阅读说明：本技术 用于治疗心血管疾病的草药-矿物质制剂及其制备方法 (Herbal-mineral formulation for treating cardiovascular disease and method for preparing the same ) 是由 M·V·谢蒂 于 2018-02-27 设计创作，主要内容包括：本文公开用于治疗心血管疾病的草药-矿物质制剂及其制备方法。公开的草药-矿物质制剂包含有助于治疗心血管疾病的草药和矿物质组分。心血管疾病可包括与心脏和血管相关的任何病症。此外,公开的制剂还可以用作抗氧化、抗应激、降血脂、致动脉粥样硬化、抗高血压、抑制凋亡和心脏保护剂。(Disclosed herein are herbal-mineral formulations for the treatment of cardiovascular diseases and methods for their preparation. The disclosed herbal-mineral formulation contains herbal and mineral components that are useful in treating cardiovascular disease. Cardiovascular disease may include any condition associated with the heart and blood vessels. In addition, the disclosed formulations may also be used as antioxidant, anti-stress, hypolipidemic, atherogenic, antihypertensive, apoptosis-inhibiting and cardioprotective agents.)

1. A formulation for the treatment and management of cardiovascular disease comprising:

herbal ingredients including Terminalia arjuna, Sida romboilia, Withania somnifera, Tinospora cordifolia, punica granatum, Phyllanthus emblica and Commiphora myrrha, or extracts thereof; and

mineral components including Ganoderma sinense and bhasma.

2. The formulation of claim 1, wherein Terminalia arjuna is present in an amount of 8 to 12 wt.%, Sidaromabilia is present in an amount of 2 to 6 wt.%, Withania somnifera is present in an amount of 2 to 6 wt.%, Tinospora cordifolia is present in an amount of 2 to 6 wt.%, pomegranate is present in an amount of 2 to 6 wt.%, Phyllanthus emblica is present in an amount of 2 to 6 wt.%, and Commiphora indica is present in an amount of 2 to 6 wt.%.

3. The formulation of claim 1, wherein the herbal component further comprises at least one herbal selected from the group consisting of: embelia obovata, madder, nardostachys chinensis, myrobalan, terminalia rubra, piper longum, black pepper, ginger, Boerhavia diffusa, bamboo nectar, Madhuka indica, neem, picrorhiza rhizome, holy basil, Steriospermum suaveolens, premna crenata, catalpa ovata, aegle marmelo, oroxylum indicum, Desmodium gangeticum, rabbit tailed grass, burbergia, solanum xanthocarpum and tribulus terrestris, or extracts thereof.

4. The formulation of claim 3, wherein the herbs are present in an amount of 4% by weight or less.

5. The formulation of claim 1, wherein the mineral component comprises at least one bhasma selected from the group consisting of: muktasukti bhasma, Loha bhasma, Abhraka bhasma, Swarnamaksikahasma, and Pravala bhasma.

6. The formulation of claim 1, wherein the crabapple is present in an amount of 1 to 3% by weight.

7. The formulation of claim 5, wherein Muktasukti bhasma is present in an amount of 2 wt.% or less, Lohabhasma is present in an amount of 2 wt.% or less, Abhraka bhasma is present in an amount of 3 wt.% or less, Swarnamaksika bhasma is present in an amount of 2 wt.% or less, and Pravala bhasma is present in an amount of 2 wt.% or less.

8. The formulation according to claim 1, further comprising a suitable excipient, preferably gum arabic.

9. The formulation of claim 1, wherein the formulation is in the form of a powder.

10. The formulation of claim 1, wherein the formulation is in the form of a tablet.

11. The formulation of claim 10, wherein the tablet is in the form of a 500mg tablet.

12. Use of the formulation according to claim 1 for the preparation of a medicament for the treatment and prevention of cardiovascular diseases.

13. Use of a formulation according to claim 1 in the manufacture of a medicament for reducing the risk of cardiovascular disease.

14. A method of making the formulation of claim 1, comprising:

grinding bhasmas and Leisha mellea;

adding fine powder of herbal materials; and

the grind broth is added while grinding is continued to obtain a ground substance.

