Pharmaceutical composition comprising plant extracts, use of said composition for the treatment of herpes, and medicinal product comprising said composition

Abstract

The present invention relates to a pharmaceutical composition particularly indicated for the treatment of herpes, comprising plant extracts known from Traditional Chinese Medicine. The present invention also relates to a medicinal product comprising said pharmaceutical composition. Furthermore, the present invention relates to the use of said medicinal product for the treatment of herpes, including chronic herpes, herpes type 1, herpes type 2, and herpes zoster.

Description

Descriptive Report of Invention Patent for “PHARMACEUTICAL COMPOSITION COMPRISING PLANT EXTRACTS, USE OF SAID COMPOSITION FOR TREATMENT OF HERPES AND MEDICATION COMPRISING SAID COMPOSITION” FIELD OF INVENTION

[0001] . The present invention belongs to the technological sector of Pharmacy and refers to a pharmaceutical composition comprising specific plant extracts and a medicine comprising said composition.

[0002] . Furthermore, the present invention relates to the use of said pharmaceutical composition for the treatment of herpes. BACKGROUND OF THE INVENTION

[0003] Herpes is a disease caused by the herpes simplex virus 1 (HSV). It's an infection that begins with a tingling sensation on the lips and continues with itching until blisters finally break out. These eventually turn into sores.

[0004] Transmission occurs through saliva droplets, kissing, contaminated objects in the mouth, and so on. Therefore, it is quite common for the first contact with HSV to occur in childhood.

[0005] The most common locations are the lips and genital area, but herpes can appear anywhere on the skin.

[0006] . Some treatments for herpes are known, including medications for local use (in the form of creams or solutions) or oral use, in the form of tablets.

[0007] . We highlight below some teachings from the state of the art that refer to this matter:

[0008] . WO 2018079514 relates to an extract composition for the treatment and / or prevention of herpes infection. It is a natural antiherpetic agent with a potent effect against herpes infection. It is a composition for the treatment and / or prevention of herpes infection. herpes comprising a heat-dried maitake extract and a vacuum-dried maitake extract.

[0009] . CN 101390921 refers to a composition of starwort with glycopeptides and flavones. This document reveals a dark brown compound with a molecular weight of 1,000–100,000, composed of a total glycopeptide and a total flavonoid component, and Stellaria extract. The combination can be used as a medication for the treatment of diseases including HIV, hepatitis viruses, influenza viruses such as highly pathogenic avian influenza, condyloma virus, herpes viruses, and mumps virus.

[0010] . Document BR 10 2019 016046 2 discloses a topical formulation containing mangiferin with activity against herpes simplex virus type 1, acyclovir-sensitive and -resistant strains, and its production process. This document addresses a topical antiviral formulation to aid in the control of herpes simplex virus type 1 (HSV-1) infections, both acyclovir-sensitive and -resistant strains. The formulation comprises mangiferin and glycosylated xanthone.

[0011] . And document BR 10 2019 015154 4 describes a formulation containing a nucleoside analogue in combination with lysine for the treatment and prophylaxis of herpes. This is a formulation containing a nucleoside analogue in combination with lysine.

[0012] . Therefore, there is no solution in the state of the art equivalent to that presented here in the present invention, which refers to an innovative combination of plant extracts with significant efficacy for the treatment of herpes. OBJECTIVES OF THE INVENTION

[0013] . Thus, it is an object of the present invention to provide a new medicament for the treatment of herpes.

[0014] . Another objective of the present invention is to provide a treatment indicated for chronic or non-chronic herpes, types herpes 1, herpes 2 and herpes zoster.

[0015] . It is also an objective of the present invention to provide a medicine comprising extracts proven to be effective for other diseases.

[0016] . It is also an object of the present invention to provide a medicament for the treatment of herpes to be administered orally.

[0017] . It is another objective of the present invention to provide a medicament comprising plant extracts.

[0018] . Another objective of the present invention is to provide a safe and healthy medicine for humans that is also economically accessible. SUMMARY OF THE INVENTION

[0019] . The present invention achieves these and other objectives by means of a pharmaceutical composition particularly indicated for the treatment of herpes that comprises extracts of the following plants: - Radix rehmanniae (tuber of the species Rehmannia glutinosa Libosch); - Radix paeonia or Radix paeonia rubra (root of Paeonia lactiflora Pali or P. veitchii Lynch, from the Ranunculaceae family); - Rhizoma chuanxiong (dry rhizome of Ligusticum chuanxiong Hort, family Umbelliferae); - Radix bupleuri (root of the perennial herb Bupleurum chinensis DC. or Bupleurum scorzonerifolium, from the Umbelliferae family); - Radix Glycyrrhizae (root and rhizome of the plant Glycyrrhiza uralensis Fisch, G. inflata Bat or L. glabra L, from the Leguminosae family).

[0020] . The present invention achieves these and other objectives by means of a medicament comprising the above pharmaceutical composition.

[0021] . The present invention achieves these and other objectives by using the above pharmaceutical composition to prepare a medicament for treating herpes. DETAILED DESCRIPTION OF THE INVENTION

[0022] . The present invention relates to a pharmaceutical composition particularly indicated for the treatment of herpes and comprises: - Radix rehmanniae (tuber of the species Rehmannia glutinosa Libosch); - Radix paeonia or Radix paeonia rubra (root of Paeonia lactiflora Pall or P. veitch ii Lynch, from the Ranunculaceae family); - Rhizoma chuanxiong (dry rhizome of Ligusticum chuanxiong Hort, family Umbelliferae); - Radix bupleuri (root of the perennial herb Bupleurum chinensis DC. or Bupleurum scorzonerifolium, from the Umbelliferae family); - Radix Glycyrrhizae (root and rhizome of the plant Glycyrrhiza uralensis Fisch, G. inflata Bat or L. glabra L, from the Leguminosae family).

