Preparation method of Jinhai throat-clearing teabag

Abstract

The invention relates to a preparation method of a Jinhai throat-clearing teabag. The method comprises the following steps: drying harvested honeysuckle flowers; the method comprises the following steps: steaming radix ophiopogonis, and drying; roasting platycodon grandiflorum and radix scrophulariae with honey, and crushing into coarse powder for later use; mixing the honeysuckle, the radix ophiopogonis, the Chinese olive, the dark plum and the boat-fruited sterculia seed, decocting together, filtering decoction, and concentrating under reduced pressure to obtain thick paste; crushing the liquorice into 80-120-mesh fine powder, crushing the green tea into coarse powder, and uniformly mixing the coarse powder with the honey-fried platycodon grandiflorum and the radix scrophulariae; preparing a beta-cyclodextrin inclusion complex of the dementholized peppermint oil; mixing the thick paste, the mixed powder and a beta-cyclodextrin inclusion complex of dementholized peppermint oil, uniformly mixing and granulating; wherein the weight of the honeysuckle flower is 250 g, the weight of the boat-fruited sterculia seed is 83.3 g, the weight of the dwarf lilyturf tuber is 250 g, the weight of the radix scrophulariae roasted with honey is 250 g, the weight of the Chinese olive is 250 g, the weight of the dark plum fruit is 250 g, the weight of the green tea is 83.3 g, the weight of the platycodon grandiflorum roasted with honey is 250 g, the weight of the licorice root is 220 g, and the weight of The Jinhai throat-clearing teabag prepared by the method has the advantages of quick response, high obvious effective rate, high cure rate and the like, and has no toxic or side effect.

Description

Technical Field

[0001] This invention belongs to the field of biomedicine and relates to the preparation of traditional Chinese medicine preparations, specifically to a method for preparing Jinhaiqingyan tea bags. Background Technology

[0002] Chinese Patent CN 100553665C discloses a traditional Chinese medicine for treating pharyngitis. This medicine is made from the following raw materials: honeysuckle 220-280 parts, sterculia lychnophora 50-110 parts, ophiopogon japonicus 220-280 parts, scrophularia ningpoensis 220-280 parts, chebula 220-280 parts, dried plum 220-280 parts, green tea 50-110 parts, platycodon grandiflorus 220-280 parts, licorice root 140-200 parts, and lotus oil 5-9 parts. It has the functions of clearing the lungs and stomach, clearing heat and removing fire, reducing swelling and dissipating nodules, benefiting the throat and improving voice, and promoting saliva production and opening the orifices. It is suitable for throat discomfort, dry mouth and tongue, inflammation, swelling and pain caused by various reasons, and can relieve symptoms, improve function, and enhance the body's disease resistance. This medicine has been sold on the market for many years and has a good therapeutic effect on acute and chronic pharyngitis with a high overall effective rate, but the significant efficacy and cure rate are relatively low, meaning that patients' clinical symptoms are not effectively relieved within one week of medication. Therefore, it is necessary to make appropriate improvements to the existing preparation processes or prescriptions of traditional Chinese medicines in order to improve their therapeutic effects. Summary of the Invention

[0003] In view of the shortcomings and deficiencies of the existing technology, the purpose of this invention is to provide a method for preparing Jin Hai Qing Yan tea bags. This method improves the existing preparation process and boldly attempts to increase the amount of licorice, so that the final Jin Hai Qing Yan tea bags have better therapeutic effects. Compared with the existing commercially available Jin Hai Qing Yan tea bags, it has the advantages of fast onset of action, high efficacy and cure rate, and no toxic side effects.

[0004] To achieve the above objectives, the present invention adopts the following technical solution:

[0005] A method for preparing Jin Hai Qing Yan tea bags, the method comprising the following steps:

[0006] Step 1. Dry the harvested honeysuckle to control its moisture content to 8%-12%;

[0007] Step 2. First, steam the Ophiopogon japonicus until cooked, and then dry it to ensure that the moisture content of the Ophiopogon japonicus is ≤10%.

[0008] Step 3. Roast the platycodon and scrophularia in honey, then grind them into coarse powder for later use;

[0009] Step 4. Mix the honeysuckle from Step 1, the ophiopogon japonicus from Step 2, and the five herbs: green plum, dried plum, and sterculia lychnophora. Add 6-10 times the amount of water and decoct together 2-3 times, each time for 0.5-1.5 hours. Combine the decoctions, filter, and concentrate under reduced pressure to a thick paste with a relative density of 1.30-1.38 at 60-70℃. Set aside for later use.

