Traditional Chinese medicine compound preparation and preparation method thereof

Abstract

The invention discloses a traditional Chinese medicine compound preparation and a preparation method thereof. The compound preparation is prepared from, by weight, 6-10 parts of herba ephedrae, 9-12 parts of semen armeniacae amarae, 6-9 parts of radix platycodonis, 9-15 parts of cortex mori, 6-10 parts of fritillary bulb, 10-15 parts of thorny elaeagnus leaf, 12-18 parts of herba ardisiae japonicae, 9-12 parts of folium eriobotryae, 15-30 parts of herba houttuyniae, 6-10 parts of caulis bambusae in taeniam, 6-9 parts of pericarpium citri reticulatae, 3-6 parts of spearmint and 3-6 parts of radix glycyrrhizae. The traditional Chinese medicine compound preparation disclosed by the invention creatively integrates the three effects of diffusing the lung, dispelling wind, clearing heat, reducing phlegm, moistening dryness and relieving asthma, and has a good effect in the aspect of treating exogenous cough with symptoms of acute and chronic bronchitis and cough after cold.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine technology, specifically to a traditional Chinese medicine compound preparation for treating cough due to exogenous pathogens, acute and chronic bronchitis, and post-cold cough, and its preparation method. Background Technology

[0002] External cough is a type of cough, mostly caused by exposure to wind-cold, wind-heat, or wind-dryness. Specifically, in Traditional Chinese Medicine (TCM), external cough refers to cough caused by exposure to external pathogenic factors, namely the six pathogenic factors: wind, cold, summer heat, dampness, dryness, and fire. Cough itself is divided into internal and external types, with external cough being the relative distinction between internal and external causes. Symptoms of external cough include itchy throat, throat congestion, and coughing, sometimes with white or yellow phlegm. Other symptoms include nasal congestion, runny nose, and other upper respiratory tract infection symptoms. Some patients may also experience fever and chills.

[0003] Currently, treatment mainly employs methods to dispel wind and cold, clear wind and heat, and moisten the lungs and relieve dryness. Commonly used medications include Xing Su San, Sang Xing Tang, and San Ao Tang, but the specific treatment should be determined based on a comprehensive assessment of the individual's tongue coating, pulse, and other characteristics. When coughing, it is crucial to avoid spicy foods and exposure to wind and cold to prevent catching a chill or developing a fever. Therefore, consuming fruits that nourish yin and moisten the lungs, such as pears and watermelons, is beneficial. Appropriate exercise helps strengthen the body's immunity.

[0004] Coughs caused by external pathogens can be mainly classified into the following types: Cough due to wind-cold: The onset is relatively rapid, with itchy throat and cough, thin white or sticky phlegm that is copious and easy to cough up, nasal congestion and runny nose, or chills and fever, body aches, thin white tongue coating, floating pulse, etc.

[0005] Wind-heat cough: Symptoms include thick yellow or sticky white phlegm, dry mouth and sore throat, fever and aversion to wind, thin yellow tongue coating, and floating and rapid pulse.

[0006] Cough due to lung heat: Cough due to lung heat has a lot of phlegm, the phlegm is yellow and sticky, the breath is hot from the mouth and nose, the mouth is bitter and the throat is dry, the throat is swollen and sore, and even shortness of breath when there is a high fever.

[0007] Dry cough due to lung dryness: Dry cough with little or no phlegm, itchy and sore throat, and may initially be accompanied by chills, fever, and headache.

[0008] Current status of cough: Coughs caused by external pathogens are mostly due to wind invading the lungs and phlegm obstructing the flow of qi. Existing Western medicines have problems such as strong dependence and large side effects.

[0009] Existing Chinese medicine treatments for coughs have the following shortcomings: traditional formulas such as Zhike San and Xingsu San are not effective for coughs caused by phlegm-heat in the lungs or wind-dryness damaging the lungs.

