A pharmaceutical composition for treating infant night cough, preparation and application thereof

Abstract

The application discloses a medicine composition for treating infant night cough, which is composed of Radix Bupleuri, Radix Paeoniae Alba, Fructus Aurantii Immaturus, roasted Germinated Millet, roasted Millet, Pericarpium Citri Reticulatae, Folium Pyrrosiae, Radix Trichosanthis, Radix Pulsatillae, Radix Anemarrhenae, Radix Peucedani, Radix Trichosanthis, Radix Ophiopogonis, Radix Sophorae Immaturus, and Radix Glycyrrhizae. The medicine composition can be added with pharmaceutically acceptable adjuvants to form preparations. The medicine composition and the preparations can be used for preparing medicines for treating infant night cough.

Description

Technical Field

[0001] This invention belongs to the field of pharmaceuticals, specifically relating to a pharmaceutical composition for treating nocturnal cough in children, its formulation, and its application. Background Technology

[0002] Cough is a common and frequently occurring disease in clinical practice, especially during winter and spring, and when temperatures fluctuate. Children, whose bodily functions are not yet fully developed and whose disease resistance is weaker, have a much higher incidence rate than adults, and their symptoms are often more severe. They typically experience persistent coughing, especially at night. Night cough in children refers to a cough that appears or worsens at night, with little or no coughing during the day, with or without phlegm, and is persistent and difficult to cure. It is often accompanied by other organ dysfunctions and is one of the more challenging symptoms among common childhood illnesses, seriously impacting the child's learning and quality of life. Because children are in a stage of growth and development, their organs are delicate, and their organ functions are not yet fully developed. Medication use requires extreme caution. Adult medications should not be given to children indiscriminately to avoid harming their health; therefore, the range of medications available for children is very limited. Existing pediatric cough medications often only treat the symptoms, failing to address the underlying cause of the cough, or their effectiveness is less than ideal, leading to recurring symptoms. Currently available over-the-counter cough medications for children primarily focus on moisturizing the lungs, with no specific formulations targeting nighttime coughs in children. Therefore, it is essential to develop a safe and effective medication for treating nighttime coughs in children with no side effects. Summary of the Invention

[0003] To address the shortcomings of existing technologies, the present invention aims to provide a pharmaceutical composition, its formulation, and its application for treating nocturnal cough in children. The pharmaceutical composition of the present invention has the effects of soothing the liver and relieving depression, relieving cough and resolving phlegm, and strengthening the spleen and nourishing yin. It is significantly effective in treating nocturnal cough in children and is safe with no side effects.

[0004] The objective of this invention is achieved through the following technical solution:

[0005] A pharmaceutical composition for treating nocturnal cough in children, comprising the following components by weight: Bupleurum chinense 3-15 parts, Paeonia lactiflora 3-15 parts, Citrus aurantium 3-12 parts, stir-fried germinated barley 6-15 parts, stir-fried malt 6-15 parts, Citrus reticulata peel 3-12 parts, Pinellia ternata 3-12 parts, Aster tataricus 3-12 parts, Cynanchum paniculatum 3-12 parts, Peucedanum praeruptorum 3-12 parts, Trichosanthes kirilowii 3-15 parts, Ophiopogon japonicus 3-15 parts, fermented soybean 3-15 parts, and Glycyrrhiza uralensis 2-10 parts.

[0006] Preferably, the pharmaceutical composition for treating nocturnal cough in children comprises, by weight, the following components: Bupleurum chinense 3-10 parts, Paeonia lactiflora 6-15 parts, Citrus aurantium 3-10 parts, stir-fried germinated barley 9-15 parts, stir-fried malt 9-15 parts, Citrus reticulata 3-10 parts, Pinellia ternata 3-9 parts, Aster tataricus 5-10 parts, Cynanchum paniculatum 3-10 parts, Peucedanum praeruptorum 3-10 parts, Trichosanthes kirilowii 3-10 parts, Ophiopogon japonicus 6-12 parts, fermented soybean 6-12 parts, and Glycyrrhiza uralensis 3-9 parts.