[0010] Step 5. Grind the licorice root into a fine powder of 80-120 mesh, grind the green tea into a coarse powder, and then mix it with the honey-fried platycodon root and scrophularia root from Step 3.

[0011] Step 6. Prepare beta-cyclodextrin inclusion complex of peppermint oil;

[0012] Step 7. Mix the thick paste from Step 4, the mixed powder from Step 5, the beta-cyclodextrin inclusion complex of peppermint oil from Step 6, and beta-cyclodextrin, mix well and granulate to make a blister pack.

[0013] The dosage of honeysuckle is 220-280g, malva nut is 50-110g, ophiopogon japonicus is 220-280g, honey-processed scrophularia ningpoensis is 220-280g, chebula is 220-280g, dried plum is 220-280g, green tea is 50-110g, honey-processed platycodon grandiflorus is 220-280g, licorice is 220-240g, peppermint oil is 5-9g, and beta-cyclodextrin is 50-84g.

[0014] As a preferred embodiment of the present invention, when drying honeysuckle, a four-stage variable temperature drying method is adopted. At the beginning of drying, the temperature is controlled at 30-37°C. After 2-3 hours, the temperature is increased to 42-45°C and maintained for 4-6 hours. Then, the temperature is increased to 48-50°C and maintained for 5-8 hours. Finally, the temperature is increased to 55-58°C and maintained for 5-8 hours.

[0015] As a preferred embodiment of the present invention, when drying Ophiopogon japonicus, the drying temperature is controlled at 40-60℃ and the drying cycle is 1-2 days.

[0016] As a preferred embodiment of the present invention, the specific method for honey-processed Platycodon grandiflorus is as follows: dilute refined honey with water, add the diluted refined honey to the raw Platycodon grandiflorus slices and mix well to ensure that each slice of Platycodon grandiflorus is evenly coated with honey; let the mixed Platycodon grandiflorus slices sit for 1-3 hours to moisten them, allowing them to fully absorb the honey; dry the moistened Platycodon grandiflorus slices at a temperature controlled at 75-80℃ for 1-1.5 hours; the amount of refined honey added is 15% of the weight of the raw Platycodon grandiflorus slices, and the mass ratio of refined honey to water is 3:1.

[0017] As a preferred embodiment of the present invention, the specific method for honey-processed Scrophularia ningpoensis is as follows: dilute refined honey with water, add the diluted refined honey to the Scrophularia ningpoensis and mix well to ensure that each piece of Scrophularia ningpoensis is evenly coated with honey liquid; let the mixed Scrophularia ningpoensis sit for 1-3 hours to moisten it, so that it can fully absorb the honey liquid; dry the moistened Scrophularia ningpoensis at a temperature controlled at 40-50℃ for 2-6 hours; the amount of refined honey added is 10-15% of the weight of Scrophularia ningpoensis, and the mass ratio of refined honey to water is 3:1.

[0018] As a preferred embodiment of the present invention, the preparation method of the beta-cyclodextrin inclusion complex of peppermint oil is as follows: Weigh 36g of beta-cyclodextrin and place it in a stoppered conical flask. Add 400mL of distilled water and heat to 50-60℃ to dissolve the beta-cyclodextrin. Cool to 25-30℃ and add 8.3mL of peppermint oil dropwise. Stir at a constant temperature for 2-3 hours at a speed of 300-500r / min. Refrigerate for 24 hours. After the precipitation is complete, filter and wash the precipitate 2-3 times with anhydrous ethanol until there is no oil stain on the surface of the precipitate. Vacuum dry the inclusion complex at 40-50℃ to obtain the beta-cyclodextrin inclusion complex of peppermint oil.

[0019] As a preferred embodiment of the present invention, the amount of honeysuckle is 250g, the amount of malva nut is 83.3g, the amount of ophiopogon japonicus is 250g, the amount of honey-processed scrophularia ningpoensis is 250g, the amount of chebula fruit is 250g, the amount of dried plum is 250g, the amount of green tea is 83.3g, the amount of honey-processed platycodon grandiflorus is 250g, the amount of licorice is 220g, and the amount of peppermint oil is 8.3ml, wherein the unit volume weight of the peppermint oil is 0.88g / ml to 0.908g / ml.

[0020] Advantages and beneficial effects of the present invention:

[0021] (1) Considering that the main components of honeysuckle are chlorogenic acid, isochlorogenic acid, luteolin glycoside, flavonoids and other active ingredients, these components are affected by factors such as temperature, light and oxygen. Natural sun drying or ventilation and shade drying will reduce the quality of honeysuckle. For example, natural sun drying will accelerate the decomposition of chlorogenic acid under the action of ultraviolet light. Therefore, the present invention performs drying treatment on freshly harvested honeysuckle and adopts a four-stage variable temperature drying method. This method can ensure the quality of honeysuckle, make the retention rate of effective ingredients in honeysuckle high, and make the medicinal efficacy more stable.

