Bamboo juice and radix tetrastigme composition for treating infantile common cold and high fever

Abstract

The invention belongs to the technical field of traditional Chinese medicine application, and provides a bamboo juice and radix tetrastigme composition for treating common cold and high fever in children. The composition of the bamboo juice and the radix tetrastigme provided by the invention has an obvious effect of quickly relieving the common cold and high fever in children, and provides a new medicine for treating common cold and fever in children; the pharmaceutical composition can be taken orally and is high in safety.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine application technology, and relates to a traditional Chinese medicine composition for treating colds in children. Background Technology

[0002] The information disclosed in this background section is intended to enhance understanding of the overall background of the invention and is not necessarily to be construed as an admission or in any way implying that such information constitutes prior art known to those skilled in the art.

[0003] The common cold is a frequent and prevalent illness in children, and high fever is the most common symptom. Clinically, the commonly used method is to inject steroid medications to lower the temperature. However, both the method of administration (injection) and the medications used can pose certain risks to children. Therefore, oral administration and the selection of safe drugs have always been the focus of drug development for treating colds and fevers in children.

[0004] Bamboo sap is the liquid naturally extracted from the stems of several species of the same genus, including *Phyllostachys edulis* and *Phyllostachys bambusoides*, after heating. It is sweet and cold in nature, and enters the heart, lung, and stomach meridians. It has the functions of clearing heat and resolving phlegm, calming the nerves and promoting urination. It is used for cough with excessive phlegm due to lung heat, high fever with thirst, shortness of breath, and chest tightness. *Trifolium repens* is the fresh or dried tuberous root of *Cephalotaxus fortunei*, a plant in the vitiaceae family. It is slightly bitter and neutral in nature. It enters the liver and lung meridians; it has the functions of clearing heat and detoxifying, reducing swelling and relieving pain, and resolving phlegm and dissipating nodules. It is used for infantile high fever with convulsions and whooping cough.

[0005] From the perspective of modern pharmacology and clinical application, bamboo sap has not been found to have a significant effect in lowering body temperature, but it is effective in relieving cough and expectoration. Trifoliate orange only has a certain effect in lowering body temperature, and its effect on reducing high fever is not significant. Summary of the Invention

[0006] In order to provide a new option for treating high fever caused by colds in children, the present invention provides a traditional Chinese medicine composition that has a significant therapeutic effect on treating colds and fever in children. This composition can be used alone or in combination with other traditional Chinese medicines for the treatment of colds in children.

[0007] To achieve the above objectives, the present invention adopts the following technical solution.

[0008] Application of bamboo sap and trifoliate orange in the preparation of antipyretics or cold medicines for children.

[0009] The antipyretic medication is used to treat fever caused by the common cold or influenza.

[0010] The cold mentioned refers to the common cold or influenza; it plays a role in rapidly lowering body temperature in cold medicines.

[0011] The mass ratio of bamboo sap to *Trifolium repens* is (1-10):(1-10); preferably, the mass ratio of bamboo sap to *Trifolium repens* is (5-10):(5-10); more preferably, the mass ratio of bamboo sap to *Trifolium repens* is 9:6.

[0012] A traditional Chinese medicine composition is made from the following raw materials in parts by weight: 1-10 parts of bamboo sap and 1-10 parts of *Trifolium repens*.

[0013] Preferably, the above-mentioned traditional Chinese medicine composition is made from the following raw materials in parts by weight: 6-10 parts of bamboo sap and 6-10 parts of *Trifolium repens*.

[0014] More preferably, the above-mentioned traditional Chinese medicine composition is made from the following raw materials in parts by weight: 9 parts bamboo sap and 6 parts *Trifolium repens*.

[0015] The traditional Chinese medicine composition is used to treat fever caused by the common cold or influenza.

[0016] The preparation method of the above-mentioned traditional Chinese medicine composition includes the following steps: a) Obtained by uniformly mixing bamboo sap or dried bamboo sap with *Trifolium repens* powder; or, b) Obtain by uniformly mixing bamboo sap or dried bamboo sap with the extract of *Trifolium repens*.

[0017] Preferably, the extract of *Trifolium repens* is prepared by the following method: Extract the *Tripterygium wilfordii* by adding 8-10 times its weight of water or 30% v / v-95% v / v ethanol solution. Concentrate or dry the extract to obtain the final extract.

[0018] The extraction method is at least one of the following: immersion, percolation, or reflux.

[0019] A drug containing the above-mentioned traditional Chinese medicine composition.