[0007] More preferably, the pharmaceutical composition for treating nocturnal cough in children is composed of the following components by weight: Bupleurum chinense 6-10 parts, Paeonia lactiflora 6-10 parts, Citrus aurantium 5-10 parts, stir-fried germinated barley 9-15 parts, stir-fried malt 9-15 parts, Citrus reticulata peel 6-10 parts, Pinellia ternata 6-10 parts, Aster tataricus 6-10 parts, Cynanchum paniculatum 6-10 parts, Peucedanum praeruptorum 6-10 parts, Trichosanthes kirilowii 5-10 parts, Ophiopogon japonicus 6-10 parts, fermented soybean 6-10 parts, and Glycyrrhiza uralensis 5-10 parts.

[0008] In the pharmaceutical composition of this invention, Bupleurum enters the liver and gallbladder meridians, soothes the liver and relieves stagnation, and expels pathogenic factors. White peony nourishes yin and blood and softens the liver. The two herbs work together to soothe and soften the liver. Immature bitter orange eliminates stagnation and phlegm, promotes qi circulation and relieves pain. The three herbs work together to regulate qi and harmonize blood, inhibiting the invasion of liver fire into the lungs. Fried germinated barley and fried malt, which strengthen the spleen and improve appetite, are added as the principal herbs to achieve the effect of regulating both the liver and spleen. Tangerine peel and prepared pinellia (prepared pinellia) dry dampness, resolve phlegm, strengthen the spleen and regulate qi. In this formula, the herbs aster, cynanchum, and angelica dahurica, which enter the lung meridian, are combined to form a warm but not hot, moist but not greasy combination that assists the principal herbs in strengthening the spleen, resolving dampness, relieving cough, and eliminating phlegm. The formula is further supplemented with trichosanthes root, ophiopogon root, and fermented soybean, which clear heat, purge fire, moisten the lungs, and generate fluids. This combination treats dryness damaging the lungs and stomach, causing dry throat and thirst, while also dispelling external pathogens to relieve irritability. Prepared licorice root moistens the lungs, relieves cough, and harmonizes the other herbs, serving as the guiding herb. Together, the formula achieves the effects of soothing the liver, relieving depression, stopping cough, eliminating phlegm, strengthening the spleen, and nourishing yin.

[0009] The drug composition for treating nighttime cough in children can also be formulated with pharmaceutically acceptable excipients to produce preparations such as decoctions, oral liquids, traditional Chinese medicine mixtures, ointments, granules, and pills.

[0010] The pharmaceutical composition and its preparation can be used to prepare a medicine for treating nighttime cough in children. It has the effects of soothing the liver and relieving depression, relieving cough and resolving phlegm, and strengthening the spleen and nourishing yin. It is used to treat nighttime cough in children.

[0011] Compared with the prior art, the present invention has the following beneficial effects:

[0012] 1. The pharmaceutical composition and preparation thereof for treating nocturnal cough in children as described in this invention are effective in treating nocturnal cough in children and are safe with no side effects.

[0013] 2. Because children's internal organs are delicate, their physical constitution is not yet fully developed, and their defensive functions are not yet perfect, they are easily susceptible to external pathogens that enter from the surface, causing the lung qi to lose its dispersing and descending function, leading to cough. Furthermore, children's physiological characteristics are that the liver and heart are often in excess, the spleen is often deficient, and the lungs are often weak. Therefore, the heart, liver, spleen, and lungs are physiologically mutually restrictive; once this balance is lost, it can all contribute to cough in children. Considering the pathological characteristics of night cough in children: night cough often occurs between 11:00 PM and 3:00 AM, this time is mainly governed by the gallbladder and liver meridians. The liver and lungs are the pivot of qi movement; the lungs are above the diaphragm, and their qi descends; the liver is below the diaphragm, and its qi ascends. Only when the ascending and descending functions are in harmony can the qi movement be smooth. Moreover, the Foot Jueyin Liver Meridian distributes to the chest and ribs, with branches flowing to the lungs. If the liver fails to disperse qi, and qi stagnates in the liver, the lungs will have difficulty descending qi, leading to cough due to qi reversal. This preparation, while soothing the liver and regulating qi, also has the effect of "strengthening the earth to generate metal," thereby regulating the various organs of the body and achieving a holistic conditioning effect.

