CN113350494A - A Chinese medicinal composition for transdermal administration for treating infectious diseases, and its preparation method - Google Patents

A Chinese medicinal composition for transdermal administration for treating infectious diseases, and its preparation method Download PDF

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CN113350494A
CN113350494A CN202110445838.1A CN202110445838A CN113350494A CN 113350494 A CN113350494 A CN 113350494A CN 202110445838 A CN202110445838 A CN 202110445838A CN 113350494 A CN113350494 A CN 113350494A
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traditional chinese
chinese medicine
vaccine
infectious diseases
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王九生
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Wang Linyang
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Wang Linyang
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Abstract

The invention discloses a vaccine traditional Chinese medicine composition for treating infectious diseases by transdermal administration, wherein the vaccine is bacillus calmette guerin, and the traditional Chinese medicine composition comprises the following traditional Chinese medicine raw materials in parts by weight: 0-20 parts of coptis chinensis, 5-20 parts of rheum officinale, 0-9 parts of aloe, 0-16 parts of dandelion, 8-20 parts of isatis root, 6-20 parts of honeysuckle, 5-20 parts of fructus forsythiae, 0-8 parts of andrographis paniculata, 1-10 parts of radix bupleuri, 2-11 parts of sweet wormwood herb, 0-9 parts of phellodendron and 0-9 parts of scutellaria baicalensis. The invention realizes transdermal drug delivery by means of BCG and traditional Chinese medicine, replaces a painful BCG intradermal injection method, has obvious curative effects on various infectious diseases such as tonsillitis, pneumonia, nasosinusitis, appendicitis, otitis media, cholecystitis, influenza and the like, has short treatment period of 2 to 11 days, is simple to use, does not need injection or medicine taking, has no side effect, takes effect quickly, and replaces antibiotics by traditional Chinese medicine.

Description

A Chinese medicinal composition for transdermal administration for treating infectious diseases, and its preparation method
Technical Field
The invention relates to the technical field of transdermal administration of pharmaceutical compositions, in particular to a vaccine traditional Chinese medicine composition for treating infectious diseases by transdermal administration and a preparation method thereof.
Background
Transdermal drug delivery is one method of drug absorption through the skin. The process of the drug passing through the stratum corneum after application to the skin, diffusing through the skin, being absorbed by the capillaries or lymphatic vessels into the systemic circulation is called percutaneous absorption or transdermal absorption. Transdermal administration has its unique advantages. Such as: transdermal administration can avoid first pass effect of liver and degradation of medicine in gastrointestinal tract, and the medicine absorption is not affected by gastrointestinal tract factors, so as to reduce individual difference of medicine administration. Reduces toxic and side effects, is convenient to use, and is particularly suitable for patients who are not suitable for oral administration.
BCG vaccine is live vaccine prepared by freeze drying attenuated bovine tubercle bacillus, and is mainly used for preventing tuberculosis, treating infantile asthmatic bronchitis and adjuvant treating tumor. The administration of BCG is usually intradermal injection or intratumoral injection, and transdermal administration is rarely seen. Patent application CN201210063961.8 provides a method of transdermal drug delivery comprising: disinfecting the skin of the subject; pre-treating the skin of a subject with a microneedle array stamp to create micropores that penetrate the stratum corneum layer of the skin; adhering a transdermal drug delivery cartridge loaded with a drug to be delivered and hyaluronidase to the skin of a subject and keeping for a period of time; and removing the transdermal drug delivery cartridge from the skin of the subject; wherein, the transdermal drug delivery patch contains an antibacterial preservative. The specification of this application specifically mentions a method for treating tuberculosis by transdermal administration of BCG. But actually it needs to make micro-holes on the skin with micro-needle array stamp before transdermal administration and realize transdermal administration of bcg vaccine by means of penetration enhancer hyaluronidase. It can be seen that it does not achieve transdermal administration of bcg without damaging the skin surface layer. Patent application CN201811003395.5 provides a bioabsorbable painless transdermal drug delivery microneedle patch, including the base with fix the needle body that contains the bacterin on the base, the base is prepared by the aqueous solution of soluble material A, the needle body is prepared by needle body preparation liquid, and needle body preparation liquid includes the aqueous solution and the bacterin of soluble material B. In the microneedle patch, the vaccine is uniformly dispersed in the needle body part and can be completely released in the skin, the dissolution of the microneedle solves the problems of secondary harm of medical waste of the needle head after subcutaneous injection administration and the like, and the administration dosage is accurate and the speed is controllable. The specification of this application specifically states that transdermal administration of BCG can be achieved. However, transdermal delivery of this solution, which is essentially accomplished by the microneedles passing through the stratum corneum layer of the skin, requires disruption of the top layer of the skin. It can be seen that transdermal administration of bcg is currently achieved by disrupting the stratum corneum with microneedles and by the penetration-promoting action of hyaluronidase.