15. The method of preparing a formulation according to claim 14, wherein the bhasmas is at least one selected from the group consisting of: muktasukti bhasma, Loha bhasma, Abhraka bhasma, Swarnamaksika bhasma, and Pravala bhasma.

16. The method of preparing a formulation as claimed in claim 14, wherein the fine powdered herbal medicine comprises the following fine powdered forms: terminalia arjuna (bark of trunk), Sida romboilia (dry root), Withania somnifera (dry root), Rubia cordifolia (dry root), Nardostachys chinensis (dry root), Boerhavia diffusa (dry root), picrorhiza kurroa (dry root), Steriospermum suaveolens (dry root), Premnamuronata (dry root), Stauntonia chinensis (dry root), Aesculus mukoreana (dry root), Mucuna cunculus (dry root), Mucuna cuneata (dry root), Pedunculus indicus (dry root), Pepper (dry fruit), Tribulus terrestris (dry root), Pedunculus albus (dry bark), Solanum indicum (dry plant), Rabdosia japonica (dry plant), Desmodium gangeticum (dry plant), Arctium cordifolia (dry stem), Punica acuta (dry fruit), ginger (dry root, dhkava (dry root), Phyllostachys nigra (dry fruit), Myrrh (dry fruit), and gum.

17. The method of preparing a formulation according to claim 14, wherein the grinding decoction is a decoction of at least one herb selected from the group consisting of: terminalia arjuna, Asparagus racemosus, Ferula asafoetida, Cuminum cyminum, Mirabilis rhododendron, Montana balm, Ocimum sanctum, Aloe vera, Plantago asiatica, Steriospermum suaveolens, Premna mcronata, Pyrola ovata, Aegle marmelos, oroxylum indicum, Desmodium gingetium, Dolabella asiatica, Solanum indicum, Solanum xanthocarpum and Tribulus terrestris.

18. A method of reducing the risk of cardiovascular disease comprising administering a therapeutically effective amount of the formulation of claim 1.

19. A method of treating and preventing cardiovascular disease comprising administering a therapeutically effective amount of the formulation of claim 1.

20. The method for the treatment and prevention of cardiovascular diseases according to claim 19, wherein said formulation is administered preferably at a dose of 500mg tablets twice daily.

21. A method of treating and preventing cardiovascular disease comprising administering a therapeutically effective amount of the formulation of claim 1.

22. The method of treating and preventing cardiovascular disease of claim 19, wherein the therapeutically effective amount is 500 to 1000mg administered one to three times daily.

23. The method of treating/preventing cardiovascular disease according to claim 19, wherein the formulation is administered with the administration of at least one other agent that treats cardiovascular disease.

Technical Field

Embodiments disclosed in the present specification relate to herbal-mineral formulations effective in the treatment and prevention of cardiovascular and related complications. It also relates to a process for the preparation of such a formulation.

Background

Cardiovascular disease (CVD) has been observed to be one of the leading causes of death worldwide. It is a group of diseases related to the heart and blood vessels. It includes coronary artery disease, cardiovascular disease, hypertensive heart disease, peripheral artery disease, etc.

Atherosclerosis is a condition of accumulation in arteries and is the leading cause of CVD. Risk factors for CVD include high blood pressure, hypertension, stress, hyperlipidemia, diabetes, lack of physical activity, obesity, and the like. These are risk factors that may be adjusted to prevent CVD. There are other unsupervised risk factors such as age, gender, family history, etc.

Most CVD can be prevented by mitigating established risk factors. The implementation of certain lifestyle changes, such as maintaining a healthy diet, limited drinking, smoking cessation, reducing sugar consumption, stress management, etc., may prove helpful in reducing the risk of developing CVD. However, if lifestyle changes prove insufficient to prevent CVD, medication or medical procedures may be required.

As one of the leading causes of death worldwide, extensive research has been conducted to develop drugs capable of treating CVD. Modern medicine provides a wide range of drugs for this purpose. The treatment of these drugs depends on the type of CVD. Various types of drugs include ACE inhibitors, antiarrhythmics, angiotensin II receptor blockers, calcium channel blockers, digoxin, diuretics, nitrates, and the like. However, managing CVD can be a lifelong endeavor and may require the use of large amounts of drugs. When used extensively, antagonistic interventions often have adverse or adverse side effects.

