COMPOSITION, METHODS OF MAKING AND USING FOR TREATING A VIRAL INFECTION, INCLUDING CORONAVIRUS INFECTION
20230127168 · 2023-04-27
Inventors
Cpc classification
A61K9/06
HUMAN NECESSITIES
A61K9/16
HUMAN NECESSITIES
A61K47/44
HUMAN NECESSITIES
A61K9/0095
HUMAN NECESSITIES
A61K2300/00
HUMAN NECESSITIES
A61K2300/00
HUMAN NECESSITIES
A61K36/736
HUMAN NECESSITIES
A61K36/736
HUMAN NECESSITIES
A61K9/0056
HUMAN NECESSITIES
A61K9/0014
HUMAN NECESSITIES
International classification
A61K36/736
HUMAN NECESSITIES
A61K47/44
HUMAN NECESSITIES
A61K9/00
HUMAN NECESSITIES
Abstract
A composition from Traditional Chinese Medicine (TCM) ingredients makes it possible to treat those infected with a virus, including, e.g., coronavirus or the flu, including but not limited to COVID-19 or Influenza A (“FluA”). Although makeable by other methods, the composition is makeable from a decoction of the TCM ingredients. Although usable for other purposes, the composition may be used to treat a patient in need of treatment for a virus, e.g., coronavirus infection, such as COVID-19 infection, or, e.g., the flu, such as FluA, by administering to the patient an effective amount of the composition.
Claims
1. A method of treating a patient in need of treatment for coronavirus infection, comprising administering to the patient an effective amount of the composition comprising, a decoction of a precursor composition comprising one or more ingredients chosen from: Lonicera japonica; Forsythia suspensa; Panax ginseng; Schizonepeta tenuifolia; Scrophularia ningpoensis; Prunus armeniaca; honeycomb; Gleditsia sinensis; and Glycyrrhiza uralensis.
2. The method of claim 1, wherein the coronavirus infection is a SARS-CoV infection.
3. The method of claim 1, wherein the coronavirus infection is from a SARS-CoV-2 infection.
4. The method of claim 1, wherein the coronavirus infection is from COVID-19.
5. The method of claim 1, wherein the composition comprises a decoction of a precursor composition comprising Lonicera japonica; Forsythia suspensa; Panax ginseng; Schizonepeta tenuifolia; Scrophularia ningpoensis; Prunus armeniaca; at least one honeycomb chosen from Polistes mandarinus Saussure, P. olivaceus, P. japonicus Saussure, and Parapolybia varia Fabricius; Gleditsia sinensis; and Glycyrrhiza uralensis; or a decoction of a precursor composition comprising the ingredients of composition #2 to 511 in table 1 (
6. The method of claim 5, wherein the composition is in the form of a powder or paste made from the decoction whose supernatant aqueous phase is separated from the nonsoluble part of the precursor composition and is at least partially evaporated.
7. The method of claim 6, wherein the supernatant aqueous phase is separated from the nonsoluble part of the precursor composition and is evaporated to dryness.
8. The method of claim 5, wherein the composition further comprises a pharmaceutically or dietary acceptable excipient.
9. The method of claim 8, wherein the pharmaceutically or dietary acceptable excipient is chosen from solvents, binders, lubricants, herbal carriers, oils and salts.
10. The method of claim 5, wherein the composition is in a form suitable for oral administration.
11. The method of claim 10, wherein the form suitable for oral administration is chosen from tablets, pellets, lozenges, granules, capsules, solutions, emulsions, and suspensions.
12. The method of claim 11, wherein the form suitable for oral administration is a dietary supplement.
13. A precursor composition, comprising Lonicera japonica; Forsythia suspensa; Panax ginseng; Schizonepeta tenuifolia; Scrophularia ningpoensis; Prunus armeniaca; honeycomb; Gleditsia sinensis; and Glycyrrhiza uralensis; or a precursor composition #2 to 511 in table 1 (
14. A composition in the form of a powder made from the decoction whose supernatant aqueous phase is separated from the nonsoluble part of the precursor composition of claim 13 and is at least partially evaporated to form a powder or paste.
15. A composition of claim 14, wherein the supernatant aqueous phase is separated from the nonsoluble part of the precursor composition and is evaporated to form a powder.
16. The composition of claim 13, wherein the composition further comprises a pharmaceutically or dietary acceptable excipient.
17. The composition of claim 16, wherein the pharmaceutically or dietary acceptable excipient is chosen from solvents, binders, lubricants, herbal carriers, oils and salts.
18. The composition of claim 13, wherein the composition is in a form suitable for oral administration.
19. The composition of claim 13, wherein the precursor composition comprises Lonicera japonica; Forsythia suspensa; Panax ginseng; Schizonepeta tenuifolia; Scrophularia ningpoensis; Prunus armeniaca; at least one honeycomb chosen from Polistes mandarinus Saussure, P. olivaceus, P. japonicus Saussure, and Parapolybia varia Fabricius; Gleditsia sinensis; and Glycyrrhiza uralensis; or the ingredients of composition #2 to 511 in table 1 (
20. (canceled)
Description
BRIEF DESCRIPTION OF THE DRAWINGS
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EMBODIMENTS
[0061] Reference will now be made in detail to embodiments, examples of test results for which are in the accompanying drawings.
[0062] As used herein, the word “exemplary” means “serving as an example, instance or illustration.” The embodiments described herein are not limiting, but rather are exemplary only. It should be understood that the described embodiments are not necessarily to be construed as preferred or advantageous over other embodiments. Moreover, the terms “embodiment(s) of the invention”, “embodiment(s)” or “invention” do not require that all embodiments of the invention include the discussed feature, advantage or mode of operation.
