Traditional Chinese medicine preparation for treating AIDS and preparation method thereof

Abstract

The invention provides a traditional Chinese medicine preparation for treating AIDS and a preparation method thereof, and relates to the technical field of traditional Chinese medicine preparations. The preparation is prepared from the following components in parts by mass: 1-5 parts of ginseng, 10-20 parts of astragalus membranaceus, 5-15 parts of herba patriniae, 5-15 parts of poria cocos, 5-15 parts of angelica sinensis, 5-15 parts of radix paeoniae rubra, 5-15 parts of liquorice, 5-15 parts of radices trichosanthis, 1-5 parts of stiff silkworm, 5-15 parts of platycodon grandiflorum, 20-40 parts of lonicerae flos, 5-15 parts of folium mori, 20-40 parts of dandelion and 10-20 parts of fermented soybean. The technical problems of large side effects, easy generation of drug resistance and high price of western medicines are solved. The traditional Chinese medicine preparation has the advantages of few side effects, good curative effect and low price, and has good clinical value and social benefit in popularization and use.

Description

Technical Field

[0001] The present invention relates to the technical field of Chinese medicine preparations, and in particular to a Chinese medicine preparation for treating AIDS and a preparation method thereof. Background Art

[0002] AIDS, or acquired immune deficiency syndrome (AIDS), is a disease caused by the human immunodeficiency virus (HIV) that is recognized worldwide as one of the most serious infectious diseases that endangers health. In the past 40 years, HIV has spread rapidly and widely around the world. Therefore, research on the prevention and treatment of AIDS has become a major problem that the medical community needs to overcome urgently, and it is also a bottleneck problem that many medical experts are actively exploring and discussing.

[0003] So far, there is no specific drug or treatment that can completely cure AIDS. It is difficult to achieve long-term stable treatment for HIV-infected people by antiviral therapy alone. Western medicine HAART therapy mainly inhibits the replication of HIV in the body, which can initially reduce its morbidity and mortality, but it has problems such as large toxic side effects and drug resistance, which limits its widespread use; at the same time, asymptomatic HIV-infected people do not advocate antiviral treatment, resulting in asymptomatic HIV-infected people currently in a state where no medicine is available. Traditional Chinese medicine treatment is considered a potential treatment method. For example, astragalus, dodder, Ligustrum lucidum, angelica, and codonopsis have been proven to have certain anti-AIDS effects, but these traditional Chinese medicines still cannot completely block the replication and development of HIV and still have certain limitations. In view of the current technical problems, we urgently need a traditional Chinese medicine preparation to solve the above problems. Summary of the invention

[0004] One of the purposes of the present invention is to provide a Chinese medicine preparation to solve the technical problems of Western medicine in treating AIDS, such as large side effects, easy drug resistance and high price.

[0005] The traditional Chinese medicine preparation provided by the invention is prepared from the following components by weight: 1-5 parts of ginseng, 10-20 parts of astragalus, 5-15 parts of patrinia herb, 5-15 parts of tuckahoe, 5-15 parts of angelica, 5-15 parts of red peony root, 5-15 parts of liquorice, 5-15 parts of trichosanthes, 1-5 parts of bombyx batryticatus, 5-15 parts of platycodon, 20-40 parts of honeysuckle, 5-15 parts of mulberry leaf, 20-40 parts of dandelion and 10-20 parts of light fermented black beans.

[0006] Furthermore, the preparation is made of the following components in parts by mass: 2-4 parts of ginseng, 13-17 parts of astragalus, 8-12 parts of patrinia herb, 8-12 parts of poria, 8-12 parts of angelica, 8-12 parts of red peony root, 8-12 parts of licorice, 8-12 parts of trichosanthes, 2-4 parts of bombyx batryticatus, 8-12 parts of platycodon, 25-35 parts of honeysuckle, 8-12 parts of mulberry leaves, 25-35 parts of dandelions and 13-17 parts of fermented black beans.

[0007] Furthermore, the preparation is made of the following components in parts by mass: 3 parts of ginseng, 15 parts of astragalus, 10 parts of patrinia herb, 10 parts of poria, 10 parts of angelica, 10 parts of red peony root, 10 parts of licorice, 10 parts of trichosanthes, 3 parts of bombyx batryticatus, 10 parts of platycodon, 30 parts of honeysuckle, 10 parts of mulberry leaves, 30 parts of dandelions and 15 parts of light fermented black beans.

[0008] Furthermore, the traditional Chinese medicine preparation also includes 30-70 parts of soluble starch.

[0009] Furthermore, the dosage form of the traditional Chinese medicine preparation includes granules, granules, pills, capsules or tablets.

[0010] The Chinese medicinal preparation for treating AIDS of the present invention has the functions of supporting healthy energy, replenishing qi and blood, and expelling toxins, and can be used for patients with weak constitution, pale complexion, fear of wind and cold, susceptibility to cold, occasional spontaneous sweating, pale tongue, weak or thready pulse and other qi and blood deficiency symptoms; and can be used for treating patients with AIDS syndrome with the above-mentioned qi and blood deficiency symptoms.