In the aspect of treating infectious diseases such as appendicitis, tonsillitis, otitis media, pneumonia, nasosinusitis, cholecystitis, influenza and the like, human beings still adopt injection and oral antibiotics to resist infection or adopt oral traditional Chinese medicines to treat. The search does not find a precedent that the BCG vaccine is combined with the traditional Chinese medicine to treat infectious diseases such as pneumonia and the like by adopting a transdermal administration mode. Therefore, the vaccine traditional Chinese medicine composition for treating infectious diseases by transdermal administration and the preparation method thereof are pioneering achievements in the field, and the traditional Chinese medicine composition has important significance for replacing antibiotics.
Disclosure of Invention
In view of the defects of the prior art, the applicant develops a vaccine traditional Chinese medicine composition for treating infectious diseases by transdermal administration through years of research and summary, and specifically discloses a preparation method and a use method of the vaccine traditional Chinese medicine composition.
The scheme of the invention comprises the following contents:
a vaccine traditional Chinese medicine composition for treating infectious diseases through transdermal administration is a BCG vaccine, and comprises the following traditional Chinese medicine raw materials in parts by weight: 0-20 parts of coptis chinensis, 5-20 parts of rheum officinale, 0-9 parts of aloe, 0-16 parts of dandelion, 8-20 parts of isatis root, 6-20 parts of honeysuckle, 5-20 parts of fructus forsythiae, 0-8 parts of andrographis paniculata, 1-10 parts of radix bupleuri, 2-11 parts of sweet wormwood herb, 0-9 parts of phellodendron and 0-9 parts of scutellaria baicalensis.
Preferably, the traditional Chinese medicine composition also comprises the following traditional Chinese medicine raw materials in parts by weight: 3-10 parts of folium isatidis, 0-10 parts of herba violae, 0-8 parts of rhizoma paridis, 0-3 parts of radix sophorae tonkinensis and 0-8 parts of salvia miltiorrhiza.
Preferably, the traditional Chinese medicine composition comprises the following traditional Chinese medicine raw materials in parts by weight: 10-20 parts of coptis chinensis, 5-20 parts of rheum officinale, 2-9 parts of aloe, 5-16 parts of dandelion, 8-16 parts of isatis root, 6-10 parts of honeysuckle, 5-12 parts of fructus forsythiae, 3-8 parts of andrographis paniculata, 1-3 parts of radix bupleuri, 2-11 parts of sweet wormwood herb, 3-9 parts of golden cypress, 2-9 parts of scutellaria baicalensis, 3-7 parts of folium isatidis, 5-10 parts of herba violae, 3-8 parts of rhizoma paridis, 1-3 parts of vietnamese sophora root and 3-8 parts of salvia miltiorrhiza.
Preferably, the bcg vaccine of the present invention is a whole vaccine.