[0063] Some embodiments address the challenged functions of the body infected with various viruses and diseases, such as influenza and COVID-19, along with related corona viruses and other viruses, which are overwhelmed as the virus spreads from person to person and to different parts of the body, by providing the nutraceuticals that support the molecules. The embodiments may work to support the lungs, heart, immune system, and brain. The embodiments may also provide nutraceuticals elsewhere in the body to the end organs where the virus affects the body. By strengthening these core organs and systems within the body, the embodiments work to prevent the contraction or and mitigate the effects of influenza and COVID-19, along with related corona viruses and other viruses. The embodiments may adjust body functions, help restore balance in human body, and/or improve body immune functions by enabling itself to dispel pathogenic factors through perspiration, purgation and emetic therapy.
[0064] An embodiment includes a formulation of prevention and/or mitigation of influenza and COVID-19, along with related corona viruses and other viruses. The formulation may include herbs and other nutraceuticals. Exemplary herbs and nutraceuticals suitable for the composition include honeysuckle (1), Forsythia suspensa (2), suncured ginseng (3), schizonepeta (4), Scrophularia ningpoensis (5), apricot kernel (6), honeycomb (7), Gleditsia sinensis (8), and/or liquorice (9). The exemplary combination of herbs and nutraceuticals is based on supporting biological function and mechanism of interest in combatting contraction and symptoms of influenza and COVID-19, along with related corona viruses and other viruses, such as providing support to the lungs, brain, immune system, and heart.
[0065] Precursor Ingredients
[0066] A precursor composition comprises combinations of one or more ingredients selected from the following 9 TCM ingredients: Lonicera japonica (1); Forsythia suspensa (2); Panax ginseng (3); Schizonepeta tenuifolia (4); Scrophularia ningpoensis (5); Prunus armeniaca (6); Honeycomb (7); Gleditsia sinensis (8); and Glycyrrhiza uralensis (9).
[0067] In some embodiments, the precursor composition comprises the listed ingredients in
[0068] All these 9 ingredients and decoction thereof are available from vendors such as Shanghai Cai Tong De Pharmacy, China and others.
[0069] In some embodiments, the precursor composition comprises the combinations of TCM ingredients in Table 1 (
[0070] Lonicera japonica (#1) is sometimes called Jin Yin Hua or Lonicerae Japonicae Flos or honeysuckle flower. In some embodiments, Lonicera japonica (#1) makes use of dried flower buds. In some embodiments, the Lonicera japonica (#1) is Lonicera japonica Thunb.
[0071] Forsythia suspensa (#2) is sometimes called Lian Qiao or Forsythiae Fructus. Forsythia suspensa (#2) makes use of dried fruit. In some embodiments, Forsythia suspensa (#2) is Forsythia suspensa (Thunb.) Vahl.
[0072] Panax ginseng (#3) is sometimes called Ren Shen or Ginseng Radix et Rhizoma. Panax ginseng (#3), in some embodiments, makes use of dried root or rhizome. In some embodiments, the Panax ginseng (#3) is Panax ginseng C. A. Mey.
[0073] Schizonepeta tenuifolia (#4) is sometimes called Jing Jie or Schizonepetae Herba or Japanese Catnip. Schizonepeta tenuifolia (#4), in some embodiments, makes use of the stem or bud. In some embodiments, Schizonepeta tenuifolia (#4) is Schizonepeta tenuifolia Briq.
[0074] Scrophularia ningpoensis (#5) is sometimes called Xaun Shen or Scrophulariae Radix. Scrophularia ningpoensis (#5), in some embodiments, makes use of dried root or rhizome. In some embodiments, Scrophularia ningpoensis (#5) is Scrophularia ningpoensis Hemsl.
[0075] Prunus armeniaca (#6), sometimes called Ku Xing Ren or Armeniacae Semen Amarum or apricot kernel. Prunus armeniaca (#6), in some embodiments, makes use of ripe seed or kernel. In some embodiments, Prunus armeniaca (#6) is Prunus armeniacavar. ansu Maxim.
[0076] Honeycomb (#7), sometimes called Feng Fang or Vespae Nidus, is of wasp nests. In some embodiments, the honeycomb (#7) is chosen from those of Polistes mandarinus Saussure, P. olivaceus, P. japonicus Saussure, and Parapolybia varia Fabricius. In any embodiment, unless otherwise specified, the honeycomb is choosable from Polistes mandarinus Saussure, P. olivaceus, P. japonicus Saussure, and Parapolybia varia Fabricius.
[0077] Gleditsia sinensis (#8) is sometimes called Zao Jiao Ci or Gleditsiae Spina. Gleditsia sinensis (#8), in some embodiments, makes use of thorns. In some embodiments, the Gleditsia sinensis (#8) is Gleditsia sinensis Lam.
[0078] Glycyrrhiza uralensis (#9) is sometimes called Gan Cao or Glycyrrhizae Radix et Rhizoma or Licorice. Glycyrrhiza uralensis (#9), in some embodiments, makes use of dried root or rhizome. In some embodiments, the Glycyrrhiza uralensis (#9) is Glycyrrhiza uralensis Fisch.
