CN111729052A

CN111729052A - Traditional Chinese medicine composition, preparation method and application in preparation of heat-clearing and detoxifying drugs

Info

Publication number: CN111729052A
Application number: CN202010357191.2A
Authority: CN
Inventors: 何述金; 周代俊; 费翔; 肖功定; 欧阳习叶
Original assignee: HUNAN XINHUI PHARMACEUTICAL CO Ltd
Current assignee: HUNAN XINHUI PHARMACEUTICAL CO Ltd
Priority date: 2020-04-29
Filing date: 2020-04-29
Publication date: 2020-10-02

Abstract

The invention relates to a traditional Chinese medicine composition, a preparation method and application in the aspect of preparing heat-clearing and detoxifying drugs, wherein the composition comprises, by weight, 1.8-2.2 parts of mulberry leaf and hericium erinaceus transformed mycelium, 1.8-2.2 parts of areca nut, 0.8-1.2 parts of mangnolia officinalis, 0.8-1.2 parts of rhizoma anemarrhenae, 0.8-1.2 parts of peony, 0.8-1.2 parts of scutellaria baicalensis, 0.4-0.6 part of liquorice and 0.4-0.6 part of amomum tsao-ko.

Description

Traditional Chinese medicine composition, preparation method and application in preparation of heat-clearing and detoxifying drugs

Technical Field

The invention belongs to the technical field of traditional Chinese medicine compositions, and particularly relates to a traditional Chinese medicine composition, a preparation method and application thereof in preparing heat-clearing and detoxifying drugs.

Background

Dayunyin original named Dayuan powder was originated by Wu and Wu Zheng in Ming Dynasty in Wen Yi Lun. Is prepared from seven Chinese medicinal herbs including areca-nut, magnolia bark, tsaoko cardamon, anemarrhena rhizome, peony root, baikal skullcap root and licorice root. Can be used for treating pestilence or malaria with one to three diseases per day. Wu He also points out that Bing Lang removes Ling nan miao qi, Magnolia bark breaks through grumpness, and tsaoko fruit removes the latent evil, "three ingredients coordinate to directly reach its nest, so that the pathogenic qi fails to disappear, and four ingredients are behind membrane original … …, which are not concocted. The main herbs of Da Yuan Yin are Cao Guo and Zhi mu, where the herb is used to treat cold with exclusive predominance of taiyin and Zhi mu is used to treat heat with exclusive predominance of yangming. It is clinically indicated for cold of stomach and intestine type in summer and autumn with damp-heat obstructing the middle energizer, manifested as fluctuating chills and fever, persistent sensation in the successive days, fullness in chest and epigastrium, nausea and vomiting, even loose stool.

The original drink formula is as follows: betel nut two cents, magnolia bark one cents, tsaoko nut five cents, anemarrhena rhizome one cents, peony one cents, scutellaria baicalensis one cents and liquorice five cents. Remarking: in the clear, 596.8g for 1 jin and 3.73g for 1 jin.

The Dayunyuan drink is mainly used for treating: opening up the membrane source and removing the filth and turbid. Pestilence or malaria, pathogen hidden in the membranous origin. It is effective in resisting cold and heat, or three times a day, or once a day, with untimely hair, chest distress, nausea, headache, dysphoria, wiry and rapid pulse, deep red tongue with greasy and dirty coating, or white and thick coating, such as powder accumulation.

Disclosure of Invention

The invention aims to solve the technical problem of providing a traditional Chinese medicine composition, a preparation method and application in the aspect of preparing heat-clearing and detoxifying drugs.

The invention comprises a traditional Chinese medicine composition which comprises the following components in parts by weight,

1.8-2.2 parts of mulberry leaf and hericium erinaceus transformed mycelium, 1.8-2.2 parts of areca nut, 0.8-1.2 parts of mangnolia officinalis, 0.8-1.2 parts of rhizoma anemarrhenae, 0.8-1.2 parts of peony, 0.8-1.2 parts of scutellaria baicalensis, 0.4-0.6 part of liquorice and 0.4-0.6 part of amomum tsao-ko.