[0023] . Furthermore, the composition of the present invention may comprise other extracts combined with those above, including: - Semen persicae (Prunus persica seed - Carthami threads (dried flower of Carthamus tinctorius); - Radix angelicae sinensis or Angelica sinensis radix (root of the species Angelica sinensis); - Radix achyranthis bidentatae (dried root of the species Achyranthes bidentata Bl. and Cyathula officinalis Kuan, from the Amaranthaceae family); - Fructus aurantii or fructus aurantii immaturus (The immature fruit of Citrus aurantium L. or C. sinensis Osbeck, from the Rutaceae family); - Radix platycodi (dried root of Platycodon grandiflorum (Jacq.) A. DC., from the Campanulaceae family).

[0024] Preferably, the extracts are present in the composition of the present invention in an amount ranging from 1% to 60%, by mass, based on the total mass of the composition.

[0025] . Such extracts present the following definitions:

[0026] . The natural extracts mentioned above and included in the present invention are further detailed below:

[0027] . 1 . Semen persicae

[0028] It is commonly used to treat blood stasis, as an anticoagulant, antiphlogistic, and anodyne, in traditional Chinese medicine (source: YANG, Chuanbin et al. Bioactivity-guided fractionation identifies amygdalin as a potent neurotrophic agent from herbal medicine Semen persicae extract. BioMed. Research International, v. 2014, 2014). This stagnation is described in Traditional Chinese Medicine (TCM) theory as a slowing or accumulation of blood due to a disruption of heart Qi. It is often understood in terms of hematological disorders such as hemorrhage, congestion, thrombosis, or local ischemia, and in terms of tissue changes (source: https: / / en.wikiDedia.orq / wiki / Blood stasis). S. persicae is also used in many herbal medicine formulations, including Bu-Yang-Huan-Wu-Tang (also designated as ISF-1) for the treatment of post-stroke disorders. St.persicae is one of the traditional Chinese medicines commonly used to increase blood circulation in Traditional Chinese Medicine. Taoren (Semen persicae) is a neutral drug in nature and has a bitter-sweet flavor. It has the effect of activating blood stasis and loosening the bowels to relieve constipation. It is also used for dysmenorrhea and fall injuries, among other uses recorded in the Pharmacopoeia of the People's Republic of China (source: XI, Shengyan et al. Toxicity and clinical reasonable application of Taoren (Semen persicae) based on ancient and modern literature research. Journal of Traditional Chinese Medicine, v. 33, n. 2, p. 272-279, 2013. Available at: file: / / / C: / Users / asthe / Downloads / Toxicity_and_clinical_reasonable_application_of_Ta.pdf).

[0029] . 2. Carthami flos:

[0030] . Carthami fios, the dried flower of Carthamus tinctorius, has been commonly used in traditional Chinese medicine to treat a wide range of diseases, such as coronary heart disease, angina pectoris, heart disease, gynecological conditions, stroke, and hypertension. In China, Carthami fios has been used as a medicine for over 2,100 years (source: Tu, Yanhua et al. Carthami fios: a review of its ethnopharmacology, pharmacology, and clinical applications. Revista Brasileira de Farmacognosia, v. 25, n. 5, p. 553-566, 2015).

[0031] It also has protective effects on brain tissue, myocardial tissue, and osteoblasts, as well as antithrombotic, anti-inflammatory, and antitumor effects, which, to some extent, are closely linked to reports of promoting blood circulation, removing blood stasis, and relieving pain, conditions recorded in ancient Chinese documents. It is used in the treatment of coronary heart disease, diabetes, and orthopedic conditions, among others. C. fios is also used in cases of angina pectoris, coronary heart disease, thromboangiitis obliterans, and erythema multiforme (source: WU, JY-C. et al. Chemotherapeutic activities of Carthami fios and its reversal effect on multidrug resistance in cancer cells. African Journal of Traditional, Complementary and Alternative Medicines, v. 10, n. 4, p. 36-40, 2013).

[0032] . 3. Radix angelicae sinensis

[0033] Angelicae sinensis Radix is ​​the dried root of the herb Angelica sinensis, popularly known as "female ginseng." It is widely used in Traditional Chinese Medicine (TCM), present in more than 80 formulas (source: https: / / www.clinicahiraoka.com.br / tag / radix-angelica-sinensis / ). It is indicated for the treatment of hypertension, arthritis, anemia, cirrhosis, constipation, migraines, postpartum abdominal pain, uterine bleeding, rheumatism, ulcers, menopausal symptoms, and irregular menstruation. Its functional properties include analgesic, antibiotic, anticoagulant, antirheumatic, antianemic, antiasthmatic, anti-inflammatory, laxative, uterine stimulant, cardiac tonic, and respiratory tonic (source: https: / / www.tuasaude.com / donq-quai / ).

[0034] . Called dong quai or danggui, it is also known as the "queen" of women's herbs and has been used for thousands of years by Chinese women to nourish and balance the reproductive system. Its name means "obliged to return", which means the return of the normal functions of the female organism (source: httos: / / www.oficinadeervas.com.br / conteudo / donq-quai- anqelica-sinensis).