[0010] Therefore, a new compound preparation is needed to improve the shortcomings of existing traditional Chinese medicine. Summary of the Invention

[0011] To address the aforementioned problems, this invention provides a traditional Chinese medicine compound preparation and its preparation method, specifically a traditional Chinese medicine preparation for treating exogenous cough, acute and chronic bronchitis, and post-cold cough.

[0012] In a first aspect, the present invention discloses a traditional Chinese medicine compound preparation based on relieving cough and asthma by clearing the lungs and resolving phlegm. The compound preparation comprises the following medicinal ingredients in parts by weight: Ephedra 6-10 parts, Bitter Almond 9-12 parts, Platycodon 6-9 parts, Mulberry Bark 9-15 parts, Fritillaria 6-10 parts, Elaeagnus Leaf 10-15 parts, Lysimachia christinae 12-18 parts, Loquat Leaf 9-12 parts, Houttuynia cordata 15-30 parts, Bamboo Shavings 6-10 parts, Tangerine Peel 6-9 parts, Spearmint 3-6 parts, and Licorice 3-6 parts.

[0013] On the other hand, the present invention also discloses a method for preparing the above-mentioned traditional Chinese medicine compound preparation, which includes the following steps: S1. Put the prescribed amount of herbs Elaeagnus pungens leaves, dwarf tea, apricot kernel, spearmint, dried tangerine peel, and houttuynia cordata into an extraction tank, add an appropriate amount of water, heat and extract the volatile oil for 1-3 hours, filter the distilled water extract and collect it in a separate container. S2. Add an appropriate amount of ethanol solution to the volatile oil, mix well, then add the stabilizer, keep at 10-20℃, stir for 1-2 hours, and then refrigerate at 2-8℃ to obtain a volatile oil mixture. S3. Add 8-10 times the amount of water to the prescribed amount of medicinal materials Platycodon grandiflorus, Morus alba root bark, Eriobotrya japonica leaf, Ephedra sinica, Bambusa textilis, Glycyrrhiza uralensis, and dregs. Decoction twice, 1-2 hours each time. Combine the decoctions and filter. Combine the filtrate with the distilled aqueous solution and concentrate to a relative density of 1.1-1.2. Add 0.1-1% flocculant and stir for 0.5-1 hour. Then let it stand at 10-20℃ for 10-12 hours to precipitate. After that, centrifuge and filter. Concentrate the filtrate to a relative density of 1.15-1.45 to obtain the clear extract. S4. Bake the fritillaria bulb at 40-50℃ for 4-8 hours, then grind it into a very fine powder using a grinder and set aside for later use; S5. Add appropriate excipients, fritillaria powder, and volatile oil extracted in step S1 to the ointment, and use a suitable preparation process to add appropriate excipients to make granules, oral liquids, syrups, mixtures, capsules, or tablets.

[0014] Preferably, the stabilizer is one or more of hydroxypropyl β-cyclodextrin, β-cyclodextrin, and sulfobutyl β-cyclodextrin. Preferably, the amount of stabilizer is 10-50% of the volatile oil content.

[0015] Preferably, the flocculant is one or more of chitosan, gum arabic, agar, methylcellulose, and hydroxypropyl methylcellulose.

[0016] Preferably, the excipients are one or more of dextrin, mannitol, lactose, sucrose, croscarmellose sodium, ethanol, Tween 80, and potassium sorbate.

[0017] Preferably, in step S5, the volatile oil mixture is added when the material temperature reaches 35-38°C.

[0018] Preferably, the volatile oil is added by spraying when preparing granules, capsules, or tablets.

[0019] Preferably, when preparing oral liquids, syrups, or compound preparations, an appropriate amount of stabilizer is added before the volatile oil is added to the materials, and then added to the solution.