[0014] 3. The pharmaceutical composition and preparation for treating nocturnal cough in children described in this invention are pure traditional Chinese medicine preparations and have no toxic side effects.

[0015] 4. The pharmaceutical composition for treating nighttime cough in children described in this invention has a moderate taste and is easily accepted by children.

[0016] 5. The pharmaceutical composition and preparation for treating nocturnal cough in children described in this invention are inexpensive, have good efficacy, and require a short treatment period. Detailed Implementation

[0017] The present invention will be further described below with reference to the embodiments, but the present invention is not limited to the embodiments. Example 1

[0018] A pharmaceutical composition for treating nighttime cough in children, comprising the following components: Bupleurum chinense 6g, Paeonia lactiflora 6g, Citrus aurantium 5g, stir-fried germinated barley 9g, stir-fried malt 9g, Citrus reticulata 6g, Pinellia ternata 6g, Aster tataricus 6g, Cynanchum paniculatum 6g, Peucedanum praeruptorum 6g, Trichosanthes kirilowii 5g, Ophiopogon japonicus 6g, fermented soybean 6g, and prepared licorice root 5g. Example 2

[0019] A pharmaceutical composition for treating nocturnal cough in children, comprising the following components: Bupleurum chinense 3g, Paeonia lactiflora 3g, Citrus aurantium 3g, stir-fried germinated barley 6g, stir-fried malt 6g, Citrus reticulata 3g, Pinellia ternata 3g, Aster tataricus 3g, Cynanchum paniculatum 3g, Peucedanum praeruptorum 3g, Trichosanthes kirilowii 3g, Ophiopogon japonicus 3g, fermented soybean 3g, and prepared licorice root 2g. Example 3

[0020] A pharmaceutical composition for treating nocturnal cough in children, comprising the following components: Bupleurum chinense 15g, Paeonia lactiflora 15g, Citrus aurantium 12g, stir-fried germinated barley 15g, stir-fried malt 15g, Citrus reticulata 12g, Pinellia ternata 12g, Aster tataricus 12g, Cynanchum paniculatum 12g, Peucedanum praeruptorum 12g, Trichosanthes kirilowii 15g, Ophiopogon japonicus 15g, fermented soybean 15g, and Glycyrrhiza uralensis 10g. Example 4

[0021] A pharmaceutical composition for treating nighttime cough in children, comprising the following components: Bupleurum chinense 9g, Paeonia lactiflora 8g, Citrus aurantium 8g, stir-fried germinated barley 10g, stir-fried malt 10g, Citrus reticulata 8g, Pinellia ternata 9g, Aster tataricus 6g, Cynanchum paniculatum 8g, Peucedanum praeruptorum 8g, Trichosanthes kirilowii 9g, Ophiopogon japonicus 9g, fermented soybean 10g, and prepared licorice root 5g. Example 5

[0022] A pharmaceutical composition for treating nocturnal cough in children, comprising the following components: Bupleurum chinense 3g, Paeonia lactiflora 6g, Citrus aurantium 8g, stir-fried germinated barley 10g, stir-fried malt 12g, Citrus reticulata 12g, Pinellia ternata 3g, Aster tataricus 5g, Cynanchum paniculatum 8g, Peucedanum praeruptorum 10g, Trichosanthes kirilowii 15g, Ophiopogon japonicus 3g, fermented soybean 6g, and prepared licorice root 9g. Example 6

[0023] A pharmaceutical composition for treating nocturnal cough in children, comprising the following components: Bupleurum chinense 6g, Paeonia lactiflora 8g, Citrus aurantium 10g, stir-fried germinated barley 12g, stir-fried malt 15g, Citrus reticulata 3g, Pinellia ternata 6g, Aster tataricus 6g, Cynanchum paniculatum 10g, Peucedanum praeruptorum 12g, Trichosanthes kirilowii 3g, Ophiopogon japonicus 6g, fermented soybean 10g, and prepared licorice root 10g. Example 7

