A Chinese medicine composition for improving clinical symptoms of HIV infected persons, and its preparation and application

Abstract

The present invention discloses a Chinese medicine composition for improving clinical symptoms of HIV-infected patients, and its preparation and application. The Chinese medicine composition for improving clinical symptoms of HIV-infected patients is composed of pearl powder, cycad leaves and poplar flower seeds in a weight ratio of 1:3 to 10:2 to 10. The present invention only uses pearl powder, cycad leaves and poplar flower seeds to formulate a prescription. The synergistic effect between the raw materials is very significant in improving the clinical symptoms of HIV-infected patients. The applicant found in clinical experiments that compared with traditional Western medicine treatment alone, the CD4 + The number of T cells recovered significantly (P < 0.05), and the clinical symptoms were significantly alleviated (P < 0.05). Later follow-up also found that the clinical efficacy score was better.

Description

Technical Field

[0001] The present invention relates to the technical field of traditional Chinese medicine pharmaceutical preparation, and in particular to a traditional Chinese medicine composition for improving clinical symptoms of HIV infected persons, and a preparation and application thereof. Background Art

[0002] AIDS (Acquired Immune Deficiency Syndrome, AIDS) is a highly harmful infectious disease caused by infection with the human immunodeficiency virus (HIV). HIV is a virus that attacks the human immune system. It destroys the most important CD4 + T cells are the main target of attack, and a large number of these cells are destroyed, causing the body to lose its immune function. The average incubation period of HIV in the human body is 8 to 9 years. During the incubation period of the HIV virus, the infected person may not have any clinical symptoms. Once AIDS develops, the patient will have various clinical manifestations. Generally, the initial symptoms are like the common cold and flu, and there may be general fatigue, loss of appetite, fever, etc. As the disease worsens, the symptoms increase day by day, such as Candida albicans infection on the skin and mucous membranes, herpes simplex, herpes zoster, purpura, blood blisters, ecchymosis, etc.; then gradually invade the internal organs, and unexplained persistent fever occurs, which can last up to 3 to 4 months; cough, shortness of breath, dyspnea, persistent diarrhea, blood in the stool, hepatosplenomegaly, and concurrent malignant tumors may also occur. The clinical symptoms are complex and varied, but not all of the above symptoms appear in every patient. When invading the lungs, dyspnea, chest pain, cough, etc. often occur; invading the gastrointestinal tract can cause persistent diarrhea, abdominal pain, weight loss, etc.; it can also invade the nervous system and cardiovascular system.

[0003] At present, Western medicine cocktail therapy and highly effective antiretroviral therapy have achieved certain results in alleviating patients' pain and prolonging their lifespan, but the price of Western medicine treatment is relatively expensive, and on the other hand, the toxic side effects of the drugs may make some patients unable to bear it. A group of HIV studies in Switzerland showed that 45% of patients receiving antiretroviral therapy (ART) experienced clinical adverse events and 27% experienced laboratory adverse events. Drug-related events may occur in the early stage (the first few weeks or months of treatment), including rash and abnormal liver function caused by non-nucleoside drugs; drug-related events may also occur in the late stage (after 6 months or longer), including mitochondrial toxicity caused by long-term use of nucleoside drugs, such as severe lactic acidosis, myopathy, cardiomyopathy, pancreatitis, peripheral neuritis, etc.

[0004] Traditional Chinese medicine treatment is to prescribe the right medicine for patients with different physical conditions, so as to achieve the purpose of regulating the overall dialectical syndrome of the body. It can provide a new way for Western medicine anti-HIV virus treatment, improve the body's immune function, improve the patient's quality of life, and reduce the toxic side effects of antiviral drugs. After searching, there are many prescriptions for the treatment of AIDS using traditional Chinese medicine, such as:

[0005] The invention patent with publication number CN1679737A discloses a Chinese medicine preparation for treating AIDS made from the following raw materials by weight: 6-12 parts of pearl, 10-20 parts of Chuanqi, 5-10 parts of Curcuma, 5-10 parts of artificial bezoar, 8-15 parts of Trichosanthes, 5-10 parts of Scutellaria, 1-2 parts of Fritillaria, 5-10 parts of Aucklandia, 5-10 parts of Rhubarb, and 0.5-1 part of Borneol. Studies have shown that the prescription inhibits HIV by 97.7%, can significantly enhance the body's immune function, and has no toxic reactions.