[0079] In some embodiments, the precursor composition comprises one of TCM ingredients in Table 1 (
[0080] In some embodiments, the precursor composition comprises two of TCM ingredients in Table 1 (
[0081] In some embodiments, the precursor composition comprises three of TCM ingredients in Table 1 (
[0082] In some embodiments, the precursor composition comprises four of TCM ingredients in Table 1 (
[0083] In some embodiments, the precursor composition comprises five of TCM ingredients in Table 1 (
[0084] In some embodiments, the precursor composition comprises six of TCM ingredients in Table 1 (
[0085] In some embodiments, the precursor composition comprises seven of TCM ingredients in Table 1 (
[0086] In some embodiments, the precursor composition comprises eight of TCM ingredients in Table 1 (
[0087] In some embodiments, the precursor composition comprises ingredients #1, #2, and #4. In some embodiments, the precursor composition comprises ingredients #1, #2, and #4, and one, two or three ingredients from ingredients #3, #5, and #6. In some embodiments, the precursor composition comprises ingredients #1, #2, #3, and #4 or #1, #2, #3, #4, and #5 or #1, #2, #3, #4, and #6 or #1, #2, #4, and #5 or #1, #2, #4, #5, and #6 or #1, #2, #4, and #6.
[0088] In some embodiments, the precursor composition comprises two or more of the nine TCM ingredients present in an amount ranging from the lower amount to the higher amount in the following parts by weight in Table 2.
TABLE-US-00001 TABLE 2 Lonicera Forsythia Panax Schizonepeta Scrophularia Prunus Gleditsia Glycyrrhiza japonica suspensa ginseng tenuifolia ningpoensis armeniaca honeycomb sinensis uralensis Ingredient # 1 2 3 4 5 6 7 8 9 Lower 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 Higher 25.00 41.00 40.00 26.00 25.00 20.00 19.00 18.00 11.00
[0089] In some embodiments, the precursor composition comprises two or more of the nine TCM ingredients present in an amount ranging from the lower amount to the higher amount in the following parts by weight in Table 3.
TABLE-US-00002 TABLE 3 Lonicera Forsythia Panax Schizonepeta Scrophularia Prunus Gleditsia Glycyrrhiza japonica suspensa ginseng tenuifolia ningpoensis armeniaca honeycomb sinensis uralensis Ingredient # 1 2 3 4 5 6 7 8 9 Lower 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 Higher 5.00 19.00 20.00 4.00 5.00 1.00 1.50 2.00 1.00
[0090] In some embodiments, the precursor composition comprises two or more of the nine TCM ingredients, which if present, are present in an amount ranging from the lower amount to the higher amount in the following parts by weight in Table 4.
TABLE-US-00003 TABLE 4 Lonicera Forsythia Panax Schizonepeta Scrophularia Prunus Gleditsia Glycyrrhiza japonica suspensa ginseng tenuifolia ningpoensis armeniaca honeycomb sinensis uralensis Ingredient # 1 2 3 4 5 6 7 8 9 Lower 5.00 19.00 20.00 4.00 5.00 1.00 1.50 2.00 1.00 Higher 25.00 41.00 40.00 26.00 25.00 20.00 19.00 18.00 11.00
[0091] Making the Composition
[0092] In some embodiments, the composition comprises a decoction of the precursor composition. In some embodiments, the composition is in the form of a powder or paste made from the decoction whose supernatant aqueous phase was separated (from the residual part of the precursor composition) and was at least partially evaporated. In some embodiments, the composition is in the form of a powder made from the decoction whose supernatant aqueous phase was separated (from the residual part of the precursor composition) and was substantially or fully evaporated.
[0093] A method includes decocting the ingredients or the precursor composition. In some embodiments, the method includes combining the ingredients of the precursor composition and thereafter decocting the ingredients of the precursor composition.
[0094] In some embodiments, the precursor composition is boiled in an aqueous fluid optional comprising less than 50 v/v % an alcohol, such as ethanol, to form the composition. In some embodiments, the alcohol is present in the aqueous fluid at 0, 10, 20, 30, or 40% v/v %. In some embodiments, the aqueous fluid is water. In some embodiments, the precursor composition is boiled under pressure, that is, at a pressure that is 5-100% or 10-50% or 15-35% 760 mmHg. In some embodiments, the composition is in the form of a powder or paste made from the decoction whose supernatant aqueous phase was separated (from the residual part of the precursor composition) and was at least partially evaporated. In some embodiments, the composition is in the form of a powder made from the decoction whose supernatant aqueous phase was separated (from the residual part of the precursor composition) and was substantially or fully evaporated.
[0095] Composition
[0096] In some embodiments, the composition is made from a decoction of a precursor composition #1-511 in table 1 (
[0097] In some embodiments, the composition is made from a decoction of a precursor composition which comprises the listed ingredients in
[0098] In some embodiments, the composition is made from a decoction of a precursor composition which comprises the ingredients of precursor composition #1. In some embodiments, precursor composition #1 has ingredients present in a relative amount less than the maximum amount shown in table 2 or table 3. In some embodiments, precursor composition #1 has ingredients present in the relative amount shown in table 4. In some embodiments, the composition is in the form of a powder or powder made from the decoction whose supernatant aqueous phase was separated (from the residual part of the precursor composition) and was at least partially evaporated.