[0011] According to TCM theory, AIDS falls into the categories of "latent Qi plague", "epidemic disease", "deficiency", "Yin Yang change", "accumulation", "lumps", "scrofula" and so on. AIDS is caused by damp-heat epidemic toxins invading the human body, directly damaging the foundation of the congenital and acquired nature, causing imbalance of Yin and Yang, damage to multiple organs, and a variety of symptoms, and finally leading to the decline of the fatal Yuan. The clinical manifestations are deficiency of many Qi in Wei Qi, Ying Qi, Zong Qi, organs, and meridians. Qi deficiency runs through the whole process and is manifested in all stages; it is highly lethal and has a high mortality rate. The damage to the Yuan Qi and the deficiency of the Yuan Qi are the specific manifestations of the damp-heat epidemic toxins directly damaging the Qi of the Yuan Qi. In terms of the etiology and pathogenesis of AIDS in TCM, there are mainly the epidemic toxin theory, damp-heat theory, deficiency toxin theory, latent evil theory, etc. At present, the more recognized one is the epidemic toxin theory. Epidemic toxin is one of the causes of disease in warm disease studies and is a highly contagious pathogenic evil. However, the "epidemic poison" caused by AIDS has its own particularity. It is transmitted through blood, mother-to-child or sexual contact, and invades the blood vessels through the essence and skin. The "epidemic poison" caused by AIDS is the direct pathogenic factor of AIDS, which greatly affects the entire process of the occurrence, development and outcome of AIDS. Phlegm and dampness are the material basis of its unique development and evolution; dampness and blood stasis are both pathological products and pathogenic factors belonging to "poisonous evil".

[0012] AIDS involves a wide range of TCM symptoms, and the onset of the disease is as severe as "latent heat disease", where the pathogen directly enters the blood. It ends with the strong pathogen and the weak righteousness, and the separation of yin and yang. The most prominent clinical manifestation of AIDS is the deficiency of righteousness, and the treatment should focus on strengthening the righteousness and nourishing the root. When necessary, the principle of "treating the symptoms in an emergency" or "treating the symptoms and the root" should be applied. Therefore, the treatment principle of TCM is: for early AIDS patients, most of them are righteousness deficiency and are affected by the pathogen, so they should strengthen the righteousness and eliminate the pathogen; in the middle stage, they are mostly accompanied by heat, toxicity, phlegm and blood stasis. At this time, if the righteousness is still capable of attacking, it is appropriate to use methods such as clearing away heat and detoxification, resolving phlegm and removing blood stasis, softening and dispersing nodules, and appropriately supplementing with strengthening the righteousness; in the late stage, due to the prolonged disease, the righteousness is greatly deficient and there are many complications such as phlegm nodules and tumors, so strengthening the righteousness should be the main treatment, and appropriate products for eliminating the pathogen should be used. In combination with the different clinical manifestations of AIDS in different stages, the commonly used treatment methods in clinical Chinese medicine mainly include soothing the liver and relieving depression, soothing the liver and nourishing the spleen, invigorating Qi and strengthening the spleen, invigorating Qi and consolidating the exterior, invigorating Qi and nourishing blood, nourishing Yin and relieving exterior symptoms, clearing and draining the Yangming meridian, resolving dampness and detoxifying, cooling blood and detoxifying, clearing the lungs and nourishing Yin, extinguishing wind and resolving phlegm, nourishing the liver and kidneys, and tonifying the kidneys and replenishing essence.

[0013] In view of the above-mentioned traditional Chinese medicine treatment method, the present invention selects ginseng, astragalus, patrinia, tuckahoe, angelica, red peony root, liquorice, radix trichosanthis, bombyx batryticatus, platycodon grandiflorum, honeysuckle, mulberry leaf, dandelion and light fermented black beans to assist in the healthy qi, replenish qi and blood, and expel poison. In the prescription, ginseng assists in the healthy qi to eliminate evil, sits in the central region, and the commander of the war is the monarch; astragalus, tuckahoe, and liquorice replenish qi and invigorate the spleen, assist in the healthy qi, and angelica and red peony root replenish blood and promote blood circulation as the ministers; honeysuckle, dandelion, patrinia clear away heat and detoxify, bombyx batryticatus resolves phlegm and disperses nodules, and platycodon grandiflorum removes phlegm and discharges pus; light fermented black beans relieve the symptoms and eliminate restlessness as the guiding drug. All the drugs are used together to play the effects of assisting the healthy qi, replenishing qi and blood, and expelling poison. Glycyrrhizin (GL) in the licorice in the prescription is recognized to have an inhibitory effect on HIV. It can inhibit the expression of viral antigens, inhibit the formation of macrophages, and inhibit the replication of HIV. Radix Trichosanthis can inhibit the replication of HIV, inhibit the activity of reverse transcriptase, block the release of P24 antigen from infected macrophages, and selectively kill macrophages infected with HIV.

[0014] The second object of the present invention is to provide a method for preparing a Chinese medicine preparation, comprising the following steps:

[0015] (1) Grind ginseng, astragalus, patrinia, tuckahoe, angelica, red peony root, liquorice, trichosanthes root, bombyx batryticatus, platycodon, honeysuckle, mulberry leaf, dandelion and light black bean into fine powder according to proportion, pass through a 100-mesh sieve, and set aside the fine powder. Add 5-7 times the amount of 40%-80% ethanol to the coarse powder and the remaining medicinal materials for reflux extraction for 2-5 hours, pass through a 200-mesh sieve, recover ethanol from the filtrate, and concentrate to obtain ointment I;

[0016] (2) Add 4-8 times the amount of water to the residue, extract for 1-3 hours, pass through a 200-mesh sieve, combine the filtrate with ointment I, and concentrate under reduced pressure to 1.25 g / cm 3 (50°C), concentrated to obtain ointment II;

[0017] (3) taking another 30-70 parts of soluble starch and mixing it with ointment II to prepare granules;

[0018] (4) The granules obtained in step (3) are prepared into various oral preparations according to conventional methods.