Preferably, the preparation method of the vaccine traditional Chinese medicine composition comprises the following steps: mixing the Chinese medicinal materials, pulverizing to obtain mixed powder, extracting with organic solvent, and filtering to obtain Chinese medicinal extractive solution which can be used together with BCG vaccine. The dosage ratio of the BCG vaccine to the traditional Chinese medicine raw materials is 0.5-1 mg: 2-12 g.
Preferably, the preparation method of the vaccine traditional Chinese medicine composition comprises the following steps: mixing and crushing traditional Chinese medicine raw materials to obtain mixed medicinal powder, wherein the ratio of materials to liquid is 20-60 g: leaching 100mL of the extract with an ethanol solution with the volume concentration of 60-80% for 1-2 weeks, and filtering to obtain a traditional Chinese medicine extract, wherein the traditional Chinese medicine extract and the BCG are used simultaneously.
The invention relates to a traditional Chinese medicine vaccine preparation for treating infectious diseases by transdermal administration, which takes the traditional Chinese medicine vaccine composition as an effective component. Preferably, the vaccine traditional Chinese medicine preparation further comprises pharmaceutically acceptable auxiliary materials, and the dosage of the auxiliary materials is added according to the pharmaceutical requirements.
The pharmaceutically acceptable adjuvants include ethanol, menthol, azone and sodium chloride.
Preferably, the dosage form of the vaccine traditional Chinese medicine preparation is a transdermal administration dosage form, and the dosage form comprises a liquid dosage form, a semisolid dosage form, a solid dosage form or a gas dosage form.
Preferably, the liquid dosage form comprises lotion and liniment, the semisolid dosage form comprises ointment, gel and paste, the solid dosage form comprises emplastrum and powder, and the gas dosage form comprises aerosol.
Preferably, the infectious diseases comprise appendicitis, tonsillitis, otitis media, pneumonia, nasosinusitis, cholecystitis and influenza.
The invention provides two using modes of a BCG vaccine traditional Chinese medicine composition: 1) firstly, 1-5 mL of auxiliary materials such as azone and the like are smeared on the shank and/or the thigh to be dried, and then 1-2 mL of BCG vaccine and 10-20 mL of traditional Chinese medicine extracting solution are smeared; 1-3 times a day; 2) firstly, preparing the BCG vaccine and the traditional Chinese medicine extracting solution into a BCG vaccine traditional Chinese medicine mixed preparation, smearing auxiliary materials (1-5 mL) such as azone on legs and/or thighs for drying before use, and then smearing the preparation. 1-3 times a day.
The compatibility relationship of the components in the vaccine traditional Chinese medicine composition is as follows:
in the formula, coptis, phellodendron, scutellaria, common andrographis, honeysuckle, forsythia, dandelion and isatis root are used as monarch drugs for clearing heat and purging fire, clearing heat and removing toxicity and resisting inflammation; aloe, radix et rhizoma Rhei, herba Artemisiae Annuae, bupleuri radix purgative, relieving exterior syndrome, cooling blood, and removing heat as ministerial drugs. Folium Isatidis, herba Violae, rhizoma paridis, radix Sophorae Tonkinensis and Saviae Miltiorrhizae radix are used as adjuvant drugs. The medicines are used together to achieve the effect of treating infectious diseases by transdermal administration.
The invention has the following beneficial effects:
A. the invention combines 0.5mg/1ml of BCG originally used for intradermal injection with traditional Chinese medicines, realizes transdermal drug delivery by the BCG and the traditional Chinese medicines, and replaces a painful BCG intradermal injection method.
B. The BCG vaccine and traditional Chinese medicine composition formula has obvious curative effects on various infectious diseases such as tonsillitis, pneumonia, nasosinusitis, appendicitis, otitis media, cholecystitis, influenza and the like, and has short treatment period and quick response.
C. The traditional Chinese medicine composition disclosed by the invention is combined with the BCG vaccine whole vaccine for use, the skin surface layer is not required to be damaged, the traditional Chinese medicine composition and the BCG vaccine mutually promote penetration, the transdermal absorption rate of the drug effect components is accelerated, the dosage is reduced, and the treatment period is shortened.