[0035] It is a herb also commonly used to enrich the blood, promote blood circulation, and modulate the immune system. It is effective in treating blood deficiency patterns and menstrual disorders, such as dysmenorrhea and irregular menstrual cycles. Research has shown that danggui and its active ingredients, including anti-arthrosclerotic, antihypertensive, anti-inflammatory, and antioxidant agents that limit platelet aggregation, are effective in reducing cerebral infarct size and improving neurological deficit scores (source: WU, Yi-Chian; HSIEH, Ching-Liang. Pharmacological effects of Radix angelica sinensis (Danggui) on cerebral infarction. Chinese Medicine, v. 6, n. 1, p. 1-5, 2011).

[0036] Modern science has found that dang quai is rich in vitamin A, vitamin B12, folinic acid, biotin, cobalt, and iron. Research has indicated that phthalides, organic acids and their esters, and polysaccharides are the main chemical components related to the bioactivity and pharmacological properties of dang quai. Some of these, such as Z-ligustilide and ferulic acid, are often selected as marker compounds to evaluate the quality of dang quai (source: Yl, Lunzhao et al. The analysis of Radix angelicae sinensis (Dang quai). Journal of Chromatography A, v. 1216, n. 11, p. 1991-2001, 2009). A study evaluated the antioxidant action, using common tests such as DPPH, ABTS and lipid peroxidation, identifying its constitution of phenolic compounds (source: LI, Xican; WU, Xiaoting; HUANG, Ling. Correlation between antioxidant activities and phenolic contents of Radix angelicae sinensis (Danggui). Molecules, v. 14, n. 12, p. 5349-5361 , 2009).

[0037] . 4. Radix rehmanniae

[0038] . Rehmanniae radix preparation has antioxidant, antisenescent, anti-inflammatory, and neuroprotective properties. It is the most popular traditional Chinese medicinal compound (TCMC) used in the treatment of attention deficit hyperactivity disorder (ADHD). The level of catalpol, an iridoid glycoside, in the extract is an indicator of the quality of rehmanniae, according to the Chinese pharmacopoeia (source: YUAN, Haixia et al. The therapeutic effect of the Chinese herbal medicine, rehmanniae radix preparata, in attention deficit hyperactivity disorder via reversal of structural abnormalities in the cortex. Evidence-Based Complementary and Alternative Medicine, 2018).

[0039] The anti-fatigue effects of Radix rehmanniae polysaccharide preparations (RRPP) were studied in mice. It was observed that RRPP is responsible for the pharmacological anti-fatigue effect of Radix rehmanniae preparation. The mechanism was related to increased hepatic glycogen storage and decreased accumulation of SUN (serum urea nitrogen) and BLA (blood lactic acid) (source: TAN, Wei et al. Anti-fatigue activity of polysaccharides extract from Radix Rehmanniae Preparata. International journal of biological macromolecules, v. 50, n. 1, p. 59-62, 2012).

[0040] The aqueous extract of Radix rehmanniae was investigated for its effects on wound healing in a rat model of diabetic foot ulcers, and its mechanism of action was detailed. The results demonstrated that Radix rehmanniae was effective in promoting the healing of diabetic foot ulcers in rats through tissue regeneration, angiogenesis, and inflammation control, but not blood glucose control. One study provided scientific support for the traditional use of Radix rehmanniae in diabetic foot ulcers (source: LAU, TW et al. Pharmacological investigation on the wound healing effects of Radix Rehmanniae in an animal model of diabetic foot ulcer. Journal of Ethnopharmacology, v. 123, n. 1, p. 155-162, 2009).

[0041] . Furthermore, antioxidant effects were observed, data involving blood glucose reduction, effects on the autonomic nervous system and effects on the human body (source: KIM, Seok-hee; YOOK, Tae-han; KIM, Jong-uk. Rehmanniae radix, an effective treatment for patients with various inflammatory and metabolic diseases: Results from a review of Korean publications. Journal of pharmacopuncture, v. 20, n. 2, p. 81, 2017).

[0042] The aqueous extract of Radix rehmanniae can protect the gastric mucosa, restrict pulmonary fibrosis, and exhibit hematopoietic activity, including anti-inflammatory and antitumor properties, blood sugar-lowering properties, and vascular endothelial cell proliferation. Oligosaccharides, the main chemical components of Radix rehmanniae, can increase the proliferation of skeletal myoblasts and protect and induce the differentiation of adipose-derived mesenchymal stromal cells and bone marrow mesenchymal stem cells. Both oligosaccharides and catalpol have blood sugar-lowering and memory-enhancing effects.Polysaccharides extracted from Radix rehmanniae are able to accelerate hematopoiesis function, protect adipose tissue-derived mesenchymal stromal cells, induce the differentiation of bone marrow mesenchymal stem cells into nerve cells, and restrict the central nervous system (source: LIU, WeiXin et al. Pharmacological actions of Radix Rehmanniae and its active components: research advances. Journal of International Pharmaceutical Research, v. 36, n.

[0043] . 5. Radix achyranthis bidentatae

[0044] Radix achyranthis bidentatae is the dried root of Achyranthis bidentata Blume (Amaranthaceae) and is used in traditional Chinese medicine (TCM). The dry extract of Achyranthes bidentata, also known as Niu Xi in Chinese medicine, is obtained through aqueous extraction. Its best-known use is associated with its beneficial effects in the treatment of arthritis. Furthermore, it benefits the liver, kidneys, muscles, and bones, and can also treat other conditions such as back pain, gonalgia, edema, headache, vertigo, and toothache. Studies indicate that this medicinal plant contains steroids, saponins, polysaccharides, flavonoids, anthraquinones, and other chemical constituents (source: http: / / florien.com.br / wD-content / uoloads / 2018 / 02 / RADIX-ACHYRANTHIS.pdf).