Preferably, the composition comprises the following components in percentage by weight,

2 parts of mulberry leaf and hericium erinaceus transformed mycelium, 2 parts of betel nut, 1 part of mangnolia officinalis, 1 part of rhizoma anemarrhenae, 1 part of peony, 1 part of scutellaria baicalensis, 0.5 part of liquorice and 0.5 part of amomum tsao-ko.

Preferably, the preparation method of the mulberry leaf hericium erinaceus transformed mycelium comprises the steps of inoculating hericium erinaceus into a culture medium, carrying out mycelium transformation culture for 30-40 days at the temperature of 20-27 ℃, taking out, and drying to obtain a biotransformation mycelium; the culture medium comprises the following components in parts by weight:

100-150 parts of mulberry leaves, 65-75 parts of wheat bran and 70-100 parts of water.

The application provides a preparation method of a traditional Chinese medicine composition, which comprises the steps of mixing all the components, adding water for soaking, decocting, filtering, concentrating filtrate, centrifuging, adding auxiliary materials, and drying to obtain the traditional Chinese medicine composition.

Preferably, the weight of water is 8 times the total weight of the components.

Preferably, the decocted medicine residues are added with 6 times of water by weight for decoction, filtrate is obtained by filtration, and the filtrate is mixed with the first filtrate and then concentrated.

Preferably, the auxiliary material is dextrin accounting for 10 percent of the weight of the traditional Chinese medicine composition.

Preferably, the drying mode is vacuum belt drying, and the drying temperature is 105 ℃.

The application provides application of a traditional Chinese medicine composition in preparation of a heat-clearing and detoxifying medicine.

The invention has the beneficial effects that the mulberry leaf transformed mycelium is added on the basis of the traditional ancient formula based on the original drink so as to improve the curative effect of the traditional ancient formula in the aspects of clearing heat and removing toxicity. Mulberry leaf has the efficacies of dispelling wind and heat from the body, clearing lung and moistening dryness, and clearing liver and improving vision, has the functions of treating wind-heat type common cold and lung-heat type dry cough, is often matched with chrysanthemum, honeysuckle, mint, radix peucedani, platycodon root and the like for application, and generally has the curative effect only on mild fever type cough. The application finds that the traditional Chinese medicine composition obtained by directly mixing the mulberry leaves and the Dayunyuan drink has limited curative effect, and the curative effect of the traditional Chinese medicine composition is not greatly different from that of the Dayunyuan drink. However, when the mycelium of the mulberry leaves and the hericium erinaceus obtained by biotransformation of the mulberry leaves is converted, the curative effect of the traditional Chinese medicine composition on clearing heat and removing toxicity is greatly improved after the mycelium of the mulberry leaves and the hericium erinaceus is matched with the formula of the original drink.

The invention is based on the original drink, and adds mulberry leaves and hericium erinaceus to convert mycelium, thereby producing unexpected effects.

Drawings

Fig. 1 is a flow chart of a preparation method of the present application.

Detailed Description

Example 1

The traditional Chinese medicine composition comprises the following components: 932g of areca nut, 466g of mangnolia officinalis, 466g of rhizoma anemarrhenae, 466g of radix paeoniae alba, 466g of radix scutellariae, 233g of liquorice, 233g of amomum tsao-ko and 932g of mulberry leaf hericium erinaceus transformed mycelium.

The preparation method of the mulberry leaf hericium erinaceus transformed mycelium comprises the steps of inoculating hericium erinaceus into a culture medium, carrying out mycelium transformation culture for 30-40 days at the temperature of 20-27 ℃, taking out, and drying to obtain a biotransformation mycelium; the culture medium comprises the following components in parts by weight:

100 parts of mulberry leaves, 70 parts of wheat bran and 80 parts of water.