Detailed Description
In order to better understand the technical content of the invention, specific examples are provided below to further illustrate the invention.
Example 1
A vaccine traditional Chinese medicine composition for treating infectious diseases by percutaneous administration comprises a BCG vaccine whole vaccine (specification is 0.5mg/1mL) and the following traditional Chinese medicine raw materials in parts by weight: 10 parts of coptis chinensis, 3 parts of phellodendron, 5 parts of scutellaria baicalensis, 20 parts of rheum officinale, 2 parts of aloe, 5 parts of dandelion, 10 parts of isatis root, 6 parts of honeysuckle, 10 parts of fructus forsythiae, 5 parts of folium isatidis, 5 parts of Chinese violet, 5 parts of andrographis paniculata, 1 part of radix bupleuri, 3 parts of rhizoma paridis, 3 parts of subprostrate sophora, 4 parts of sweet wormwood and 3 parts of salvia miltiorrhiza.
Example 2
A vaccine traditional Chinese medicine composition for treating infectious diseases by percutaneous administration comprises a BCG vaccine whole vaccine (specification is 0.5mg/1mL) and the following traditional Chinese medicine raw materials in parts by weight: 12 parts of coptis chinensis, 5 parts of phellodendron, 5 parts of scutellaria baicalensis, 13 parts of rheum officinale, 2 parts of aloe, 5 parts of dandelion, 8 parts of isatis root, 7 parts of honeysuckle, 7 parts of fructus forsythiae, 3 parts of folium isatidis, 5 parts of Chinese violet, 8 parts of andrographis paniculata, 3 parts of radix bupleuri, 8 parts of rhizoma paridis, 3 parts of subprostrate sophora, 2 parts of sweet wormwood and 4 parts of salvia miltiorrhiza.
Example 3
A vaccine traditional Chinese medicine composition for treating infectious diseases by percutaneous administration comprises a BCG vaccine whole vaccine (specification is 0.5mg/1mL) and the following traditional Chinese medicine raw materials in parts by weight: 12 parts of coptis chinensis, 9 parts of phellodendron, 3 parts of scutellaria baicalensis, 13 parts of rheum officinale, 3 parts of aloe, 6 parts of dandelion, 8 parts of isatis root, 6 parts of honeysuckle, 12 parts of fructus forsythiae, 3 parts of folium isatidis, 6 parts of Chinese violet, 3 parts of andrographis paniculata, 2 parts of radix bupleuri, 3 parts of rhizoma paridis, 1 part of subprostrate sophora, 2 parts of sweet wormwood and 8 parts of salvia miltiorrhiza.
Example 4
A vaccine traditional Chinese medicine composition for treating infectious diseases by percutaneous administration comprises a BCG vaccine whole vaccine (specification is 0.5mg/1mL) and the following traditional Chinese medicine raw materials in parts by weight: 20 parts of coptis chinensis, 3 parts of phellodendron, 2 parts of scutellaria baicalensis, 13 parts of rheum officinale, 2 parts of aloe, 14 parts of dandelion, 8 parts of isatis root, 6 parts of honeysuckle, 5 parts of fructus forsythiae, 4 parts of folium isatidis, 10 parts of Chinese violet, 3 parts of andrographis paniculata, 1 part of radix bupleuri, 3 parts of rhizoma paridis, 1 part of subprostrate sophora, 2 parts of sweet wormwood and 3 parts of salvia miltiorrhiza.
