoxyethylene hydrogenated castor oil 60 was changed to 1000 mg.

[0028] Example 6 The cold syrup of Example 6 was obtained in the same manner as Example 1, except that 4000 mg of Platycodon grandiflorum liquid extract was added instead of the Nandina oleracea liquid extract and licorice extract in Example 1, and the amount of polyoxyethylene hydrogenated castor oil 60 was changed to 600 mg.

[0029] Comparative Example 1 A cold syrup of Comparative Example 1 was obtained in the same manner as in Example 1, except that 600 mg of polysorbate 80 was added instead of polyoxyethylene hydrogenated castor oil 60.

[0030] Comparative Example 2 A cold syrup of Comparative Example 2 was obtained in the same manner as in Example 1, except that polyoxyethylene hydrogenated castor oil 60 was not added.

[0031] Comparative Example 3 A cold syrup of Comparative Example 3 was obtained in the same manner as in Example 1, except that 100 mg of ephedra extract was added instead of dl-methylephedrine hydrochloride, Nandina fruit fluid extract, and licorice extract in Example 1, and 600 mg of polysorbate 80 was added instead of polyoxyethylene hydrogenated castor oil 60.

[0032] Comparative Example 4 A cold syrup of Comparative Example 4 was obtained in the same manner as in Example 1, except that 100 mg of ephedra extract was added instead of dl-methylephedrine hydrochloride, Nandina fruit fluid extract, and licorice extract in Example 1, and polyoxyethylene hydrogenated castor oil 60 was not added.

[0033] Comparative Example 5 A cold syrup of Comparative Example 5 was obtained in the same manner as in Example 1, except that 600 mg of polysorbate 60 was added instead of polyoxyethylene hydrogenated castor oil 60 in Example 1.

[0034] Comparative Example 6 The cold syrup of Comparative Example 6 was obtained in the same manner as in Example 1, except that 6000 mg of platycodon liquid extract was added instead of the nandina fruit liquid extract and licorice extract in Example 1, and 1000 mg of polysorbate 80 was added instead of polyoxyethylene hydrogenated castor oil 60.

[0035] Comparative Example 7 The cold syrup of Comparative Example 7 was obtained in the same manner as in Example 1, except that 6000 mg of Platycodon grandiflorum liquid extract was added instead of the Nandina fruit liquid extract and licorice extract in Example 1, and polyoxyethylene hydrogenated castor oil 60 was not added.

[0036] Comparative Example 8 The cold syrup of Comparative Example 8 was obtained in the same manner as in Example 1, except that 4000 mg of platycodon liquid extract was added instead of the nandina fruit liquid extract and licorice extract in Example 1, and 600 mg of polysorbate 80 was added instead of polyoxyethylene hydrogenated castor oil 60.

[0037] Comparative Example 9 The cold syrup of Comparative Example 9 was obtained in the same manner as in Example 1, except that 4000 mg of Platycodon grandiflorum liquid extract was added instead of the Nandina fruit liquid extract and licorice extract in Example 1, and polyoxyethylene hydrogenated castor oil 60 was not added.

[0038] [Test Example 1: Appearance] 60 mL of each cold syrup from Examples 1 to 6 and Comparative Examples 1 to 9 was placed in a transparent glass container (7K glass bottle, full capacity: 75.5 mL, inner mouth diameter: 29 mm, body diameter: 43 mm, body height: 78 mm), and the appearance of the content liquid was visually observed from the side of the bottle. Suppression of turbidity was evaluated according to the following criteria. <Appearance evaluation criteria> 〇: No turbidity or precipitates ×: Significant turbidity or precipitates present

[0039] [Test Example 2: Taste] An appropriate amount of each of the cold syrups of Examples 1 to 6 and Comparative Examples 1 to 9 was placed in the mouth, and a sensory evaluation was carried out according to the following criteria. <Taste evaluation criteria> 〇: Easy to drink with little bitterness or astringency ×: Strong bitterness and astringency make it difficult to drink

[0040] [Test Example 3: Stability (presence or absence of precipitation after storage)] The cold syrups of Examples 1 to 6 and Comparative Examples 1 to 9 were placed in predetermined amounts in the 7K standard bottles used in Test Example 1 and stored for 7 days under conditions of 40°C±2°C / 75% RH±5% RH. After storage, the state of the contents was visually observed while irradiating light from the bottom of the container. The presence or absence of precipitation was evaluated according to the following criteria. <Stability evaluation criteria> ○: No precipitation occurs ×: Precipitation occurs

[0041] The formulations of the cold syrups prepared in the present examples and comparative examples, as well as the evaluation results of Test Examples 1 to 3, are shown in Tables 1 and 2.

[0042] [Table 1]

[0043] [Table 2]

[0044] A formulation (Example 1) containing acetaminophen (antipyretic analgesic), diphenhydramine hydrochloride (antihistamine), dextromethorphan hydrobromide (antitussive), potassium guaiacolsulfonate (expectorant), dl-methylephedrine hydrochloride (bronchodilator), Nandina fruit fluid extract (herbal medicine), and licorice extract (herbal medicine) combined with polyoxyethylene hydrogenated castor oil (HCO-60) had an appearance free of turbidity or precipitates, and no precipitation was observed even after 7 days of storage under conditions of 40°C ± 2°C / 75%RH ± 5%RH. It also had a mild, non-astringent taste and was easy to drink. Similarly, a formulation (Example 4) in which the polyoxyethylene hydrogenated castor oil 60 in Example 1 was replaced with polyoxyethylene hydrogenated castor oil 50 also had an appearance free of turbidity or precipitates, and no precipitation was observed even after 7 days of storage. It also had a mild, non-astringent taste and was easy to drink. Similar results were also obtained in a formulation of Example 1 that did not contain the bronchodilator dl-methylephedrine hydrochloride (Example 2), a formulation of Example 1 that combined ephedra extract instead of dl-methylephedrine hydrochloride, Nandina fruit extract, and licorice extract (Example 3), and a formulation of Example 1 that combined platycodon extract instead of Nandina fruit extract and licorice extract (Examples 5 and 6).

