Traditional Chinese medicine composition containing bulbus fritillariae cirrhosae powder and preparation method thereof

Abstract

The invention relates to the technical field of traditional Chinese medicine processing, in particular to a traditional Chinese medicine composition containing bulbus fritillariae cirrhosae powder and a preparation method thereof.The traditional Chinese medicine composition containing the bulbus fritillariae cirrhosae powder is prepared from, by weight, 5-10 parts of a component A, 100-150 parts of a component B, 5-10 parts of a component C and 20-30 parts of a component D serving as an auxiliary material; wherein the component A is prepared from the following components in parts by weight: 5 to 10 parts of bulbus fritillariae cirrhosae powder, 10 to 15 parts of radix adenophorae, 10 to 15 parts of honeysuckle flower and 15 to 20 parts of folium eriobotryae; the component B is prepared from the following components in parts by weight: 80-120 parts of snow pear juice and 30-70 parts of white radish juice; and the component C is 5-10 parts of onion extract. According to the traditional Chinese medicine composition, the traditional Chinese medicine composition in an existing formula is optimized, the lung moistening effect is better, meanwhile, separation of effective components of the medicinal raw materials can be effectively increased, the preparation method is adjusted, and the effects of the medicinal materials are reserved to the maximum extent.

Description

Technical Field

[0001] The invention relates to the technical field of traditional Chinese medicine processing, in particular to a traditional Chinese medicine composition containing Fritillaria cirrhosa powder and a preparation method thereof. Background Art

[0002] Fritillaria cirrhosa D. Don is a perennial herbaceous plant of the genus Fritillaria, Liliaceae, with a plant height of up to 50 cm. The leaves are opposite, and the leaves are linear to linear-lanceolate. The flowers are usually single, purple to yellow-green, and each flower has leaf-like bracts, which are narrow and long, with anthers close to the base, and the capsule has narrow wings on the long ridges. It blooms from May to July and bears fruit from August to October. It is mainly distributed in Tibet, Yunnan and Sichuan in China, and is also found in Gansu, Qinghai, Ningxia, Shaanxi and Shanxi, and is also distributed in Nepal. It usually grows in forests, under bushes, grasslands or river beaches, valleys and other wetlands or rock crevices. This species is one of the main sources of the medicinal material "Sichuan Fritillaria". It is a precious Chinese medicinal material for moistening the lungs and relieving coughs, with a long history of application and is well-known both at home and abroad.

[0003] Fritillaria cirrhosa powder is a common finished product of Fritillaria cirrhosa. Fritillaria cirrhosa powder can be used in the form of pure Fritillaria cirrhosa powder or in combination with prescriptions to enhance the efficacy. When the latter is used in combination with other Chinese medicinal materials, the raw material of Fritillaria cirrhosa needs to be processed and mixed with other medicinal components. For example, Fritillaria cirrhosa can be used together with Adenophora radix and Ophiopogon japonicus to nourish yin and moisten the lungs, resolve phlegm and relieve cough, which is more suitable for those with long-term cough and yin deficiency and lung dryness; Fritillaria cirrhosa can also be matched with Scutellaria baicalensis and loquat leaves to clear heat, resolve phlegm and relieve cough, which is usually suitable for those with phlegm-heat cough; if it is phlegm-fire stagnation, it can be matched with Scrophularia ningpoensis and oysters to achieve the effect of softening and dispersing nodules; Fritillaria cirrhosa can also be used together with Forsythia suspensa and honeysuckle to achieve the effects of clearing heat, detoxifying and reducing swelling; in addition, Fritillaria cirrhosa can also be used as an auxiliary treatment for a variety of diseases, such as cough due to deficiency or dry cough due to lung heat, or suffering from scrofula, lung abscess and mastitis. Based on the above prescriptions with different therapeutic effects, when preparing the functional finished product Fritillaria cirrhosa powder to enter the market, it is necessary to process Fritillaria cirrhosa and other medicinal materials. The most common processing technology is to extract the Chinese medicinal materials into extracts, dry them, and then crush and sieve them. For example, vacuum drying, vacuum drying the extract and then crushing it into extract powder, but it has the disadvantages of long drying time, large loss of effective ingredients, adhesion of dry paste, need for re-crushing and difficulty in crushing, etc. The process operation is complicated, the production cost is high, and the microbial indicators are not easy to control.

[0004] The existing technology uses a relatively advanced spray drying method. After the thin material is atomized in the drying chamber, the water vaporizes rapidly in contact with hot air to obtain a dry product. This method can directly dry solutions and emulsions into powder or granular products, eliminating the evaporation and crushing processes. The spray dryer disperses the material to be dried into very fine mist-like particles through mechanical action (increasing the water evaporation area and accelerating the drying process). When in contact with hot air, most of the water is removed in an instant, and the solid matter in the material is dried into powder.