Example 5
A vaccine traditional Chinese medicine composition for treating infectious diseases by percutaneous administration comprises a BCG vaccine whole vaccine (specification is 0.5mg/1mL) and the following traditional Chinese medicine raw materials in parts by weight: 10 parts of coptis chinensis, 3 parts of phellodendron, 2 parts of scutellaria baicalensis, 14 parts of rheum officinale, 2 parts of aloe, 16 parts of dandelion, 16 parts of isatis root, 10 parts of honeysuckle, 5 parts of fructus forsythiae, 3 parts of folium isatidis, 5 parts of Chinese violet, 3 parts of andrographis paniculata, 1 part of radix bupleuri, 3 parts of rhizoma paridis, 1 part of subprostrate sophora, 3 parts of sweet wormwood and 3 parts of salvia miltiorrhiza.
Example 6
A vaccine traditional Chinese medicine composition for treating infectious diseases by percutaneous administration comprises a BCG vaccine whole vaccine (specification is 0.5mg/1mL) and the following traditional Chinese medicine raw materials in parts by weight: 12 parts of coptis chinensis, 5 parts of phellodendron, 9 parts of scutellaria baicalensis, 5 parts of rheum officinale, 9 parts of aloe, 5 parts of dandelion, 8 parts of isatis root, 6 parts of honeysuckle, 6 parts of fructus forsythiae, 7 parts of folium isatidis, 5 parts of Chinese violet, 3 parts of andrographis paniculata, 3 parts of radix bupleuri, 8 parts of rhizoma paridis, 3 parts of subprostrate sophora, 3 parts of sweet wormwood and 3 parts of salvia miltiorrhiza.
Example 7
A vaccine traditional Chinese medicine composition for treating infectious diseases by percutaneous administration comprises a BCG vaccine whole vaccine (specification is 0.5mg/1mL) and the following traditional Chinese medicine raw materials in parts by weight: 20 parts of isatis root, 10 parts of dyers woad leaf, 20 parts of weeping forsythia, 20 parts of honeysuckle flower, 10 parts of bupleurum root, 9 parts of rhubarb and 11 parts of sweet wormwood herb.
The vaccines used in examples 1-7 were whole BCG vaccines. The traditional Chinese medicine raw materials are extracted by ethanol to obtain traditional Chinese medicine extracting solution for use. The traditional Chinese medicine extracting solution is as follows: taking all the traditional Chinese medicine raw materials, crushing, mixing, and mixing according to a material-liquid ratio of 50 g: 100mL of the extract was extracted with 75% by volume of an ethanol solution for 1 week, and the resulting ethanol extract was filtered.
The application mode of the vaccine traditional Chinese medicine composition in the embodiment 1-7 is as follows: firstly, coating azone (about 5mL) on legs and thighs to be dried, and then coating 1-2 mL of BCG vaccine (intradermal injection, specification of 0.5mg/1mL) and 10-20 mL of traditional Chinese medicine extracting solution; the dosage is 2 times a day.
In addition, the ratio of the materials to the liquid can be 20-60 g: 100mL, and leaching for 1-2 weeks. The concentration of the traditional Chinese medicine ethanol extract is properly adjusted, so that the effect of the medicine is not obviously influenced.
In order to be used conveniently, the vaccine traditional Chinese medicine composition can be added with auxiliary materials to be prepared into other transdermal administration dosage forms such as ointment and the like.
The treatment effect of the scheme of the invention is fully verified in the practical application process. The treatment results for years show that the vaccine traditional Chinese medicine composition or preparation provided by the invention has obvious curative effects on various infectious diseases such as appendicitis, tonsillitis, otitis media, pneumonia, nasosinusitis, cholecystitis, influenza and the like. The inventor commonly uses the scheme of the invention for more than 50 cases of chronic tonsillitis for years, treats more than 20 cases of appendicitis, otitis media, pneumonia, nasosinusitis, cholecystitis and influenza, and has the cure rate of more than 95 percent after statistics. The following table 1 provides diagnostic criteria and therapeutic efficacy judgment criteria for treating the above diseases. Cases diagnosed by hospitals above the county level can be redetermined without following the table below.