[0006] The invention patent with publication number CN107362308A discloses a Chinese medicine preparation for treating AIDS, including Chinese medicine pills and medicine guides; wherein the Chinese medicine pills include the following raw materials in parts by weight: 20-30 parts of silver bupleurum, 20-30 parts of Lycium bark, 20-30 parts of safflower, 15-20 parts of chuanxiong, 30-50 parts of red peony root, 20-30 parts of earthworm, 15-30 parts of trigonosciadium japonicum, 10-20 parts of dragon tooth, 20-50 parts of dragon bone, 20-30 parts of maotouhui, 20-35 parts of raspberry, 20-30 parts of mulberry silkworm cocoon, 20-50 parts of pomegranate peel, 10-20 parts of blood charcoal, 20-50 parts of gentiana macrophylla, 20-30 parts of sea sand. ~50 parts, 10-20 parts of cloves, 10-20 parts of borneol, 1-2 parts of musk, 12-20 parts of whole scorpion, 10-20 parts of Panax notoginseng, 20-30 parts of peach kernel, 25-60 parts of myrrh, 10-20 parts of lithospermum, 20-50 parts of pollen, 10-20 parts of earthworm, 10-20 parts of fennel, 6-10 parts of light powder, 10-20 parts of male flowers of Dracaena cycad, 20-30 parts of Dracaena seeds, 20-30 parts of placenta and 400-900 parts of honey; the medicine leads include 10-20 parts of tortoise shell glue, 10-20 parts of ginseng, 50-200 parts of astragalus, 50-200 parts of pitted jujube and 200-900 parts of water.

[0007] The invention patent with publication number CN105031463A discloses an anti-AIDS Chinese medicine composition, the raw materials of which are as follows: 9-11g of Danshen, 10-14g of Beiqi, 9-11g of Ginseng, 7-9g of Cimicifuga, 8-10g of Tripterygium wilfordii, 5-7g of Prunella Vulgaris, 9-11g of Polygonum cuspidatum, 5-7g of Polygonum multiflorum, 7-9g of Lobelia, 9-11g of Viola yedoensis, 9-11g of Bidens pilosa, 7-9g of Jianzhongxiao, 9-11g of Duchesnea indica, 9-11g of Folium scabra 11g, rose 5-7g, smilax china 7-9g, epimedium 9-11g, smilax glabra 14-16g, sophora flavescens 7-9g, rhizoma dioscoreae 5-7g, honeysuckle 9-11g, nightshade 7-9g, bupleurum 9-11g, cycad 9-11g, lithospermum 7-9g, toad venom 2-4g, oldenlandia diffusa 9-11g, august 7-9g, chuanberry 8-10g, shimizushi 9-11g, senecio 5-7g, coptis 5-7g, andrographis paniculata 9-1 1g, vine pear root 9-11g, tomb back 8-10g, Guanzhong 5-7g, stir-fried fish maw 5-7g, white tribulus 9-11g, Gynostemma pentaphyllum 18-22g, rhubarb 9-11g, single general 9-11g, cinnabar lotus 9-11g, Xu Changqing 9-11g, Qujiecao 9-11g, black face god 9-11g, flying centipede 9-11g, licorice 18-22g, quick-tempered 9-11g, spring does not see 9-11g, pearl 2-4g, Gelsemium 7-9 g, 10-14g of lion seven, 8-10g of single herb, 14-16g of bright fungus, 9-11g of American shangluzi, 5-7g of artillery armor, 14-16g of yizhiren, 16-20g of sea cuttlebone, 11-13g of tongtiancao, 9-11g of yellow vine, 9-11g of wild zizyphus, 14-16g of cat's claw, 11-13g of kiwi root, 14-16g of deer mouth grass, 7-9g of buddlejac, 8-10g of hanxincao, 7-9g of yew, 6 geckos, and 3 leeches. The Chinese medicine composition can reduce the course of the disease in infected people, alleviate the symptoms of AIDS patients, and finally achieve the purpose of curing AIDS, providing an economical and effective supplementary means for the treatment of AIDS.

[0008] Although the above-mentioned Chinese medicine prescriptions all have certain therapeutic effects, their prescriptions are too complicated. Summary of the invention

[0009] The technical problem to be solved by the present invention is to provide a Chinese medicine composition with simple formula and significant effect for improving clinical symptoms of HIV infected persons, as well as preparation and application thereof.

[0010] The Chinese medicinal composition for improving clinical symptoms of HIV infected persons of the present invention is composed of pearl powder, cycad leaves and poplar flower seeds in a weight ratio of 1:3-10:2-10.