[0005] Research the formula of Fritillaria cirrhosa powder and continuously optimize the production process in order to maximize the medicinal properties of the raw materials and save costs. Summary of the invention

[0006] The technical problem to be solved by the present invention is to provide a traditional Chinese medicine composition containing Fritillaria cirrhosa powder and a preparation method thereof, which optimizes the traditional Chinese medicine composition with an existing formula to have a better effect on moistening the lungs and relieving cough, and can effectively increase the precipitation of effective ingredients of the medicinal raw materials, adjust the preparation method, and retain the efficacy of the medicinal materials to the greatest extent.

[0007] In order to solve the above technical problems, the present invention adopts the following technical solutions: A traditional Chinese medicine composition containing Fritillaria cirrhosa powder is prepared from 5-10 parts by weight of component A, 100-150 parts by weight of component B, 5-10 parts by weight of component C and 20-30 parts by weight of component D as an auxiliary material; wherein component A is prepared from the following components by weight: 5-10 parts by weight of Fritillaria cirrhosa powder, 10-15 parts by weight of Adenophora radix, 10-15 parts by weight of honeysuckle and 15-20 parts by weight of loquat leaves; component B is prepared from the following components by weight: 80-120 parts by weight of snow pear juice and 30-70 parts by weight of white radish juice; and component C is 5-10 parts by weight of onion extract.

[0008] Preferably, the component D is one or more of white dextrin, lactose, maltodextrin, soluble starch and β-cyclodextrin.

[0009] Preferably, the onion extract is onion essential oil.

[0010] The method for preparing the traditional Chinese medicine composition containing Fritillaria cirrhosa powder according to any one of the above items comprises the following steps: S1, preparing component A: weighing each medicinal material in component A according to the formula, washing with clean water and drying at 40°C for 40 minutes, mixing and grinding each medicinal material, and then passing through a 40-mesh sieve to obtain a mixed powder for use; S2, preparing component B: washing and draining fresh snow pear and white radish, and then juicing them separately for later use; S3, preparing component C: extracting onion essential oil from fresh onions; S4, fermenting medicinal materials: mixing the squeezed juices obtained in step S1 and S2 according to the formula, fermenting them with Lactobacillus plantarum, and taking the upper fermentation clear liquid; S5, weighing the auxiliary material component D and the onion essential oil of component C in the formula amount, adding them to the fermentation clear liquid prepared in step S4, stirring and mixing them evenly to obtain a medicinal solution, and spray-drying the medicinal solution with a spray dryer to prepare a Sichuan Fritillaria powder Chinese medicine composition.

[0011] Preferably, the specific extraction method of onion essential oil in step S3 is: take fresh onion, wash and cut into strips, dry at 60° C., crush to obtain onion powder, add dichloromethane to the onion powder and shake well, extract by microwave, dehydrate and then perform reduced pressure distillation to obtain onion essential oil.

[0012] Preferably, the solid-liquid ratio of onion powder to dichloromethane is 1:8.6.

[0013] Preferably, the microwave extraction conditions are set as follows: microwave power 389 W, temperature 29.8° C., and extraction time 7.6 min.

[0014] Preferably, the specific method of fermenting medicinal materials in step S4 comprises the following steps: S41, prepare seed culture medium: take peptone, beef extract, yeast extract powder, glucose, triammonium citrate, Tween 80, sodium acetate, dipotassium hydrogen phosphate, magnesium sulfate, manganese sulfate, adjust the pH value to 6.8-7.0, make up to volume with distilled water, and sterilize at 118 °C for 20 min; S42, preparing fermentation medium: taking snow pear juice and white radish juice, adding mixed drug powder and sucrose according to the formula ratio, sterilizing in a water bath at 85°C for 30 min, and rapidly cooling to 40°C; S43, seed culture: Lactobacillus plantarum was inoculated on the seed culture medium and cultured at 36°C for 12 h until the logarithmic growth phase; S44, fermentation culture: the seed culture solution obtained in step S43 is inoculated into the fermentation medium, and cultured at a constant temperature of 36° C. for 56 h.

[0015] Preferably, the specific method of spray drying in step S5 is: the fermented cultured fermentation liquid is evenly mixed with the onion essential oil of the auxiliary material component D and the component C to prepare the medicinal liquid, and the inlet air temperature is set to 35-45°C, the air input volume is 4 m3 / h, and the peristaltic pump flow rate is 12 mL / min for spray drying to obtain a traditional Chinese medicine composition containing Fritillaria cirrhosa powder.