The preparation method comprises the following steps: adding 8 times of water into the above 8 raw materials, soaking for 30min, boiling, slightly boiling for 2 hr, filtering, and standing the filtrate; adding 6 times of water into the residue, boiling, slightly boiling for 1 min, filtering, mixing the two filtrates, concentrating, centrifuging, adding appropriate amount of adjuvant, vacuum belt drying, adding appropriate amount of adjuvant, mixing, vacuum belt drying, dry granulating, and making into granule 1000 g. The specific preparation process is shown in figure 1.

Example 2 Water extraction Process study

Investigation of whether the medicinal materials are soaked or not and the extraction times

The method comprises the following steps: 130.6g of each of the two medicinal decoction pieces are weighed according to the mixture ratio of the prescription. Respectively as follows: 29.02g of mulberry leaf and hericium erinaceus transformed mycelium, 29.02g of areca nut, 14.51g of mangnolia officinalis, 14.51g of rhizoma anemarrhenae, 14.51g of radix paeoniae alba, 14.51g of scutellaria baicalensis, 7.26g of liquorice and 7.26g of amomum tsao-ko. Placing in 2000ml round flask, decocting with water for three times, soaking in 10 times of water for 30min, extracting for 1 hr, filtering while hot, cooling the filtrate to room temperature, and measuring volume to obtain DY-A₁Sampling; adding 8 times of water for the second time, extracting for 1 hr, filtering while hot, cooling the filtrate to room temperature, and measuring volume to obtain DY-A₂Sampling; adding 8 times of water for the third time, extracting for 1 hr, filtering while hot, cooling the filtrate to room temperature, and measuring volume to obtain DY-A₃And (5) sampling. Extracting with 10 times of water in the same way without soaking to obtain DY-B₁Sampling; adding 8 times of water for the second time to extract DY-B₂Sampling; adding 8 times of water for the third time, and extracting DY-B₃And (5) sampling. Concentrating the filtrate at 65 ℃, fixing the volume to 500ml, and measuring the dry extract yield of 6 samples.

And (3) determination of dry extract yield: precisely measuring 25ml of the above extractive solution with known volume, placing in an evaporation dish with constant weight, evaporating to dryness in a water bath, drying at 105 deg.C for 3 hr, cooling in a drier for 30min, rapidly weighing, and drying in an oven at 105 deg.C to constant weight. Calculating to obtain the product; the extract yield is (weight of dried extract and evaporating dish-weight of evaporating dish) x (volume of filtrate to constant volume/volume of filtrate to suction)/weight of decoction pieces x 100%.

Results and discussion

Table 1: examination result of dry extract yield

As can be seen from the data in Table 1, the medicinal materials in the formula are extracted after being soaked for 30min, and the yield of the obtained dry paste is higher than that of the dry paste which is not soaked and extracted; the data result of the extraction times survey shows that about 90 percent of dry paste can be obtained after twice extraction, the comprehensive consideration is that the time is saved, the production efficiency is improved, and the medicinal materials are soaked for 30min before the extraction because the medicinal materials are not too much energy is not consumed before the extraction, and the extraction times can be twice.

Investigation of water addition

The extraction method comprises weighing 130.6g each of the three medicinal materials according to the prescription ratio. Respectively as follows: 29.02g of mulberry leaf and hericium erinaceus transformed mycelium, 29.02g of areca nut, 14.51g of mangnolia officinalis, 14.51g of rhizoma anemarrhenae, 14.51g of radix paeoniae alba, 14.51g of scutellaria baicalensis, 7.26g of liquorice and 7.26g of amomum tsao-ko. Placing in a 2000ml round-bottom flask, adding water, decocting twice, adding 10 times of water for soaking for 30min for the first time, extracting for 2h, filtering while hot, filtering the filtrate for later use, adding 8 times of water for the second time, extracting for 1h, filtering while hot, combining the two filtrates, cooling to room temperature, and measuring the volume to obtain DY-C sample. Extracting with the same method, adding 8 times of water for the first time, and adding 6 times of water for the second time to obtain 6 times of water extractive solution, DY-D sample, of the medicinal materials. Extracting with the same method, adding 6 times of water for the first time, and adding 4 times of water for the second time to obtain 6 times of 4 times of water extractive solution of medicinal materials, and DY-E sample. And determining the dry extract yield of the decoction.

