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Corporate Office
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Gugulipid Products

 

Sabinsa Corporation supplies the following Gugulipid® products

  • Gugulipid® Granules is standardized for a minimum of 2.5% guggulsterones Z & E that is suitable for preparing tablets.
  • Gugulipid® 40 Mesh is standardized for a minimum of 2.5% guggulsterones Z & E. It has a particle size that makes it suitable for preparing capsules.
  • Gugulipid® Soft Extract is standardized for a minimum of 7.5% guggulsterones Z & E that is suitable for preparing soft gel dosage forms.

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Recommended Dosage

 

The recommended dosage of Gugulipid® is the amount equivalent to 25 mg of guggulsterones three times a day.

1. Indian Pharmacopoeia (IP 1996) Delhi: Controller of Publications,Vol.II pp. 357-358

Gugu 1
Gugu 2

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Sabinsa Studies On Gugulipid

 

1. Open Field Study to Evaluate Gugulipid® in the Treatment of Dyslipidemias – Department of Veterans Affairs Medical Center (Arizona)

The purpose of this study is to investigate the effect of Gugulipid® on serum lipids (i.e. cholesterol, LDL, HDL, triglycerides) in individuals with dyslipidemias. All individuals are volunteers who have serum cholesterol levels > 200 mg/dL. Serum cholesterol levels and the levels of other parameters are measured prior to and after treatment with Gugulipid®.

2. IND Study #59, 172 – Randomized, Double-Blind, Placebo-Controlled Trial Evaluating the Safety and Efficacy of Gugulipid® in Americans with Hypercholesterolemia – University of Pennsylvania.

The purpose of this study is to evaluate the efficacy and safety of Gugulipid® in Americans with dyslipidemias. The participants of the study are volunteers, 18 years and older, who have LDL levels between 130-190 mg/dL and triglycerides less than 400 mg/dL. The safety of the study will be measured by self-reported adverse events. In addition hematological and blood biochemistry parameters will be assessed throughout the study to monitor safety and efficacy. The efficacy of Gugulipid® will be measured as a percent change from baseline in total cholesterol, LDL, HDL, and triglycerides in Gugulipid® versus placebo groups.

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Safety and Toxicity

 

The CDRI (Central Drug Research Institute) Lucknow, conducted the following studies in mice rats, rabbits, and rhesus monkeys.

  • acute toxicity
  • subacute and chronic toxicity
  • teratogenic and mutagenic

The results indicated that Gugulipid® extract was safe for human consumption.

A four-week, phase 1 (safety on chronic administration) study was conducted on 21 subjects with the following conditions.

  • 9 patients with Hypertension
  • 3 patients with IHD
  • 2 patients with Diabetes Mellitus
  • 3 patients with Diabetes Mellitus & Hypertension
  • 3 patients with IHD & Hypertension
  • 1 patient with Gout

All subjects received 400 mg of Gugulipid® three times a day (equivalent to 25 mg of guggulsterones). No adverse effects were reported for liver function, blood glucose, blood urea levels, hematological parameters, or electrocardiogram results. Only one patient complained of epigastric fullness three days after Gugulipid® administration that was controlled by antacids.

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Traditional Uses and Contemporary Significance to Health

 

Gugulipid® has a long history of use in Ayurveda. The Atharva Veda, one of the four well-known holy scriptures (Vedas) of the Hindus, is the earliest reference to the medicinal and therapeutic properties of guggul. Detailed descriptions regarding the actions, uses, and indications as well as the varieties of guggul have been described in the Ayurvedic treatises, Charaka (1000 B.C.), Sushruta Samhita (600 B.C.), and Vagbhata (7th century A.D.). In addition, various Nighantus (medical lexicons) were written between the 12th and 14th centuries A.D. that were based on the Ayurvedic literature.

Sanskrit 1
Original Sanskrit verse from Atharva Veda that refers to the medicinal values of guggul.

Translation for Sanskrit verse: (“Yakshma” (disease), it cannot appear in sun light. Guggulu is the best medicine, because it develops through the rays of hot sun on specific circumstances. Guggulu has an aromatic odour.

It removes the disease, like that of a deer that runs away on seeing the horse. A mixture of Guggulu and common salt remove the disease along with their complications.)

Sanskrit 2
Original Sanskrit verse from the Sushruta Samhita (600 B.C.)