[0019] The third object of the present invention is to provide a Chinese medicine preparation for use in treating AIDS.

[0020] The traditional Chinese medicine preparation provided by the invention has the advantages of good therapeutic effect and small side effects, and at the same time has low treatment cost, thus reducing the economic burden on patients.

[0021] The preparation method of the traditional Chinese medicine preparation provided by the invention is simple, easy to prepare and can be widely promoted. DETAILED DESCRIPTION

[0022] The embodiments of the present invention will be described in detail below in conjunction with the examples, but it will be appreciated by those skilled in the art that the following examples are only used to illustrate the present invention and should not be construed as limiting the scope of the present invention. If specific conditions are not specified in the examples, they are carried out according to conventional conditions or conditions recommended by the manufacturer. If the manufacturer is not specified for the reagents or instruments used, they are all conventional products that can be purchased commercially.

[0023] According to one aspect of the present invention, the present invention provides a traditional Chinese medicine preparation, which is made of the following components in parts by mass: 1-5 parts of ginseng, 10-20 parts of astragalus, 5-15 parts of patrinia herb, 5-15 parts of tuckahoe, 5-15 parts of angelica, 5-15 parts of red peony root, 5-15 parts of licorice, 5-15 parts of trichosanthes, 1-5 parts of bombyx batryticatus, 5-15 parts of platycodon, 20-40 parts of honeysuckle, 5-15 parts of mulberry leaves, 20-40 parts of dandelions and 10-20 parts of fermented black beans.

[0024] In a typical but non-limiting embodiment of the present invention, the mass fraction of ginseng is, for example, 1, 2, 3, 4 or 5 parts.

[0025] In a typical but non-limiting embodiment of the present invention, the mass fraction of Astragalus is 10, 11, 12, 13, 14, 15, 16, 17, 18, 19 or 20 parts.

[0026] In a typical but non-limiting embodiment of the present invention, the mass fraction of Patrinia salsa is 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 or 15 parts.

[0027] In a typical but non-limiting embodiment of the present invention, the mass fraction of Poria cocos is 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 or 15 parts.

[0028] In a typical but non-limiting embodiment of the present invention, the mass parts of Angelica sinensis are 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 or 15 parts.

[0029] In a typical but non-limiting embodiment of the present invention, the mass fraction of red peony root is 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 or 15 parts.

[0030] In a typical but non-limiting embodiment of the present invention, the mass fraction of liquorice is 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 or 15 parts.

[0031] In a typical but non-limiting embodiment of the present invention, the mass fraction of Radix Trichosanthis is 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 or 15 parts.

[0032] In a typical but non-limiting embodiment of the present invention, the mass proportion of the silkworm is, for example, 1, 2, 3, 4 or 5 parts.

[0033] In a typical but non-limiting embodiment of the present invention, the mass proportion of Platycodon grandiflorum is 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 or 15 parts.

[0034] In a typical but non-limiting embodiment of the invention, the mass fraction of honeysuckle is 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39 or 40 parts.

[0035] In a typical but non-limiting embodiment of the present invention, the mass proportion of mulberry leaves is 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 or 15 parts.

[0036] In a typical but non-limiting embodiment of the invention, the mass fraction of dandelion is 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39 or 40 parts.

[0037] In a typical but non-limiting embodiment of the present invention, the mass fraction of light fermented black beans is, for example, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19 or 20 parts.

[0038] In a preferred embodiment of the present invention, the Chinese medicine preparation further comprises 30-70 parts of soluble starch.

[0039] In a typical but non-limiting embodiment of the present invention, the mass fraction of soluble starch is, for example, 30, 35, 40, 45, 50, 55, 60, 65 or 70 parts.

[0040] In a preferred embodiment of the present invention, the dosage form of the Chinese medicine preparation includes granules, granules, pills, capsules or tablets.

[0041] According to a second aspect of the present invention, the present invention provides a method for preparing a Chinese medicine preparation, comprising the following steps:

[0042] (1) Grind ginseng, astragalus, patrinia, tuckahoe, angelica, red peony root, liquorice, trichosanthes root, bombyx batryticatus, platycodon, honeysuckle, mulberry leaf, dandelion and light black bean into fine powder according to proportion, pass through a 100-mesh sieve, and set aside the fine powder. Add 5-7 times the amount of 40%-80% ethanol to the coarse powder and the remaining medicinal materials for reflux extraction for 2-5 hours, pass through a 200-mesh sieve, recover ethanol from the filtrate, and concentrate to obtain ointment I;

[0043] (2) Add 4-8 times the amount of water to the residue, extract for 1-3 hours, pass through a 200-mesh sieve, combine the filtrate with ointment I, and concentrate under reduced pressure to 1.25 g / cm 3 (50°C), concentrated to obtain ointment II;

[0044] (3) taking another 30-70 parts of soluble starch and mixing it with ointment II to prepare granules;

[0045] (4) The granules obtained in step (3) are prepared into various oral preparations according to conventional methods.