[0020] The present invention has the following advantages: the combination of bamboo sap and trifoliate orange provided by the present invention has a significant effect on quickly relieving high fever in children with colds, and provides a new drug for treating colds and fever in children; it can be administered orally and has high safety. Detailed Implementation

[0021] The present invention will be further described below with reference to the embodiments, but the present invention is not limited to the following embodiments.

[0022] Example 1: Preparation of a composition of bamboo sap and *Trifolium repens* Take 60g of *Trifolium repens*, add water and decoct twice. Add 10 times the amount of water for the first decoction and 8 times the amount of water for the second decoction. Decoction for 1 hour each time. Combine the decoctions and concentrate them into a clear paste. Add 90g of bamboo sap to the San Ye Qing Qing Gao, mix well, dry at low temperature, grind finely, add an appropriate amount of dextrin to 95g, mix well, and obtain composition 1.

[0023] Example 2: Preparation of a composition of bamboo sap and *Trifolium repens* Take 60g of *Trifolium repens*, add 30% ethanol and heat under reflux to extract twice. Add 10 times the amount of ethanol for the first extraction and 8 times the amount for the second extraction. Extract for 1 hour each time. Combine the extracts, recover the ethanol and concentrate to a clear extract. Add 90g of bamboo sap to the San Ye Qing Qing Gao, mix well, dry at low temperature, grind finely, add an appropriate amount of dextrin to 95g, mix well, and obtain composition 2.

[0024] Example 3 Preparation of a composition of bamboo sap and three-leaf green leaves Take 60g of *Trifolium repens*, add 75% ethanol and heat under reflux to extract twice. Add 10 times the amount of ethanol for the first extraction and 8 times the amount for the second extraction. Extract for 1 hour each time. Combine the extracts, recover the ethanol and concentrate to a clear extract. Add 90g of bamboo sap to the San Ye Qing Qing Gao, mix well, dry at low temperature, grind finely, add an appropriate amount of dextrin to 95g, mix well, and obtain composition 3.

[0025] Example 4: Preparation of a composition of bamboo sap and three-leaf green. Take 60g of *Trifolium repens*, add 95% ethanol and heat under reflux to extract twice. Add 10 times the amount of ethanol for the first extraction and 8 times the amount for the second extraction. Extract for 1 hour each time. Combine the extracts, recover the ethanol and concentrate to a clear extract. Add 90g of bamboo sap to the San Ye Qing Qing Gao, mix well, dry at low temperature, grind finely, add an appropriate amount of dextrin to 95g, mix well, and obtain composition 4.

[0026] Example 5: Antipyretic effect of the combination of bamboo sap and *Trifolium repens* on a rat fever model. 1. Preparation of the medicinal solution Take the compositions from Examples 1-4, dissolve them in water, and prepare a medicinal solution containing 1.5g of Chinese medicine per 1mL.

[0027] Take bamboo sap, add water, and make a medicinal solution containing 0.90g of bamboo sap in 1mL.

[0028] Take 60g of Clematis armandii, add water and decoct twice. Add 10 times the amount of water for the first decoction and 8 times the amount of water for the second decoction. Decoction for 1 hour each time. Combine the decoctions, concentrate them, add water, and make 1mL of decoction containing 0.60g of Clematis armandii.

[0029] Take 60g of Clematis armandii, add 75% ethanol and heat under reflux to extract twice. Add 10 times the amount of ethanol for the first extraction and 8 times the amount of water for the second extraction. Extract for 1 hour each time. Combine the extracts, recover the ethanol, concentrate, add water, and prepare a 1mL solution containing 0.60g of Clematis armandii.

[0030] Take aspirin tablets, grind them into a fine powder, add water, and make a solution containing 0.1g of aspirin in 1mL.

[0031] 2. Animal Model Construction SD rats, weighing (200±20) g each, were used, with half males and half females. Rectal temperature was measured using an electronic thermometer two days prior to the experiment, once daily for three consecutive days. Rats with body temperatures between 36.6 and 38.3℃, with fluctuations within 0.2℃, were selected, and their average temperature was used as the pre-drug administration temperature. Subsequently, a 20% yeast suspension (10 mL / kg) was injected subcutaneously. Rectal temperature was measured in all rats 5 hours later, and rats with a temperature increase of more than 1℃ were selected for the experimental study.