Alternatively, ayurvedic intervention is also known in the treatment of cardiovascular diseases. Based on an understanding of the healing properties of various herbs, a number of herbal formulations have been developed. However, the effectiveness of such formulations is controversial. There is a need for an effective method of treating/managing cardiovascular disease.

Summary of The Invention

It is a primary object of embodiments disclosed herein to provide compositions and methods for treating cardiovascular disease.

It is a second object of embodiments disclosed herein to provide compositions and methods for preventing cardiovascular disease.

It is another object of embodiments disclosed herein to provide an herbal-mineral formulation and a method of making the same.

These and other objects of the embodiments herein will be better understood and appreciated when considered in conjunction with the following description and the accompanying drawings. It should be understood, however, that the following description, while indicating preferred embodiments and numerous specific details thereof, is given by way of illustration and not of limitation. Many changes and modifications may be made within the scope of the embodiments herein without departing from the spirit thereof, and the embodiments herein include all such modifications.

Brief Description of Drawings

Embodiments disclosed herein are illustrated in the accompanying drawings, in which like reference numerals refer to corresponding parts throughout the various views. The embodiments herein will be better understood from the following description with reference to the accompanying drawings, in which:

FIG. 1(a) depicts a scheme for the preparation of Swarna Makshika Bhasma;

FIG. 1(b) depicts a flow diagram for the preparation of Abhraka Bhasma;

FIG. 1(c) depicts a scheme for the preparation of Loha Bhasma;

FIG. 1(d) depicts a scheme for the preparation of Mukta sukti Bhasma;

FIG. 1(e) depicts a scheme for the preparation of Pravala Bhasma;

FIG. 2 depicts a flow chart for the preparation of a fortified tablet;

FIG. 3 depicts the effect of test drugs on CK-MB activity;

FIG. 4 depicts the effect of test drugs on Na + K + ATPase;

FIG. 5 depicts the effect of test drugs on Mg2+ ATPase;

FIG. 6 depicts the effect of test drugs on Ca2+ ATPase;

FIG. 7 depicts the effect of test drugs on lipid peroxide content;

FIG. 8 depicts the effect of test drugs on superoxide dismutase activity;

figure 9 depicts the effect of test drugs on GSH activity;

figure 10 depicts the effect of test drugs on GPX activity;

FIG. 11 depicts the effect of test drugs on apoptosis markers;

FIG. 12 depicts the effect of systolic blood pressure of a test drug; and

fig. 13 depicts testing the effect of diastolic blood pressure of a drug according to embodiments disclosed herein.

Detailed Description

The embodiments herein and the various features and advantageous details thereof are explained more fully with reference to the non-limiting embodiments that are illustrated in the accompanying drawings and detailed in the following description. Descriptions of well-known components and processing techniques are omitted so as to not unnecessarily obscure the embodiments herein. The examples used herein are intended merely to facilitate an understanding of ways in which the embodiments herein may be practiced and to further enable those of skill in the art to practice the embodiments herein. Accordingly, these examples should not be construed as limiting the scope of the embodiments herein.

Embodiments herein enable an herbal-mineral formulation having therapeutic value, and a method of making the formulation. The herbal-mineral formulation disclosed herein is useful for the treatment and prevention of cardiovascular diseases and complications associated with the cardiovascular system. In various embodiments herein, cardiovascular disease may include any condition associated with the heart and blood vessels, such as cardiac arrhythmias, ischemic heart disease, coronary artery disease, valve defects, and the like. Furthermore, complications associated with the cardiovascular system may be any condition commonly known to be associated with or considered a risk factor for CVD, including hypertension, elevated blood glucose, hyperlipidemia, and the like. The disclosed formulations are also useful as antioxidant, anti-stress, hypolipidemic, atherogenic, antihypertensive, apoptosis-inhibiting and cardioprotective agents. Thus, embodiments disclosed herein enable methods of treating/preventing cardiovascular disease. Also disclosed are embodiments of a method of reducing the risk of cardiovascular disease.