[0016] Beneficial effects of the present invention: The traditional medicinal diet recipe uses Fritillaria cirrhosa and snow pear as the main medicines of the formula, which is used to eliminate phlegm and relieve cough. The present invention adds Adenophora scutellariae, honeysuckle and loquat leaves as auxiliary ministers of Fritillaria cirrhosae, which enhances the lung moistening and phlegm-resolving effect of Fritillaria cirrhosae. Adenophora scutellariae clears the lungs and resolves phlegm, and loquat leaves clear the lungs and relieve cough, while honeysuckle has the effects of clearing away heat and detoxifying, and relieving adverse reactions and vomiting. The three are compatible with Fritillaria cirrhosae to make the lung clearing and cough-relieving effect of the medicine better, and also have the effects of clearing heat and detoxifying; snow pear has the effects of promoting body fluid and quenching thirst, resolving phlegm and relieving cough, and moistening the lungs, and it mainly plays the effect of promoting body fluid and quenching thirst after being matched with Fritillaria cirrhosae; however, the above combination is of cold nature, and it is not suitable for people with spleen and stomach deficiency and coldness, so it is matched with white radish, which is rich in mustard Oil, crude fiber, amylase, and a variety of amino acids, trace elements, carbohydrates, minerals, etc. Drinking the juice of white radish can promote digestion, speed up gastrointestinal motility, and people with spleen and stomach deficiency can also take it for treatment. On this basis, it is matched with onion essential oil, using its heat to neutralize the coldness of the above ingredients. Moreover, onion essential oil is mainly composed of sulfur-containing volatile oils, which has significant anti-inflammatory, antioxidant, antibacterial and anti-tumor effects. While assisting Fritillaria cirrhosa and snow pear to moisten the lungs and relieve cough, promote fluid production and quench thirst, it can also play an anti-inflammatory role, accelerate the body's recovery, and stabilize the efficacy of the medicine.

[0017] In the present invention, Lactobacillus plantarum is used to ferment Fritillaria cirrhosa, Adenophora adenophora, Flos lochiae, Pyrus scabra and white radish, and the content of polyphenols, flavonoids and other effective ingredients in the finished product is significantly increased by using traditional Chinese medicine fermentation technology, the efficacy of the medicinal materials is greatly enhanced, and an antioxidant effect is exhibited.

[0018] The present invention adopts the technology of low-temperature spray drying, which can effectively improve the discharge efficiency, reduce the loss of raw materials and the destruction of functional components, and save production costs. DETAILED DESCRIPTION

[0019] In order to facilitate the understanding of those skilled in the art, the present invention is further described below in conjunction with embodiments, and the contents mentioned in the implementation modes are not intended to limit the present invention.

[0020] Fritillaria cirrhosa: has the effects of clearing heat and moistening the lungs, resolving phlegm and relieving cough, dispersing nodules and eliminating carbuncles.

[0021] Adenophora: It has the effects of nourishing yin and clearing the lungs, benefiting the stomach and producing body fluid, resolving phlegm, and invigorating qi.

[0022] Honeysuckle: It has the effects of clearing away heat, detoxifying, and dispersing wind-heat. Honeysuckle is cold in nature, so it is not suitable for people with spleen and stomach deficiency and cold, as well as qi deficiency, sores, and pus.

[0023] Loquat leaves: have the effects of clearing the lungs and relieving cough, relieving adverse qi and stopping vomiting.

[0024] Snow pear: It has the effects of promoting salivation and quenching thirst, resolving phlegm and relieving cough, and moistening the lungs.

[0025] White radish: has anti-inflammatory and cough-relieving, digestion-promoting, and antioxidant effects.

[0026] β-cyclodextrin: It is an organic compound with a molecular formula of C42H70O35 and a molecular weight of 1134.984. It is a white to light yellow powder with a slight pectin-specific aroma and a slightly sweet and slightly sour taste. It is soluble in water and is used as a new type of pharmaceutical excipient to increase the stability of drugs, prevent drug oxidation and decomposition, improve drug solubility and bioavailability, reduce drug toxicity and side effects, and cover up drug odor and stink.

[0027] Example 1

[0028] Extracting onion essential oil Wash and cut fresh onions into strips, dry them at 60°C, and crush them to obtain onion powder. Weigh 100g of onion powder, add dichloromethane to the onion powder and shake well. Use microwave extraction, the solid-liquid ratio of onion powder to dichloromethane is 1:8.6 (g / ml), the microwave power is 389W, the temperature is 29.8°C, the extraction time is 7.6min, and onion essential oil is obtained by dehydration and reduced pressure distillation. The yield of onion essential oil is 0.512%.

[0029] The yield of onion essential oil is calculated as follows:

[0030] Among them, m 0 is the mass of essential oil, g; m is the mass of onion powder, g.