And (3) determination of dry extract yield: the method is the same as the dry extract yield determination of water extraction process research.

Results and discussion

Table 2: examination result of dry extract yield

Sample (I)

Weight of evaporating dish

Weight after sample application

Volume of filtrate

Draw filtrate volume

Weight of decoction pieces

Extract yield

DY-C

44.8419g

45.4079g

1433ml

25ml

130.6g

24.84％

DY-D

43.5168g

44.2811g

1021ml

25ml

130.6g

23.90％

DY-E

43.0063g

44.0897g

688ml

25ml

130.6g

22.83％

The results in table 2 show that the 10 times and 8 times of water extraction yield is slightly higher than 8 times and 6 times and 4 times of water extraction yield, but is only higher than about 10 percent, and as the water addition amount is larger, water resources are wasted, and meanwhile, the concentration time of the extracting solution is greatly increased, so that the working efficiency is influenced; and because 6 times and 4 times of water can not completely submerge the medicinal materials in the extraction process. Considering comprehensively, the recipe is determined to be extracted twice, respectively 8 times and 6 times.

Extraction time review

The extraction method comprises weighing 130.6g each of the three medicinal materials according to the prescription ratio. Respectively as follows: 29.02g of mulberry leaf and hericium erinaceus transformed mycelium, 29.02g of areca nut, 14.51g of mangnolia officinalis, 14.51g of rhizoma anemarrhenae, 14.51g of radix paeoniae alba, 14.51g of scutellaria baicalensis, 7.26g of liquorice and 7.26g of amomum tsao-ko. Placing in a 2000ml round-bottom flask, adding water, decocting twice, adding 10 times of water for soaking for 30min for the first time, extracting for 2h, filtering while hot, filtering the filtrate for later use, adding 8 times of water for the second time, extracting for 2h, filtering while hot, combining the two filtrates, cooling to room temperature, and measuring the volume to obtain DY-F sample. Extracting with the same method for 2h for the first time and 1h for the second time to obtain 2h +1h extractive solution of medicinal materials, and DY-G sample. Extracting with the same method for the first time for 1.5H and the second time for 1H to obtain extract of medicinal materials for 1.5H +1H, and DY-H sample. And determining the dry extract yield of the decoction.

And (3) determination of dry extract yield: the method is the same as 'determination of dry extract yield in water extraction process research'

Results and discussion

Table 3: examination result of dry extract yield

Sample (I)

Weight of evaporating dish

Weight after sample application

Volume of filtrate

Draw filtrate volume

Weight of decoction pieces

Extract yield

DY-F

43.0063g

43.7121g

1126ml

25ml

130.6g

24.34％

DY-G

47.2324g

47.7763g

1377ml

25ml

130.6g

22.94％

DY-H

45.4865g

45.9352g

1584ml

25ml

130.6g

21.77％

The data in table 3 show that the longer the extraction time, the more dry paste is indeed obtained, and the longer the decoction time, the higher the energy consumption in connection with the scale production. Therefore, in order to ensure the stability of the process and the energy consumption, the time for extracting twice is determined to be 2 hours and 1 hour respectively by comprehensive consideration.

By combining the investigation results of all factors influencing the water extraction process of the formula, the optimal water extraction process prepared by the formula is determined: extracting with water for 2 times, soaking for 30min, extracting with 8 times of water for 2 hr for the first time, and extracting with 6 times of water for 1 hr for the second time.