[0022] (2) The present invention steams Ophiopogon japonicus, thereby destroying the dense cell wall structure of the tuberous root of Ophiopogon japonicus, making the active ingredients (such as saponins and polysaccharides) inside more easily dissolved during decoction, thereby improving the absorption and utilization rate of the medicinal ingredients by the human body and avoiding the problem of "insufficient efficacy" caused by the low dissolution rate of raw products; in addition, after steaming, the "coldness" of Ophiopogon japonicus will be significantly mitigated, which can not only retain the core function of nourishing yin and promoting body fluid, but also reduce damage to the spleen and stomach. Moreover, steaming can make the "nourishing and greasy nature" of Ophiopogon japonicus more moderate, and can more accurately exert the function of "nourishing yin without stagnation of spleen and moisturizing dryness without being cold".

[0023] (3) In this invention, the Ophiopogon japonicus is steamed and then dried. The drying method can preserve the active ingredients such as Ophiopogon japonicus saponins, Ophiopogon japonicus polysaccharides, and flavonoids in Ophiopogon japonicus more completely.

[0024] (4) This invention uses honey-processed Platycodon grandiflorus. By reasonably controlling the amount of honey and water used in the honey-processing process, as well as the temperature and time of drying, the total saponins of Platycodon grandiflorus can be prevented from being enzymatically hydrolyzed, so that the active ingredients such as total saponins of Platycodon grandiflorus are preserved intact and the content of effective ingredients is higher.

[0025] (5) This invention uses honey-processed Scrophularia ningpoensis. By reasonably controlling the amount of honey and water used in the honey-processing process, as well as the temperature and time of drying, the content of effective components in Scrophularia ningpoensis can be higher and the pharmacological effects can be stronger.

[0026] (6) In preparing Jinhaiqingyan tea bags, this invention boldly attempted to increase the amount of licorice and pulverize it into finer particles. Unexpectedly, it was found that the prepared tea bags had a faster onset of action, and the cure rate and efficacy were significantly higher than those of the existing preparation process. Patients' clinical symptoms could basically disappear after one week of continuous use. It is considered that while licorice harmonizes the various drugs, the appropriate concentration of active ingredients such as glycyrrhizic acid also plays a role. It may increase the permeability of water-soluble active ingredients (such as chlorogenic acid in honeysuckle) by changing the tight junction structure of intestinal mucosal epithelial cells, thereby improving absorption and thus increasing the bioavailability of the drug. It may also be that the appropriate amount of glycyrrhizic acid inhibits CYP3A4 enzyme, thereby reducing the liver metabolism rate of active ingredients such as harpagoside in Scrophularia ningpoensis, increasing their blood drug concentration, thereby improving the efficacy and significantly increasing the cure rate and efficacy.

[0027] (7) This invention breaks the original prescription dosage requirements and increases the dosage of licorice. However, through adverse reactions of patients after taking the drug and long-term toxicity tests, it can be seen that the dosage of licorice is within the safe range. Increasing the dosage of licorice will not increase the toxic side effects of the drug.

[0028] (8) In preparing the beta-cyclodextrin inclusion complex of peppermint oil, the present invention improves the process by adjusting the ratio of beta-cyclodextrin to peppermint oil, thereby reducing the amount of beta-cyclodextrin used while ensuring the inclusion rate and avoiding waste of beta-cyclodextrin. In addition, the present invention also adds beta-cyclodextrin during the mixing and granulation process. At this time, beta-cyclodextrin mainly plays the role of thickening and stabilizing, reducing drug degradation and extending the drug's shelf life. Detailed Implementation

[0029] This invention discloses a method for preparing Jin Hai Qing Yan tea bags. Those skilled in the art can refer to the content of this document and appropriately modify the component parameters or process parameters to achieve the desired result. It should be particularly noted that all similar substitutions and modifications are obvious to those skilled in the art and are considered to be included within the scope of protection of this invention.

[0030] Example 1

[0031] A method for preparing Jin Hai Qing Yan tea bags, the method comprising the following steps:

[0032] Step 1. Dry the harvested honeysuckle to control its moisture content at 8%-12%. Specifically, the honeysuckle is dried using a four-stage variable temperature drying method. At the beginning of the drying process, the temperature is controlled at 30-37℃. After 2-3 hours, the temperature is increased to 42-45℃ and maintained for 4-6 hours. Then, the temperature is increased to 48-50℃ and maintained for 5-8 hours. Finally, the temperature is increased to 55-58℃ and maintained for 5-8 hours.