[0099] In some embodiments, the composition is made from a decoction of a precursor composition which comprises one of TCM ingredients in Table 1 (
[0100] In some embodiments, the composition is made from a decoction of a precursor composition which comprises the ingredients of precursor composition #128, 192, 224, 240, 248, 252, 254, 255, 320, 352, 368, 376, 380, 382, 383, 416, 432, 440, 444, 446, 447, 464, 472, 476, 478, 479, 488, 492, 494, 495, 500, 502, 503, 506, 507, or 509. In some embodiments, each of these precursor compositions has ingredients, which, if present, are present in the relative amount shown in table 2 or table 3 or table 4. In some embodiments, the composition is in the form of a powder or powder made from the decoction whose supernatant aqueous phase was separated (from the residual part of the precursor composition) and was at least partially evaporated.
[0101] In some embodiments, the composition is made from a decoction of a precursor composition which comprises the ingredients of precursor composition #64, 96, 112, 120, 124, 126, 127, 160, 176, 184, 188, 190, 191, 208, 216, 220, 222, 223, 232, 236, 238, 239, 244, 246, 247, 250, 251, 253, 288, 304, 312, 316, 318, 319, 336, 344, 348, 350, 351, 360, 364, 366, 367, 372, 374, 375, 378, 379, 381, 400, 408, 412, 414, 415, 424, 428, 430, 431, 436, 438, 439, 442, 443, 445, 456, 460, 462, 463, 468, 470, 471, 474, 475, 477, 484, 486, 487, 490, 491, 493, 498, 499, 501, or 505. In some embodiments, each of these precursor compositions has ingredients, which, if present, are present in the relative amount shown in table 2 or table 3 or table 4. In some embodiments, the composition is in the form of a powder or powder made from the decoction whose supernatant aqueous phase was separated (from the residual part of the precursor composition) and was at least partially evaporated.
[0102] In some embodiments, the composition is made from a decoction of a precursor composition which comprises the ingredients of precursor composition #32, 48, 56, 60, 62, 63, 80, 88, 92, 94, 95, 104, 108, 110, 111, 116, 118, 119, 122, 123, 125, 144, 152, 156, 158, 159, 168, 172, 174, 175, 180, 182, 183, 186, 187, 189, 200, 204, 206, 207, 212, 214, 215, 218, 219, 221, 228, 230, 231, 234, 235, 237, 242, 243, 245, 249, 272, 280, 284, 286, 287, 296, 300, 302, 303, 308, 310, 311, 314, 315, 317, 328, 332, 334, 335, 340, 342, 343, 346, 347, 349, 356, 358, 359, 362, 363, 365, 370, 371, 373, 377, 392, 396, 398, 399, 404, 406, 407, 410, 411, 413, 420, 422, 423, 426, 427, 429, 434, 435, 437, 441, 452, 454, 455, 458, 459, 461, 466, 467, 469, 473, 482, 483, 485, 489, or 497. In some embodiments, each of these precursor compositions has ingredients, which, if present, are present in the relative amount shown in table 2 or table 3 or table 4. In some embodiments, the composition is in the form of a powder or powder made from the decoction whose supernatant aqueous phase was separated (from the residual part of the precursor composition) and was at least partially evaporated.
[0103] In some embodiments, the composition is made from a decoction of a precursor composition which comprises the ingredients of precursor composition #16, 24, 28, 30, 31, 40, 44, 46, 47, 52, 54, 55, 58, 59, 61, 72, 76, 78, 79, 84, 86, 87, 90, 91, 93, 100, 102, 103, 106, 107, 109, 114, 115, 117, 121, 136, 140, 142, 143, 148, 150, 151, 154, 155, 157, 164, 166, 167, 170, 171, 173, 178, 179, 181, 185, 196, 198, 199, 202, 203, 205, 210, 211, 213, 217, 226, 227, 229, 233, 241, 264, 268, 270, 271, 276, 278, 279, 282, 283, 285, 292, 294, 295, 298, 299, 301, 306, 307, 309, 313, 324, 326, 327, 330, 331, 333, 338, 339, 341, 345, 354, 355, 357, 361, 369, 388, 390, 391, 394, 395, 397, 402, 403, 405, 409, 418, 419, 421, 425, 433, 450, 451, 453, 457, 465, or 481. In some embodiments, each of these precursor compositions has ingredients, which, if present, are present in the relative amount shown in table 2 or table 3 or table 4. In some embodiments, the composition is in the form of a powder or powder made from the decoction whose supernatant aqueous phase was separated (from the residual part of the precursor composition) and was at least partially evaporated.
[0104] In some embodiments, the composition is made from a decoction of a precursor composition which comprises the ingredients of precursor composition #8, 12, 14, 15, 20, 22, 23, 26, 27, 29, 36, 38, 39, 42, 43, 45, 50, 51, 53, 57, 68, 70, 71, 74, 75, 77, 82, 83, 85, 89, 98, 99, 101, 105, 113, 132, 134, 135, 138, 139, 141, 146, 147, 149, 153, 162, 163, 165, 169, 177, 194, 195, 197, 201, 209, 225, 260, 262, 263, 266, 267, 269, 274, 275, 277, 281, 290, 291, 293, 297, 305, 322, 323, 325, 329, 337, 353, 386, 387, 389, 393, 401, 417, or 449. In some embodiments, each of these precursor compositions has ingredients, which, if present, are present in the relative amount shown in table 2 or table 3 or table 4. In some embodiments, the composition is in the form of a powder or powder made from the decoction whose supernatant aqueous phase was separated (from the residual part of the precursor composition) and was at least partially evaporated.