[0024] A pharmaceutical composition for treating nocturnal cough in children, comprising the following components: Bupleurum chinense 9g, Paeonia lactiflora 10g, Citrus aurantium 12g, stir-fried germinated barley 15g, stir-fried malt 6g, Citrus reticulata 6g, Pinellia ternata 9g, Aster tataricus 10g, Cynanchum paniculatum 12g, Peucedanum praeruptorum 3g, Trichosanthes kirilowii 5g, Ophiopogon japonicus 9g, fermented soybean 12g, and prepared licorice root 2g. Example 8

[0025] A pharmaceutical composition for treating nighttime cough in children, comprising the following components: Bupleurum chinense 10g, Paeonia lactiflora 15g, Citrus aurantium 3g, stir-fried germinated barley 6g, stir-fried malt 9g, Citrus reticulata 8g, Pinellia ternata 10g, Aster tataricus 12g, Cynanchum paniculatum 3g, Peucedanum praeruptorum 6g, Trichosanthes kirilowii 9g, Ophiopogon japonicus 10g, fermented soybean 15g, and prepared licorice root 3g. Example 9

[0026] A pharmaceutical composition for treating nocturnal cough in children, comprising the following components: Bupleurum chinense 15g, Paeonia lactiflora 3g, Citrus aurantium 5g, stir-fried germinated barley 9g, stir-fried malt 10g, Citrus reticulata 10g, Pinellia ternata 12g, Aster tataricus 3g, Cynanchum paniculatum 6g, Peucedanum praeruptorum 8g, Trichosanthes kirilowii 10g, Ophiopogon japonicus 15g, fermented soybean 3g, and prepared licorice root 5g. Example 10

[0027] A decoction of a pharmaceutical composition for treating nocturnal cough in children is prepared by weighing the medicinal materials according to the weight of any one of the pharmaceutical compositions described in Examples 1-9, and following the steps below: soaking all the medicinal materials in 5 times the amount of cold water for 20 minutes, bringing to a boil over high heat, simmering over low heat for 40 minutes, and reducing to about 60% of the original volume.

[0028] Application Example 1 – Observation on the efficacy of the pharmaceutical composition for treating nocturnal cough in children according to the present invention in treating nocturnal cough in children.

[0029] 1. Clinical data collection

[0030] The 100 cases collected were all from patients in our hospital, including 64 males and 36 females; aged 1 month to 12 years; with a course of illness ranging from 1 day to 3 months; 62 cases had received treatment elsewhere before seeking medical attention, and 38 cases had not received treatment. Clinical manifestations: Coughing occurred at night or after falling asleep, mostly during the hours of Zi (11 PM - 1 AM) and Chou (1 AM - 3 AM); it was an irritating cough, mainly dry, occasionally with sputum, sometimes accompanied by coughing with vomiting, or severe coughing and vomiting; body temperature was normal, there was no difficulty breathing, no cough or only occasional coughing during the day, and mostly no other obvious symptoms; appetite and bowel movements were normal; chest X-ray and blood routine tests were normal. Other diseases with cough as the main symptom (bronchitis, pneumonia, tuberculosis, etc.) were excluded.

[0031] 2. Treatment methods

[0032] One hundred cases were randomly divided into a treatment group and a control group, with 50 cases in each group. There were no statistically significant differences between the two groups in terms of age, disease duration, and disease score (P>0.05), making them comparable.

[0033] Treatment group: The medication administered was a decoction prepared according to the method described in Example 1 and Example 10, taken orally, one dose daily, divided into four administrations: one after breakfast, lunch, and dinner, and one at 10:30 PM. Dosage varied by age group: 0.1-2 years: 15-30 mL / dose; 2-5 years: 60 mL / dose; 5-9 years: 90 mL / dose.

[0034] Control group: received routine treatment, including oral compound methoxyphenamine 20mg, 3 times / day, and oral cetirizine 2.5-5.0mg, once / day.