[0033] Step 2. First, steam the Ophiopogon japonicus until cooked, and then dry it to make the moisture content of the Ophiopogon japonicus ≤10%. Specifically, when drying the Ophiopogon japonicus, the drying temperature is controlled at 40-60℃ and the drying cycle is 1-2 days.

[0034] Step 3. Honey-processed Platycodon grandiflorus and Scrophularia ningpoensis are ground into coarse powder for later use. Specifically, the method for honey-processing Platycodon grandiflorus is as follows: dilute refined honey with water, add the diluted refined honey to the raw Platycodon grandiflorus slices and mix well to ensure that each slice of Platycodon grandiflorus is evenly coated with honey; let the mixed Platycodon grandiflorus slices sit for 1-3 hours to allow them to fully absorb the honey; then dry the soaked Platycodon grandiflorus slices at a temperature of 75-80℃ for 1-1.5 hours; the amount of refined honey added is 15% of the weight of the raw Platycodon grandiflorus slices, and the mass ratio of refined honey to water is 3:1.

[0035] The specific method for processing honey-processed Scrophularia is as follows: dilute refined honey with water, add the diluted refined honey to the Scrophularia and mix well to ensure that each piece of Scrophularia is evenly coated with honey; let the mixed Scrophularia sit for 1-3 hours to moisten it and allow it to fully absorb the honey; dry the moistened Scrophularia at a temperature of 40-50℃ for 2-6 hours; the amount of refined honey added is 10-15% of the weight of the Scrophularia, and the mass ratio of refined honey to water is 3:1.

[0036] Step 4. Mix the honeysuckle from Step 1, the ophiopogon japonicus from Step 2, and the five herbs: green plum, dried plum, and sterculia lychnophora. Add 8 times the amount of water and decoct together twice, 1 hour each time. Combine the decoctions, filter, and concentrate under reduced pressure to a thick paste with a relative density of 1.30 to 1.38 at 60 to 70°C. Set aside for later use.

[0037] Step 5. Grind the licorice root into a fine powder of 80-120 mesh, grind the green tea into a coarse powder, and then mix it with the honey-fried platycodon root and scrophularia root from Step 3.

[0038] Step 6. Preparation of beta-cyclodextrin inclusion complex of menthol oil; specifically, the preparation method of beta-cyclodextrin inclusion complex of menthol oil is as follows: weigh 36g of beta-cyclodextrin, place it in a stoppered conical flask, add 400mL of distilled water, heat to 50-60℃ to dissolve the beta-cyclodextrin, cool to 25-30℃, add 8.3ml of menthol oil dropwise, stir at a constant temperature for 2-3 hours at a speed of 300-500r / min; refrigerate for 24 hours, filter after complete precipitation, wash the precipitate 2-3 times with anhydrous ethanol until there are no oil stains on the surface of the precipitate; vacuum dry the inclusion complex at 40-50℃ to obtain beta-cyclodextrin inclusion complex of menthol oil.

[0039] Step 7. Mix the thick paste from Step 4, the mixed powder from Step 5, the beta-cyclodextrin inclusion complex of peppermint oil from Step 6, and beta-cyclodextrin (47.3g), mix well and granulate to make 1g blister packs.

[0040] The dosage of honeysuckle is 250g, malva nut is 83.3g, ophiopogon japonicus is 250g, honey-processed scrophularia ningpoensis is 250g, chebula is 250g, dried plum is 250g, green tea is 83.3g, honey-processed platycodon grandiflorus is 250g, licorice is 220g, and peppermint oil is 8.3ml. The unit volume weight of peppermint oil is 0.88g / ml to 0.908g / ml, and the total amount of beta-cyclodextrin is 83.3g.

[0041] It should be noted that in this embodiment, the processing methods of Platycodon grandiflorus, Scrophularia ningpoensis, and Ophiopogon japonicus were investigated. The processing methods for Ophiopogon japonicus included steaming and sun-drying, steaming followed by drying, honey-processing (soaking Ophiopogon japonicus in honey and then drying), and stir-frying (stir-frying over low heat until the surface of Ophiopogon japonicus turns slightly yellow or light brown). Analysis of their effective components revealed that the processing method significantly affected the content of effective components in Ophiopogon japonicus. The content of effective components was highest in Ophiopogon japonicus that was steamed and then dried, significantly higher than that in the raw product, honey-processed, and stir-fried products. Therefore, in this embodiment, Ophiopogon japonicus that was steamed and then dried was used as the medicinal material. The processing methods for Platycodon grandiflorus and Scrophularia ningpoensis included honey-processing, salt-processing, and vinegar-processing. Analysis of the effective components in processed Platycodon grandiflorus and Scrophularia ningpoensis showed that honey-processed Platycodon grandiflorus and honey-processed Scrophularia ningpoensis had the highest content of effective components, higher than that in the raw product. Therefore, honey-processed Platycodon grandiflorus and honey-processed Scrophularia ningpoensis were used as the medicinal material.