[0046] In a typical but non-limiting embodiment of the present invention, in step 1, the amount of ethanol used is 5, 6 or 7 times the amount of the coarse powder and the remaining medicinal materials; the concentration of ethanol is 40%, 45%, 50%, 55%, 60%, 65%, 70%, 75% or 80%; and the extraction time is 2, 2.5, 3, 3.5, 4, 4.5 or 5 hours.

[0047] In a typical but non-limiting embodiment of the present invention, in step 2, the amount of water used is, for example, 4, 5, 6, 7 or 8 times that of the medicinal residue; and the extraction time is, for example, 1, 1.5, 2, 2.5, or 3 hours.

[0048] In a typical but non-limiting embodiment of the present invention, in step 3, the amount of soluble starch and ginseng powder is 30, 35, 40, 45, 50, 55, 60, 65 or 70 parts.

[0049] According to a third aspect of the present invention, the present invention provides a use of a traditional Chinese medicine preparation in treating AIDS.

[0050] The technical solution provided by the present invention is further described below in conjunction with embodiments and comparative examples.

[0051] Embodiment 1:

[0052] This embodiment provides a traditional Chinese medicine preparation, which is made of the following components in parts by mass: 5 parts of ginseng, 20 parts of astragalus, 15 parts of patrinia, 15 parts of tuckahoe, 15 parts of angelica, 15 parts of red peony root, 15 parts of licorice, 5 parts of trichosanthes, 1 part of bombyx batryticatus, 5 parts of platycodon, 20 parts of honeysuckle, 5 parts of mulberry leaves, 20 parts of dandelions and 10 parts of light fermented black beans.

[0053] Preparation method: (1) Grind 5 g of ginseng, 20 g of astragalus, 15 g of patrinia, 15 g of tuckahoe, 15 g of angelica, 15 g of red peony root, 15 g of liquorice, 5 g of trichosanthes, 1 g of bombyx batryticatus, 5 g of platycodon, 20 g of honeysuckle, 5 g of mulberry leaf, 20 g of dandelion and 10 g of light black bean into fine powder, pass through a 100-mesh sieve, and set aside the fine powder. Add 7 times the amount of 40% ethanol to the coarse powder and the remaining medicinal materials, reflux and extract for 5 hours, pass through a 200-mesh sieve, recover ethanol from the filtrate, and concentrate to obtain ointment I;

[0054] (2) Add 8 times the amount of water to the residue, extract for 3 hours, pass through a 200-mesh sieve, combine the filtrate with the alcohol-extracted ointment I, and concentrate under reduced pressure to 1.25 g / cm 3 (50°C), concentrated to obtain ointment II;

[0055] (3) Take another 70 g of soluble starch and ginseng powder and mix them with ointment II to make granules, divide them into packages, and make whole granules.

[0056] (4) Packing the particles obtained in step (3) into bags.

[0057] Embodiment 2:

[0058] This embodiment provides a traditional Chinese medicine preparation, which is made of the following components in parts by mass: 1 part of ginseng, 10 parts of astragalus, 5 parts of patrinia herb, 5 parts of tuckahoe, 5 parts of angelica, 5 parts of red peony root, 5 parts of licorice, 15 parts of trichosanthes, 5 parts of bombyx batryticatus, 15 parts of platycodon, 40 parts of honeysuckle, 15 parts of mulberry leaves, 40 parts of dandelions and 20 parts of light fermented black beans.

[0059] Preparation method: (1) Grind 1 g of ginseng, 10 g of astragalus, 5 g of patrinia, 5 g of poria, 5 g of angelica, 5 g of red peony root, 5 g of liquorice, 15 g of trichosanthes root, 5 g of bombyx batryticatus, 15 g of platycodon, 40 g of honeysuckle, 15 g of mulberry leaf, 40 g of dandelion and 20 g of light black bean into fine powder, pass through a 100-mesh sieve, and set aside the fine powder. Add 5 times the amount of 80% ethanol to the coarse powder and the remaining medicinal materials, reflux and extract for 2 hours, pass through a 200-mesh sieve, recover ethanol from the filtrate, and concentrate to obtain ointment I;

[0060] (2) Add 4 times the amount of water to the residue, extract for 1 hour, pass through a 200-mesh sieve, combine the filtrate with the alcohol-extracted ointment I, and concentrate under reduced pressure to 1.25 g / cm 3 (50°C), concentrated to obtain ointment II;

[0061] (3) Take another 30 g of soluble starch and ginseng powder and mix them with ointment II to make granules, divide them into packages, and make whole granules.

[0062] (4) Packing the particles obtained in step (3) into bags.

[0063] Embodiment 3:

[0064] This embodiment provides a traditional Chinese medicine preparation, which is made of the following components in parts by mass: 4 parts of ginseng, 17 parts of astragalus, 12 parts of patrinia, 12 parts of tuckahoe, 12 parts of angelica, 12 parts of red peony root, 12 parts of licorice, 8 parts of trichosanthes, 2 parts of bombyx batryticatus, 8 parts of platycodon, 25 parts of honeysuckle, 8 parts of mulberry leaves, 25 parts of dandelions and 13 parts of light fermented black beans.