TABLE 1
Figure BDA0003036803570000051
Figure BDA0003036803570000061
According to statistics, the treatment course of curing appendicitis, tonsillitis, otitis media, pneumonia and cholecystitis in the scheme is 5-6 days, the treatment course of curing pneumonia is 7-8 days, the treatment course of nasosinusitis is 9-11 days, and the treatment course of influenza is 2-4 days. The formulas of the above examples 1 to 7 are respectively the optimal formulas for treating appendicitis, tonsillitis, otitis media, pneumonia, sinusitis, cholecystitis and influenza in sequence.
Some treatment cases are provided below, and the prescription used in each case is the formula provided in the above examples 1 to 7 (the formula of examples 1 to 7 is used in sequence in case 1 to case 7).
Case 1: the medicine is suitable for men, is 66 years old, has chronic tonsillitis, suppuration and fever in the young, has the bouts once every 3 to 5 days, and has no effect after the treatment by using various antibiotics and traditional Chinese medicines, the tonsil is removed by an operation, but the operation is still poor, and the life, the study and the work are influenced. After the BCG vaccine and the traditional Chinese medicine are administrated for 5 days in 83 years and 7 months, the disease is cured, and no relapse occurs.
Case 2: aged XX, female, aged 67 years, with pneumonia (8 months in 2003 and 3 months in 2014) twice to county level medical department, taking X-ray film to confirm diagnosis, fever 39-40 degrees, severe cough, poor appetite, bedridden, and recovery after 7 days of BCG (bacillus calmette guerin) and traditional Chinese medicine transdermal drug delivery treatment without antibiotic treatment. After 4 years of follow-up, the body is completely recovered, and cold is rarely caused.
Case 3: forest XX, women, 51 years old, chief complaint several years ago have sinusitis, headache, nasal obstruction, running nasal discharge, visit and use many antibiotics treatment effect not good in county level hospital, give calmette-guerin vaccine + traditional chinese medicine percutaneous administration treatment 9 days of clinical symptoms disappear in 2006, beat CT piece more than 1-2 months, suggest that each sinus intracavity shows well, follow-up visit two years after fully recovering has no recurrence.
Case 4: xue XX, male, 53 years old, acute appendicitis in 9 months 2003, the B-ultrasound diagnosis in county level hospital, pain difficult to endure, vomit after eating, at that time, BCG + Chinese traditional medicine percutaneous medication treatment is given for 5 days, then recovery is achieved, and no recurrence is seen until now in 3 years.
Case 5: the king XX is a medicine for women, the women are 11 years old, the patients with otitis media, pain is difficult to endure, two ears are purulent, hearing is declined before 5 years old, after 5 days of treatment by bcg vaccine and traditional Chinese medicine transdermal administration, symptoms such as ear pain, ear purulence, hearing decline and the like disappear, and no recurrence is found in 6 years follow-up.
Case 6: the symbol XX shows that the female is 50 years old, suffers from chronic cholecystitis 11 years ago, feels dull pain under the right rib, is full of fullness and aggravates when eating greasy food, looks like knife cutting when aggravating, and is diagnosed as the chronic cholecystitis by hospitals. The effect is not good after the antibiotics treatment is frequently used, after the BCG vaccine and the traditional Chinese medicine are used for percutaneous administration treatment for 5 days, the symptoms disappear, the gallbladder is checked to be normal by B ultrasonic, no relapse occurs in 7 years of follow-up visit, and the mental state is good.
Case 7: yellow XX, male, 10 years old, 6 years old, flu season had flu (county level diagnosis) cold, fever 39-40 degrees, cough, runny nose, headache intolerable, given BCG vaccine and traditional Chinese medicine transdermal drug delivery treatment after 3 days to recover.
The above description is only for the purpose of illustrating the preferred embodiments of the present invention and is not to be construed as limiting the invention, and any modifications, equivalents, improvements and the like that fall within the spirit and principle of the present invention are intended to be included therein.