[0045] . Radix achyranthis bidentatae (RAB), a member of the Amaranthaceae family, has been widely used in Traditional Chinese Medicine (TCM) for 1,000 years. The growing interest in medicines derived fromRAB has led to the discovery of triterpenoid saponins, phytoecdysones, polysaccharides, and many other compounds, as well as investigations into its pharmacology. A large number of pharmacological studies have demonstrated that RAB and its active components possess a range of pharmacological activities, including antitumor, antifertility, antisenile, and anti-inflammatory effects. Currently, the traditional uses of RAB have been greatly expanded. Experimental studies indicate that RAB possesses a range of pharmacological activities, including antitumor, immunostimulatory, antifertility, antibacterial, anti-inflammatory, cognitive-enhancing, antisenile, and anti-osteoporosis properties. In terms of treatment, RAB has been used to influence blood carbohydrate metabolism, accelerate growth, and improve the modulatory function of the immune system (source: YANG, Liu et al. Investigation of radix achyranthis bidentatae phytochemistry and pharmacology).World Journal of Traditional Chinese Medicine, vol. 5, no. 1, p. 50, 2019).

[0046] . Furthermore, a study was conducted to determine whether alcoholic extracts of Radix Achyranthis Bidentatae can inhibit non-enzymatic saccharification in a dose-dependent manner in an in vitro model. The aim was to examine the effect of Radix achyranthis bidentatae on advanced glycation end products and learning and memory abilities in ovariectomized rats.

[0047] Biochemical tests showed that RAB treatment decreased superoxide dismutase activity in serum and frontal cortex and increased serum glutathione peroxidase levels in ovariectomized rats. Furthermore, there was no apparent effect on malonaldehyde levels. These experimental findings indicate that Radix achyranthis bidentatae inhibits the production of advanced glycation end products and their accumulation in brain tissue, improving learning and memory capabilities in ovariectomized rats. These effects may be associated with the extract's antioxidant activity (source: WANG, Yuefen et al. Radix Achyranthis Bidentatae improves learning and memory capabilities in ovariectomized rats). Neural Regeneration Research, v. 8, n. 18, p. 1644, 2013). Another study demonstrated the ability of RAB decoction to improve memory in mice (source: AILIAN, Ma; HUAN, Guo. Effect of Radix Achyranthis Bidentatae on Memory and Endurance. Journal of Chinese Medicinal Materials, p. 12, 1998).

[0048] A study used a network pharmacology approach to elucidate the molecular mechanism governing the effect of Radix achyranthis bidentatae (RAB) on osteoarthritis. The results concluded that RAB exhibits the characteristics of being multisystemic, multicomponent, and multitarget. Possible mechanisms of action of RAB include regulating immune and inflammatory responses, reducing chondrocyte apoptosis, and protecting the articular synovial membrane and cartilage to control disease progression. The active ingredients of RAB, such as sterols and flavonoids, show strong potential as drug candidates for the treatment of osteoarthritis (source: ZHANG, Laigen et al. Network pharmacology approach to uncover the mechanism governing the effect of Radix Achyranthis Bidentatae on osteoarthritis. BMC Complementary Medicine and Therapies, v. 20, p. 1-12, 2020).

[0049] . 6. Fructus aurantii

[0050] Bitter orange has several properties. Among them, it combats arthritis, makes the blood more alkaline, rejuvenates the body, has a laxative effect, suppresses appetite, combats inflammation and rheumatism, and infections (source: Bitter Orange - Fructus Aurantii Immaturus - 60 capsules - Nutrivale (natulha.com.br). Fructus aurantii is an authentic herb of local varieties in Zhejiang, China, generally used to treat gastrointestinal diseases (source: LI, Lili et al. Role of Quzhou Fructus Aurantii extract in preventing and treating acute lung injury and inflammation. Scientific Reports, v. 8, n. 1, p. 1-11, 2018). This species presents flavonoids in its constitution (source: JIANG, Yi-hao et al. Flavonoids of Fructus aurantii processed using the Zhangband system. Biomedical Research, 2017), and ten new ones were reported for this species, demonstrating antioxidant activity (source: LIN, Zongtao et al.Identification of antioxidants in Fructus aurantii and its quality. evaluation using a new online combination of analytical techniques. Food Chemistry, v. 134, n. 2, p. 1181-1191, 2012). Other biological activities described for this species include antitumor, antihypertensive, and anti-inflammatory (source: ZHANG, Xianhua et al. Pharmacokinetic study of 7 compounds following oral administration of Fructus aurantii to depressive rats. Frontiers in Pharmacology, v. 9, p. 131, 2018).