[0065] Preparation method: (1) 4 g of ginseng, 17 g of astragalus, 12 g of patrinia, 12 g of tuckahoe, 12 g of angelica, 12 g of red peony root, 12 g of liquorice, 8 g of trichosanthes, 2 g of bombyx batryticatus, 8 g of platycodon, 25 g of honeysuckle, 8 g of mulberry leaf, 25 g of dandelion and 13 g of light black bean curd are crushed into fine powder, passed through a 100-mesh sieve, and the fine powder is reserved for later use. The coarse powder and the remaining medicinal materials are added with 6 times the amount of 70% ethanol for reflux extraction for 4 hours, passed through a 200-mesh sieve, and the filtrate is used to recover ethanol, which is concentrated to obtain ointment I;

[0066] (2) Add 7 times the amount of water to the residue, extract for 2 hours, pass through a 200-mesh sieve, combine the filtrate with the alcohol-extracted ointment I, and concentrate under reduced pressure to 1.25 g / cm 3 (50°C), concentrated to obtain ointment II;

[0067] (3) Take another 60 g of soluble starch and ginseng powder and mix them with ointment II to make granules, divide them into packages, and make whole granules.

[0068] (4) Packing the particles obtained in step (3) into bags.

[0069] Embodiment 4:

[0070] This embodiment provides a traditional Chinese medicine preparation, which is made of the following components in parts by mass: 2 parts of ginseng, 13 parts of astragalus, 8 parts of patrinia, 8 parts of poria, 8 parts of angelica, 8 parts of red peony root, 8 parts of licorice, 12 parts of trichosanthes, 4 parts of bombyx batryticatus, 12 parts of platycodon, 35 parts of honeysuckle, 12 parts of mulberry leaves, 35 parts of dandelions and 17 parts of light fermented black beans.

[0071] Preparation method: (1) 2 g of ginseng, 13 g of astragalus, 8 g of patrinia, 8 g of poria, 8 g of angelica, 8 g of red peony root, 8 g of liquorice, 12 g of trichosanthes, 4 g of bombyx batryticatus, 12 g of platycodon, 35 g of honeysuckle, 12 g of mulberry leaf, 35 g of dandelion and 17 g of light black bean curd are crushed into fine powder, passed through a 100-mesh sieve, and the fine powder is reserved for later use. The coarse powder and the remaining medicinal materials are added with 6 times the amount of 50% ethanol for reflux extraction for 5 hours, passed through a 200-mesh sieve, and the filtrate is used to recover ethanol, which is concentrated to obtain ointment I;

[0072] (2) Add 5 times the amount of water to the residue, extract for 2 hours, pass through a 200-mesh sieve, combine the filtrate with the alcohol-extracted ointment I, and concentrate under reduced pressure to 1.25 g / cm 3 (50°C), concentrated to obtain ointment II;

[0073] (3) Take another 40 g of soluble starch and ginseng powder and mix them with ointment II to make granules, divide them into packages, and make whole granules.

[0074] (4) Packing the particles obtained in step (3) into bags.

[0075] Embodiment 5:

[0076] This embodiment provides a traditional Chinese medicine preparation, comprising the following raw materials in parts by mass: 3 parts of ginseng, 15 parts of astragalus, 10 parts of patrinia herb, 10 parts of poria, 10 parts of angelica, 10 parts of red peony root, 10 parts of licorice, 10 parts of trichosanthes, 3 parts of bombyx batryticatus, 10 parts of platycodon, 30 parts of honeysuckle, 10 parts of mulberry leaves, 30 parts of dandelions and 15 parts of light fermented black beans.

[0077] Preparation method: (1) 3 g of ginseng, 15 g of astragalus, 10 g of patrinia, 10 g of poria, 10 g of angelica, 10 g of red peony root, 10 g of liquorice, 10 g of trichosanthes, 3 g of bombyx batryticatus, 10 g of platycodon, 30 g of honeysuckle, 10 g of mulberry leaf, 30 g of dandelion and 15 g of light black bean curd are crushed into fine powder, passed through a 100-mesh sieve, and the fine powder is reserved for later use. The coarse powder and the remaining medicinal materials are added with 6 times the amount of 60% ethanol for reflux extraction for 5 hours, passed through a 200-mesh sieve, and the filtrate is used to recover the ethanol, which is concentrated to obtain ointment I;

[0078] (2) Add 6 times the amount of water to the residue, extract for 3 hours, pass through a 200-mesh sieve, combine the filtrate with the alcohol-extracted ointment I, and concentrate under reduced pressure to 1.25 g / cm 3 (50°C), concentrated to obtain ointment II;

[0079] (3) Take another 50 g of soluble starch and ginseng powder and mix them with ointment II to make granules, divide them into packages, and make whole granules.

[0080] (4) Packing the particles obtained in step (3) into bags.

[0081] Embodiment 6:

[0082] This embodiment provides a traditional Chinese medicine preparation, comprising the following raw materials in parts by mass: 4 parts of ginseng, 15 parts of astragalus, 10 parts of patrinia herb, 10 parts of poria, 15 parts of angelica, 5 parts of red peony root, 10 parts of licorice, 10 parts of trichosanthes, 3 parts of bombyx batryticatus, 15 parts of platycodon, 20 parts of honeysuckle, 10 parts of mulberry leaves, 30 parts of dandelion and 15 parts of light fermented black beans.