[0020] Compared with the prior art, the beneficial effects of the present invention are: The main innovation of the traditional Chinese medicine compound preparation disclosed in this invention is the innovative integration of the three effects of dispelling wind and clearing heat, resolving phlegm, and moistening dryness and relieving asthma. It has good effects in treating exogenous cough, with symptoms including acute and chronic bronchitis and post-cold cough. Specifically: (1) Elaeagnus pungens leaves are a folk remedy for cough relief. When combined with dwarf ground ivy tea (for expectoration and cough relief), it enhances the cough relief effect. (2) Spearmint has the effect of relieving wind and soothing the throat. Compared with the peppermint used in traditional formulas, it has the dual effect of antibacterial and taste. (3) Bamboo shavings and houttuynia cordata have the effect of strengthening lung heat, and have a good effect on the high incidence of phlegm-heat syndrome in modern people.

[0021] The basic principles of monarch, minister, assistant, and guide in the composition (weight) of traditional Chinese medicine prescriptions are as follows: The principal ingredient, ephedra 6-10g, has the effect of ventilating the lungs and relieving asthma, while bitter almond 9-12g has the effect of lowering qi and relieving cough. The auxiliary herbs are Platycodon grandiflorus 6-9, which has the effect of clearing the lungs and eliminating phlegm; Morus alba root bark 9-15, which has the effect of purging the lungs and relieving asthma; and Fritillaria cirrhosa 6-10, which has the effect of clearing heat and moistening the lungs. The adjuvant herbs are: Elaeagnus pungens leaves 10-15g for antitussive effect, Dioscorea opposita leaves 12-18g for expectorant effect, Eriobotrya japonica leaves 9-12g for lung-clearing and stomach-soothing effect, Houttuynia cordata leaves 15-30g for heat-clearing and detoxifying effect, Bambusa textilis 6-10g for clearing heat and phlegm, and Citrus reticulata peel 6-9g for regulating qi and drying dampness. The main ingredients are spearmint 3-6, which has the effect of dispelling evil and relieving sore throat, and licorice 3-6, which has the effect of harmonizing the effects of other herbs.

[0022] Meanwhile, in order to adapt to the complex symptoms of exogenous cough and achieve comprehensive consideration, this invention also aims to reduce the side effects of various medicinal materials and ensure medication safety. Thirdly, through compatibility analysis, the effects of the herbal formula in this invention can be better utilized. The specific compatibility principle of this invention is as follows: The pathogenesis of the disease is as follows: external pathogenic factors invade the lungs, lung qi rises in reverse, cough occurs, and lung heat obstructs the lungs, lung qi fails to circulate, phlegm and turbidity obstruct the flow of fluids, and wind and dryness injure the body fluids.

[0023] Fritillaria, bamboo shavings, and houttuynia cordata - for lung heat stagnation; ephedra, platycodon, and apricot kernel - for impaired lung function; mulberry bark, platycodon, and apricot kernel - for phlegm obstruction; oleaster leaf and loquat leaf - for wind-dryness damaging body fluids; licorice and spearmint - for harmonizing the effects of other herbs. Detailed Implementation

[0024] The technical solutions of the present invention will be clearly and completely described below with reference to the embodiments of the present invention. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments.

[0025] Example 1 The traditional Chinese medicine compound preparation disclosed in this embodiment is an oral liquid preparation.

[0026] The prescription for the oral liquid preparation is as follows: Ephedra 600g, bitter almond 900g, Platycodon grandiflorus 600g, mulberry bark 900g, fritillaria 600g, Elaeagnus pungens leaf 1000g, dwarf tea 1200g, loquat leaf 900g, houttuynia cordata 1500g, bamboo shavings 600g, tangerine peel 600g, spearmint 300g, and licorice 300g.