[0031] Example 2

[0032] Preparation of component A Weigh the raw materials of each medicinal material in component A: 5g of Fritillaria cirrhosa powder, 15g of Adenophora radix, 10g of honeysuckle and 20g of loquat leaves, rinse them with clean water and dry them at 40°C for 40min, mix and grind the medicinal materials of each component and pass them through a 40-mesh sieve to obtain mixed powder 1 for later use.

[0033] Weigh the raw materials of each medicinal material in component A: 8g of Fritillaria cirrhosa powder, 12g of Adenophora radix, 12g of honeysuckle and 18g of loquat leaves, rinse with clean water and dry at 40°C for 40 min, mix and grind the medicinal materials of each component and pass through a 40-mesh sieve to obtain mixed powder 2 for later use.

[0034] Weigh the raw materials of each medicinal material in component A: 10g of Fritillaria cirrhosa powder, 10g of Adenophora radix, 15g of honeysuckle and 15g of loquat leaves, rinse with clean water and dry at 40°C for 40min, mix and grind the medicinal materials of each component and pass through a 40-mesh sieve to obtain mixed powder 3 for later use.

[0035] Preparation of component B Take fresh pears and white radishes, wash and drain them, then squeeze out the juice without adding water and set aside.

[0036] Example 3

[0037] Fermented herbs 1. Prepare seed culture medium: Take 10.0g of peptone, 10.0g of beef extract, 5.0g of yeast extract powder, 20.0g of glucose, 2.0g of triammonium citrate, 1.0mL of Tween 80, 5.0g of sodium acetate, 2.0g of dipotassium hydrogen phosphate, 0.42g of magnesium sulfate, 0.25g of manganese sulfate, adjust the pH value to 6.8-7.0, and dilute to 1000mL with distilled water. Sterilize at 121℃ for 20min.

[0038] 2. Prepare fermentation medium: Take snow pear juice and white radish juice, add mixed powder and sucrose according to the formula ratio, sterilize in 85℃ water bath for 30min, and quickly cool to 40℃. The proportion of each component is as shown in Table 1 below: Table 1 Ratio of fermentation medium (g)

[0039] 3. Seed culture: Take Lactobacillus plantarum Zw-1 (a strain preserved in Hebei Fermentation Engineering Technology Research Center) and inoculate it on the seed culture medium. Culture it at 36°C for 12 hours until the logarithmic growth phase.

[0040] 4. Fermentation culture: Take 5 ml of the obtained seed culture solution and inoculate it into fermentation medium No. 1-9 respectively, and culture it at a constant temperature of 36°C for 56 hours.

[0041] Comparative Example 1 Fermentation medium 10: Take 150 g of snow pear juice, add 8 g of Fritillaria powder (which is directly washed, dried, crushed and passed through a 40-mesh sieve) and 15 g of sucrose according to the formula ratio, sterilize in an 85°C water bath for 30 min, and quickly cool to 40°C.

[0042] Fermentation medium 11: Take 150 g of snow pear juice, add 8 g of mixed powder 2 and 15 g of sucrose according to the formula ratio, sterilize in a water bath at 85°C for 30 min, and quickly cool to 40°C.

[0043] Fermentation medium 12: Take 100 g of snow pear juice and 50 g of white radish juice, add 8 g of Fritillaria powder (which is directly washed, dried, crushed and sieved through a 40-mesh sieve) and 15 g of sucrose according to the formula ratio, sterilize in a water bath at 85°C for 30 min, and quickly cool to 40°C.

[0044] Fermentation medium 13: Take 150 g of white radish juice, add 8 g of mixed powder 2 and 15 g of sucrose according to the formula ratio, sterilize in an 85°C water bath for 30 min, and quickly cool to 40°C.

[0045] Comparative Example 2 Take 100g of snow pear juice and 50g of white radish juice, add 8g of mixed powder 2, and mix well.

[0046] Test Example 1 The polyphenol concentrations in the supernatant samples of the fermentation medium cultured in the above Example 3 and Comparative Example 1 and the mixed solution of Comparative Example 2 were tested.

[0047] The Folin-Ciocalteu colorimetric method was used. 1 mL of sample was placed in a 25 mL colorimetric tube, and 5 mL of distilled water, 1 mL of color developer and 3 mL of 75% sodium carbonate solution were added. The mixture was shaken and color developed for 2 h. Distilled water was used instead of the sample as a blank control. The absorbance was measured at a wavelength of 765 nm to calculate the polyphenol concentration.

[0048] The flavonoid concentrations in the samples cultured in the fermentation medium in the above Example 3 and Comparative Example 1 and the mixed solution in Comparative Example 2 were tested.