[0011] The formula in the present invention is improved by the inventor from the secret recipe handed down from his ancestors. The inventor conducted acute and chronic toxicity tests on the secret recipe handed down from his ancestors in the early stage, and no toxic and side effects were found in clinical practice. The medicine is safe to use. In further clinical application, it was found that it also has a good effect on improving the body's immunity. Therefore, the inventor made improvements on the basis of the secret recipe to obtain the existing formula composed of 3 medicines. The poplar flower seeds involved in the formula are granular seeds in the female inflorescence of the poplar. The flowering period of the poplar tree is usually from March to April. The poplar flower seeds involved in the present invention are obtained by picking or collecting the female inflorescences that fall to the ground during the flowering period, drying (sun drying or low-temperature baking), and then peeling off the granular seeds from the dried female inflorescence of the poplar. The dried female inflorescence of the poplar is as follows Figure 1 As shown in the figure, the poplar flower seeds peeled from the dried female inflorescence of the poplar are as follows Figure 2 shown.

[0012] Preferably, the weight ratio of the pearl powder, cycad leaves and poplar flower seeds is 1:4-7:3-6; more preferably, the weight ratio of the pearl powder, cycad leaves and poplar flower seeds is 1:4-5:3-4; more preferably, the weight ratio of the pearl powder, cycad leaves and poplar flower seeds is 1:5:4.

[0013] The present invention also provides a Chinese medicine composition preparation for improving clinical symptoms of HIV infected persons, which contains the Chinese medicine composition for improving clinical symptoms of HIV infected persons.

[0014] The Chinese medicine composition preparation for improving clinical symptoms of HIV-infected patients can be a conventional dosage form in the prior art, such as powder, granules, tablets, capsules, decoctions, oral liquids or pills.

[0015] The preparation method of the Chinese medicine composition preparation for improving the clinical symptoms of HIV infected persons comprises: weighing pearl powder, cycad leaves and poplar flower seeds according to the proportion, decocting or extracting with water, collecting the decoction or extract, and preparing the preparation according to the existing conventional processing method. In the specific preparation method, the parameters such as the amount of water, the number and time of decoction or extraction are the same as those in the prior art. It is preferred to soak for a period of time before decoction or extraction after adding water, which is more conducive to the dissolution of the active ingredients in the Chinese medicine.

[0016] Generally, the Chinese medicine composition for improving clinical symptoms of HIV-infected patients of the present invention is prepared into a decoction for oral administration according to the following method:

[0017] Weigh each raw material drug according to the ratio, soak it in a container, then add water and boil it. After boiling, filter it and concentrate the decoction to contain 0.5 to 1 gram of raw drug per milliliter of liquid to obtain a water decoction.

[0018] In the above preparation method, the soaking time of each raw material in the extraction tank is usually 1 to 3 hours; the number of decoctions can be 1 to 3 times, the decoction time each time is usually 0.5 to 3 hours, and the amount of water added each time is 4 to 10 times the total weight of the raw material.

[0019] The dosage of the Chinese medicine composition of the present invention is 120 to 200 g of the raw medicine per day for adults, preferably 130 to 160 g / day.

[0020] The present invention also includes the use of the above-mentioned Chinese medicine composition for improving clinical symptoms of HIV-infected persons in the preparation of drugs for treating AIDS, or in the preparation of drugs for improving clinical symptoms of HIV-infected persons.

[0021] Compared with the prior art, the present invention only uses pearl powder, iron tree leaves and poplar flower seeds to formulate a prescription. The raw materials of each ingredient synergize with each other and have a very significant effect of improving the clinical symptoms of HIV-infected patients. The applicant found in clinical experiments that compared with traditional Western medicine alone, the combination of the traditional Western medicine and the Chinese medicine composition of the present invention can significantly improve the CD4 + The number of T cells recovered significantly (P < 0.05), and the clinical symptoms were significantly alleviated (P < 0.05). Later follow-up also found that the clinical efficacy score was better. BRIEF DESCRIPTION OF THE DRAWINGS

[0022] Figure 1 This is a photo of the dried female inflorescence of poplar.

[0023] Figure 2 This is a photo of poplar flower seeds peeled from the dried female inflorescence of the poplar tree. DETAILED DESCRIPTION

[0024] In order to better explain the technical solution of the present invention, the present invention is further described in detail below in conjunction with embodiments, but the embodiments of the present invention are not limited thereto.

[0025] Example 1

[0026] Weigh pearl powder, cycad leaves and poplar flower seeds in a weight ratio of 1:5:4, put them in a ceramic container, add water equivalent to 8 times the total weight of the raw materials, soak for 1 hour, and then boil. After boiling for 1 hour (start timing from the boiling of the liquid), filter and collect the decoction; add water equivalent to 5 times the total weight of the raw materials to the residue and boil for 1 hour (start timing from the boiling of the liquid), filter and collect the decoction; combine the decoctions and concentrate to contain 1 gram of crude drug per milliliter of liquid to obtain a water decoction.