[0051] Another study showed that the main components of Fructus aurantii are naringin, narirutin, hesperidin, and neohesperidin, which constitute an important type of flavonoids (source: BAI, Yong-feng et al. The flavonoid-rich Quzhou Fructus Aurantii extract modulates gut microbiota and prevents obesity in high-fat diet-fed mice. Nutrition & Diabetes, v. 9, n. 1, p. 1-11, 2019). Flavonoids modulate the composition of the gut microbiota, which plays an important role in preventing obesity and associated metabolic diseases. In this study, we investigated the effect of total flavonoids in Fructus aurantii extract on the gut microbial community of mice fed a high-fat diet. The data indicated that F. aurantii significantly reduced obesity, inflammation, and hepatic steatosis. Another activity observed was the antidepressant action, demonstrated by the reduction in mobility time, in our own model (source: ZHANG, Ying-jin et al.Fructus Aurantii induced antidepressant effect via its monoaminergic mechanism and prokinetic action in rats. Phytomedicine, v. 19, n. 12, p. 1 (Will 07, 2012).

[0052] . As additional biological activities, a blood pressure-lowering action was observed in studies carried out with rats with portal hypertension. Fructus aurantii (2.8-280 pg / ml) induced dose-dependent contractile responses, mainly in the aorta and mesenteric artery, but little response in the portal vein. The results showed that Fructus aurantii infusion reduced portal pressure, possibly through arterial vasoconstriction (source: HUANG, Yi-Tsau et al. Fructus aurantii reduced portal pressure in portal hypertensive rats. Life Sciences, v. 57, n. 22, p. 2011-2020, 1995).

[0053] . Another study evaluated the anti-inflammatory activity of the extract of Fructus aurantii in a Zebra fish model of transgenic neutrophils induced by copper sulfate (CuSC .õF ). A significant anti-inflammatory effect was observed, reducing the number of neutrophils at the site of inflammation.

[0054] . 7. Radix paeonia

[0055] Radix paeonia is the dried root of Paeonia lactiflora, known in Traditional Chinese Medicine (TCM) as Chi Shao or Bai Shao. It has been traditionally used for over 1,200 years to treat hepatitis, dysmenorrhea, cramps, and spasms. According to TCM, this root falls into the category of substances that regulate the blood and the subcategory of substances that purge "heat" from the blood. Paeonia lactiflora acts as an ally in the treatment of liver diseases (source: https: / / florien.com.br / wD-content / uploads / 2018 / 02 / RADIX-PAEONIAE-LACTIFLQRAE.pdf).

[0056] Studies indicate its hepatoprotective action, significantly reducing the levels of the liver markers ALT and AST. Paeonia lactiflora can improve the immune system and reduce the levels of inflammatory mediators, in addition to suppressing the production of pro-inflammatory cytokines, such as TNF-a and IL-1. In animal models, it reduced induced edema and arthritis and reduced the synthesis of nitric oxide and prostaglandins from macrophages.

[0057] It is widely used in Asia as an anti-allergy agent, in the treatment of rheumatoid and autoimmune diseases, such as lupus, and to strengthen the immune system. This species is described as containing monoterpenes and monoterpene glycosides (such as paeoniflorin, albiflorin, oxipaeoniflorin), gallotannins, triterpenoids such as B-sitosterol, daucosterol, benzoic acid, and carbohydrates (source: Assessment report on Paeonia lactiflora Pallas, radix (Paeoniae radix alba) (europa.eu)). Radix paeonia rubra belongs to the category of heat-clearing and blood-cooling medicines, bitter in taste and has the function of clearing heat and cooling blood, as well as dispelling stasis to relieve pain (source: TAN, Yu-Qing et al. Efficacy, Chemical constituents, and pharmacological actions of Radix Paeoniae rubra and Radix Paeoniae Alba. Frontiers in Pharmacology, v. 11, p. 1054, 2020).

[0058] . The crude extract, fractions, and subtractions derived from R. paeonia were evaluated for antioxidant activity. The results demonstrated that gallic acid, (+) catechin, galloyl-paeoniflorin, and galloyl-oxypaeoniflorin were the main antioxidant constituents of this species (source: HUANG, Hai-lan; WANG, Guo-ming; XU, Bo. Study on Antioxidant Activity and Constituents of Radix Paeonia veitchii [J], Food Science, v. 7, 2007). The anti-inflammatory effects of the alcoholic extract of Radix paeonia alba were observed in two types of mouse models: xylene-induced ear edema and gar-induced chronic granuloma. The analgesic effects of the alcoholic extract of R. paeonia were observed in two types of mouse models: the classical writhing test caused by cold acetate and hot bath methods (source: XU, Juan; GUO, Hong-ke; PENG, Yan-juan.The Correlation Between PGE2 and the Anti-Inflammatory and Analgesic Effects of the Alcohol Extract from Radix Paeonia Alba. Journal of Chengdu Medical College, p. 06, 2014).

[0059] . 8. Rhizoma chuanxiong

[0060] . Rhizoma chuanxiong (Ligusticum chuanxiong HORT.) is a traditional Chinese medicinal herb commonly used for the treatment of cardiovascular diseases (source: LI, Song-Lin et al. Post-Harvest Alteration of the Main Chemical Ingredients in Ligusticum chuanxiong H ORT. (Rhizoma Chuanxiong). Chemical and Pharmaceutical Bulletin, v. 55, n. 1, p. 140-144, 2007 and YAN, Ru et al. Pharmacokinetics and metabolism of ligustilide, a major bioactive component in Rhizoma Chuanxiong, in the rat. Seven metabolites of ligustilide (major bioactive component of R. chuanxiong) were identified, and three of them were unequivocally characterized as butylidenophthalide, senkyunolide I, and senkyunolide H. These three compounds also occurred naturally in the herb and were reported to be bioactive.Chuanxiong, an herbal medicine derived from the root or rhizome of Rhizoma chuanxiong, has long been used in China to treat cardiovascular diseases, including coronary heart disease, hypertension, arrhythmia, heart failure, dilated cardiomyopathy, dyslipidemia, and myocarditis. The benefits of using Chuanxiong. are attributed to its vasodilation, anti-inflammatory, anticoagulant, free radical scavenging and microcirculatory effects (source: GUO, Ming; LIU, Yue; SHI, Dazhuo. Cardiovascular actions and therapeutic potential of tetramethylpyrazine (active component isolated from Rhizoma Chuanxiong): roles and mechanisms. BioMed Research International, v. 2016, 2016).