[0049] Using NaNO 2 -Al(NO 3 ) 3 -NaOH colorimetric method. Take 1 mL of sample in a 10 mL volumetric flask, add 4 mL of 70% ethanol and 0.3 mL of 5% NaNO 2 The solution was allowed to stand for 6 min. 0.3 mL 10% Al (NO 3 ) 3 Let stand for 6 min. Add 4 mL of 4% NaOH solution, let stand for 10 min, and dilute to volume with 70% ethanol. Use 70% ethanol instead of the sample as a blank control. Measure the absorbance at 510 nm and calculate the flavonoid concentration.

[0050] The test results are shown in Table 2 below.

[0051] Table 2 Contents of polyphenols and flavonoids in samples

[0052] The above test uses the content of polyphenols and flavonoids as the test index, and the test results show that after the medicinal material raw materials are processed by fermentation technology in the present invention, the content of polyphenols, flavonoids and other effective ingredients in the finished product can be significantly increased, greatly enhancing the efficacy of the medicinal material. The fermentation conditions are set as follows: the yield of the effective ingredients polyphenols and flavonoids is the highest when the mixed powder is 2, the snow pear juice is 100g, and the white radish juice is 50g.

[0053] Example 4

[0054] Spray drying The fermented liquid was evenly mixed with the onion essential oil of the auxiliary material component D and the component C, and the prepared liquid was put into a spray dryer. The inlet air temperature was set to 35-45°C, the air input was 4 m3 / h, and the peristaltic pump flow rate was 12 mL / min for spray drying to obtain a traditional Chinese medicine composition containing Fritillaria cirrhosa powder.

[0055] 4-1. Select fermentation medium 5 to cultivate the obtained upper fermentation clear liquid 100 ml, add 5 g of onion essential oil and 30 g of β-cyclodextrin, mix well, put the prepared liquid into a spray dryer, set the inlet air temperature to 35-45 ° C, the air input volume to 4 m3 / h, and the peristaltic pump flow rate to 12 mL / min for spray drying to obtain a traditional Chinese medicine composition 1 containing Fritillaria cirrhosa powder.

[0056] 4-2. Select fermentation medium 5 to cultivate the obtained upper fermentation clear liquid 100 ml, add 8 g of onion essential oil and 25 g of β-cyclodextrin, mix well and put the prepared liquid into a spray dryer, set the inlet air temperature to 35-45 ° C, the air input volume to 4 m3 / h, and the peristaltic pump flow rate to 12 mL / min for spray drying to obtain a traditional Chinese medicine composition 2 containing Fritillaria cirrhosa powder.

[0057] 4-3. Select fermentation medium 5 to cultivate the obtained upper fermentation clear liquid 100 ml, add 10 g of onion essential oil and 20 g of β-cyclodextrin, mix well and put the prepared liquid into a spray dryer, set the inlet temperature to 35-45 ° C, the air input volume to 4 m3 / h, and the peristaltic pump flow rate to 12 mL / min for spray drying to obtain a traditional Chinese medicine composition 3 containing Fritillaria cirrhosa powder.

[0058] Comparative Example 3 Select 100 ml of the upper fermentation clear liquid obtained by culturing the fermentation medium 10, add 20 g of β-cyclodextrin, mix well and put the prepared liquid into a spray dryer, set the inlet air temperature to 35-45°C, the air input volume to 4 m3 / h, and the peristaltic pump flow rate to 12 mL / min for spray drying to obtain snow pear powder containing Fritillaria cirrhosa.