Translation for Sanskrit verse:
(Rasa (Digestive juice/chyle) is responsible for either obese or slim body. Six types of Rasa’s are described in the Ayurveda.

A person who consumes Kaphaz diet (heavy, oily or fatty food such as meat, fish poultry and sweets), over eating, excessive sleeping and lack of exercise will lead to the development of ‘Ama'(non-pathogenic abdominal disturbances) of sweet taste is produced in the body and develops obesity. This ‘Amarasa’ is more sticky (i.e., oily) in nature, which creates obesity.

Short breath, thirst, hunger, sleep, sweating, foul odour from the body, tiredness and unclear voice are characteristics of obesity. This patient will not be able to discharge his routine systematic work due to delicate system Medha or adipose tissue/ hyperlipidemia and kapha blocks the channels that supply the reproductive tissue or the reproductive system (sukravahasrotas) as a result he will develop impotence. He will be less immune due to the obstruction of other systems (srotas). Important diseases that occur in obese persons are pramehapeedika (carbuncle, diabetic foot ulcers), fever, fistula, tumors and other types of neurological disorders. They may die by one of the above mentioned diseases. In obese people all diseases are complicated. Disease symptoms are seen before the channels are blocked and hence, those who has the tendency to become hyperlipidemic, have to give up the consumption of hyperlipidemic diet and regularise their other habits.

For the treatment of obesity, Sushrutha stated that guggulu, shilajit, triphala, (containing equal amount of fruit powders of Terminalaia chebula, T. bellerica and Emblica officinalis), Lohabhasma (purified and micronized iron as per ayurvedic system), Rasayan (particular ayurvedic preparations) honey, barley, green gram, millets, etc., have to be included in the diet, which are responsible for reducing fat. Physical exercise should be practiced daily.)

The list of traditional uses for guggulu is extensive. It has been indicated for healing bone fracture to inflammation, arthritis, cardiovascular conditions, obesity, and lipid disorders. Several other external and internal uses for guggul have been described in folklore and ethnomedicine as well. Although, several therapeutic uses were indicated for guggul, the Indian gum resin was mainly used for treating various types of arthritis. Ayurvedic physicians extensively used guggul for treating arthritis and related conditions for centuries.

Research regarding guggul’s use as a hypolipidemic agent did not begin until 1964. It is said that Satyavati and Dwarakanath were inspired to investigate guggul’s lipid-lowering properties based on the strong analogy between the ancient concept of medoroga in the Sushruta Samhita (600 B.C.) and the modern concept of the pathogenesis of atherosclerosis and its fatal complications. Preclinical and clinical studies were conducted over a period of two years to investigate guggul’s lipid-lowering properties. The following results were reported:

  • In cholesterol-induced hyperlipidemic rabbits, an aqueous extract of crude gum guggul significantly lowered the serum cholesterol, phospholipids as well as protected against atherosclerosis (at the fatty streak stage).
  • The gum resin reduced the body-weight of animals.
  • Significant reductions in serum cholesterol levels were observed in obese and hypercholesterolemic patients using crude gum guggul.

These studies resulted in the publication Satyavati’s doctoral thesis titled “Effect of an indigenous drug on disorders of lipid metabolism with special reference to atherosclerosis and obesity (medoroga)” that was submitted to Banaras Hindu University (BHU). This pioneering work, published in 1966, provoked much interest among Indian scientists at BHU and institutions elsewhere. A number of preclinical and clinical studies were undertaken on gum guggul with emphasis on it hypolipidemic and related properties. These were soon followed by phytochemical and pharmacognostic studies. Finally in 1988, gugulipid was available as a hypolipidemic agent on the Indian market.

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Importance of Proper Analytical Methodology

 

IMPORTANCE OF PROPER ANALYTICAL METHODOLOGY AND THE 10% GUGULIPID MYTH

Muhammed Majeed, Ph.D., Lakshmi Prakash, Ph.d. and S.Natarajan, Ph.D.