[0027] Example 2

[0028] Pearl powder, iron tree leaves and poplar flower seeds are weighed in a weight ratio of 1:6:3, placed in an extraction tank, and extracted with water for 3 times (the amount of water used in the first extraction is 10 times the total weight of the raw material, and the extraction time is 2 hours (starting from the boiling of the liquid); the amount of water used in the second and third extractions is 5 times the total weight of the raw material, and the extraction time is 1 hour (starting from the boiling of the liquid)), the extracts are collected and combined, concentrated under reduced pressure to an extract, dried, crushed, added with auxiliary materials, and made into granules by wet granulation.

[0029] Example 3

[0030] Weigh pearl powder, iron tree leaves and poplar flower seeds in a weight ratio of 1:10:2, put them in an extraction tank, add water to extract twice (the amount of water used in each extraction is 10 times the total weight of the raw material, and the extraction time is 2 hours (starting from the boiling of the liquid), collect and combine the extracts, reduce pressure and concentrate to extract, dry, crush, add auxiliary materials, and make tablets according to conventional processes.

[0031] Example 4

[0032] Pearl powder, cycad leaves and poplar flower seeds are weighed in a weight ratio of 1:4:6, the cycad leaves and poplar flower seeds are crushed into 200 meshes, mixed evenly with the pearl powder, and then packaged and sterilized to obtain a powder.

[0033] Experimental example: Clinical trial of the Chinese medicine composition of the present invention on AIDS

[0034] 1. Experimental subjects and methods

[0035] 1.1 The experimental subjects were 62 middle-aged and elderly patients with AIDS admitted to a People's Hospital of Qinzhou, Guangxi (hereinafter referred to as Qinzhou Hospital) from June 2010 to April 2020, including 34 males and 28 females, aged 42 to 71 years old with an average age of (51.8±9.7) years. They were randomly divided into a control group of 28 cases and a study group of 34 cases. There was no significant difference in gender composition and age between the two groups.

[0036] 1.2 Inclusion and Exclusion Criteria

[0037] Inclusion criteria: patients confirmed HIV positive by ELISA test in a hospital in Qinzhou and Western blot test in Guangxi Center for Disease Control and Prevention, regardless of gender, CD4 + T cell count is less than 350 / ml.

[0038] Exclusion criteria: patients with severe heart, liver, kidney dysfunction and other important organ disorders; patients with severe neurological and psychiatric diseases; patients with active opportunistic infections; patients who had received prior anti-opportunistic infection treatment; patients who had recently used or used during treatment drugs that may cause conflicting results with this study.

[0039] 1.3 Treatment methods

[0040] The 28 patients in the control group were given highly active antiretroviral therapy: Kaletra 250 mg, taken orally twice a day; Lamivudine 300 mg, taken orally once a day; Zidovudine 300 mg, taken orally twice a day; and opportunistic infections were treated at the same time. The treatment lasted for half a year.

[0041] In addition to the above western medicine treatment, the 34 patients in the study group took one packet of the water decoction of the Chinese medicine composition of the present invention (prepared according to the method described in Example 1 of the present invention and packaged at 160 ml / pack) orally once a day for a total of 3 months and then stopped for observation. All patients signed informed consent.

[0042] 1.4 Treatment judgment criteria, clinical symptoms and efficacy

[0043] Refer to the syndrome, sign classification and scoring standards in the "Clinical Technical Program for the Treatment of AIDS in 5 Provincial Hospitals of Traditional Chinese Medicine (Trial)" formulated by the State Administration of Traditional Chinese Medicine. Use the quantitative scoring method of traditional Chinese medicine symptoms and signs, and record once every 2, 4, and 6 months after treatment. CD4 + T lymphocyte counts were performed using XL flow cytometer matching reagents produced by Beckman Co., USA, and MR23 desktop centrifuge produced by Jouan, France. All patients underwent CD4+ T lymphocyte counts before and after treatment, and CD4 was recorded 2, 4, and 6 months after treatment. + Increase and decrease values ​​of T cell count.

[0044] 1.5 Statistical methods SPSS 13.0 software was used, and the mean was expressed as X ± S. The x2 test and variance analysis were performed.

[0045] 2. Results

[0046] 2.1 Analysis of clinical symptom improvement between the two groups

[0047] After 2 months of treatment, the difference in fatigue symptoms between the two groups was statistically significant (P < 0.05); after 4 months of treatment, the difference in fever symptoms between the two groups was statistically significant (P < 0.05); after 6 months of treatment, the difference in fatigue, diarrhea, fever, rash, etc. between the two groups was statistically significant (P < 0.05). The results are shown in Table 1.