Preparation

Embodiments disclosed herein provide an herbal-mineral formulation having herbs and minerals. In embodiments, the herbal-mineral formulation comprises an herbal component and a mineral component. In further embodiments, the herbal-mineral formulation comprises an herbal component, a mineral component, and a suitable excipient.

Herbal components

In embodiments, the herbal components include the following herbs: terminalia arjuna, Sida romboilia, Withania somnifera, Tinospora cordifolia, punica granatum, embelia chebula, Rubia cordifolia, Nardostachys jatamansi, Emblica officinalis, Terminalia chebula, Terminalia glauca, Piper longum, Piper nigrum, Zingiber officinale, Borahavira diffusa, Phyllanthus urinaria, Madhuka indica, Neem, picrorhiza kurroa, Ocimum sanctum, Myrrh, oroxylum indicum, Desmodium ganticum, Leptospermum, Hibiscus spinosa and Solanum xanthocarpum, or extracts thereof, or effective ingredients extracted from these herbs.

In embodiments, the herbal component may include the herbal as a whole, or may include specific portions of the herbal, such as roots, fruits, stems, leaves, rhizomes, and the like. In an embodiment, the herbal composition comprises the bark of the Terminalia arjuna; sidarombifolia root, withania, madder, nardostachys chinensis, Boerhavia diffusa, picrorhiza kurroa, Steriospermumuaveolens, Premna mcronata, catalpa ovata, aegle marmelo, oroxylum indicum, and Kandelia candel; fruit of Conus Conomonus, fructus Phyllanthi, fructus Chebulae, fruit tree of Terminalia sericea, fructus Piperis Longi, fructus Piperis Nigri, and fructus Tribuli; bark of neem; solanum xanthocarpum, Rabdosia rabbit, Desmodium gangeticum; stem of tinospora cordifolia; pomegranate rind; rhizomes of ginger; secretion of bamboo nectar; madhuka indica flowers; gum resin of holy basil leaf and commiphora mukul or extracts thereof. However, the claimed scope of the herbal component also includes other parts of the herb, such as leaves, flowers, etc., that would not otherwise interfere with the intended function of the herbal-mineral formulation.

The herbs disclosed herein (in whole or in part) can be included in the formulation in any form generally known in the art. For example, the herbs may be processed to form extracts, dried, powdered, granulated, concentrated, and the like. In embodiments, the herbs are dried and pulverized, which is further incorporated into the formulation.

In an embodiment, the herbal component comprises 8 to 12% by weight of Terminalia arjuna, 2 to 6% by weight of Sidarombifolia, 2 to 6% by weight of Withania somnifera, 2 to 6% by weight of Tinospora cordifolia, 2 to 6% by weight of punica granatum, 2 to 6% by weight of Phyllanthus emblica, and 2 to 6% by weight of Commiphora myrrha. Furthermore, in a further embodiment, the herbal component comprises preferably ≤ 4 wt% of at least one of embelia oblonga, madder, nardostachys chinensis, myrobalan, acerola, piper longum, black pepper, ginger, Boerhaviadiffusa, bamboo nectar, Madhuka indica, neem, picrorhiza rhizome, holy basil, Steriospermum suaveolens, Premna mucronata, catalpa ovata, aegle marmelo, oroxylum indicum, Desmodium gangeticum, rabbit tailgrass, bur eggplant, yellow eggplant, and tribulus terrestris.

Mineral component

In embodiments, the mineral component comprises bhasma or a calcined formulation, such as Swarna Makshikabhasma, ahraka bhasma, Loha bhasma, Muktasukti bhasma, and Pravala bhasma. Alternatively, the mineral component may also be selected from at least one of iron, mica, pyrite, and coral. In disclosed embodiments, bhasmas together with herbal components form a bioavailable herbal-mineral complex that can be used to treat cardiovascular disease and related complications. In another embodiment, the mineral component further comprises a ganoderma lucidum. However, within the scope of the claims provided herein, other similar calcined preparations or minerals are included, including, alternatively or additionally, with respect to the herbal-mineral preparation, that would not otherwise interfere with the intended function of the herbal-mineral preparation.

In embodiments, the mineral component comprises 1 to 4% by weight of lucidium officinale. In another embodiment, the mineral component comprises 2% or less by weight Muktasukti bhasma, 2% or less by weight Loha bhasma, 3% or less by weight Abhraka bhasma, 2% or less by weight Swarnamaksika bhasma, and 2% or less by weight Pravala bhasma.