Investigation of concentration temperature

The experimental method comprises the steps of weighing 87.07g of mulberry leaf hericium erinaceus transformed mycelium, 87.07g of areca nut, 43.53g of mangnolia officinalis, 43.53g of rhizoma anemarrhenae, 43.53g of radix paeoniae alba, 43.53g of radix scutellariae, 21.77g of liquorice, 21.77g of fructus amomi and 391.8g of the total. Placing in a decocting container, and decocting twice. Adding 8 times of water for the first time, decocting for 2h, filtering, and collecting filtrate; adding 6 times of water for the second time, decocting for 1 hr, filtering, and collecting filtrate; mixing the two filtrates, and averagely dividing into trisections, which are respectively numbered as DY-I sample, DY-J sample and DY-K sample. The concentration temperature of the DY-I sample is set to be 55 ℃, the concentration temperature of the DY-J sample is set to be 65 ℃, and the concentration temperature of the DY-K sample is set to be 75 ℃. Respectively concentrating, and making into 250 ml. The dry extract yield of the decoction was determined and the concentration time was recorded.

Results and discussion

Table 4: concentration temperature investigation results

The data in table 4 show that the higher the concentration temperature is, the shorter the concentration time is, but the higher the temperature is, the more the effect is. The data in Table 4 show that the concentration at 55 ℃, 65 ℃ and 75 ℃ has little influence on the yield of dry paste. Therefore, in order to ensure the stability of the process, the concentration temperature of the method is determined to be 65 ℃ in comprehensive consideration.

Investigation of different adjuvants

The test method comprises the steps of weighing 116.09g of mulberry leaf hericium erinaceus transformed mycelium, 116.09g of areca nut, 58.04g of mangnolia officinalis, 58.04g of rhizoma anemarrhenae, 58.04g of radix paeoniae alba, 58.04g of radix scutellariae, 29.03g of liquorice, 29.03g of fructus amomi and 522.4g of the total. Placing in a decocting container, and decocting twice. Adding 8 times of water for the first time, decocting for 2h, filtering, and collecting filtrate; adding 6 times of water for the second time, decocting for 1 hr, filtering, and collecting filtrate; mixing the two filtrates, and concentrating to obtain medicinal liquid with specific gravity of 1.20. The sample is divided into four equal parts which are respectively numbered as DY-L sample, DY-M sample, DY-N sample and DY-O sample. Setting a DY-L sample, adding 13g of corn starch (which is converted into 10 percent of the feeding amount of the decoction pieces); adding 13g of dextrin into the DY-M sample; adding 13g of hydroxypropyl cellulose into the DY-N sample; no auxiliary materials are added in the DY-O sample. Respectively adopting vacuum belt drying. Collecting extract powder. And calculating the yield of the dry powder of the extract powder, measuring the moisture of the extract powder, and observing the drying condition of the liquid medicine in the drying process.

TABLE 5 examination of various adjuvants

The data in table 5 show that the drying effect is significantly better with the addition of the auxiliary materials than without the addition of the auxiliary materials; the starch powder added in the prescription is seriously sticky and is not beneficial to material collection; after the hydroxypropyl methylcellulose is added, the liquid medicine is viscous, so that the cloth is not facilitated, and the drying uniformity is influenced; the dextrin-added liquid medicine has good fluidity, better drying effect and good powder fluidity. Therefore, in order to ensure the stability of the process and the rationality of the production, the auxiliary material selected by the prescription is determined to be dextrin by comprehensive consideration.