[0059] Test Example 2 Evaluation of lung moistening and cough relieving effects: 140 ICR mice weighing 18-22g were selected and randomly divided into 8 groups, half male and half female. They were blank control group (normal saline), positive drug control group (20mg dextromethorphan / kg), high-dose group of Sichuan Fritillaria-Snow Pear fermented product prepared in comparative example 3 (6g dose / kg), medium-dose group of Sichuan Fritillaria-Snow Pear fermented product prepared in comparative example 3 (3g dose / kg), low-dose group of Sichuan Fritillaria-Snow Pear fermented product prepared in comparative example 3 (1.5g dose / kg), high-dose group of traditional Chinese medicine composition containing Sichuan Fritillaria powder prepared in Example 4-1 (6g dose / kg), medium-dose group of traditional Chinese medicine composition containing Sichuan Fritillaria powder prepared in Example 4-1 (3g dose / kg), high-dose group of traditional Chinese medicine composition containing Sichuan Fritillaria powder prepared in Example 4-1 (1.5g dose / kg), high-dose group of traditional Chinese medicine composition containing Sichuan Fritillaria powder prepared in Example 4-2 (6g dose / kg), and high-dose group of traditional Chinese medicine composition containing Sichuan Fritillaria powder prepared in Example 4-2 The high-dose group and the medium-dose group of the traditional Chinese medicine composition of Fritillaria cirrhosa powder (3g dose / kg), the high-dose group and the low-dose group of the traditional Chinese medicine composition containing Fritillaria cirrhosa powder prepared in Example 4-2 (1.5g dose / kg), the high-dose group of the traditional Chinese medicine composition containing Fritillaria cirrhosa powder prepared in Example 4-3 (6g dose / kg), the high-dose group and the medium-dose group of the traditional Chinese medicine composition containing Fritillaria cirrhosa powder prepared in Example 4-3 (3g dose / kg), and the high-dose group and the low-dose group of the traditional Chinese medicine composition containing Fritillaria cirrhosa powder prepared in Example 4-3 (1.5g dose / kg), once a day for 7 consecutive days, 1 hour after the last administration, take 0.2mL of 25wt% concentrated ammonia water and add it to a 20mL small beaker, immediately cover it with an inverted 1000mL large beaker, place the mice in the large beakers respectively, stimulate the mice for 20s, observe the coughing of the mice within 5min, record the number of coughs and calculate the cough suppression rate. In addition, the antitussive effect of the Fritillaria cirrhosa-Snow pear fermented product prepared in Comparative Example 3 and the Chinese medicine composition containing Fritillaria cirrhosa powder prepared in Example 4-2 was evaluated after three courses of treatment according to the above test method. Cough inhibition rate % = (1-number of coughs in the dose group / number of coughs in the blank control group) × 100%.

[0060] Evaluation of the effect of promoting body fluid and quenching thirst: After administration, the number of times and amount of water consumed by mice within 3 hours were observed, and the effective rate of promoting body fluid was calculated. In addition, the effect of promoting body fluid was evaluated after using the Chuanbeimu-Snow Pear fermented product prepared in Comparative Example 3 and the Chinese medicine composition containing Chuanbeimu powder prepared in Examples 4-1, 4-2, and 4-3 for 3 courses of treatment according to the above test method. Effective rate of promoting body fluid % = (1-number of times the dose group drank water / number of times the blank control group drank water) × 100%.

[0061] Table 3 Cough suppression rate and body fluid production effectiveness of Chinese medicine composition

[0062] It can be seen that compared with the blank control group, the Chinese medicine composition containing Fritillaria cirrhosa powder prepared by Example 4 of the present invention has a significant antitussive effect, wherein the effect of Example 4-2 is the most significant, and can achieve an effect comparable to or even better than that of dextromethorphan, and the present invention is a Chinese medicine preparation, which can be taken continuously for multiple courses of treatment without side effects, so as to achieve the effect of long-term improvement of lesions. The raw materials of the present invention are reasonably compatible, and the effects complement each other, and they play the role of dispelling wind and clearing heat, moistening the lungs and invigorating qi, relieving asthma and relieving cough, and eliminating phlegm and detoxifying together. At the same time, the Chinese medicine composition containing Fritillaria cirrhosa powder prepared by Examples 4-1, 4-2, and 4-3 of the present invention also has the effect of promoting body fluid and quenching thirst, wherein the effect of Example 4-2 is the best.

[0063] Test Example 3 Anti-inflammatory efficacy test A total of 93 CP patients who visited the Shuangliu District Traditional Chinese Medicine Hospital of Chengdu from June 2023 to January 2024 were divided into a control group, observation group 1, and observation group 2 by random number table method, with 31 cases in each group. This study was approved by the Medical Ethics Committee of the hospital (ethics approval number: 20200523Y).

[0064] Inclusion criteria: (1) Meet the diagnostic criteria of Western medicine, with hyperplasia of lymph follicles in the throat wall, hypertrophy and hyperplasia of the pharyngeal mucosa, or dryness, atrophy, and adhesion of secretions, and chronic congestion of the pharynx, which is dark red; (2) The patient meets the diagnostic criteria of traditional Chinese medicine and is diagnosed as a yin deficiency type, with symptoms of dry and sore throat, burning sensation in the throat, coughing without sputum, frequent craving for water but not much to drink, dark red congestion in the pharynx, dry or atrophic mucosa, red tongue, and thin pulse; (3) Disease duration ≥ 1 year.

[0065] Exclusion criteria: (1) Patients with laryngeal diseases such as chronic laryngitis and laryngeal cough; (2) Patients with laryngeal tumors; (3) Patients with chronic inflammation of the lower respiratory tract; (4) People with allergic constitution; (5) Patients with obvious tonsil enlargement; (6) Patients with concurrent autoimmune diseases.