Gugulipid®, a registered trademark of Sabinsa Corporation, is the standardized extract of the oleogum resin of Commiphora mukul, an Indian medicinal plant. This resin is a mixture of diterpenes, sterols, steroids, esters and higher alcohols. The active ingredients responsible for the use of the plant in the maintenance of healthy cholesterol levels, are the guggulsterones, specifically guggulsterone E and guggulsterone Z. When purchasing guggul products, it is vital that the extract be assessed for purity and appropriate standardization. Sabinsa’s product Gugulipid® (supplied in powder form) is purified and standardized to contain a minimum of 2.5% guggulsterones E and Z. The Indian Pharmacopeia (IP) limits the maximum level of guggulsterones (E and Z) to 4.0 to 6.0% in a soft extract.

It is probable that powdered guggul products which claim an active ingredient level in excess of 6.0% may be crude and unpurified extracts. In clinical studies, the administration of crude (unpurified) guggul caused mild side effects such as skin rashes, diarrhea and irregular menstruation. There are no reports of these undesirable effects with a purified and appropriately standardized extract.

GUGGULSTEROLS

GUGGULSTEROLSGUGGULSTEROLS

Estimation of Guggulsterones and Guggulsterols in Gugulipid® extract:

The methods used include UV (ultraviolet) spectrophotometry and HPLC (High Pressure Liquid Chromatography).

UV Analysis

This method involves measuring the optical density of a solution of a known concentration at a particular wave length. All components that have the UV absorption spectrum at that wave length will absorb UV light in proportion to their amount in solution. Since UV is a cumulative function, the results will be for the total amount of sterone, sterol and steroidal components present.

An examination of the chemical structures reveals that the guggulsterones, Z&E, and the guggulsterols have the following similarities:

  • They are tetracyclic
  • They have an alpha-beta unsaturated ketone Carbonyl at Position 3
  • They have an olefinic double bond at Position 4

Therefore, if a sample of powdered guggul extract is analyzed by UV method, the results would be cumulative, including a variety of structurally similar compounds and in excess of the actual guggulsterone levels.

HPLC Analysis 2

This method offers a more accurate analysis of guggulsterols and guggulsterones content. It involves the following steps:

  • Physical separation of the mixture into individual components.
  • Elution of the separated components from the chromatographic column at different rates.
  • Using UV detector, only the eluted components (one particular compound at a time) is quantitated. This procedure ensures that each component is quantitated separately.

HPLC CHROMATOGRAMS OF THE Z AND E GUGGULSTERONES (STANDARDS)

CHROMATOGRAMSCHROMATOGRAM
HPLC CHROMATOGRAM OF A GUGULIPID® SAMPLECHROMATOGRAMS

TYPICAL ANALYTICAL RESULTS :

Guggulsterones content in commercial Commiphora mukul extract samples.

Sample ID Label claim (%) By HPLC (%) By UV (%)
1 2.5 2.5 4.8
2 2.5 2.6 5.3
3 (SE)* 16.0 3.6 16.5
4 10.0 1.1 10.6

* SE : Soft extract

Thus, a sample analyzed as containing 10.6% active constituents (by UV method) could be erroneously labeled as containing 10% guggulsterones. It would actually contain only 1.1% guggulsterones (the value determined by HPLC), the remainder being sterol compounds.

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Mechanism of Action

 

The studies on gum guggul indicate that its hypolipidemic activity can be attributed to more than one mechanism. Some of the possible mechanisms include:

  1. Inhibition of cholesterol biosynthesis
  2. Enhancing the rate of excretion of cholesterol
  3. Promoting rapid degradation of cholesterol
  4. Thyroid stimulation
  5. Alteration of biogenic amines
  6. High affinity binding and anion exchange.

The first 3 mechanisms, inhibition of cholesterol biosynthesis, enhancing rate of excretion of cholesterol, and promoting rapid degradation of cholesterol, are related in that the end result is the elimination of cholesterol. Cholesterol is an ubiquitous and important compound that is an essential component of mammalian cell membranes. It is a precursor of bile acids, steroid hormones, and vitamin D. Since cholesterol is readily synthesized in most tissues of the human body, it is not a dietary essential. In normal human adults, the largest amounts of cholesterol are found in the liver (0.3%), skin (0.3%, related to vitamin D formation), brain and nervous tissue (2.0%), intestine (0.2%) and certain endocrine glands (related to steroid hormone biosynthesis, adrenal glands contain approx. 10%). Approximately 50% of the myelin sheath (surrounds and insulates nerves) is cholesterol that is related to proper nerve conduction and normal brain function. It has been estimated that a 71 kg adult male has approximately 75 to 150 g of cholesterol in his body.