[0035] 3. Information collection methods: Patient follow-up visits or telephone follow-ups.

[0036] 4. Evaluation criteria:

[0037] (1) TCM syndrome scoring, with the scoring criteria referring to the "Guiding Principles for Clinical Research of New Chinese Medicines". The higher the score, the more severe the cough symptoms: ① Cough symptoms disappear at night and other symptoms disappear, indicating a cure, score 0; ② Cough basically disappears and other symptoms are significantly reduced, indicating a marked effect, score 1; ③ Cough is reduced and other symptoms are slightly reduced, indicating an effect, score 2; ④ Cough does not show significant improvement and other symptoms are not reduced, indicating an ineffectiveness, score 3. Total effective rate = (cured + marked effect + effective) / total number of cases. Compare the two groups of clinical adverse reactions, including dry mouth and tongue, dizziness and discomfort, nausea and vomiting.

[0038] (2) Cough symptom score: The severity of the child’s cough before and 2 weeks after medication was assessed by referring to the cough scoring criteria. The score was based on the intensity and frequency of the cough. The lower the score, the better the effect: 0 points for no cough symptoms; 1 point for occasional or short-term cough at night; 2 points for frequent cough that slightly affects normal life; 3 points for frequent cough that seriously affects daily activities and worsens at night.

[0039] 5. Treatment effect: Observe the effect after taking 2-4 doses of medicine.

[0040] 6. Results

[0041] In the treatment group, 35 cases were cured (cough disappeared, the child was normal, and there was no recurrence within 3 months), 10 cases improved (cough was significantly reduced, including marked and effective), and 5 cases were not cured (cough did not change, ineffective), with a total effective rate of 90%. The total effective rate in the control group was 60%, and the recurrence rate was higher, as shown in Table 1.

[0042]

[0043]

[0044] Table 2 shows that both the control group and the treatment group reduced cough severity and TCM symptom scores, but the degree of reduction differed between the two groups: ① Compared with the control group, the treatment group showed a greater reduction in cough severity scores, and the difference between the two groups was statistically significant. P <0.05; ② Compared with the control group, the TCM syndrome score of the treatment group decreased more significantly, and the difference between the two groups was statistically significant. P <0.05.

[0045] In summary, the decoction of the composition described in this invention has significant clinical efficacy in treating nocturnal cough in children, with an effective rate of 90%, and no adverse reactions were found.

[0046] Application Example 2 – Clinical Case of Using the Pharmaceutical Composition of the Present Invention for Treating Nighttime Cough in Children

[0047] Case 1: Patient Liu, male, 8 years old, developed fever, cough, sore throat, normal bowel movements and urination 10 days ago after catching a cold. His tongue was red with a thin white and slightly dry coating, and his pulse was wiry. After two days of symptomatic treatment with Western medicine, his body temperature returned to normal and his sore throat disappeared. However, his cough changed from daytime to nighttime, occurring between 1 and 2 a.m., and he became restless, kicked off his blankets, and lost his appetite. This continued for eight days. After visiting our hospital, we prescribed the drug composition described in Example 1 and instructed the patient to prepare the decoction orally according to the method described in Example 10. He took 90 mL of the decoction at 10:30 p.m. that night. His cough was somewhat relieved, and his restlessness was significantly alleviated. After taking two doses, his cough stopped, he regained his appetite, and all symptoms disappeared.

[0048] Case 2: Patient Zhang, male, 3 years old, developed a cough with copious white phlegm 8 days prior after catching a cold. The cough occurred both day and night, worse at night. He also experienced poor appetite, restlessness, and normal bowel movements. His tongue was pale red with a thin, slightly dry white coating, and his pulse was wiry. At 10:30 PM on the night of his visit, he took 60 mL of the decoction. Half an hour later, his cough began to lessen, and his restlessness significantly improved. After taking one dose the next day, the cough stopped, he regained his appetite, and all symptoms resolved. The medication used in this case was the drug composition described in Example 6. The patient was instructed to prepare the decoction according to the method described in Example 10.