[0061] More than 30 compounds, with a variety of different structural types, have been isolated. Some of them fall into three main chemical groups: alkaloids, phenolic acids, and phthalides. Alkaloid-type compounds include tetramethylpyrazine (TMP), L-isobutyl-L-valine anhydride, and perlolyrin; phenolic acid-type compounds include ferulic acid, coniferylferulate, and chrysophanol; and phthalide-type compounds include Z-ligustilide, butylphthalide, 3-butylidenephthalide, senkyunolide A, and levistolide (source: GUO, Ming; LIU, Yue; SHI, Dazhuo). Cardiovascular actions and therapeutic potential of tetramethylpyrazine (active component isolated from Rhizoma Chuanxiong): roles and mechanisms. BioMed Research International, v. 10, n. 2, p.

[0062] . Phthalides are important bioactive constituents of two Traditional Chinese Medicine (TCM) prescriptions derived from Radix Angelica and Rhizoma Chuanxiong. In one study, the content of eight phthalides, including Z-ligustilide, E-ligustilide, Z-butylene phthalide, E-butylene phthalide, 3-butylphthalide, neocnidilide, and senkyunolide. Additionally, the inhibition activity of essential oils on uterine contraction was evaluated in an in vitro assay, and the results showed that the activity is greater the higher the content of phthalides, which demonstrated that these are possibly the main active components that inhibit uterine contraction in mice in vitro (source: TANG, Yuping et al. Identification and comparative quantification of bioactive phthalides in essential oils from si-wu-tang, fo-shou-san, radix angelica and rhizoma chuanxiong. Molecules, v. 15, n. 1, p. 341-351, 2010).

[0063] . 9. Radix platycodi

[0064] . Radix platycodi is the root of Platycodon grandiflorus, known in Traditional Chinese Medicine (TCM) as Jie Geng. It is Traditionally used to treat sore throats, hoarseness, and coughs for thousands of years in China, Japan, and Korea. According to TCM, the root falls into the category of substances that transform phlegm and stop coughing, and into the subcategory of substances that resolve phlegm. Its properties are bitter, pungent, and neutral, and the target meridian is the lung. The dried root has the function of opening the lungs, promoting the outflow of pus, softening abscesses, and benefiting the throat. Modern studies demonstrate its anti-allergic and anti-inflammatory properties. It is reported that it inhibits allergies caused by allergic mediators. The extract has a broad effect on the innate cellular response, as well as allergic inflammation (source: RADIX-PLATYCODI.pdf (florien.com.br)).

[0065] . The biological activities described for this species include anti-inflammatory, expectorant, antitussive, antipeptic ulcer activity, antihypercholesterolemic and antihyperlipidemic activity (source: WHO Monographs on Selected Medicinal Plants - Volume 1: Radix Platycodi (digicollection.org)).

[0066] . The main chemical constituents of Radix platycodi root are triterpene saponins based on the sapogenins platycodigenin and polygalacic acid; examples are platycodins A - 1 and polygalacins D and D2 (source: WHO Monographs on Selected Medicinal Plants - Volume 1 : Radix Platycodi (digicollection.org)).

[0067] A study was conducted to evaluate the effects and mechanism of Platycodi radix on obesity and insulin resistance (source: LEE, Chae Eun et al. Long-term consumption of Platycodi radix ameliorates obesity and insulin resistance via the activation of AMPK pathways. Evidence-Based Complementary and Alternative Medicine, v. 2012, 2012). Extracts of P. radix along with the flower were tested in cultured cells and administered to mice on a high-fat diet. In cells, P. radix activated AMPK / ACC phosphorylation in C2C12 myotubes, as well as suppressed adipocyte differentiation in 3T3-L1 cells. In experimental animals, it suppressed weight gain in obese mice and improved insulin resistance. obesity-induced insulin. It also reduced elevated circulating mediators, including triglyceride (TG), T-CHO, leptin, resistin, and monocyte chemotactic protein (MCP)-1 in obesity.

[0068] The effects of Platycodi Radix extracts (PRE) on house dust mite (Dematophagoides pteronyssius) extract-induced asthma were investigated. This study suggests that PRE may be useful as a therapeutic / preventive agent in allergic airway inflammation associated with HDM (source: LEE, Hwa-Young et al. Platycodi Radix and its active compounds ameliorate against house dust mite-induced allergic airway inflammation and ER stress and ROS by enhancing anti-oxidation. Food and Chemical Toxicology, v. 123, p. 412-423, 2019).

[0069] . An aqueous extract of Platycodi radix inhibited the hydrolysis of triolein emulsified with phosphatidylcholine by pancreatic lipase in vitro and reduced the elevation of rat plasma triacylglycerol levels 2-4 h after oral administration of a lipid emulsion containing corn oil. These preliminary results suggested that the aqueous extract of Platycodi radix may inhibit the intestinal absorption of dietary fat by inhibiting its hydrolysis (source: HAN, Li-Kun et al. Platycodi radix affects lipid metabolism in mice with high-fat diet-induced obesity. The Journal of Nutrition, v. 130, n. 11, p. 2760-2764, 2000).