Nearly 50% of the cholesterol produced daily is converted to bile acids and secreted as bile salts in bile. Most of it is reabsorbed and reused via enterohepatic circulation. A portion of the cholesterol that remains (approx. 0.5 to 1 g) is used to form the steroid hormones, cell membranes, and vitamin D in the skin. Any excess cholesterol is excreted mainly in the bile and intestinal tract. Also, a small amount is excreted via the skin as desquamated cells, sweat, and sebaceous secretions.

Figure 1. Factors that influence the turnover of cholesterol in the body

Factor

Inhibition of cholesterol biosynthesis

Gugulipid® markedly inhibits liver cholesterol biosynthesis. This causes interference in lipoprotein formation and lipid turnover.

Cholesterol is primarily biosynthesized in the liver and the intestine and transported to the peripheral tissues in the form of lipoproteins. Lipoproteins are the only tissues that manufacture apolipoprotein B, the protein component of LDL and VLDL that are both cholesterol transport proteins. The rate-limiting step in cholesterol biosynthesis is the reduction of HMG-CoA to mevalonic acid by HMG-CoA reductase. Cholesterol controls its own formation by inhibiting this step (feedback inhibition).

Figure 2. Cholesterol Biosynthesis

Cholesterol Biosynthesis<

Enhancing rate of excretion of cholesterol

Gugulipid® increases fecal excretion of bile acids (cholic and deoxycholic acids) and cholesterol. This indicates a low rate of absorption of fat and cholesterol in the intestine.

In a normal, healthy adult following a low cholesterol diet, cholesterol (1300 mg) is returned to the liver to be disposed of each day (enterohepatic recirculation). The liver disposes off cholesterol by

  • excretion in the bile as free cholesterol where it is converted to bile salts
  • esterification and storage in the liver as cholesterol esters
  • and incorporation into VLDL and LDL (lipoproteins) and secretion into the circulation.

The primary bile salts include taurocholate, taurochenodeoxycholate, glycochenodeoxycholate, while the secondary ones are deoxycholate and lithocholate.

Figure 3.

Figure 3

Promoting the rapid degradation of cholesterol

Gugulipid® stimulates the LDL receptor binding activity in the liver membrane, and its hypolipidemic activity is due to rapid catabolism (degradation) of LDL.

Cholesterol biosynthesis may be suppressed by LDL-bound cholesterol. This involves specific LDL receptors that project from the surface of human cells. The first step in regulating cholesterol biosynthesis is binding of the lipoprotein LDL to these LDL receptors. As a result, the LDL particles are extracted from the blood. Saturability, high affinity, and a high degree of specificity characterize the binding reaction. Only LDL and VLDL are recognized by the LDL receptors. (They both contain apolipoprotein B-100.) The cholesterol lipoprotein is endocytosed as clathrin-coated vesicles when binding occurs at sites on the plasma membrane that contains pits coated with clathrin (a protein). Once this occurs, the coated vesicle loses its clathrin and becomes an endosome intracellularly. This process is known as receptor-mediated endocytosis. The second step involves fusion of the endosome with a lysosome that contains hydrolytic enzymes (proteases and cholesterol esterase). The LDL receptor separates from LDL and returns to the surface of the cell. Inside the lysosome LDL’s cholesterol esters become hydrolyzed by cholesterol esterase. Subsequently, free cholesterol and a long-chain fatty acid are produced. The free cholesterol diffuses into the cytoplasm where it inhibits the activity of HMG CoA reductase. Thus, it suppresses the synthesis of HMG CoA reductase. Simultaneously, fatty acyl CoA:cholesterol acyltransferase (ACAT) is activated by cholesterol and promotes the formation of cholesterol esters, primarily cholesterol oleate. The accumulation of the intracellular cholesterol eventually inhibits replenishment of LDL receptors on the cell ‘s surface, and this causes blocking of further cholesterol take and accumulation.

Reducing lipid peroxides

The protective, antioxidant properties of Gugulipid® may also play a part in its lipid lowering activity. It reduces lipid peroxides, xanthine oxidase, and increases superoxide dismutase.

Thyroid Stimulation

The lipid lowering properties of Gugulipid® may be due to its ability to increase thyroid hormone production.