[0105] In some embodiments, the composition is made from a decoction of a precursor composition which comprises the ingredients of precursor composition #4, 6, 7, 10, 11, 13, 18, 19, 21, 25, 34, 35, 37, 41, 49, 66, 67, 69, 73, 81, 97, 130, 131, 133, 137, 145, 161, 193, 258, 259, 261, 265, 273, 289, 321, or 385. In some embodiments, each of these precursor compositions has ingredients, which, if present, are present in the relative amount shown in table 2 or table 3 or table 4. In some embodiments, the composition is in the form of a powder or powder made from the decoction whose supernatant aqueous phase was separated (from the residual part of the precursor composition) and was at least partially evaporated.
[0106] In some embodiments, the composition is made from a decoction of a precursor composition which comprises the ingredients of precursor composition #2, 3, 5, 9, 17, 33, 65, 129, or 257. In some embodiments, each of these precursor compositions has ingredients, which, if present, are present in the relative amount shown in table 2 or table 3 or table 4. In some embodiments, the composition is in the form of a powder or powder made from the decoction whose supernatant aqueous phase was separated (from the residual part of the precursor composition) and was at least partially evaporated.
[0107] In some embodiments, the composition is made from a decoction of a precursor composition which comprises the ingredients of a precursor composition comprising ingredients #1, #2, and #4. In some embodiments, the composition is made from a decoction of a precursor composition which comprises the ingredients of a precursor composition comprising Ingredients #1, #2, and #4, and one, two or three ingredients from #3, #5, and #6. In some embodiments, the composition is made from a decoction of a precursor composition which comprises the ingredients of a precursor composition comprising Ingredients #1, #2, #3, and #4 or #1, #2, #3, #4, and #5 or #1, #2, #3, #4, and #6 or #1, #2, #4, and #5 or #1, #2, #4, #5, and #6 or #1, #2, #4, and #6. In some embodiments, each of these precursor compositions has ingredients, which, if present, are present in the relative amount shown in table 2 or table 3 or table 4. In some embodiments, the composition is in the form of a powder or powder made from the decoction whose supernatant aqueous phase was separated (from the residual part of the precursor composition) and was at least partially evaporated.
[0108] In some embodiments, the composition further comprises a pharmaceutically or dietary acceptable excipient. In some embodiments, the pharmaceutically or dietary acceptable excipient is chosen from solvents, binders, lubricants, herbal carriers, oils and salts.
[0109] In some embodiments, the composition comprises water, juice or glycerin. In some embodiments, the juice is elderberry juice, orange juice or apple juice. In some embodiments, the composition comprises water, elderberry juice, and glycerin.
[0110] In some embodiments, the composition is made from a decoction of a precursor composition which comprises the listed ingredients in
[0111] In some embodiments, the composition disclosed herein may be formulated in various dosage forms suitable for oral administration. In some embodiments, the composition is in the form chosen from tablets, pellets, lozenges, granules, capsules, solutions, emulsions, and suspensions. In some embodiments, the composition is in the form of a tablet, such as a 100-500 mg tablet. In some embodiments, the composition is in the form of a tincture. In some embodiments, the composition is in the form of a dietary supplement.
[0112] In some embodiments, the composition is in the form of a gel, emulsion, lotion or cream. In some embodiments, the composition is in the form of a gel, emulsion, or sprayable composition.
[0113] Treatment
[0114] Turning now to
[0115] In an exemplary embodiment, the formulation 100 may take the form of a beverage. The beverage could be consumed four ounces at a time. The formulation 100 may be consumed twice a day for 15 days. The formulation 100 may optionally be taken with or immediately before orange juice. The orange juice may improve absorption, and add a sweetness to the earthy flavor.
[0116] In another exemplary embodiment, the formulation may take the form of an anal suppository. The formulation may be inserted into the anus and absorbed into the blood vessels for rapid absorption into the body where it can aid the resistance to COVID-19.
[0117] In another exemplary embodiment, the formulation may be administered as a vapor or aerosol. The formulation may then be breathed in with normal airflow directly to the lungs. The vapor formulation may then provide support to the lungs directly in order to resist COVID-19.
[0118] In another exemplary embodiment, the formulation may be in a cream, ointment, oil, or other topical form. The formulation may be spread onto the skin where it is absorbed into the bloodstream to support the body's resistance to COVID-19. The formulation may optimally be rubbed near the lungs to provide faster access to the lungs for treatment and aid in resisting COVID-19.
[0119] Treatment of Coronavirus Infection
[0120] A method treats a patient in need of treatment for coronavirus infection by administering to the patient an effective amount of the composition disclosed herein. In some embodiments, the coronavirus infection is a SARS-CoV infection. In some embodiments, the coronavirus infection is from a SARS-CoV-2 infection. In some embodiments, the coronavirus infection is from COVID-19. In some embodiments, the patients are human.
[0121] As noted in the examples, experiments confirmed that RDS has anti-corona virus activity and determined RDS's anti-SARS-CoV activity or anti-SARS-CoV-2 activity and its half maximal inhibition dosage (IC.sub.50).
[0122] For experimental verification, RDS was be serially diluted into: 1, 1:2, 1:4, 1:8, 1:16, & 1:32 with cell culture medium (DMEM). Vero E6 (example 1) or A549(ACE2) (Example 2) cells were treated with RDS for 1 hour, and then infected with SARS-CoV (GFP) pseudovirus for 6 or 4 hours. Following infection, inhibition of viral replication was analyzed by flow cytometer for GFP expression, and IC.sub.50 values were determined.