[0042] In addition, in this embodiment, the preparation process of beta-cyclodextrin inclusion complex of peppermint oil was improved by adjusting the ratio of beta-cyclodextrin to peppermint oil and the preparation process parameters. The final determined process reduced the amount of beta-cyclodextrin used while ensuring the inclusion rate, thus avoiding waste of beta-cyclodextrin.

[0043] Comparative Example 1

[0044] The difference from Example 1 is that the licorice is pulverized into coarse powder.

[0045] Comparative Example 2

[0046] The difference from Example 1 is that the amount of licorice added is 200g.

[0047] Comparative Example 3

[0048] The difference from Example 1 is that the amount of licorice added is 167g.

[0049] Comparative Example 4

[0050] We directly used the commercially available Jinhaiqingyan tea bags (Jilin Wantong Pharmaceutical Co., Ltd.) as the control drug.

[0051] To verify the efficacy of the improved Jin Hai Qing Yan tea bag of this invention, in vitro antibacterial tests, anti-inflammatory tests, and clinical trials were conducted in this embodiment, as detailed below:

[0052] 1. In vitro antibacterial test

[0053] In this embodiment, the plate count method was used to determine the antibacterial effect of Jinhaiqingyan tea bags prepared in Example 1 and Comparative Examples 1 to 4 on common bacteria in the upper respiratory tract (Staphylococcus aureus and Streptococcus pneumoniae, purchased from Shanghai Yaji Biotechnology Co., Ltd. and Thermo Fisher Scientific, respectively). Based on the experimental results, it can be found that Example 1 and Comparative Examples 1 to 4 all have inhibitory effects on the above-mentioned bacteria. However, compared with Comparative Examples 1 to 4, especially the control drug (Comparative Example 4), the antibacterial effect of Example 1 is better. Its inhibition rate against Staphylococcus aureus is 97.37±0.4%, while the inhibition rates of Comparative Examples 1 to 4 against Staphylococcus aureus are 93.42±0.33%, 85.53±0.27%, 82.12±0.45%, and 78.38±0.24%, respectively. The inhibition rate of Example 1 against Streptococcus pneumoniae is 99.42±0.14%, while the inhibition rates of Comparative Examples 1 to 4 against Streptococcus pneumoniae are 92.27±0.27%, 87.39±0.25%, 86.73±0.19%, and 83.62±0.28%, respectively.

[0054] 2. Anti-inflammatory test

[0055] 2.1 Test Methods:

[0056] Sixty female SD rats weighing 180–220 g (purchased from Liaoning Changsheng Biotechnology Co., Ltd.) were randomly divided into four groups: a model control group (10 mL / kg distillation), a blank control group (10 mL / kg distillation), Example 1 group (3 g / kg), Comparative Example 2 group (3 g / kg), Comparative Example 3 group (3 g / kg), and Comparative Example 4 group (3 g / kg). The rats were administered the drug via gavage for 10 consecutive days. From day 4 onwards, except for the blank control group, all other rats were sprayed with 15% ammonia water into the pharynx using a large-mouth monkey head sprayer, three times each time, once in the morning and once in the afternoon, for three consecutive days to create an acute pharyngitis model. The blank control group rats were sprayed with an equal volume of physiological saline, and the drug was continued until the end of the experiment. Starting from the second day after modeling, observe the condition of the animal's pharynx daily, including the morphology and color of the mucosa. Sacrifice the animal the day after the last administration, and take pathological sections of the pharyngeal mucosa and underlying tissue for observation. Pathological grading is performed according to the following standards: A. No hyperplasia or edema of the lamina propria of the mucosa, no inflammatory cell infiltration, recorded as (-); B. Mucosal epithelial hyperplasia, edema of the lamina propria, a small amount of inflammatory cell infiltration, recorded as (+); C. Mucosal epithelial hyperplasia, congestion of blood vessels in the lamina propria, necrosis of some mucous gland epithelial cells, inflammatory cell infiltration, recorded as (++); D. Mucosal epithelial hyperplasia and keratinization, congestion of blood vessels in the lamina propria, necrosis of mucous gland epithelial cells, a large number of inflammatory cell infiltrations, recorded as (+++).