In various embodiments herein, the disclosed formulations can further include suitable excipients. A list of suitable excipients includes solvents, binders, lubricants, herbal carriers, oils and salts generally known in the art. In one embodiment, the excipient comprises gum arabic.

In addition, the amount of herbal and mineral components that may be included in various embodiments of the disclosed formulations may range from 0 to 12 weight percent. In embodiments, the formulation includes Terminalia arjuna (8-12 wt%), Sidarombifolia (2-6 wt%), Withania somnifera (2-6 wt%), Tinospora cordifolia (2-6 wt%), punica granatum (2-6 wt%), Emblica officinalis (2-6 wt%) and Commiphora myrrha (2-6 wt%), Petasites japonicus (1-4 wt%), Muktatsukti bhasma (2 wt%), Loha bhasma (2 wt%), Abhraka bhasma (3 wt%), Swarnaknaaksaksikabasma (2 wt%) and Pravala bhasma (2 wt%).

In further embodiments, the formulation further comprises preferably 4% by weight or less of at least one of embelia oblonga, madder, nardostachys chinensis, myrobalan, terminalia prunifolia, piper longum, black pepper, ginger, Boerhavia diffusa, bamboodew, Madhuka indica, neem, picrorhiza kurroa, holy basil, Steriospermum suaveolens, Premna mucronata, lycopi, kumquat, oroxylum indicum, Desmodium gangeicum, conyza blinii, belladonna xanthocarpi, and tribulus terrestris.

Furthermore, the amount of gum arabic may be any amount suitable for excipient activity. In one embodiment, the formulation may comprise from 0 to 50mg per 500mg of formulation, preferably 10% by weight of acacia gum.

However, it is apparent that slight variations in the amount of ingredients may be made without interfering with the intended function of the herbal-mineral formulation.

The herbal-mineral formulation disclosed herein can be formulated into various dosage forms to make it suitable for oral administration. The herbal-mineral formulation may be in the form of a powder, tablet, pill, lozenge, granule, capsule, solution, emulsion, suspension or any other form suitable for use. In one embodiment, the herbal-mineral formulation is formulated in a powder form suitable for oral administration. In another embodiment, the herbal-mineral formulation is formulated in tablet form, preferably a 500mg tablet. For example: table 1 describes the amount of each ingredient in a 500mg tablet.

Further disclosed herein is a tablet for the treatment/prevention of CVD and related complications. In one embodiment, the tablet is a 500mg tablet having an herbal component, a mineral component, and excipients as shown in table 1.

Table 1-each 500mg tablet comprises:

embodiments of the disclosed herbal-mineral formulations (also referred to as "drugs" or "test drugs") in tablet form are analyzed for plant components, physicochemical properties, etc. by methods well known in the art. The analyses and results obtained are included as examples only and should not be construed as limiting the scope of the claims provided herein. It will be apparent to those skilled in the art that many modifications, both to materials and methods, may be practiced without departing from the scope of the claims.

Example 1:

physical and chemical research: the physicochemical studies, such as ash value, tablet hardness, disintegration time, alcohol soluble extract value and chloroform soluble extract value, were analyzed according to the parameters given in the Indian pharmacopoeia ayurveda. The tablet disintegration time was checked with the aid of a tablet disintegrator (i.p. std.rotek) and a tablet hardness tester (sec. india) to find the hardness of the tablets. Each experiment was repeated three times. Table 2 describes the results of the physicochemical analysis.

Table 2:

test parameters	Description of the invention
		Description of the invention	Dark brown double convex round wafer
Identification	Positive for iron and calcium
		Average weight	500mg±12.5mg
Even weight	Plus or minus 2.5 percent of the actual average weight
		Hardness of tablet	3.6kg/cm2
Loss on drying	6.2％w/w
		Methanol soluble extract	41.2％w/v
Chloroform soluble extract	12.0％w/v
		Ash value	15.2％w/w
Mean disintegration time	26 minutes
		Analysis of	Each tablet contains iron-4.5 mg and calcium-15 mg