[0123] In the examples, CoV-2-PIE™ from Virongy is a viral infection enhancer designed specifically to facilitate coronavirus and pseudovirus infection of target cells. CoV-2-PIE™ is designed to facilitate the infection of a variety of host cells by coronaviruses and pseudoviruses. CoV-2-PIE™ can enhance viral infection rates by 5 to 20-fold.
[0124] In the examples, SARS-CoV-GFP is a lentivirus-based pseudovirus carrying the S gene (Spike protein gene) of SARS-CoV virus. The pseudovirus infects cells as SARS-CoV, and uses the receptor ACE2 to infect cells. But inside the pseudovirus, the genome is a GFP reporter gene rather than the SARS-CoV genome. The pseudovirus can infect a cell as SARS-CoV but cannot replicate. Thus, it is commonly used for studying SARS-CoV virus entry without the need for a BL3 lab.
[0125] Currently, Virongy is selling SARS-CoV (GFP) virus for research use. The study was performed using Virongy's SARS-CoV (GFP) pseudovirus.
[0126] Treatment of Flu Infection
[0127] The composition may be used to treat a patient in need of treatment for a viral infection, e.g., the flu, including but not limited to Influenza A (“fluA”), by administering to the patient an effective amount of the composition. In some embodiments, the patients are human.
[0128] Disinfectant
[0129] The present composition makes it possible to clean and/or disinfect surfaces of animate and inanimate objects.
[0130] In some embodiments, the method of disinfecting an animate object includes applying an effective amount of the composition to a topical surface of an animate object. In some embodiments, the composition is in the form of a gel, emulsion, lotion or cream. In some embodiments, the animate object is a human. In some embodiments, the surface is skin. In some embodiments, the skin is on a human hand.
[0131] In some embodiments, the method of disinfecting an inanimate object includes applying an effective amount of the composition to a topical surface of an inanimate object. In some embodiments, the composition is in the form of a gel, emulsion, or a sprayable composition. In some embodiments, the inanimate object is chosen from tables, hard-backed chairs, doorknobs, light switches, phones, tablets, touch screens, remote controls, keyboards, handles, desks, toilets, and sinks. In some embodiments, the composition is applied to a surface of an inanimate object. In some embodiments, the inanimate object is in a household setting. In some embodiments, the inanimate object is in an industrial or business setting. In some embodiments, the inanimate object is in a medical setting.
Example 1
[0132] A composition (“RDS”) is a decoction of Lonicera japonica; Forsythia suspensa; Panax ginseng; Schizonepeta tenuifolia; Scrophularia ningpoensis; Prunus armeniaca; honeycomb; Gleditsia sinensis; and Glycyrrhiza uralensis. See
Example 2
[0133] The following steps were performed to generate data in
[0134] 1) Seeding 1×10.sup.5 Vero-E6 cells per well in a 12-well cell culture plates in 1 ml culture medium. Grow cell overnight at 37° C.
[0135] 2) The next day, move medium from each well of the 12 well plate. Add 300 μl fresh culture medium,
[0136] 3) Add 30 μl diluted RDS to treat cells for 30 minutes at 37° C.
[0137] RDS dilution [0138] A—NO dilution [0139] B—1:1 dilution, take 1 ml A+1 ml culture medium [0140] C—1:2 dilution, take 1 ml B+1 ml culture medium [0141] D—1:4 dilution, take 1 ml C+1 ml culture medium [0142] E—1:8 dilution, take 1 ml D+1 ml culture medium [0143] F—1:16 dilution, take 1 ml E+1 ml culture medium
[0144] 4) Add 33 ul Virongy CoV-2-PIE™ (Described above) to treat cells for other 30 minutes at 37° C.
[0145] 5) Add 100 μl 60× concentrated SARS-CoV (GFP) virus, add 10% (V/V) Virongy CoV-2-PIE™.
[0146] 6) Incubate for 4 hours.
[0147] 7) Add 1 ml fresh culture medium with RDS added in concentration as listed above.
[0148] 8) Analyze cellular GFP expression by flow cytometry at 48 hours post infection.
[0149]
[0150] Conclusion: RDS inhibits SARS-CoV (GFP) viral infection of VeroE6 cells with a IC.sub.50 around 1:160 diluted concentration.
Example 3
[0151] The following steps were performed to generate data in
[0152] 1) Seeding 1×10.sup.5 A549(ACE2) cells per well in a 12-well cell culture plates in 1 ml culture medium. Grow cell overnight at 37° C.
[0153] 2) The next day, move medium from each well of the 12 well plate. Add 300 μl fresh culture medium.
[0154] 3) Add 30 μl diluted RDS to treat cells for 30 minutes at 37° C.
[0155] RDS dilution [0156] A—NO dilution [0157] B—1:1 dilution, take 1 ml A+1 ml culture medium [0158] C—1:2 dilution, take 1 ml B+1 ml culture medium [0159] D—1:4 dilution, take 1 ml C+1 ml culture medium [0160] E—1:8 dilution, take 1 ml D+1 ml culture medium [0161] F— 1:16 dilution, take 1 ml E+1 ml culture medium
[0162] 4) Add 33 ul Virongy CoV-2-PIE™ to treat cells for other 30 minutes at 37° C.
[0163] 5) Add 100 μl 60× concentrated SARS-CoV (GFP) virus, add 10% (V/V) CoV-2-PIE™.
[0164] 6) Incubate for 4 hours.
[0165] 7) After infection, cells were washed twice to remove virus and RDS.
[0166] 8) Add 1 ml fresh culture medium without RDS, culture for 48 hours
[0167] 9) Analyze cellular GFP expression by flow cytometry at 48 hours post infection.