[0083] Preparation method: (1) 4 g of ginseng, 15 g of astragalus, 10 g of patrinia, 10 g of poria, 15 g of angelica, 5 g of red peony root, 10 g of liquorice, 10 g of trichosanthes, 3 g of bombyx batryticatus, 15 g of platycodon, 20 g of honeysuckle, 10 g of mulberry leaf, 30 g of dandelion and 15 g of light black bean curd are crushed into fine powder, passed through a 100-mesh sieve, and the fine powder is reserved for later use. The coarse powder and the remaining medicinal materials are added with 5 times the amount of 60% ethanol for reflux extraction for 3 hours, passed through a 200-mesh sieve, and the filtrate is used to recover ethanol, which is concentrated to obtain ointment I;

[0084] (2) Add 5 times the amount of water to the residue, extract for 3 hours, pass through a 200-mesh sieve, combine the filtrate with the alcohol-extracted ointment I, and concentrate under reduced pressure to 1.25 g / cm 3 (50°C), concentrated to obtain ointment II;

[0085] (3) Take another 50g of soluble starch, ginseng powder and ointment II and mix them to make granules, package them and make whole granules. (4) Bag the granules obtained in step (3).

[0086] Embodiment 7:

[0087] This embodiment provides a traditional Chinese medicine preparation, comprising the following raw materials in parts by mass: 4 parts of ginseng, 15 parts of astragalus, 10 parts of patrinia herb, 10 parts of tuckahoe, 10 parts of angelica, 10 parts of red peony root, 15 parts of licorice, 10 parts of trichosanthes, 2 parts of bombyx batryticatus, 15 parts of platycodon, 25 parts of honeysuckle, 10 parts of mulberry leaves, 35 parts of dandelion and 15 parts of fermented black beans.

[0088] Preparation method: (1) 4 g of ginseng, 15 g of astragalus, 10 g of patrinia, 10 g of poria, 10 g of angelica, 10 g of red peony root, 15 g of liquorice, 10 g of trichosanthes, 2 g of bombyx batryticatus, 15 g of platycodon, 25 g of honeysuckle, 10 g of mulberry leaf, 35 g of dandelion and 15 g of light black bean curd are crushed into fine powder, passed through a 100-mesh sieve, and the fine powder is reserved for later use. The coarse powder and the remaining medicinal materials are added with 6 times the amount of 80% ethanol for reflux extraction for 4 hours, passed through a 200-mesh sieve, and the filtrate is used to recover ethanol, which is concentrated to obtain ointment I;

[0089] (2) Add 6 times the amount of water to the residue, extract for 2.5 hours, pass through a 200-mesh sieve, combine the filtrate with the alcohol-extracted ointment I, and concentrate under reduced pressure to 1.25 g / cm 3 (50°C), concentrated to obtain ointment II;

[0090] (3) Take another 40g of soluble starch and ginseng powder and mix with ointment II to make granules, divide into packages, and make whole granules. (4) Put the granules prepared in step (3) into capsules.

[0091] Embodiment 8:

[0092] This embodiment provides a traditional Chinese medicine preparation, comprising the following raw materials in parts by mass: 3 parts of ginseng, 10 parts of astragalus, 10 parts of patrinia, 10 parts of poria, 15 parts of angelica, 10 parts of red peony root, 15 parts of licorice, 10 parts of trichosanthes, 3 parts of bombyx batryticatus, 10 parts of platycodon, 25 parts of honeysuckle, 10 parts of mulberry leaves, 30 parts of dandelion and 15 parts of light fermented black beans.

[0093] Preparation method: (1) 3 g of ginseng, 10 g of astragalus, 10 g of patrinia, 10 g of poria, 15 g of angelica, 10 g of red peony root, 15 g of liquorice, 10 g of trichosanthes, 3 g of bombyx batryticatus, 10 g of platycodon, 25 g of honeysuckle, 10 g of mulberry leaf, 30 g of dandelion and 15 g of light black bean curd are crushed into fine powder, passed through a 100-mesh sieve, and the fine powder is reserved for later use. The coarse powder and the remaining medicinal materials are added with 4 times the amount of 50% ethanol for reflux extraction for 3 hours, passed through a 200-mesh sieve, and the filtrate is used to recover the ethanol, which is concentrated to obtain ointment I;

[0094] (2) Add 6 times the amount of water to the residue, extract for 4 hours, pass through a 200-mesh sieve, combine the filtrate with the alcohol-extracted ointment I, and concentrate under reduced pressure to 1.25 g / cm 3 (50°C), concentrated to obtain ointment II;

[0095] (3) Take another 60g of soluble starch, ginseng powder and ointment II and mix them to make granules, package them and make whole granules. (4) Compress the granules obtained in step (3) into tablets.

[0096] Test Example 1

[0097] 1. Materials and Methods

[0098] 1. Clinical data

[0099] 1.1 Case source

[0100] The cases were from the AIDS ward and outpatients of Chongqing Infectious Disease Hospital. All cases were HIV antibody positive after two ELISA screenings, and further confirmed by Western blot. There were 23 males and 10 females, aged 20 to 62 years old, with an average age of 40-57 years old. There were 17 cases in the asymptomatic stage and 16 cases in the disease stage.

[0101] 1.2 Diagnostic criteria

[0102] 1.2.1 Diagnostic criteria

[0103] Refer to the HIV / AIDS diagnostic criteria formulated by my country in 1996 and the HIV infection classification and AIDS diagnostic criteria revised by the US Centers for Disease Control in 1993.