[0066] There were 18 males and 13 females in the control group; the course of disease was 1-5 years, with an average of (2.58±0.40) years; the age was 18-63 years, with an average of (39.05±3.47) years; the body mass index was 18.9-28.5 kg / m 2 , average (24.70±1.22)kg / m 2 ; Disease type: 9 cases of hypertrophic type, 11 cases of atrophic type, and 11 cases of simple type.

[0067] Observation group 1: 16 males and 15 females; disease course 1-5 years, average (2.31±0.23) years; age 19-63 years, average (35.35±2.78) years; body mass index 18.3-27.9 kg / m 2 , average (24.20±1.34)kg / m 2 ; Disease type: 8 cases of hypertrophic type, 13 cases of atrophic type, and 10 cases of simple type.

[0068] The observation group included 17 males and 14 females; the course of disease was 1-5 years, with an average of (2.64±0.35) years; the age was 19-61 years, with an average of (39.24±2.51) years; the body mass index was 17.2-27.9 kg / m 2 , average (24.35±2.01)kg / m 2 ; Disease type: hypertrophic type in 9 cases, atrophic type in 9 cases, simple type in 13 cases.

[0069] There was no significant difference in gender, disease course, age, body mass index, and disease type among the three groups (P>0.05), indicating that the three groups were comparable. All patients were informed and signed consent forms.

[0070] method The control group was treated with conventional western medicine. 5 mg of dexamethasone sodium phosphate injection (production batch number: 20200520, Fujian Nanshaolin Pharmaceutical Co., Ltd., national medicine standard H35020009) and 80,000 units of gentamicin sulfate injection (production batch number: 20200412, Shanxi Shuguang Pharmaceutical Co., Ltd., national medicine standard H14021548) were added to 20 mL of 0.9% sodium chloride injection, and atomized and inhaled after thorough mixing, 20 minutes each time, once a day. Observation group 1 was treated with the Chuanbeimu-Snow Pear fermented product prepared in comparative example 3 (6 g dose / kg). Observation group 3 was treated with the Chinese medicine composition containing Chuanbeimu powder prepared in example 4-2 (6 g dose / kg). All three groups were treated for 4 consecutive weeks.

[0071] 1.3 Observation indicators (1) Clinical efficacy: Chronic congestion of pharyngeal mucosa is significantly relieved, and dryness, itching and foreign body sensation in the pharynx are significantly relieved or disappear, which is considered as markedly effective; Chronic congestion of pharyngeal mucosa is not significantly improved, and dryness, itching and foreign body sensation in the pharynx are relieved, which is considered as effective; No improvement of symptoms is considered as ineffective. Markedly effective rate + effective rate = total effective rate.

[0072] (2) Levels of inflammatory factors: 3 mL of fasting venous blood was collected from the patients before and 4 weeks after treatment, and the levels of tumor necrosis factor α (TNF-α), C-reactive protein (CRP), and interleukin 6 (IL-6) were detected by enzyme-linked immunosorbent assay.

[0073] (3) Quality of life: The Short Form 36 (SF-36) was used to assess the patients’ quality of life before and 4 weeks after treatment. The score ranged from 0 to 100, with a higher score indicating a better quality of life.

[0074] (4) TCM syndrome score: Before treatment and 4 weeks after treatment, the four symptoms of sore throat, burning throat, pharyngeal congestion, and dry pharyngeal mucosa were scored as 0, 1, 2, and 3 points respectively according to the "Standards for Diagnosis and Efficacy of TCM Diseases" according to the "Standards for Diagnosis and Efficacy of TCM Diseases".

[0075] (5) Adverse reactions: such as headache, gastrointestinal reactions, etc.

[0076] 1.4 Statistical analysis SPSS 22.0 statistical software was used for data analysis. The measurement data that conformed to the normal distribution were expressed as x±s, and the observation group 1 and the observation group 2 were compared with the control group using the t test; the enumeration data were expressed as the number of cases or percentages, and the observation group 1 and the observation group 2 were compared with the control group using the χ test. 2 P<0.05 was considered statistically significant.

[0077] Table 4 Comparison of clinical efficacy [n(%)]

[0078] Table 5 Comparison of inflammatory factor levels and quality of life scores among the three groups before and after treatment ( )

[0079] Note: Compared with the same group before treatment, .

[0080] Table 6 Comparison of TCM syndrome scores among the three groups before and after treatment ( ,point)

[0081] Note: Compared with the same group before treatment, .

[0082] In summary, the treatment of patients with Yin-deficiency type CP with the Chinese medicine composition containing Fritillaria cirrhosa powder of the present invention can reduce the level of inflammatory factors, alleviate clinical symptoms, and improve the quality of life of patients with significant effects, good safety, and beneficial prognosis.

[0083] All technical features in this embodiment can be modified in appearance according to actual needs.