Thyroid hormones control the metabolic rate of the entire body. Thyroxine (T4) and the more active triiodothyronine (T3) are the two most important hormones. Both T4 and T3 are present in tissue cells. They enter them by diffusion. Thus, the thyroid affects most tissues (e.g. cardiovascular system, gastrointestinal system, and muscular activity). Thyroid hormones provide many essential functions. They increase the metabolism of carbohydrates, enhance protein synthesis and stimulate the use and breakdown of lipid (fats).

Figure 4

Figure 4

Alteration of Biogenic Amines

Preclinical studies have reported gugulipid’s effect on biogenic amines, catecholamine and dopamine b-hydroxylase activity. This may attribute to its lipid lowering properties.

Gugulipid (100 mg/kg dose) significantly increased catecholamine levels and dopamine b-hydroxylase activity in normal rabbits. (Dopamine b-hydroxylase activity and catecholamine levels were decreased in cholesterol (500 mg/kg dose) fed rabbits. Gugulipid is noted for helping the hypercholesterolemic rabbits to recover the decrease in catecholamine synthesis.)

Gugulipid (50, 120, and 240 mg/kg doses) increased the levels of norepinephrine and dopamine and dopamine b-hydroxylase activity of the brain and heart tissues of rhesus monkeys’ in a dose-dependent manner.

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Phytochemistry of Commiphora mukul

 

Chemical investigations have focused on the oleogum resin of Commiphora mukul due to its hypolipidemic properties. The oleogum resin contains an essential oil mainly consisting of myrcene, dimyrcene, and polymyrcene. The National Chemical Laboratory (Pune, India) in collaboration with the pharmacology team of the Central Drug Research Institute (Lucknow, India) isolated and chemically characterized the hypolipidemic compounds of the oleogum resin. A stepwise extraction scheme shown in Figure 2 was used to separate the chemical constituents.

Solvent extract, using ethyl acetate, separates the oleogum resin into two parts, gum and resin. The gum is insoluble in ethyl acetate, and it is chemically characterized as a carbohydrate gum (substance belonging to the class of sugars). Because the gum did not possess lipid-lowering activities and proved toxic to experimental animals, it was not studied further. The resinous portion is soluble in ethyl acetate and possesses both anti-inflammatory and lipid-lowering properties. It was further separated into acidic, basic, and neutral fractions that comprised approximately 4%, 0.3%, and 95% of the ethyl acetate-soluble resin, respectively. The basic fraction was devoid of any activity.

Thus, it was discarded. The acidic fraction possessed significant anti-inflammatory activity. The neutral faction possessed lipid-lowering activity. The neutral fraction was further separated into ketonic and non-ketonic fractions to pinpoint the source of the hypolipidemic activity. The ketonic fraction possessed significant lipid-lowering activity, while the non-ketonic fraction showed none. The ketonic fraction is a complex mixture of chemical compounds that belong to the class of steroids as shown below.

GUGGULSTEROLS
GUGGULSTEROLS

STEROL COMPOUNDS
STEROL COMPOUNDS

GUGGULSTERONES
GUGGULSTERONES

Among the compounds listed, Z-Guggulsterone and E-Guggulsterone are responsible for the hypolipidemic activity of the gum resin. In fact, the hypolipidemic activity of Z and E guggulsterones has been determined to be quantitatively comparable to that of the total ethyl acetate extract of the gum resin.

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Commiphora Mukul

 

Commiphora mukul Engl. (synonyms: Commiphora wightii and Balsamodendron mukul), is a small tree of the Burseraceae family that is indigenous to India. It grows wild in the semi-arid states of Rajasthan, Gujarat, and Karnataka in India. The Commiphora mukul tree has an ash-colored bark that comes off in large flakes exposing the under bark that also peels away.

The gum resin of the Commiphora mukul tree is revered in Ayurveda for its medicinal properties. It is commonly called guggulu or guggul. The gum resin resides in the ducts located in the soft bark of the tree. It is obtained through a process called tapping. Circular incisions are made on the main stem, not beyond the thickness of the bark. From these incisions, a pale yellow, aromatic fluid exudes that quickly solidifies to form a golden brown or reddish brown agglomerate of tears or stalactic pieces. The dried resin has a bitter aromatic taste and a balsamic odor.

(A) The Commiphora mukul tree
Commiphora mukul tree

(B) Yellow gum resin from incision
Yellow gum resin

(C) The dried gum resin
dried gum resin

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