[0049] Case 3: Patient Li, female, 5 years old, developed fever, cough, runny nose, and sneezing 6 days prior after catching a cold. Her bowel movements were normal. Her tongue was pale red with a thin white, floating, and tight coating. After one day of symptomatic treatment with Western medicine, her temperature returned to normal, and all symptoms except the cough disappeared. The cough shifted from daytime to nighttime, occurring between 11 PM and 3 AM, accompanied by restlessness, kicking off the covers, and loss of appetite. This continued for 5 days. Both Chinese and Western medicine treatments were ineffective. She was then treated at our hospital and given a decoction of the prepared composition. She took 60 mL of the decoction at 10:30 PM that night, and the cough lessened, and the restlessness significantly improved. After taking three doses, the cough stopped, her appetite returned, and all symptoms resolved. The medication used in this case was the drug composition described in Example 9. The patient was instructed to prepare the decoction according to the method described in Example 10.

Claims

1. A pharmaceutical composition for treating nighttime cough in children, characterized in that, By weight, it consists of the following components: Bupleurum chinense 3-15 parts, Paeonia lactiflora 3-15 parts, Citrus aurantium 3-12 parts, stir-fried germinated barley 6-15 parts, stir-fried malt 6-15 parts, Citrus reticulata peel 3-12 parts, Pinellia ternata 3-12 parts, honey-processed Aster tataricus 3-12 parts, Cynanchum paniculatum 3-12 parts, Peucedanum praeruptorum 3-12 parts, Trichosanthes kirilowii 3-15 parts, Ophiopogon japonicus 3-15 parts, fermented soybean 3-15 parts, and prepared licorice root 2-10 parts.

2. The pharmaceutical composition for treating nocturnal cough in children according to claim 1, characterized in that, By weight, it consists of the following components: Bupleurum chinense 3-10 parts, Paeonia lactiflora 6-15 parts, Citrus aurantium 3-10 parts, stir-fried germinated barley 9-15 parts, stir-fried malt 9-15 parts, Citrus reticulata peel 3-10 parts, Pinellia ternata 3-9 parts, Aster tataricus 5-10 parts, Cynanchum paniculatum 3-10 parts, Peucedanum praeruptorum 3-10 parts, Trichosanthes kirilowii 3-10 parts, Ophiopogon japonicus 6-12 parts, fermented soybean 6-12 parts, and Glycyrrhiza uralensis 3-9 parts.

3. The pharmaceutical composition for treating nocturnal cough in children according to claim 2, characterized in that, By weight, it consists of the following components: Bupleurum chinense 6-10 parts, Paeonia lactiflora 6-10 parts, Citrus aurantium 5-10 parts, stir-fried germinated barley 9-15 parts, stir-fried malt 9-15 parts, Citrus reticulata peel 6-10 parts, Pinellia ternata 6-10 parts, honey-processed Aster tataricus 6-10 parts, Cynanchum paniculatum 6-10 parts, Peucedanum praeruptorum 6-10 parts, Trichosanthes kirilowii 5-10 parts, Ophiopogon japonicus 6-10 parts, fermented soybean 6-10 parts, and prepared licorice root 5-10 parts.

4. A formulation of the pharmaceutical composition for treating nocturnal cough in children according to any one of claims 1 to 3, characterized in that, The formulation is prepared by adding pharmaceutically acceptable excipients to the pharmaceutical composition.

5. The formulation of the pharmaceutical composition for treating nocturnal cough in children according to claim 4, characterized in that, The preparation is a decoction.

6. A method for preparing the formulation of the pharmaceutical composition for treating nocturnal cough in children according to claim 5, characterized in that, Includes the following steps: Soak all the medicinal materials in 5 times the amount of cold water for 20 minutes, bring to a boil over high heat, simmer over low heat for 40 minutes, and reduce to 60% of the original volume.

7. The use of the pharmaceutical composition for treating nocturnal cough in children according to any one of claims 1 to 3 in the preparation of a medicament for treating nocturnal cough in children.

8. The use of the formulation of the pharmaceutical composition for treating nocturnal cough in children according to claim 4 in the preparation of a medicament for treating nocturnal cough in children.

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