[0084] The above embodiments are preferred implementation schemes of the present invention. In addition, the present invention may also be implemented in other ways. Any obvious replacement without departing from the concept of the present technical solution is within the protection scope of the present invention.

Claims

1. A Chinese medicine composition containing Fritillaria cirrhosa powder, characterized in that: The traditional Chinese medicine composition is prepared from 5 to 10 parts by weight of component A, 100 to 150 parts by weight of component B, 5 to 10 parts by weight of component C, and 20 to 30 parts by weight of component D as an auxiliary material; Wherein, component A is prepared from the following components in parts by weight: 5-10 parts of Fritillaria cirrhosa powder, 10-15 parts of Adenophora adenophora, 10-15 parts of honeysuckle and 15-20 parts of loquat leaves; Component B is prepared from the following components in parts by weight: 80-120 parts of snow pear juice and 30-70 parts of white radish juice; Component C is 5 to 10 parts of onion extract.

2. The Chinese medicine composition containing Fritillaria cirrhosa powder according to claim 1, characterized in that: The component D is one or more of white dextrin, lactose, maltodextrin, soluble starch and β-cyclodextrin.

3. The Chinese medicine composition containing Fritillaria cirrhosa powder according to claim 1, characterized in that: The onion extract is onion essential oil.

4. The method for preparing the Chinese medicine composition containing Fritillaria cirrhosa powder according to any one of claims 1 to 3, characterized in that: The following steps are involved: S1, preparing component A: weighing each medicinal material in component A according to the formula, washing with clean water and drying at 40°C for 40 minutes, mixing and grinding each medicinal material, and then passing through a 40-mesh sieve to obtain a mixed powder for use; S2, preparing component B: washing and draining fresh snow pear and white radish, and then juicing them separately for later use; S3, preparing component C: extracting onion essential oil from fresh onions; S4, fermenting medicinal materials: mixing the squeezed juices obtained in step S1 and S2 according to the formula, fermenting them with Lactobacillus plantarum, and taking the upper fermentation clear liquid; S5, weighing the auxiliary material component D and the onion essential oil of component C in the formula amount, adding them to the fermentation clear liquid prepared in step S4, stirring and mixing them evenly to obtain a medicinal solution, and spray-drying the medicinal solution with a spray dryer to prepare a Sichuan Fritillaria powder Chinese medicine composition.

5. The method for preparing the Chinese medicine composition containing Fritillaria cirrhosa powder according to claim 4, characterized in that: The specific extraction method of onion essential oil in step S3 is: take fresh onion, wash and cut into strips, dry at 60° C., and crush to obtain onion powder, add dichloromethane to the onion powder and shake well, use microwave extraction, dehydrate and then perform reduced pressure distillation to obtain onion essential oil.

6. The method for preparing the Chinese medicine composition containing Fritillaria cirrhosa powder according to claim 5, characterized in that: The solid-liquid ratio of onion powder to dichloromethane is 1:8.

6.

7. The method for preparing the Chinese medicine composition containing Fritillaria cirrhosa powder according to claim 5, characterized in that: The conditions of microwave extraction were set as follows: microwave power 389 W, temperature 29.8 °C, and extraction time 7.6 min.

8. The method for preparing the Chinese medicine composition containing Fritillaria cirrhosa powder according to claim 4, characterized in that: The specific method of fermenting medicinal materials in step S4 comprises the following steps: S41, prepare seed culture medium: take peptone, beef extract, yeast extract powder, glucose, triammonium citrate, Tween 80, sodium acetate, dipotassium hydrogen phosphate, magnesium sulfate, manganese sulfate, adjust pH to 6.8-7.0, make up to volume with distilled water, and sterilize at 118°C for 20 min; S42, preparing fermentation medium: taking snow pear juice and white radish juice, adding mixed drug powder and sucrose according to the formula ratio, sterilizing in a water bath at 85°C for 30 min, and rapidly cooling to 40°C; S43, seed culture: Lactobacillus plantarum was inoculated on the seed culture medium and cultured at 36°C for 12 h until the logarithmic growth phase; S44, fermentation culture: the seed culture solution obtained in step S43 is inoculated into the fermentation medium, and cultured at a constant temperature of 36° C. for 56 h.

9. The method for preparing the Chinese medicine composition containing Fritillaria cirrhosa powder according to claim 4, characterized in that: The specific method of spray drying in step S5 is: the fermented cultured fermentation liquid is evenly mixed with the onion essential oil of the auxiliary material component D and the component C to prepare the medicinal liquid, and the liquid is put into the spray dryer, and the air inlet temperature is set to 35-45°C, the air input volume is 4 m3 / h, and the peristaltic pump flow rate is 12 mL / min for spray drying to obtain a traditional Chinese medicine composition containing Fritillaria cirrhosa powder.

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