[0104] 1.2.2 Diagnosis

[0105] According to the national standard "Diagnostic Criteria and Treatment Principles of HIV / AIDS", HIV infection can be divided into three stages: acute HIV infection, asymptomatic HIV infection and AIDS. Among them, patients with acute HIV infection and asymptomatic HIV infection are collectively referred to as HIV-infected persons, and patients in the AIDS stage are called AIDS patients.

[0106] 1.2.2.1 Acute HIV infection

[0107] 1.2.2.1.1 Epidemiological history: history of unsafe sexual life, history of intravenous drug use, history of transfusion of blood and blood products that have not been tested for HIV antibodies, children born to HIV antibody-positive persons, and others (such as history of occupational exposure or nosocomial infection).

[0108] 1.2.2.1.2 Clinical manifestations include fever, headache, fatigue, sore throat, general malaise, etc. Patients with infectious mononucleosis may have swollen lymph nodes in the neck, axilla and occipital region, meningoencephalitis or acute polyneuritis, rash, hepatosplenomegaly, etc.

[0109] 1.2.2.1.3 Laboratory test shows positive HIV antibody or HIV-RNA (+) in patient plasma.

[0110] 1.2.2.1.4 Diagnosis criteria The patient can be diagnosed if he / she has symptoms 1 and 2 above in the recent period and 3 is added.

[0111] 1.2.2.2 Asymptomatic HIV infection

[0112] 1.2.2.2.1 Same as “Acute HIV infection”

[0113] 1.2.2.2.2 Clinical manifestations: There are usually no symptoms, but there may be swollen lymph nodes throughout the body.

[0114] 1.2.2.2.3 Laboratory test shows positive HIV antibody or HIV-RNA (+) in patient plasma.

[0115] 1.2.2.2.4 Diagnosis criteria Patients can be diagnosed if they meet 1 or 2 of the above conditions and meet 3 of the above conditions.

[0116] 1.2.2.3 AIDS Patients with confirmed positive serum HIV antibodies or HIV-RNA (+) in plasma can be diagnosed as AIDS patients if they meet any of the following conditions.

[0117] ① Continuous fever for more than 1 month. ② Weight loss of more than 10% within 3 months, and chronic diarrhea (3 to 5 times a day) for more than 1 month. ③ Pneumocystis carinii pneumonia (PCP). ④ Kaposi's sarcoma (KS) of the skin, mucous membranes or internal organs. ⑤ Obvious fungal or other conditional pathogenic bacteria infection (such as Candida albicans infection in the mouth or internal organs). ⑥ Active pulmonary tuberculosis or non-tuberculous mycobacterial disease. ⑦ Recurrent herpes virus infection. ⑧ Generalized lymphadenopathy. ⑨ Obvious symptoms and signs of central nervous system space-occupying lesions, or the appearance of dementia. ⑩ Cytomegalovirus (CMV) infection. Toxoplasma encephalopathy. Cryptococcal meningitis or cryptococcal pneumonia. Lymphoma. Recurrent bacterial pneumonia. septicemia. Penicillium infection. CD4 lymphocyte count is less than 200 μl.

[0118] 1.3 Case selection criteria

[0119] 1.3.1 Inclusion criteria

[0120] Patients who meet the diagnostic criteria for HIV / AIDS and agree to be included in the observation and treatment and sign the informed consent form.

[0121] 1.3.2 Exclusion criteria

[0122] ① Severe cardiovascular and cerebrovascular diseases, liver and kidney diseases, blood diseases, endocrine diseases, lung diseases, and neuropsychiatric diseases before the onset of the disease;

[0123] ② Patients with severe cachexia;

[0124] ③The first 12 weeks of pregnancy.

[0125] 1.3.3 Shedding Standard

[0126] Unable to complete the follow-up or patients requesting to withdraw from the trial due to personal reasons.

[0127] 1.3.4 Elimination and termination criteria

[0128] (1) Patients with severely incomplete clinical data;

[0129] (2) Those who fail to take oral medications as required during the trial due to non-drug reasons.

[0130] (3) Patients who take medications that may affect the efficacy of treatment.

[0131] (4) Other serious diseases are discovered during the trial observation period;

[0132] (5) Serious adverse events of the trial drug occur.

[0133] 2 Treatment options

[0134] The granules provided in Example 5 were orally administered, 15 g each time, three times a day, for 3 consecutive months.

[0135] 3 Observation indicators and evaluation criteria

[0136] 3.1 Safety Observation Indicators

[0137] Changes in blood, urine routine, liver function, and kidney function.

[0138] 3.2 Efficacy observation indicators

[0139] ① Changes in clinical symptoms and signs, Karlovsky score, number of colds, and body weight before and after treatment;

[0140] ②CD4 cell count before and after treatment (detected by flow cytometer of BD Company, USA).

[0141] 3.3 Symptoms and signs efficacy criteria

[0142] Markedly effective: the symptom and sign integral value decreased by ≥70%; effective: the symptom and sign integral value decreased by ≥30% or <70%; ineffective: the symptom and sign integral value decreased by <30%. CD4 cell count efficacy criteria: effective: CD4 cell count gradually increased, CD4 increased by ≥30% or 50 / mm after treatment 3 Stable: CD4 cell count remains unchanged or gradually increases; after treatment, CD4 increases or decreases by less than 30% or 50 cells / mm 3 ; Ineffective: CD4 cell count decreased by ≥30% or 50 cells / mm 3 .