[0057] 2.2 Test Results:

[0058] In the blank control group, the pharyngeal tissue showed clear boundaries between the mucosa, submucosa, muscle layer, and adventitia. The mucosa consisted of the epithelium and lamina propria. The epithelium was non-keratinized stratified squamous epithelium; the lamina propria was dense connective tissue, without inflammatory cell infiltration, fibrous tissue hyperplasia, vascular congestion, or edema. The submucosa was loose connective tissue containing numerous mixed glands, primarily mucous glands, which were actively secreting, and the gland morphology was normal. The muscle layer consisted of skeletal muscle, with clearly visible muscle fibers and no inflammatory cell aggregation in the intercellular spaces. The adventitia was a thin layer of connective tissue without inflammatory changes. After spraying ammonia into the rat's pharynx, microscopic examination revealed congestion, edema, mucosal epithelial hyperplasia, and even necrosis of mucous gland epithelial cells, along with extensive inflammatory cell infiltration and other pathological changes. Examples 1 and Comparative Examples 2 to 4 showed varying degrees of lesion reduction after treatment; details are shown in Table 1.

[0059] Table 1. Effects of Jin Haiqing throat tea bags on the grading of pharyngeal lesions in rats with ammonia-induced acute pharyngitis (n=10)

[0060]

[0061] Note: Compared with the model control group, * P<0.05

[0062] As shown in Table 1, the model was successfully established. The treatment with Jin Hai Qing Yan tea bags from Example 1 and Comparative Examples 2 to 4 significantly reduced pharyngeal inflammation in rats, showing significant differences compared with the model control group. Moreover, Example 1 had the best anti-inflammatory effect, which was significantly better than Comparative Examples 1 to 4.

[0063] 3. Clinical trials

[0064] 3.1 General Information:

[0065] Eighty patients with acute pharyngitis were randomly divided into an observation group and a control group, with 40 patients in each group. The observation group consisted of 24 males and 16 females, aged 18–58 years, with a disease duration of 0.5–3.0 days. The control group consisted of 22 males and 18 females, aged 17–62 years, with a disease duration of 0.5–3.0 days. There were no statistically significant differences in general characteristics between the two groups, making them comparable.

[0066] 3.2 Diagnostic criteria:

[0067] The diagnostic criteria for Western medicine refer to "Otorhinolaryngology" and the diagnostic criteria for Traditional Chinese Medicine refer to "Traditional Chinese Medicine Otorhinolaryngology".

[0068] 3.3 Inclusion and Exclusion Criteria:

[0069] Inclusion criteria: ① Diagnosed with acute pharyngitis according to Western medicine diagnostic criteria and diagnosed with wind-heat syndrome according to traditional Chinese medicine diagnostic criteria; ② Age 17–67 years, course of illness <3 days; Exclusion criteria: ① Allergy to the drugs used in this study; ② Pregnancy and lactation; ③ Hepatic or renal insufficiency.

[0070] 3.4 Treatment methods:

[0071] The observation group was given Jin Hai Qing Yan tea bags from Example 1, while the control group was given Jin Hai Qing Yan tea bags from Comparative Example 4. The dose was 1g three times a day for seven consecutive days.

[0072] 3.5 Observation Indicators:

[0073] The symptom and sign scores before and after treatment were compared between the two groups; the time for the resolution of clinical symptoms and signs was compared between the two groups; and the occurrence of adverse reactions during treatment was observed. Sore throat, dry and itchy cough were used as the primary symptom observation points, and pharyngeal congestion was used as the primary physical sign observation point. Sore throat, dry and itchy cough were assessed by patients based on their subjective feelings, and the same physician assessed the degree of pharyngeal congestion. The scoring standard used was the visual analog scale, with 0 points representing normal and 10 points representing the most severe condition.

[0074] 3.6 Criteria for Evaluating Therapeutic Effect:

[0075] Referring to the "Guiding Principles for Clinical Research of New Traditional Chinese Medicines," the following criteria are defined: Cured: Symptoms lessen within 3 days of medication, clinical symptoms and signs disappear within 7 days, and the score decreases by ≥95%; Significantly Effective: Symptoms and signs significantly improve within 7 days of medication, and the score decreases by 70% to <95%; Effective: Symptoms and signs improve within 7 days of medication, and the score decreases by 30% to <70%; Ineffective: Symptoms and signs do not significantly improve within 7 days of medication, or the score decreases by <30%. The score is the sum of the patient's sore throat, dry cough, and pharyngeal congestion scores.