[0027] The preparation method of the above-mentioned oral liquid formulation includes the following steps: S1. Put the prescribed amount of herbs Elaeagnus pungens leaves, dwarf tea, almonds, spearmint, dried tangerine peel, and houttuynia cordata into a stainless steel extraction tank, add an appropriate amount of water, heat and extract the volatile oil for 2 hours, filter the distilled water extract and collect it in a separate container. S2. Add an appropriate amount of ethanol solution to the volatile oil, mix well, then add the stabilizer β-cyclodextrin, stir and mix well, keep at 15℃, stir for 2 hours, and then refrigerate at 2-8℃ for 24 hours to obtain the volatile oil mixture. S3. Add 8 times the amount of water to the prescribed amount of medicinal materials Platycodon grandiflorus, Morus alba root bark, Eriobotrya japonica leaf, Ephedra sinica, Bambusa textilis, Glycyrrhiza uralensis, and dregs. Decoct twice, 1.5 hours each time. Combine the decoctions and filter. Combine the filtrate with the distilled aqueous solution and concentrate to a relative density of 1.1-1.2. Add 0.1-1% of the flocculant chitosan and stir for 0.5-1 hour. Then let it stand at 15°C for 10 hours to precipitate. After that, centrifuge and filter. Concentrate the filtrate to a relative density of 1.15-1.25 to obtain the clear extract. S4. Bake the fritillaria bulb at 40℃ for 4 hours, then grind it into a very fine powder using a grinder and set aside. S5. Preparation of oral liquid: Add the volatile oil obtained in steps S1 and S2 to the clear extract, stir evenly while adding and stirring until evenly mixed, then add an appropriate amount of syrup, stir evenly, add water in a measured amount, filter through a 0.45μm filter membrane, then add the ultrafine powder of Fritillaria cirrhosa, stir evenly, fill into 10ml oral liquid bottles (each bottle is equivalent to 30g of raw herb) using a filling machine, and sterilize at 100℃ for 30 minutes to obtain the oral liquid.

[0028] Example 2 The traditional Chinese medicine compound preparation disclosed in this embodiment is a granule preparation.

[0029] The prescription for the granule preparation is as follows: Ephedra 1000g, Bitter Almond 1200g, Platycodon 900g, Mulberry Bark 1500g, Fritillaria 1000g, Elaeagnus Leaf 1500g, Dioscorea Root 1800g, Loquat Leaf 1200g, Houttuynia Cordata 3000g, Bamboo Shavings 1000g, Tangerine Peel 900g, Spearmint 600g, Licorice Root 600g.

[0030] The preparation method of the above-mentioned granule formulation includes the following steps: S1. Put the prescribed amount of herbs Elaeagnus pungens leaves, dwarf tea, almonds, spearmint, dried tangerine peel, and houttuynia cordata into a stainless steel extraction tank, add an appropriate amount of water, heat and extract the volatile oil for 2 hours, filter the distilled water extract and collect it in a separate container. S2. Add an appropriate amount of ethanol solution to the volatile oil, mix well, then add the stabilizer β-cyclodextrin, stir and mix well, keep at 15℃, stir for 2 hours, and then refrigerate at 2-8℃ for 24 hours to obtain the volatile oil mixture. S3. Add the prescribed amount of medicinal materials Platycodon grandiflorus, Morus alba root bark, Eriobotrya japonica leaf, Ephedra sinica, Bambusa textilis, Glycyrrhiza uralensis, and dregs to 8 times the amount of water, decoct twice, 1.5 hours each time, combine the decoctions, and filter. Combine the filtrate with the distilled aqueous solution and concentrate to a relative density of 1.1-1.2. Add 0.1-1% of the flocculant chitosan, stir for 0.5-1 hour, then let it stand at 15°C for 10 hours to precipitate. After that, centrifuge and filter, concentrate the filtrate to a relative density of 1.25-1.45 to obtain the clear extract. S4. Bake the fritillaria bulb at 40℃ for 4 hours, then grind it into a very fine powder using a grinder and set aside. S5. Granule preparation: Add the prescribed amount of fritillaria powder, dextrin, sucrose (powdered), lactose, and croscarmellose sodium. Prepare soft material using a high-speed granulator, then granulate using a high-speed granulator. Dry at 50-60℃ until the moisture content is <3.0%. Spray in the volatile oil prepared in steps (1) and (2), mix evenly, seal and place for 10 hours, then package (each bag is equivalent to 30g of raw herb) to obtain the granules.