[0168]
[0169] Conclusion: RDS inhibits SARS-CoV (GFP) viral infection of A549 (ACE2) cells with a IC.sub.50 around 1:80 diluted concentration.
Example 3
[0170] The composition of Example 1 was studied for the anti-SARS-CoV-2 activity.
SUMMARY
[0171] The study tested the anti-SARS-CoV-2 activity in the composition of Example 1, (RDS (Respiratory Detox Support)), using VIRONGY LLC's SARS-CoV-2 S protein pseudotyped GFP and luciferase reporter lentiviruses. The target cells were Vero E6 and ACE2-expressing A549 cell (human lung epithelia cell). Experiments tested and quantified the anti-SARS-CoV-2 activity of RDS, and found that RDS possesses anti-SARS-CoV-2 activity. It was discovered that:
[0172] RDS possesses anti-SARS-CoV-2 activity. The IC.sub.50 (50% virus inhibition dosage) of RDS was determined to be at 1:230-fold dilution for the inhibition of viral infection of Vero E6 cells.
[0173] RDS inhibited over 90% SARS-CoV-2 viral entry into Vero E6 cells at 1:40 dilution.
[0174] Mechanistic studies using SARS-CoV-2 pseudovirus infection of A549(ACE2) cells further confirmed that RDS blocked SARS-CoV S protein-mediated viral entry into ACE2+ target cells.
[0175] Introduction
[0176] Experiments determined whether RDS has anti-coronavirus activity and quantified its antiviral potency. For the experiments, RDS was serially diluted, and then used to treat Vero E6 or A549(ACE2) target cells to block SARS-CoV-2 pseudovirus infection. Inhibition of viral transduction and viral entry were analyzed using reporter GFP (green fluorescent protein) or Luc (luciferase) expression. The IC.sub.50 inhibition dosage was also determined.
[0177] Materials and Methods
[0178] Viruses: SARS-CoV-2(GFP) and SARS-CoV-2(Luc) reporter pseudoviruses were assembled by VIRONGY LLC using in-house lentiviral assembly system. The infectivity was quantified by infecting in-house A549(ACE2) cells.
[0179] Cell culture medium: Cells were maintained in Dulbecco-modified Eagle's medium (DMEM) (Invitrogen) containing 10% heat-inactivated FBS and 1× penicillin-streptomycin (Invitrogen).
[0180] luciferase assay: Cells were lysed using Luciferase Assay Lysis Buffer (Promega) Luminescence was measured by using GloMax® Discover Microplate Reader (Promega).
Experimental Procedure
[0181] A. Quantification of the Anti-Viral Activity of RDS Using SARS-CoV-2(Luc) Pseudovirus
[0182] Seeded were 1×10.sup.5 Vero E6 cells per well in 12-well cell culture plates in 1 ml culture medium. Grown were cells overnight at 37° C.
[0183] The next day, the medium was removed from each well of the 12 well plates. 300 μl of fresh were added to each well of the 12-well plate.
[0184] 30 μl of diluted RDS were added to the culture medium to treat cells for 30 minutes at 37° C.
[0185] RDS dilution
[0186] A—NO dilution
[0187] B—1:1 dilution, take 1 ml A+1 ml culture medium
[0188] C—1:2 dilution, take 1 ml B+1 ml culture medium
[0189] D—1:4 dilution, take 1 ml C+1 ml culture medium
[0190] E—1:8 dilution, take 1 ml D+1 ml culture medium
[0191] F—1:16 dilution, take 1 ml E+1 ml culture medium
[0192] G—1:32 dilution, take 1 ml F+1 ml culture medium
[0193] 33 μl of VIRONGY brand CoV-2-PIE were added to the medium to treat cells for another 30 minutes at 37° C.
[0194] 100 μl of concentrated SARS-CoV-2(Luc) virus were added to the medium, and then 10% (V/V) of CoV-2-PIE were added to the medium.
[0195] Cells were infected for 6 hours.
[0196] After infection, cells were washed twice to remove virus and RDS.
[0197] 1 ml of fresh culture medium without RDS were added, and the resultant medium was cultured for 72 hours.
[0198] Luc expression was analyzed by luciferase assay at 72 hours post infection.
Results
[0199] As shown in
Results
[0200] As shown in
[0201]
[0202] B. Testing Effects of RDS on the Entry of SARS-CoV-2(GFP) Pseudovirus
[0203] Seeded were 1×10.sup.5 A549(ACE2) cells per well in 12-well cell culture plates in 1 ml culture medium. Grown were cells overnight at 37° C.
[0204] The next day, the medium was removed from each well of the 12 well plates. The removed medium was added to 300 μl fresh culture medium.
[0205] 30 μl of diluted RDS were added to treat cells for 30 minutes at 37° C.
[0206] RDS dilution
[0207] A—NO dilution
[0208] B—1:1 dilution, take 1 ml A+1 ml culture medium
[0209] C—1:2 dilution, take 1 ml B+1 ml culture medium
[0210] D—1:4 dilution, take 1 ml C+1 ml culture medium
[0211] E—1:8 dilution, take 1 ml D+1 ml culture medium
[0212] F—1:16 dilution, take 1 ml E+1 ml culture medium
[0213] G—1:32 dilution, take 1 ml F+1 ml culture medium
[0214] 100 μl of concentrated SARS-CoV-2(GFP) virus were added to the medium.
[0215] The medium was incubated for 6 hours.
[0216] After infection, cells were washed twice to remove virus and RDS.