[0070] . 10. Radix bupleuri

[0071] . As a traditional herbal medicine, Radix bupleuri has been widely used for the treatment of influenza, fever, inflammation, malaria, male disorders and hepatitis in China, Japan, Korea and other Asian countries.

[0072] . According to ancient Chinese medical literature, Radix bupleuri is able to regulate external and internal metabolism, dispersing malignant heat from the surfaces, calming the liver, and promoting yang and Qi (representing "vital energy" or "vital force" in Traditional Chinese Medicine theories) (source: YANG, Fude et al. Radix Bupleuri: a review of traditional uses, botany, phytochemistry, pharmacology, and toxicology. BioMed Research International, v. 2017, 2017).

[0073] In recent decades, research on R. bupleuri has focused on its biological activities, including anti-inflammatory, anticancer, antipyretic, antimicrobial, antiviral, and hepatoprotective properties, as well as immunomodulatory and neuroregulatory effects. Additionally, R. bupleuri has also exhibited significant effects on membrane fluidity.

[0074] These studies led to the isolation of essential oils, triterpenoid saponins, polyacetylenes, flavonoids, lignans, fatty acids, and sterols. Among these, triterpenoid saponins are known to be the main bioactive compounds.

[0075] . More than 100 different triterpenoid saponins have been isolated from R. bupleuri, among them saikosaponin A, saikosaponin D, saikosaponin B2, and are considered responsible for most of the pharmacological activities of R. bupleuri (source: YUAN, Bochuan et al. A systematic review of saikosaponins and active extracts isolated from Radix Bupleuri and their applications. Pharmaceutical Biology, v. 55, n. 4, p. 1126-1136). Saikosaponin A is one of the main bioactive compounds of R. bupleuri and has effects on obesity associated with a state of low-grade inflammation (source: KIM, Sung Ok et al. Saikosaponin A, an active compound of Radix Bupleuri, attenuates inflammation in hypertrophied 3T3-L1 adipocytes via ERK / NF-KB signaling pathways. International Journal of Molecular Medicine, v. 35, n. 4, p. 1126-1136). 132, 2015).

[0076] . 1 1 . Radix glycyrrhizae

[0077] Radix Glycyrrhizae is the rhizome of Glycyrrhiza uralensis Fisch., Glycyrrhiza inflata Bat., or Glycyrrhiza glabra L., and is widely distributed in northeastern and northwestern China (source: untitled (researchgate.net)). Among the functions attributed to this species are to tonify the spleen and replenish vital energy, to soothe the lungs and stop coughing, to relax spasms and stop pain, to moderate the action of herbs, and to reduce fire and release toxins. It is used to invigorate the functions of the heart and spleen, and to treat symptoms due to a deficiency of vital energy in these organs. as a spasmolytic and antitussive for peptic ulcers and cough; as an antiphlogistic for sore throats, boils, and carbuncles; and as an antioxidant for drug poisoning (source: SHEN, Xiu-Ping; XIAO, Pei-Gen; LIU, Chang-Xiao. Research and application of Radix Glycyrrhizae. Asian J. Pharmacodyn. Pharmacokinet, v. 7, p. 181-200, 2007).

[0078] . AR glycyrrhizae has as its chemical composition, sesquiterpene saponins, such as glycyrrhizin or glycyrrhizic acid; flavonoids (isoflavones, flavones); coumarins; triterpenoids; estrogenic substances, hormonal substance, similar to deoxycorticosterone, glucose, sucrose, gums, mannitol, resins, tannins and essence (traces) (source: ALCAÇUZ.pdf (florien.com.br)).

[0079] . As biological effects, it presents action on the central nervous system, antitumor activity, anti-inflammatory, anti-ulcer, antiviral, anti-allergic activity, effect on the endocrine system and cardiovascular system, among others49. Another activity elucidated was the anti-RSV (anti-respiratory syncytial virus) effect of R. glycyrrhizae in Hela cell culture through inhibition of the cytopathic effect (source: DONG, Yanmei et al. The anti-respiratory syncytial virus (RSV) effect of Radix Glycyrrhizae in vitro. Zhong yao cai = Zhongyaocai = Journal of Chinese Medicinal Materials, v. 27, n. 6, p. 425-427, 2004).

[0080] The pharmaceutical composition of the present invention may also comprise optional components such as talc, medicinal charcoal, maltose, among others.

[0081] . In a preferred embodiment, the present invention relates to a pharmaceutical composition comprising the 11 extracts mentioned above in a certain amount illustrated below. These amounts reflect two slightly different preferred formulas.

[0082] The present invention also relates to a medicament comprising said pharmaceutical composition. Preferably, this medicament is presented as a 350 mg capsule or a 170 mg pill.

[0083] . This medicine is especially indicated for the treatment of all types of herpes. It can also be indicated for the treatment of premenstrual tension.

[0084] . In a preferred embodiment of the present invention, the composition described herein is used to prepare a medicament for treating the symptoms of the herpes simplex virus (HSV) responsible for oral herpes (HSV-1), genital herpes (HSV-2), recurrent herpes and herpes zoster.

[0085] . The first types of herpes mentioned (HSV-1 and HSV-2) are highly contagious and can be transmitted through direct contact with an infected person or through contaminated objects.