[0048] Table 1. Analysis of clinical symptom improvement in the two groups after treatment (n)

[0049]

[0050]

[0051] 2.2 CD4 between the two groups + Analysis of T cell detection

[0052] CD4 + There was a statistically significant difference in T cells before treatment and 2 months after treatment (P>0.05). There was a statistically significant difference in T cells between the two groups after 4 and 6 months of treatment (P<0.05). The results are shown in Table 2.

[0053] Table 2. CD4+T lymphocyte detection in the two groups

[0054] time Study group (n=34) Control group (n=28) t-value P-value Before taking medication 98.88±83.87 102.61±28.24 0.24 0.809 2 months of treatment 190.53±103.76 176.82±82.23 0.58 0.564 4 months of treatment 315.09±161.03 194.46±79.19 3.84 0.000 6 months of treatment 471.97±165.62 265.29±119.62 5.69 0.000 F-number 49.96 17.77 P-value 0.000 0.000

[0055] 2.3 Analysis of clinical efficacy between the two groups

[0056] The TCM judgment standard showed that there was no statistically significant difference between before medication and 2 months of treatment, but there was a statistically significant difference between 4 months and 6 months of treatment. The score of the study group was significantly lower than that of the control group as the treatment time prolonged (P < 0.05). The results are shown in Table 3

[0057] Table 3. Comparison of clinical efficacy scores between the two groups based on TCM judgment criteria

[0058] time Study group (n=34) Control group (n=28) t-value P-value Before taking medication 17.88±3.68 17.54±3.29 3.87 0.700 2 months of treatment 13.71±3.43 15.11±4.43 1.40 0.166 4 months of treatment 8.97±3.92 12.82±4.33 3.67 0.001 6 months of treatment 2.35±3.41 8.57±3.39 7.16 0.000 F-number 115.43 26.80 P-value 0.000 0.000

[0059] 3. Discussion

[0060] In the treatment observation of AIDS patients, the research group treated with the Chinese medicine composition of the present invention combined with Western medicine was compared with the control group treated with Western medicine alone, and it was found that the research group and the control group were significantly different. + T cells and quality of life have given patients hope. + The T cells were significantly higher than those in the control group, and there were statistically significant differences in the improvement of clinical symptoms, fatigue, diarrhea, fever, and rash between the two groups.

[0061] The clinical efficacy analysis between the two groups showed that the TCM judgment standard showed that before and after taking the Chinese medicine composition of the present invention, the score of the research group was significantly lower than that of the control group as the treatment time prolonged. Therefore, the Chinese medicine composition of the present invention has an anti-HIV virus effect and can inhibit the reproduction of HIV virus. CD4 + T cells are not destroyed, CD4 + T cells can survive better, improve immunity, prevent opportunistic infections and fight against malignant tumors.

[0062] It has been 16 years since the first AIDS patient was treated and observed, and he is still living safely and healthily. Except for a few who did not adhere to the treatment, all other AIDS patients who received treatment can live normally and survive for a long time. This has opened up a new treatment method for AIDS patients.

Claims

1. A Chinese medicine composition for improving clinical symptoms of HIV-infected patients, characterized in that: The invention is composed of pearl powder, iron tree leaves and poplar flower seeds in a weight ratio of 1:3-10:2-10.

2. The Chinese medicine composition according to claim 1, characterized in that: The weight ratio of the pearl powder, cycad leaves and poplar flower seeds is 1:4-7:3-6.

3. The Chinese medicine composition according to claim 1, characterized in that: The weight ratio of the pearl powder, cycad leaves and poplar flower seeds is 1:5:

4.

4. A Chinese medicine composition preparation for improving clinical symptoms of HIV-infected patients, characterized in that: A Chinese medicine composition for improving clinical symptoms of HIV-infected patients as claimed in claim 1.

5. The Chinese medicine composition preparation for improving clinical symptoms of HIV-infected patients according to claim 4, characterized in that: The preparation is in the form of powder, granule, tablet, capsule, decoction, oral liquid or pill.

6. The method for preparing the Chinese medicine composition preparation for improving clinical symptoms of HIV infected persons as claimed in claim 4, characterized in that: Weigh pearl powder, cycad leaves and poplar flower seeds according to the proportion, add water for decoction or extraction, collect the decoction or extraction, and further prepare into a preparation.

7. The preparation method according to claim 6, characterized in that: After adding water, soak first and then decoct or extract.

8. Use of the Chinese medicine composition according to claim 1 in the preparation of a medicament for improving clinical symptoms of HIV-infected patients.

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