[0032] 3. Experimental Grouping Rats were randomly divided into 7 groups of 10 rats each: blank control group (water), aspirin positive control group (0.1 g / kg), Example 2 group (15 g crude drug / kg), Example 3 group (15 g crude drug / kg), bamboo sap group (9 g crude drug / kg), *Trifolium repens* water extract group (6 g crude drug / kg), and *Trifolium repens* alcohol extract group (6 g crude drug / kg). All rats were then administered the corresponding drugs by gavage. Body temperature was measured at 1, 2, 3, 4, and 5 hours after administration. The average body temperature before administration was used as the basal body temperature. Changes in body temperature at each measurement time point were calculated and compared. The results are shown in Table 1.

[0033] Table 1. Antipyretic effect of bamboo sap and trifoliate orange in rats Note: ★ P <0.05, ★★ P <0.01.

[0034] Table 1 shows that the combination of bamboo sap and *Trifolium repens* exhibits good antipyretic effects. Whether using the water extract or the three ethanol concentrations of *Trifolium repens* extract, the combination with bamboo sap shows a significant antipyretic effect one hour after administration, showing a significant difference compared to the blank control group but no significant difference compared to the aspirin group, indicating that the combination of bamboo sap and *Trifolium repens* has a rapid antipyretic effect. During the 5-hour observation period, the combination of bamboo sap and *Trifolium repens* consistently showed good antipyretic effects. The bamboo sap group showed some antipyretic effect, which took 3 hours to take effect; the water extract and 75% ethanol extract of *Trifolium repens* also showed some antipyretic effects, but the onset was slower. The bamboo sap group took 2 hours to take effect, the water extract took 4 hours, and the 75% ethanol extract took 3 hours. These results indicate that the combination of bamboo sap and *Trifolium repens* can exert a synergistic effect, enhancing the antipyretic effect and resulting in a better and faster antipyretic speed.

[0035] Application Example 1: The combination of bamboo sap and *Trifolium repens* was used for treating colds and fever in children. General information: 38 patients aged 2-10 years, with body temperatures ranging from 38.8℃ to 39.6℃; 30 boys and 26 girls. Patients were administered bamboo sap and *Trifolium repens* combination prepared according to Examples 1 and 2, respectively, along with ibuprofen suspension (Motrin, 100mL:2g). The bamboo sap and *Trifolium repens* combination group received an equivalent of 9g of bamboo sap and 6g of *Trifolium repens* three times daily. Example 2 group consisted of 18 patients, and Example 3 group consisted of 20 patients.

[0036] Efficacy criteria: Cure criteria: Body temperature returns to normal within 3 days after taking the medicine and does not recur.

[0037] Table 2. Therapeutic effects of the combination of bamboo sap and trifoliate orange on high fever due to cold. Table 2 shows that the combination of bamboo sap and *Trifolium repens* can relieve high fever caused by colds in a relatively short time. The effective rates of restoring body temperature to normal within 2 hours were 33% and 45%, respectively; within 4 hours, the effective rates were 78% and 90%, respectively; and within 24 hours, the effective rates of restoring body temperature to normal without recurrence were 89% and 95%, respectively. Compared to the ibuprofen suspension group, the combination of bamboo sap and *Trifolium repens* had a slower antipyretic speed (the effective rate of ibuprofen suspension within 2 hours was 56%), but the antipyretic effect of the combination group was more prolonged. After 24 hours, 44% of patients in the ibuprofen suspension group experienced a recurrence of body temperature, while only 1 patient (2.6%) in the combination group experienced a recurrence of body temperature. Therefore, bamboo sap and *Trifolium repens* are superior to commonly used clinical agents in suppressing recurrent high fever in children.

[0038] Example 6 Preparation of a composition of bamboo sap and three-leaf green leaves Take 50g of Clematis armandii, add 30% ethanol and heat under reflux to extract twice. Add 10 times the amount of 70% ethanol for the first extraction and 8 times the amount of 70% ethanol for the second extraction. Extract for 1 hour each time. Combine the extracts, recover the ethanol and concentrate to a clear extract. Take 100g of bamboo sap, freeze-dry it, pulverize it into a fine powder, then add it to the San Ye Qing Qing paste, mix well, dry it at low temperature, grind it into a fine powder, add an appropriate amount of dextrin to 95g, mix well, and obtain the composition; it can significantly reduce the body temperature of fever model rats.