[0143] 4. Statistical methods

[0144] SPSS software was used for statistics. The count data were expressed as rate (%). The differences among the groups were compared by one-way analysis of variance, and the difference was considered statistically significant when P < 0.05.

[0145] 2. Research Results

[0146] After treatment, the symptom and sign score was 60.61% effective, and the effective rate was 33.33%. The CD4 cell count was 42.42% effective, and the stable rate was 39.39%. The changes in related indicators before and after treatment are shown in Table 1. After treatment, the patient's original symptoms and signs were significantly reduced, weight increased, and the Karofsky score increased, indicating that the prescription provided by the present invention has the effect of improving the clinical symptoms and signs of HIV / AIDS, improving the quality of life of patients, increasing the immunity of HIV / AIDS patients, and slowing down the destruction of CD4 cells.

[0147] Safety test: No obvious abnormalities were found in routine blood, urine, liver function and kidney function tests.

[0148] Table 1 Changes of relevant indicators before and after treatment

[0149] <![CDATA[CD 4 cells / U]]> Total volume of symptoms and signs Karofsky Points Number of colds (per month) Weight(kg) Before treatment 247.71±224.56 10.6±6.65 89.34±6.30 0.21±0.59 54.32±8.32 After treatment 273.33±142.90* 1.92±4.18* 97.86±4.51* 0.08±0.37 54.56±8.39*

[0150] Note: Compared with before treatment, *P<0.01

[0151] Conclusion

[0152] No obvious toxicity or side effects were found in blood and urine routine tests, and the patient's quality of life was good. The increase in CD4+T lymphocytes indicated that the patient's immune function could be enhanced and the synthesis of HIV could be inhibited. It has the effects of strengthening the body and eliminating evil, treating both the symptoms and the root causes, and is an effective prescription for the treatment of AIDS.

[0153] The embodiments described above are only descriptions of the preferred embodiments of the present invention, and are not intended to limit the scope of the present invention. Without departing from the design spirit of the present invention, various modifications and improvements made to the technical solutions of the present invention by ordinary technicians in this field should fall within the protection scope determined by the claims of the present invention.

Claims

1. A Chinese medicine preparation for treating AIDS, characterized in that: The preparation is made of the following components in parts by mass: 1-5 parts of ginseng, 10-20 parts of astragalus, 5-15 parts of patrinia herb, 5-15 parts of tuckahoe, 5-15 parts of angelica, 5-15 parts of red peony root, 5-15 parts of licorice, 5-15 parts of trichosanthes, 1-5 parts of bombyx batryticatus, 5-15 parts of platycodon, 20-40 parts of honeysuckle, 5-15 parts of mulberry leaves, 20-40 parts of dandelions and 10-20 parts of fermented black beans.

2. The Chinese medicine preparation according to claim 1, characterized in that: The preparation is made of the following components in parts by mass: 2-4 parts of ginseng, 13-17 parts of astragalus, 8-12 parts of patrinia herb, 8-12 parts of tuckahoe, 8-12 parts of angelica, 8-12 parts of red peony root, 8-12 parts of licorice, 8-12 parts of trichosanthes, 2-4 parts of bombyx batryticatus, 8-12 parts of platycodon, 25-35 parts of honeysuckle, 8-12 parts of mulberry leaves, 25-35 parts of dandelions and 13-17 parts of fermented black beans.

3. The Chinese medicine preparation according to claim 1, characterized in that: The preparation is made of the following components in parts by mass: 3 parts of ginseng, 15 parts of astragalus, 10 parts of patrinia herb, 10 parts of tuckahoe, 10 parts of angelica, 10 parts of red peony root, 10 parts of licorice, 10 parts of trichosanthes, 3 parts of bombyx batryticatus, 10 parts of platycodon, 30 parts of honeysuckle, 10 parts of mulberry leaves, 30 parts of dandelions and 15 parts of light fermented black beans.

4. The Chinese medicine preparation according to any one of claims 1 to 3, characterized in that: The traditional Chinese medicine preparation also includes 30-70 parts of soluble starch.

5. The Chinese medicine preparation according to any one of claims 1 to 4, characterized in that: The dosage form of the traditional Chinese medicine preparation includes granules, granules, pills, capsules or tablets.

6. The method for preparing the Chinese medicine preparation according to any one of claims 1 to 4, characterized in that: The steps include: (1) Grind ginseng, astragalus, patrinia, tuckahoe, angelica, red peony root, liquorice, trichosanthes root, bombyx batryticatus, platycodon, honeysuckle, mulberry leaf, dandelion and light black bean into fine powder according to proportion, pass through a 100-mesh sieve, and set aside the fine powder. Add 5-7 times the amount of 40%-80% ethanol to the coarse powder and the remaining medicinal materials for reflux extraction for 2-5 hours, pass through a 200-mesh sieve, recover ethanol from the filtrate, and concentrate to obtain ointment I; (2) Add 4-8 times the amount of water to the residue, extract for 1-3 hours, pass through a 200-mesh sieve, combine the filtrate with ointment I, and concentrate under reduced pressure to 1.25 g / cm 3 (50°C), concentrated to obtain ointment II; (3) taking another 30-70 parts of soluble starch and mixing it with ointment II to prepare granules; (4) The granules obtained in step (3) are prepared into various oral preparations according to conventional methods.

7. Use of the traditional Chinese medicine preparation according to any one of claims 1 to 4 in the treatment of AIDS.