[0031] Example 3 The traditional Chinese medicine compound preparation disclosed in this embodiment is a syrup preparation.

[0032] The prescription for the syrup preparation is as follows: Ephedra 500g, bitter almond 1000g, Platycodon grandiflorus 700g, mulberry bark 1200g, fritillaria 800g, Elaeagnus pungens leaf 1200g, dwarf tea 1500g, loquat leaf 1000g, houttuynia cordata 1800g, bamboo shavings 800g, dried tangerine peel 800g, spearmint 500g, and licorice 500g.

[0033] The preparation method of the above-mentioned syrup formulation includes the following steps: S1. Put the prescribed amount of herbs Elaeagnus pungens leaves, dwarf tea, almonds, spearmint, dried tangerine peel, and houttuynia cordata into a stainless steel extraction tank, add an appropriate amount of water, heat and extract the volatile oil for 2 hours, filter the distilled water extract and collect it in a separate container. S2. Add an appropriate amount of ethanol solution to the volatile oil, mix well, then add the stabilizer β-cyclodextrin, stir and mix well, keep at 15℃, stir for 2 hours, and then refrigerate at 2-8℃ for 24 hours to obtain the volatile oil mixture. S3. Add 8 times the amount of water to the prescribed amount of medicinal materials Platycodon grandiflorus, Morus alba root bark, Eriobotrya japonica leaf, Ephedra sinica, Bambusa textilis, Glycyrrhiza uralensis, and dregs. Decoct twice, 1.5 hours each time. Combine the decoctions and filter. Combine the filtrate with the distilled aqueous solution and concentrate to a relative density of 1.1-1.2. Add 0.1-1% of the flocculant chitosan and stir for 0.5-1 hour. Then let it stand at 15°C for 10 hours to precipitate. After that, centrifuge and filter. Concentrate the filtrate to a relative density of 1.15-1.25 to obtain the clear extract. S4. Bake the fritillaria bulb at 40℃ for 4 hours, then grind it into a very fine powder using a grinder and set aside. S5. Syrup preparation: Add the volatile oil obtained in steps (1) and (2) to the clear extract and the very fine powder of fritillaria, stir evenly, then add the volatile oil to the clear extract while stirring until evenly mixed, then add an appropriate amount of syrup and honey, in a quantitative manner, stir evenly, and fill into 100ml oral liquid bottles (ml is equivalent to 3g of raw medicine) using a filling machine.

[0034] Example 4 This example is a treatment efficacy trial.

[0035] Experimental Design: Forty-eight mice, weighing between 18-22g, with equal numbers of males and females, were randomly divided into four groups: Example 1 group, Example 2 group, positive control group, and blank control group. The mice were administered the following formulations via gavage: the formulation invented in Example 1, the formulation invented in Example 2, a commercially available bronchodilator syrup (manufacturer: Chongqing Fuling Pharmaceutical Factory Co., Ltd., Taiji Group; trade name: Taiji), and physiological saline. One hour after administration, concentrated ammonia (approximately 26% concentration) was sprayed into the mice's nostrils for 20 seconds. Immediately after spraying, the mice were removed, and the number of coughs and latency period within 2 minutes were recorded. Specific data are shown in Table 1 below.

[0036] Table 1: Antitussive effects of each experimental preparation on ammonia-induced cough in mice ( ±s) Note: Compared with the control group, *P<0.01, indicating that the treatment example 1 group and the treatment example 2 group have extremely significant therapeutic effects.