Claims (10)

1. The vaccine traditional Chinese medicine composition for treating infectious diseases through transdermal administration is characterized in that the vaccine is bacillus calmette guerin, and the traditional Chinese medicine composition comprises the following traditional Chinese medicine raw materials in parts by weight: 0-20 parts of coptis chinensis, 5-20 parts of rheum officinale, 0-9 parts of aloe, 0-16 parts of dandelion, 8-20 parts of isatis root, 6-20 parts of honeysuckle, 5-20 parts of fructus forsythiae, 0-8 parts of andrographis paniculata, 1-10 parts of radix bupleuri, 2-11 parts of sweet wormwood herb, 0-9 parts of phellodendron and 0-9 parts of scutellaria baicalensis.
2. The vaccine traditional Chinese medicine composition for treating infectious diseases through transdermal administration according to claim 1, which is characterized by further comprising the following traditional Chinese medicine raw materials in parts by weight: 3-10 parts of folium isatidis, 0-10 parts of herba violae, 0-8 parts of rhizoma paridis, 0-3 parts of radix sophorae tonkinensis and 0-8 parts of salvia miltiorrhiza.
3. The vaccine traditional Chinese medicine composition for treating infectious diseases through transdermal administration according to claim 1, which is characterized by comprising the following traditional Chinese medicine raw materials in parts by weight: 10-20 parts of coptis chinensis, 5-20 parts of rheum officinale, 2-9 parts of aloe, 5-16 parts of dandelion, 8-16 parts of isatis root, 6-10 parts of honeysuckle, 5-12 parts of fructus forsythiae, 3-8 parts of andrographis paniculata, 1-3 parts of radix bupleuri, 2-11 parts of sweet wormwood herb, 3-9 parts of golden cypress, 2-9 parts of scutellaria baicalensis, 3-7 parts of folium isatidis, 5-10 parts of herba violae, 3-8 parts of rhizoma paridis, 1-3 parts of vietnamese sophora root and 3-8 parts of salvia miltiorrhiza.
4. The method for preparing the vaccine traditional Chinese medicine composition according to claim 1, wherein the traditional Chinese medicine raw materials are mixed and then crushed to obtain mixed medicinal powder, the mixed medicinal powder is extracted by an organic solvent and filtered to obtain traditional Chinese medicine extracting solution, and the traditional Chinese medicine extracting solution and the BCG vaccine are used simultaneously; the dosage ratio of the BCG vaccine to the traditional Chinese medicine raw materials is 0.5-1 mg: 2-12 g.
5. The method of claim 4, comprising the steps of: mixing and crushing traditional Chinese medicine raw materials to obtain mixed medicinal powder, wherein the ratio of materials to liquid is 20-60 g: leaching 100mL of the extract with an ethanol solution with the volume concentration of 60-80% for 1-2 weeks, and filtering to obtain a traditional Chinese medicine extract, wherein the traditional Chinese medicine extract and the BCG are used simultaneously.
6. A traditional Chinese medicine vaccine preparation for treating infectious diseases by transdermal administration, which is characterized in that the traditional Chinese medicine vaccine preparation takes the traditional Chinese medicine vaccine composition of claim 1 as an effective component.
7. The Chinese medicinal preparation of claim 6, wherein the vaccine Chinese medicinal preparation further comprises pharmaceutically acceptable adjuvants, and the adjuvants are added according to pharmaceutical requirements.
8. The vaccine traditional Chinese medicine preparation according to claim 7, wherein the pharmaceutically acceptable adjuvants comprise ethanol, menthol, azone and sodium chloride.
9. The vaccine traditional Chinese medicine preparation according to claim 6, wherein the dosage form of the vaccine traditional Chinese medicine preparation is a transdermal administration dosage form, and the dosage form comprises a liquid dosage form, a semisolid dosage form, a solid dosage form or a gas dosage form.
10. The vaccine composition of claim 1 or the vaccine preparation of claim 7, wherein the infectious diseases include appendicitis, tonsillitis, otitis media, pneumonia, sinusitis, cholecystitis, and influenza.
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