[0045] On the other hand, a formulation (Comparative Example 1) in which polyoxyethylene hydrogenated castor oil (HCO-60) was replaced with polysorbate 80, a common solubilizer, in the formulation of Example 1 had a good appearance and suppressed precipitation after the above-mentioned 7-day storage, but had an extremely bitter and acrid taste and was unpleasant. Similarly, a formulation (Comparative Example 3) in which polyoxyethylene hydrogenated castor oil (HCO-60) was replaced with polysorbate 80 in the formulation of Example 3, a formulation (Comparative Example 5) in which polyoxyethylene hydrogenated castor oil (HCO-50) was replaced with polysorbate 60 in the formulation of Example 4, and a formulation (Comparative Example 6) in which polyoxyethylene hydrogenated castor oil (HCO-60) was replaced with polysorbate 80 in the formulation of Example 5 had no problems with appearance or suppression of precipitation after 7-day storage, but resulted in an unpleasant taste. In addition, in the formulation of Example 6, polyoxyethylene hydrogenated castor oil (HCO-60) was replaced with polysorbate 80 (Comparative Example 8), the appearance was good but the taste was poor, and precipitation was observed after storage for 7 days. In addition, the formulation of Example 1, which did not contain polyoxyethylene hydrogenated castor oil (HCO-60) (Comparative Example 2), had a good taste, but exhibited significant turbidity and precipitated appearance, and clear precipitation was observed after the above-mentioned 7-day storage. Similarly, the formulation of Example 3, which did not contain polyoxyethylene hydrogenated castor oil (HCO-60) (Comparative Example 4), also had no problem with taste, but was found to have problems with appearance and precipitation prevention. Furthermore, the formulation of Example 5, which did not contain polyoxyethylene hydrogenated castor oil (HCO-60) (Comparative Example 7), and the formulation of Example 6, which did not contain polyoxyethylene hydrogenated castor oil (HCO-60) (Comparative Example 9), had no problem with taste or appearance, but precipitation was observed after 7 days of storage, resulting in problems with precipitation prevention.

[0046] From the above results, it was confirmed that the incorporation of polyoxyethylene hydrogenated castor oil is useful for cold syrups containing herbal medicines, antipyretics, analgesics, antihistamines, antitussives, and expectorants that have a good appearance free of turbidity or precipitates, a good flavor free of bitterness or astringency when drunk, and stability problems free from precipitation after storage.

Claims

1. A cold syrup containing an antipyretic analgesic, an antihistamine, a cough suppressant, and an expectorant, It is characterized by containing herbal medicine and polyoxyethylene hydrogenated castor oil, A cold syrup, wherein the herbal medicine comprises at least one selected from the group consisting of Nanjingjiang, Ephedra, and Platycodon grandiflorum.

2. 2. The cold syrup according to claim 1, wherein the herbal medicine and the polyoxyethylene hydrogenated castor oil are contained in a mass ratio of herbal medicine (equivalent to the original herbal medicine):polyoxyethylene hydrogenated castor oil = 1:0.01 to 1:

2.

3. The cold syrup according to claim 1, wherein the herbal medicine is selected from Nanjingjiao and further contains licorice.

4. 2. The cold syrup according to claim 1, wherein the herbal medicine is Ephedra.

5. 2. The cold syrup according to claim 1, wherein the herbal medicine is Platycodon grandiflorum.

6. 2. The cold syrup according to claim 1, wherein the herbal medicine is formulated in the form of a herbal medicine containing at least one selected from the group consisting of Nandina Root, Ephedra Root, and Platycodon Root.

7. 2. The cold syrup of claim 1, further comprising a bronchodilator.

8. 2. The cold syrup according to claim 1, wherein the antipyretic and analgesic is acetaminophen.

9. 2. The cold syrup according to claim 1, wherein the antihistamine is at least one selected from the group consisting of chlorpheniramine maleate, d-chlorpheniramine maleate, and diphenhydramine hydrochloride.

10. 2. The cold syrup according to claim 1, wherein the antitussive agent is at least one selected from the group consisting of dihydrocodeine phosphate, tipepidine citrate, and dextromethorphan hydrobromide hydrate.

11. 2. The cold syrup according to claim 1, wherein the expectorant is at least one selected from the group consisting of guaifenesin and potassium guaiacolsulfonate.

12. 8. The cold syrup according to claim 7, wherein the bronchodilator is dl-methylephedrine hydrochloride.

13. 13. The cold syrup according to any one of claims 1 to 12, further comprising, as other ingredients, at least one selected from the group consisting of alloclamide hydrochloride, cloperastine hydrochloride, cloperastine fendizoate, codeine phosphate hydrate, dibunate sodium, tipepidine hibenzate, dextromethorphan phenolphthalin salt, pentoxyverine citrate, dimemorfan phosphate, noscapine, noscapine hydrochloride hydrate, dl-methylephedrine saccharin salt, potassium cresolsulfonate, bromhexine hydrochloride, L-carbocysteine, L-ethylcysteine ​​hydrochloride, belladonna total alkaloids, isopropamide iodide, senega, ginger, Ziryu, ginseng, and Chinese laurel.

14. The polyoxyethylene hydrogenated castor oil is 60 mg per 120 mL of the total amount of cold syrup. The cold syrup according to claim 1, wherein the amount of the compound is in the range of 1000 mg to 1000 mg.

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