[0076] 3.7 Results:

[0077] The clinical efficacy of the two groups is detailed in Table 2, and the time for the resolution of clinical symptoms and signs in the two groups is detailed in Table 3.

[0078] Table 2 Comparison of clinical efficacy (%)

[0079] Group Number of examples get well Effective efficient invalid Observation group 40 20(50％) 17(42.5) 3 0 control group 40 8(20％) 15(37.5％) 15 2

[0080] As shown in Table 2, the total effective rates of both the observation group and the control group were relatively high, but the cure rate and significant efficacy rate of the observation group were significantly higher than those of the control group, and the differences were statistically significant (P<0.05). Therefore, the clinical efficacy of the observation group was better than that of the control group.

[0081] Table 3 Comparison of time for resolution of clinical symptoms and signs (days)

[0082] Group Number of examples Sore throat Dry, itchy cough Pharyngeal congestion Observation group 40 <![CDATA[2.53±0.54 * ]]> <![CDATA[2.69±0.26 * ]]> <![CDATA[3.08±0.26 * ]]> control group 40 4.87±0.75 4.66±1.13 4.69±0.63

[0083] As shown in Table 3, the time for the relief of sore throat, dry cough, and pharyngeal congestion in the observation group was significantly shorter than that in the control group, and the difference was statistically significant (P<0.05).

[0084] This invention observed adverse reactions in two groups during treatment. The results showed that neither the observation group nor the control group experienced adverse reactions such as gastrointestinal discomfort or abnormal liver and kidney function.

[0085] Considering the increased dosage of licorice in this invention, a long-term toxicity test was conducted on the improved Jin Hai Qing Yan tea bag to ensure drug safety and efficacy. Eighty SD rats (60-120g, purchased from Liaoning Changsheng Biotechnology Co., Ltd.), half male and half female, were randomly divided into four groups according to weight and sex: a blank control group, and three dosage groups (high, medium, and low) of Jin Hai Qing Yan tea bag (Example 1), with 20 rats in each group. Males and females were housed separately. The rats were given distilled water, 24g / kg, 16g / kg, and 6g / kg of Jin Hai Qing Yan tea bag daily for three consecutive months. During the experiment, animal behavior, diet, fur, and urination / defecation were observed daily, and weight was measured every 7 days. After the last administration, eight animals (half male and half female) were randomly selected from each group and fasted for 12 hours while allowing free access to water. Blood samples were then collected for hematological and liver and kidney function tests. Heart, spleen, liver, lungs, and kidneys were weighed, and their organ coefficients were calculated using the formula: Organ Coefficient = (Organ Weight ÷ Body Weight). Simultaneously, a piece was taken from each organ, fixed in formalin, embedded in paraffin, and prepared as tissue sections for pathological examination. The remaining animals were then discharged from medication and fed for two weeks before undergoing the same treatment and further examinations.

[0086] Results: Gavage administration to rats for 3 months had no significant effect on weight gain, hematological parameters (hemoglobin Hb, white blood cell (WBC), red blood cell (RBC)), blood biochemical parameters (alanine aminotransferase (ALT), aspartate aminotransferase (AST), total protein (TP), albumin (ALB), globulin (GLO), albumin / globulin ratio (A / G), total bilirubin (T-BIL), direct bilirubin (D-BIL), blood urea nitrogen (BUN), creatinine (CRE), blood glucose (GLU), total cholesterol (CHO), organ coefficients, or the histological structure of the heart, liver, spleen, lungs, and kidneys. Furthermore, there was no significant delayed toxicity after drug withdrawal, demonstrating that increasing the dosage of licorice does not introduce toxic side effects. Detailed pathological results of the heart, liver, and kidneys are provided in Table 2.

[0087] Table 2. Pathological examination results of heart, liver, and kidney in long-term toxicity tests.

[0088]

[0089]

[0090] The above-described specific examples are for illustrative purposes only and are not intended to limit the scope of the invention. Those skilled in the art can make various simple deductions, modifications, or substitutions based on the principles of this invention. Therefore, the scope of protection of this invention should be determined by the scope of the claims.