[0086] . HSV-1 is commonly associated with oral herpes, causing sores around the mouth and on the lips, although it can also cause genital lesions through oral sex. HSV-2, in turn, is predominantly associated with genital herpes, causing lesions in the genital area, groin, and buttocks.

[0087] Symptoms of herpes include painful blisters, sores, or ulcers in the affected area, accompanied by burning, itching, or tingling sensations. These lesions may be accompanied by symptoms such as fever, headache, muscle pain, and swollen lymph nodes.

[0088] Shingles is caused by the varicella-zoster virus, the same virus that causes chickenpox. After an initial chickenpox infection, the virus remains dormant in the nerve ganglia. When reactivated, usually due to a decrease in immunity, the virus causes shingles. Symptoms include intense pain, tingling, itching, and a rash with red, fluid-filled blisters. These blisters usually appear on a unilateral strip of the body, following the path of an affected sensory nerve. In some cases, complications such as postherpetic neuralgia, which is persistent pain after the rash has disappeared, can occur.

[0089] . The disease can appear continuously, being called recurrent herpes, and is therefore serious and can lead to death, when it settles in the brain.

[0090] . The present composition comprises the following preferred embodiments:

[0091] Examples of two preferred embodiments of the pharmaceutical composition of the present invention

[0092] . The examples below should be read as illustrative and not limitative of the present invention:

[0093] . Formula 1

[0094] . Formula 2

[0095] . Protocol indicated for application of the drug of the present invention:

[0096] . 1 . Angelica & Platycodon formula (MTC): Take two 350 mg capsules three times a day.

[0097] 2. Xue Fu Zhu Yu Wan (Taimin): Take eight pills 3x daily. Eight pills = 1360 mg

[0098] . Having described an example of a preferred embodiment of the present invention, it should be understood that the scope of the present invention encompasses other possible variations of the inventive concept described, being limited only by the content of the appended claims, including possible equivalents.

Claims

CLAIMS 1. Pharmaceutical composition particularly indicated for the treatment of herpes, characterized by comprising: - Radix rehmanniae (tuber of the species Rehmannia glutinosa Libosch); - Radix paeonia or Radix paeonia rubra (root of Paeonia lactiflora Pali or P. veitchii Lynch, from the Ranunculaceae family); - Rhizoma chuanxiong (dry rhizome of Ligusticum chuanxiong Hort, family Umbelliferae); - Radix bupleuri (root of the perennial herb Bupleurum chinensis DC. or Bupleurum scorzonerifolium, from the Umbelliferae family); - Radix Glycyrrhizae (root and rhizome of the plant Glycyrrhiza uralensis Fisch, G. inflata Bat or L. glabra L, from the Leguminosae family).

2. Pharmaceutical composition according to claim 1, characterized by comprising the following quantities: - Radix rehmanniae in an amount ranging from 1% to 60% by mass; - Radix paeonia in an amount ranging from 1% to 60% by mass; - Rhizoma chuanxiong in an amount ranging from 1% to 60% by mass; - Radix bupleuri in an amount ranging from 1% to 60% by mass; - Radix Glycyrrhizae in an amount ranging from 1% to 60% by mass; All masses are based on the total mass of the composition.

3. Pharmaceutical composition according to claim 1 or 2, characterized by comprising Semen persicae (seed of Prunus persica) in an amount ranging from 1% to 60%, by mass, based on the total mass of the composition.

4. Pharmaceutical composition according to any of the claims 1 to 3 characterized by comprising Carthami fios (dried flower of Carthamus tinctorius) in an amount ranging from 1% to 60%, by mass, based on the total mass of the composition.

5. Pharmaceutical composition according to any one of claims 1 to 4, characterized in that it comprises Radix angelicae sinensis or Angelica sinensis radix (root of the species Angelica sinensis) in an amount ranging from 1% to 60%, by mass, based on the total mass of the composition.

6. Pharmaceutical composition according to any one of claims 1 to 5, characterized in that it comprises Radix achyranthis bidentatae (dried root of the species Achyranthes bidentata BI. and Cyathula officinalis Kuan, of the Amaranthaceae family) in an amount ranging from 1% to 60%, by mass, based on the total mass of the composition.

7. Pharmaceutical composition according to any one of claims 1 to 6, characterized in that it comprises Fructus aurantii or fructus aurantii immaturus (The immature fruit of Citrus aurantium L. or C. sinensis Osbeck, of the Rutaceae family) in an amount ranging from 1% to 60%, by mass, based on the total mass of the composition.

8. Pharmaceutical composition according to any one of claims 1 to 7, characterized in that it comprises Radix platycodi (dried root of Platycodon grandiflorum (Jacq.) A. DC., of the Campanulaceae family) in an amount ranging from 1% to 60%, by mass, based on the total mass of the composition.

9. Pharmaceutical composition according to any one of claims 1 to 8, characterized in that it comprises at least one optional component selected from talc, medicinal charcoal, maltose and a combination thereof.

10. Medication particularly indicated for the treatment of herpes, characterized by comprising a pharmaceutical composition as defined in any one of claims 1 to 9.

11. Medication according to claim 10, characterized in that it is presented as a 350 mg capsule or a 170 mg pill.

12. Use of a pharmaceutical composition as defined in any one of claims 1 to 9, characterized in that it is to prepare a medicament for treating herpes, including chronic or non-chronic herpes, herpes type 1, herpes type 2 and herpes zoster.

13. Use according to any one of claims 10 to 12, characterized in that the medication in capsule or pill form is administered three times a day.