[0217] 1 ml of fresh culture medium without RDS were added and then cultured for 48 hours.
[0218] Cellular GFP expression was analyzed by flow cytometry at 48 hours post infection.
Results
[0219] As shown in
Example 4
[0220] The Study of the Anti-Flu a Virus Activity of RDS
SUMMARY
[0221] The effects of RDS for the inhibition of FluA virus infection of MDCK cells were tested. Infectious FluA (GFP) reporter virus was assembled and used to infect MDCK cells in the presence or absence of RDS (composition of example 1), which were serially diluted (1:10, 1:20, 1:40, 1:80, 1:160, 1:320). Inhibition of viral infection was quantified at 36 hours post infection using flow cytometry. To monitor cytotoxicity of RDS, propidium iodide (PI) was added to stain for dead cells. GFP+ cells were analyzed only in live cell population to exclude non-specific cytotoxic effects. This experiment demonstrated that RDS completely blocked viral infection at dilutions from 1:10 to 1:80, and partially inhibited FluA at 1:160 and 1:320 dilution.
[0222] Introduction
[0223] This experiment determined whether RDS has anti-Flu A activity and quantified its antiviral potency. For the experiments, RDS was serially diluted, and then used to treat MDCK cells to block Flu A infection. Inhibition of viral infection were analyzed using reporter GFP (green fluorescent protein).
[0224] Materials and Methods
[0225] Viruses: Flu A(GFP) reporter virus were assembled by Virongy LLC. The infectivity was quantified by infecting human MDCK cells.
[0226] Cell culture medium: Cells were maintained in Dulbecco-modified Eagle's medium (DMEM) (Invitrogen) containing 10% heat-inactivated FBS and 1× penicillin-streptomycin (Invitrogen).
Experimental Procedure
[0227] Quantification of the Anti-Viral Activity of RDS Using FluA (GFP) Reporter Virus
[0228] Seeded were 1×10.sup.5 MECK cells per well in 12-well cell culture plates in 1 ml culture medium. Grown were cells overnight at 37° C.
[0229] The next day, the medium was removed from each well of the 12 well plates. 300 μl of fresh culture medium were added to each well of the 12-well plate.
[0230] 30 μl of diluted RDS were added to the medium to treat cells for 30 minutes at 37° C.
[0231] RDS dilution
[0232] A—NO dilution
[0233] B—1:1 dilution, take 1 ml A+1 ml culture medium
[0234] C—1:2 dilution, take 1 ml B+1 ml culture medium
[0235] D—1:4 dilution, take 1 ml C+1 ml culture medium
[0236] E—1:8 dilution, take 1 ml D+1 ml culture medium
[0237] F—1:16 dilution, take 1 ml E+1 ml culture medium
[0238] G—1:32 dilution, take 1 ml F+1 ml culture medium
[0239] 500 μl of FluA (GFP) virus were added to the medium, and then 10% (V/V) RDS were added to the medium.
[0240] The cells were infected for 6 hours.
[0241] After infection, the supernatant was removed.
[0242] 1 ml of fresh culture medium with RDS were added to the removed medium and then cultured for 36 hours.
[0243] GFP expression was analyzed at 36 hours post infection by flow cytometer.
Results
[0244] As shown in
Example 5
[0245] Precursor compositions A-N comprises two or more of the nine TCM ingredients present in an amount shown in the row of the examples in the following parts by weight in Table 5.
TABLE-US-00004 TABLE 5 Polistes Lonicera Forsythia Panax Schizonepeta Scrophularia Prunus mandarinus Gleditsia Glycyrrhiza japonica suspensa ginseng tenuifolia ningpoensis armeniaca Saussure sinensis uralensis Ingredient # 1 2 3 4 5 6 7 8 9 Ex. A 11.00 25.00 37.00 5.00 7.50 1.10 16.50 3.00 1.80 Ex. B 40.00 32.00 23.00 20.00 18.00 15.00 3.00 1.00 Ex. C 19.00 21.00 24.00 9.00 19.00 18.60 2.20 2.80 Ex. D 10.00 20.00 20.00 20.00 2.90 3.90 18.00 10.00 Ex. E 14.00 24.00 34.00 20.00 19.00 18.00 14.00 10.00 Ex. F 5.00 20.00 20.00 20.00 20.00 4.00 2.50 8.00 Ex G 7.00 38.00 40.00 4.50 10.00 18.00 17.00 2.00 Ex. H 23.00 19.00 20.00 5.50 14.50 19.00 3.00 2.40 Ex. I 5.00 41.00 23.00 25.00 25.00 2.00 4.00 2.00 Ex. J 23.50 20.00 38.00 5.00 5.00 1.00 1.50 15.00 Ex. K 10.00 21.00 31.00 21.00 22.00 19.00 10.00 Ex. L 35.00 20.00 20.00 7.00 3.00 10.00 Ex. M 19.00 20.00 25.00 10.00 8.50 Ex. N 40.00 20.00 30.00 20.00
[0246] Precursor Exs. A-N are added to cold water (5-12 times the weight of the precursor composition and boiled for 60-90 minutes at room pressure and filtered after boiling. The separated aqueous phases from Exs. A-N are optionally concentrated by evaporation to a paste or power. The decoctions from Exs. A-N or paste or power are useable for administration and for further formulation into disinfectants.
[0247] Other embodiments will be apparent to those skilled in the art from consideration of the specification and practice of the present description. It is intended that the specification and examples be considered as exemplary only.