Claims

1. A method for preparing Jin Hai Qing Yan tea bags, characterized in that, The method includes the following steps: Step 1. Dry the harvested honeysuckle to control its moisture content to 8%-12%; Step 2. First, steam the Ophiopogon japonicus until cooked, and then dry it to ensure that the moisture content of the Ophiopogon japonicus is ≤10%. Step 3. Roast the platycodon and scrophularia in honey, then grind them into coarse powder for later use; Step 4. Mix the honeysuckle from Step 1, the ophiopogon japonicus from Step 2, and the five herbs: green plum, dried plum, and sterculia lychnophora. Add 6-10 times the amount of water and decoct together 2-3 times, each time for 0.5-1.5 hours. Combine the decoctions, filter, and concentrate under reduced pressure to a thick paste with a relative density of 1.30-1.38 at 60-70℃. Set aside for later use. Step 5. Grind the licorice root into a fine powder of 80-120 mesh, grind the green tea into a coarse powder, and then mix it with the honey-fried platycodon root and scrophularia root from Step 3. Step 6. Prepare beta-cyclodextrin inclusion complex of peppermint oil; Step 7. Mix the thick paste from Step 4, the mixed powder from Step 5, the beta-cyclodextrin inclusion complex of peppermint oil from Step 6, and beta-cyclodextrin, mix well and granulate to make a blister pack. The dosage of honeysuckle is 220-280g, malva nut is 50-110g, ophiopogon japonicus is 220-280g, honey-processed scrophularia ningpoensis is 220-280g, chebula is 220-280g, dried plum is 220-280g, green tea is 50-110g, honey-processed platycodon grandiflorus is 220-280g, licorice is 220-240g, peppermint oil is 5-9g, and beta-cyclodextrin is 50-84g.

2. The preparation method of Jinhai Qingyan tea bag according to claim 1, characterized in that, When drying honeysuckle, a four-stage variable temperature drying method is adopted. At the beginning of drying, the temperature is controlled at 30-37℃. After 2-3 hours, the temperature is increased to 42-45℃ and maintained for 4-6 hours. Then, the temperature is increased to 48-50℃ and maintained for 5-8 hours. Finally, the temperature is increased to 55-58℃ and maintained for 5-8 hours.

3. The preparation method of Jinhai Qingyan tea bag according to claim 1, characterized in that, When drying Ophiopogon japonicus, the drying temperature should be controlled at 40-60℃, and the drying cycle should be 1-2 days.

4. The preparation method of Jinhai Qingyan tea bag according to claim 1, characterized in that, The specific method for processing honey-processed Platycodon grandiflorus is as follows: dilute refined honey with water, add the diluted refined honey to the raw Platycodon grandiflorus slices and mix well to ensure that each slice is evenly coated with honey; let the mixed Platycodon grandiflorus slices sit for 1-3 hours to allow them to fully absorb the honey; dry the soaked Platycodon grandiflorus slices at a temperature of 75-80℃ for 1-1.5 hours; the amount of refined honey added is 15% of the weight of the raw Platycodon grandiflorus slices, and the mass ratio of refined honey to water is 3:

1.

5. The preparation method of Jinhai Qingyan tea bag according to claim 1, characterized in that, The specific method for processing honey-processed Scrophularia is as follows: dilute refined honey with water, add the diluted refined honey to the Scrophularia and mix well to ensure that each piece of Scrophularia is evenly coated with honey; let the mixed Scrophularia sit for 1-3 hours to moisten it and allow it to fully absorb the honey; dry the moistened Scrophularia at a temperature of 40-50℃ for 2-6 hours; the amount of refined honey added is 10-15% of the weight of Scrophularia, and the mass ratio of refined honey to water is 3:

1.

6. The preparation method of Jinhai Qingyan tea bag according to claim 1, characterized in that, The preparation method of beta-cyclodextrin inclusion complex of peppermint oil is as follows: Weigh 36g of beta-cyclodextrin and place it in a stoppered conical flask. Add 400mL of distilled water and heat to 50-60℃ to dissolve the beta-cyclodextrin. Cool to 25-30℃ and add 8.3mL of peppermint oil dropwise. Stir at a constant temperature for 2-3 hours at a speed of 300-500r / min. Refrigerate for 24 hours. After the precipitation is complete, filter and wash the precipitate 2-3 times with anhydrous ethanol until there are no oil stains on the surface of the precipitate. Vacuum dry the inclusion complex at 40-50℃ to obtain the beta-cyclodextrin inclusion complex of peppermint oil.

7. The preparation method of Jinhai Qingyan tea bag according to claim 1, characterized in that, The dosage of honeysuckle is 250g, malva nut is 83.3g, ophiopogon japonicus is 250g, honey-processed scrophularia ningpoensis is 250g, chebula is 250g, dried plum is 250g, green tea is 83.3g, honey-processed platycodon grandiflorus is 250g, licorice is 220g, and peppermint oil is 8.3ml. The unit volume weight of peppermint oil is 0.88g / ml to 0.908g / ml.

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