Confirmation of the amount of auxiliary Material

The test method comprises the steps of weighing 87.07g of mulberry leaf hericium erinaceus transformed mycelium, 87.07g of areca nut, 43.53g of mangnolia officinalis, 43.53g of rhizoma anemarrhenae, 43.53g of radix paeoniae alba, 43.53g of scutellaria baicalensis, 21.77g of liquorice, 21.77g of fructus amomi and 391.8g of the total. Placing in a decocting container, and decocting twice. Adding 8 times of water for the first time, decocting for 2h, filtering, and collecting filtrate; adding 6 times of water for the second time, decocting for 1 hr, filtering, and collecting filtrate; mixing the two filtrates, and concentrating to obtain medicinal liquid with specific gravity of 1.20. Evenly dividing the mixture into three equal parts which are respectively numbered as follows; respectively numbered as DY-P sample, DY-Q sample and DY-R sample. Setting DY-P sample to be added with 6.5g of dextrin (equivalent to 5% of the feeding amount of the decoction pieces), DY-Q sample to be added with 13g of dextrin (10% of the feeding amount of the decoction pieces), and DY-R sample to be added with 19.5g of dextrin (15% of the feeding amount of the decoction pieces). Respectively adopting vacuum belt drying to collect extract powder. And calculating the dry powder yield and the moisture of the extract powder and observing the drying condition.

TABLE 6 table of the results of the comparative test for the confirmation of the amount of auxiliary materials

The data in table 6 show that the greater the amount of adjuvant, the better the drying effect; according to experimental data, the drying effect is not large in the drying process when a small amount of auxiliary materials are added, but the amount of the auxiliary materials is increased, so that the powder has better flowability; the powder drying effect and the moisture absorption of the powder are almost eliminated by adding 10 percent and 15 percent of dextrin for drying, the difference of the fluidity is not large, and the method is suitable for large-scale production. In order to ensure the stability of the process, the auxiliary materials of the formula are determined to be added with 10 percent of dextrin in consideration.

Confirmation of specific gravity of drug solution

The test method comprises the steps of weighing 87.07g of mulberry leaf hericium erinaceus transformed mycelium, 87.07g of areca nut, 43.53g of mangnolia officinalis, 43.53g of rhizoma anemarrhenae, 43.53g of radix paeoniae alba, 43.53g of scutellaria baicalensis, 21.77g of liquorice, 21.77g of fructus amomi and 391.8g of the total. Placing in a decocting container, and decocting twice. Adding 8 times of water for the first time, decocting for 2h, filtering, and collecting filtrate; adding 6 times of water for the second time, decocting for 1 hr, filtering, and collecting filtrate; mixing the two filtrates, and averagely dividing into trisections, which are respectively numbered as DY-S sample, DY-T sample and DY-U sample. And respectively concentrating the DY-S sample until the specific gravity of the liquid medicine is 1.10, concentrating the DY-T sample until the specific gravity of the liquid medicine is 1.20, and concentrating the DY-U sample until the specific gravity of the liquid medicine is 1.30. 13g of dextrin (reduced to 10% of the feeding amount of the decoction pieces) is added into each part. Respectively adopting vacuum belt drying. Collecting extract powder. Calculating the dry powder yield of the extract powder, and observing the drying condition of the liquid medicine in the drying process.

Results and discussion

TABLE 7 table of results of specific gravity determination and comparison tests of medicinal liquids

The data in Table 7 show that the higher the specific gravity of the liquid medicine, the smaller the bubble generation and the smaller the loss during drying, whereas when the specific gravity of the liquid medicine is 1.10 and the liquid medicine is dried, the liquid medicine is boiled seriously and splashed out. The drying effect is better when the specific gravity of the liquid medicine is higher in combination with large-scale production; however, the higher the specific gravity of the concentrated liquid medicine is, the more energy is consumed and the more liquid medicine is consumed. Comprehensively considering: the optimal specific gravity of the dry liquid medicine of the formula is 1.20-1.25.