[0037] The results showed that the cough incubation period in both Example 1 and Example 2 groups was longer than that in the blank control group, and the number of coughs was significantly less in both groups, while there was no significant difference compared to the positive control group. This indicates that the examples provided by the present invention have significant therapeutic effects.

[0038] The above descriptions are merely some embodiments of the present invention. It should be noted that those skilled in the art can make other modifications and improvements without departing from the inventive concept of the present invention, and these all fall within the protection scope of the present invention.

Claims

1. A traditional Chinese medicine compound preparation, characterized in that, The compound preparation comprises the following medicinal ingredients in parts by weight: Ephedra 6-10 parts, Bitter Almond 9-12 parts, Platycodon 6-9 parts, Mulberry Bark 9-15 parts, Fritillaria 6-10 parts, Elaeagnus Leaf 10-15 parts, Lysimachia christinae 12-18 parts, Loquat Leaf 9-12 parts, Houttuynia cordata 15-30 parts, Bamboo Shavings 6-10 parts, Tangerine Peel 6-9 parts, Spearmint 3-6 parts, and Licorice 3-6 parts.

2. The method for preparing the traditional Chinese medicine compound preparation according to claim 1, characterized in that, The method includes the following steps: S1. Put the prescribed amount of herbs Elaeagnus pungens leaves, dwarf tea, apricot kernel, spearmint, dried tangerine peel, and houttuynia cordata into an extraction tank, add an appropriate amount of water, heat and extract the volatile oil for 1-3 hours, filter the distilled water extract and collect it in a separate container. S2. Add an appropriate amount of ethanol solution to the volatile oil, mix well, then add the stabilizer, keep at 10-20℃, stir for 1-2 hours, and then refrigerate at 2-8℃ to obtain a volatile oil mixture. S3. Add 8-10 times the amount of water to the prescribed amount of medicinal materials Platycodon grandiflorus, Morus alba root bark, Eriobotrya japonica leaf, Ephedra sinica, Bambusa textilis, Glycyrrhiza uralensis, and dregs. Decoction twice, 1-2 hours each time. Combine the decoctions and filter. Combine the filtrate with the distilled aqueous solution and concentrate to a relative density of 1.1-1.

2. Add 0.1-1% flocculant and stir for 0.5-1 hour. Then let it stand at 10-20℃ for 10-12 hours to precipitate. After that, centrifuge and filter. Concentrate the filtrate to a relative density of 1.15-1.45 to obtain the clear extract. S4. Bake the fritillaria bulb at 40-50℃ for 4-8 hours, then grind it into a very fine powder using a grinder and set aside for later use; S5. Add appropriate excipients, fritillaria powder, and volatile oil extracted in step S1 to the ointment, and use a suitable preparation process to add appropriate excipients to make granules, oral liquids, syrups, mixtures, capsules, or tablets.

3. The preparation method according to claim 2, characterized in that, The stabilizer is one or more of hydroxypropyl β-cyclodextrin, β-cyclodextrin, and sulfobutyl β-cyclodextrin.

4. The preparation method according to claim 3, characterized in that, The amount of stabilizer is 10-50% of the volatile oil content.

5. The preparation method according to claim 4, characterized in that, The flocculant is one or more of chitosan, gum arabic, agar, methylcellulose, and hydroxypropyl methylcellulose.

6. The preparation method according to claim 5, characterized in that, The excipients are one or more of dextrin, mannitol, lactose, sucrose, croscarmellose sodium, ethanol, Tween 80, and potassium sorbate.

7. The preparation method according to claim 6, characterized in that, In step S5, the volatile oil is added when the material temperature reaches 35-38℃.

8. The preparation method according to claim 7, characterized in that, When preparing granules, capsules, and tablets, the volatile oil is added by spraying.

9. The preparation method according to claim 7, characterized in that, When preparing oral liquids, syrups, or compound preparations, add an appropriate amount of stabilizer before adding the volatile oil to the materials, and then add it to the solution.

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