[0039] Example 7 Preparation of a composition of bamboo sap and three-leaf green leaves Take 70g of Clematis armandii, add 30% ethanol and heat under reflux to extract twice. Add 10 times the amount of 75% ethanol for the first extraction and 8 times the amount of 75% ethanol for the second extraction. Extract for 1 hour each time. Combine the extracts, recover the ethanol and concentrate to a clear extract. Add 80g of bamboo sap to the San Ye Qing Qing Gao (a traditional Chinese medicine paste), mix well, dry at low temperature, grind finely, add an appropriate amount of dextrin to 95g, mix well, and obtain the composition; it can significantly reduce the body temperature of fever model rats.

[0040] Example 8 Preparation of a composition of bamboo sap and three-leaf green leaves Take 80g of Clematis armandii, add 30% ethanol and heat under reflux to extract twice. Add 10 times the amount of 50% ethanol for the first extraction and 8 times the amount of 50% ethanol for the second extraction. Extract for 1 hour each time. Combine the extracts, recover the ethanol and concentrate to a clear extract. Add 70g of bamboo sap to the San Ye Qing Qing Gao (a traditional Chinese medicine formula), mix well, dry at low temperature, grind finely, add an appropriate amount of dextrin to 95g, mix well, and obtain the composition; it can significantly reduce the body temperature of fever model rats.

[0041] Example 9 Preparation of a composition of bamboo sap and three-leaf green leaves Take 90g of Clematis armandii, add 30% ethanol and heat under reflux to extract twice. Add 10 times the amount of 75% ethanol for the first extraction and 8 times the amount of 50% ethanol for the second extraction. Extract for 1 hour each time. Combine the extracts, recover the ethanol and concentrate to a clear extract. Add 60g of bamboo sap to the San Ye Qing Qing Gao (a traditional Chinese medicine paste), mix well, dry at low temperature, grind finely, add an appropriate amount of dextrin to 95g, mix well, and obtain the composition; it can significantly reduce the body temperature of fever model rats.

[0042] Example 10 Preparation of a composition of bamboo sap and *Trifolium repens* Take 100g of Clematis armandii, add 30% ethanol and heat under reflux to extract twice. Add 10 times the amount of 75% ethanol for the first extraction and 10 times the amount of 50% ethanol for the second extraction. Extract for 1 hour each time. Combine the extracts, recover the ethanol and concentrate to a clear extract. Add 50g of bamboo sap to the San Ye Qing Qing Gao (a traditional Chinese medicine paste), mix well, dry at low temperature, grind finely, add an appropriate amount of dextrin to 95g, mix well, and obtain the composition; it can significantly reduce the body temperature of fever model rats.

[0043] The above description is merely an embodiment of this application and is not intended to limit the scope of this application. Various modifications and variations can be made to this application by those skilled in the art. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of this application should be included within the scope of the claims of this application.

Claims

1. Application of bamboo sap and trifoliate orange in the preparation of antipyretics or cold medicines for children.

2. The application according to claim 1, characterized in that, The antipyretic medication is used to treat fever caused by the common cold or influenza.

3. The application according to claim 2, characterized in that, The cold mentioned refers to the common cold or influenza; bamboo sap and trifoliate orange peel have a rapid effect in lowering body temperature in cold medicines.

4. The application according to claim 1, characterized in that, The mass ratio of bamboo sap to *Trifolium repens* is (1-10):(1-10); (5-10):(5-10); or 9:

6.

5. A traditional Chinese medicine composition, characterized in that, It is made from the following ingredients in parts by weight: 1-10 parts bamboo sap and 1-10 parts three-leaf green.

6. The traditional Chinese medicine composition according to claim 5, characterized in that, It is made from the following raw materials in parts by weight: 6-10 parts bamboo sap and 6-10 parts three-leaf green; or, 9 parts bamboo sap and 6 parts three-leaf green.

7. The traditional Chinese medicine composition according to claim 5, characterized in that, The traditional Chinese medicine composition is used to treat fever caused by the common cold or influenza.

8. A method for preparing a traditional Chinese medicine composition as described in any one of claims 5-7, characterized in that, Includes the following steps: a) Obtained by uniformly mixing bamboo sap or dried bamboo sap with *Trifolium repens* powder; or, b) Obtain by uniformly mixing bamboo sap or dried bamboo sap with the extract of *Trifolium repens*.

9. The preparation method according to claim 8, characterized in that, The extract of *Trifolium repens* was prepared by the following method: Extract the Tripterygium wilfordii by adding 8-10 times its weight of water or 30% v / v-95% v / v ethanol solution. The extract is obtained by concentrating or drying the extract. The extraction method is at least one of the following: immersion, percolation, or reflux.

10. A medicine comprising the traditional Chinese medicine composition as described in any one of claims 5-7.

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