Confirmation of drying temperature

The test method comprises the steps of weighing 87.07g of mulberry leaf hericium erinaceus transformed mycelium, 87.07g of areca nut, 43.53g of mangnolia officinalis, 43.53g of rhizoma anemarrhenae, 43.53g of radix paeoniae alba, 43.53g of scutellaria baicalensis, 21.77g of liquorice, 21.77g of fructus amomi and 391.8g of the total. Placing in a decocting container, and decocting twice. Adding 8 times of water for the first time, decocting for 2h, filtering, and collecting filtrate; adding 6 times of water for the second time, decocting for 1 hr, filtering, and collecting filtrate; mixing the filtrates, concentrating to specific gravity of 1.20, adding dextrin 39.2g (calculated as 10% of the amount of decoction pieces), dividing into three equal parts, respectively numbered DY-V sample, DY-W sample and DY-X sample, and vacuum belt drying. The drying temperature of the DY-V sample is set to be 95 ℃, the drying temperature of the DY-W sample is set to be 105 ℃, and the drying temperature of the DY-X sample is set to be 115 ℃. Respectively collecting extract powders. And (4) calculating the dry powder yield of the extract powder, measuring the moisture of the extract, and observing the drying condition of the liquid medicine in the drying process.

Results and discussion

TABLE 8 drying temperature comparison confirmation comparison test result table

The data in Table 8 show that wall sticking occurs when dried at 95 ℃; however, the drying results at 105 ℃ and 115 ℃ are not very different, and the color of the powder obtained by drying at 115 ℃ is darker than that of the powder obtained by drying at 105 ℃. And in combination with large-scale production, the drying energy consumption of the equipment is higher than the drying energy consumption of the equipment when the temperature is raised to 115 ℃ than the heating temperature is raised to 105 ℃. Comprehensively considering: the optimum drying temperature for the square vacuum belt drying was 105 ℃.

Comparative example 1

The traditional Chinese medicine composition comprises the following components: 932g of areca nut, 466g of mangnolia officinalis, 466g of rhizoma anemarrhenae, 466g of radix paeoniae alba, 466g of radix scutellariae, 233g of liquorice and 233g of amomum tsao-ko. The other steps are the same as in example 1.

Comparative example 2

The traditional Chinese medicine composition comprises the following components: 932g of areca nut, 466g of mangnolia officinalis, 466g of rhizoma anemarrhenae, 466g of radix paeoniae alba, 466g of radix scutellariae, 233g of liquorice, 233g of amomum tsao-ko and 932g of mulberry leaf. The other steps are the same as in example 1.

Experimental example 1

Western diagnostic criteria:

made according to the diagnosis standard of upper respiratory tract infection in the interior science of the Ministry of Zhongnan mountain.

(1) Nasopharynx symptoms and signs mainly show nasal symptoms such as sneezing, nasal obstruction, watery nasal discharge, cough, dry throat, throat itching or burning sensation and the like, acute tonsillitis has obvious pharyngalgia, fever, chilliness and body temperature of more than 39 ℃, and the body is inspected to have obvious congestion of the pharynx, tonsil swelling and lymph node swelling sometimes.

(2) Auxiliary inspection, virus infected leucocyte is normal or low, the proportion of lymphocyte is increased, and the bacterial infected person can have leucocyte count and neutrophilia and nucleus left shift. The patients with the symptoms, signs and negative auxiliary examination can be clinically diagnosed according to chest X-ray representation or subjected to pathogenic blood detection.

The traditional Chinese medicine diagnosis standard is as follows:

the Chinese medicine symptom diagnostic standard refers to the Chinese traditional medicine clinical research guide principle (trial) Chinese traditional medicine clinical research standard, and the symptoms comprise fever, chills, headache and body pain, pharynx red, cough, red tongue, thin white or yellow fur, and floating and rapid or superficial and slippery pulse.

Case inclusion criteria:

(1) those who meet the criteria of Western diagnosis and the criteria of Chinese medicine syndrome diagnosis;

(2) the body temperature is more than or equal to 37.4 ℃.

The treatment method comprises the following steps:

the granules prepared by the formula of the application example 1 are decocted in water for taking, the single dose is 80g, 3 doses are taken every day, the body temperature is recovered to 37.0 ℃, the taking is stopped, and the patients are cured after no fever is observed for 3 days.

The evaluation standard of curative effect is as follows:

the curative effect is evaluated according to the guiding principle of clinical research of new traditional Chinese medicine.

And (3) healing: within 72 hours of treatment, the body temperature returns to normal (the axillary temperature is 37 ℃, and the temperature does not rise any more), and the clinical symptoms disappear.

The effect is shown: within 72 hours of treatment, the body temperature returns to normal, and most of clinical symptoms disappear.

The method has the following advantages: within 72 hours of treatment, the body temperature decreased earlier and the clinical symptoms partially disappeared.

And (4) invalidation: within 72 hours of treatment, the body temperature did not drop or rise, and no improvement in clinical symptoms occurred.

Calculating the formula: the cure rate is 100% of the number of cure cases/total cases; the significant efficiency is 100% of the number of significant examples/total examples; effective rate is 100% of effective cases/total cases; inefficiency-100% of non-valid cases/total cases.

Analysis of results

TABLE 1 Chinese medicinal composition antipyretic effect table

Assessment of efficacy	Recovery method	Show effect	Is effective	Invalidation	Total up to
						Number of cases	94	4	2	0	100
Percentage of	94％	4％	2％	0	100％

As can be seen from the above table, the treatment of 110 cases of upper respiratory tract infection with exogenous wind-heat fever by using the formulation of example 1 has a cure rate of 94%, a significant efficiency of 4%, an effective rate of 2% and a non-effective rate of 0.

Symptom improvement condition: the fever of the patient is reduced after the medicine is taken, the symptom is relieved, and the disease condition is obviously improved.

Analysis of toxic side effects

In 100 observed patients, after taking the traditional Chinese medicine, mild diarrhea does not appear, and the probability of side effects is only 0%.

Experimental example 2

For comparative analysis of the drug effects of the present application, a comparative test was conducted in which the drug of comparative example 2 was tested following the standards and contents of experimental example 1. The duration and symptoms of the patients were the same as those in Experimental example 1. The results obtained are shown in table 2.

TABLE 2 Chinese medicinal composition antipyretic effect table

Assessment of efficacy	Recovery method	Show effect	Is effective	Invalidation	Total up to
						Number of cases	67	7	5	1	80
Percentage of	83.75％	8.75％	6.25％	1.25	100％

In conclusion, the recovery rate of the original drink added with the mulberry leaves is 83.75%, but the recovery rate of the composition obtained by converting the mulberry leaves into the mycelia is 94%, and nearly 10% is mentioned. Greatly improves the curative effect of the medicine.

Claims

1. A traditional Chinese medicine composition is characterized by comprising the following components by weight,

2. The traditional Chinese medicine composition as claimed in claim 1, which comprises the following components by weight,

3. The traditional Chinese medicine composition as claimed in claim 1 or 2, wherein the mulberry leaf hericium erinaceus transformed mycelium is prepared by inoculating hericium erinaceus into a culture medium, performing mycelium transformation culture at 20-27 ℃ for 30-40 days, taking out, and drying to obtain a biotransformed mycelium; the culture medium comprises the following components in parts by weight:

4. A process for the preparation of a Chinese medicinal composition as claimed in any one of claims 1 to 3 which comprises the steps of mixing all the components, immersing in water, decocting, filtering, concentrating the filtrate, centrifuging, adding adjuvants and drying.

5. The preparation method of the Chinese medicinal composition as claimed in claim 4, wherein the weight of the water is 8 times of the total weight of the components.

6. The preparation method of the Chinese medicinal composition as claimed in claim 4 or 5, wherein the decoction dregs are decocted with 6 times of water, filtered to obtain a filtrate, and the filtrate is mixed with the first filtrate and then concentrated.

7. The method for preparing a Chinese medicinal composition as claimed in claim 4 or 5, wherein the adjuvant is dextrin in an amount of 10% by weight of the Chinese medicinal composition.

8. The method for preparing a Chinese medicinal composition according to claim 4 or 5, wherein the drying manner is vacuum belt drying.

9. The method for preparing a Chinese medicinal composition according to claim 8, wherein the drying temperature is 105 ℃.

10. Application of a Chinese medicinal composition in preparing heat-clearing and detoxicating medicine is provided.