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STANDARDIZATION AND EVALUATION OF DRUG HERBAL FORMULAS

STANDARDS AND ASSESSMENT OF HERBAL DRUG FORMULATIONS

1Sunita Panchawat, 1Kamal Singh Rathore, 2Dr.SSSisodia, 3dr. RKNema

1BN Girls PG College of Pharmacy, Udaipur-313 002 Raj.INDIA

2BN PG College of Pharmacy, Udaipur

3Rishiraj College Pharmacy, Udaipur

Email: kamalsrathore@yahoo.com

Mobile: +919887111211 (Sunita P.), +919828325713 (Kamal)

Herbal Medicines for Standardization and Evaluation: – In recent years there has been strong demand for products derived from plants in developed countries. These products are increasingly sought as medicinal products, nutraceuticals and cosmetics. (1) There are over 6000 herbal manufacturer in India. More than 4000 units are producing medicines Ayurveda. Due to lack infrastructure, skilled workforce and rigorous methods reliable regulatory laws most of these manufacturers produce products based on very tentative. (2)

To have a good coordination between the quality of raw materials, process materials and finished products, it has become essential to develop methods reliable quality, specific and sensitive control with a combination of classical and modern instrumental methods of analysis. Standardization is an essential step to ensure quality control of herbal medicines. (3) "Standards", a term used to describe all measures taken during the manufacturing process and quality control that leads to a reproducible quality. It also covers the entire field of study since the birth of a plant for clinical application. It also means adjusting the herbal substance, preparation of a defined content of a component or group of substances with known therapeutic activity respectively by adding excipients or by mixing herbal drugs or herbal preparations of drugs (4). "Evaluation of a drug: Confirmation of their identity and determine their quality and purity and the detection of adulteration of their nature (5).

Standardization of herbal medicines is not easy task since many factors influence fitness and reproducible therapeutic effect. In order to obtain quality products herbal oriented, the care should be taken right to the correct identification of plants, the station and the catchment area and the process of extraction and purification and rationalization of the combination in the case of drugs polyherbal (3).

The standardization of raw drug materials includes the following steps: –

1. Authentication: – Each and every step has to be authenticated.

a) Stage of the collection.

b) parts of the plant collection.

c) The regional situation.

d) Botanical phytomorphology identity, microscopic and histological analysis (characteristic of the cell walls contents of the cell, starch grains, calcium oxalate crystals, hairs, fibers, vessels. Etc.) (6) Several studies of histological parameters are: –

1. constant leaf: – List of Palisade, vein islet number, vein termination, the number of stomata, and stomatal index.
2. Trichomes.
3. Stomata.
4. quantitative microscopy.
5. taxonomic identity.
6. Foreign matter.
7. Organoleptic evaluation.
8. Ash values and extractive values.
9. Determination of moisture content.
10. evaluation Chrometographic and spectroscopic.
11. Heavy metal determination.
12. Pesticide residues.
13. Microbial contamination.
14. Radioactive contamination.

The herbal formulation in general can be standardized schematically as to formulate the medication used raw materials collected from different localities and comparative chemical efficiency of the different batches of the formulation must be observed. Preparations with better clinical efficacy must be selected. After all the routine physical, chemical and pharmacological parameters to monitor for all lots to select the final finished product to validate the manufacturing process. (6)

The parameters of stability of herbal formulations that include physics, chemistry and parameters Microbiological are:

physical parameters include color, odor, appearance, clarity, viscosity, moisture content, pH, disintegration time, friability, hardness, flow capacity, flocculation, sedimentation, sedimentation rate, and the ash values.

Chemical parameters including limit tests, chemical testing, chemical analysis, etc.

Chromatographic analysis of herbs can be done with TLC, HPLC, HPTLC, GC, UV, GC-MS, etc fluorimetry

microbiological parameters are viable content total, total mold count, total coliforms and counted. Limiters can be used as a quantitative tool or semi-quantitative to determine and control the amount impurities such as reagents used in the extraction of various herbs, impurities ships directly from the manufacturing and solvents, etc.

GUIDELINES FOR THE STANDARDIZATION OF HERBAL DRUGS

WHO Guidelines: –

The issue of normalization of herbal medicines is very broad and deep. The guidelines set by WHO can be summarized as follows: –

• Reference to the identity drug. Botanical sensory evaluation, the characters, foreign organic matter, microscopic, histological, histochemical evaluation, quantitative measurements, etc.
• Reference to the physicochemical nature of the drug. physical and chemical identity, fingerprints Chromatography ash values, extractive values, moisture content, volatile oil and alkaloids tests, quantitative estimation protocols etc.
• The reference to the pharmacological parameters, the profiles of biological activity, the values of the bitterness, the hemolytic index, astringency, swelling factor, foaming index etc.
• The toxicity of pesticide residues details, heavy metals, microbial contamination and total viable count, the agents pathogens such as E. coli, Salmonalla, P.aeroginosa, S. aureus, Enterobacteriaceae, etc.
• Microbial contamination.
• Pollution radioactive.

Modern monographs ayurveda herbal

In modern ayurvedic herbal monographs normalization parameters are discussed comprehensively so. According to the monograph modern ayurvedic protocols of quality control include:

Synonyms, publication related to the plant, the components of the present methods of analysis.

Description of evaluation: description of the drug, phytomorphological, microscopic, organoleptic evaluation, foreign matter, etc.

WHO GUIDELINES MONOGRAPH TITLE (7)

Botanical - Sensory evaluation, foreign matter, Microscopy measurement.

Physicochemical TLC: – Ash, extractable matter, water content and volatile matter, volatile oils.

Pharmacology: – value bitterness, hemolytic activity, astringency, law index, foaming index.

Toxicology: – Pesticide residues, arsenic, metals.

Microbial contamination: – Total viable count, pathogens, aflatoxins, radioactive contamination.

STANDARDIZATION OF DRUGS / herbal

Commercial production of medicinal plants and their rapidly growing business sector of the industry today, the increasing demand due t6o plant medicinal supply line is adversely affected leading to adulteration and substitution of genuine drugs.

1. Fluorescence temple: – When an extract of the plant was in a fluorescent silica gel layer and exposed to ultraviolet light, appears to place on a fluorescent background, causing so off and is directly proportional to the concentration of the extract. Plate of silica gel GF was used as an adsorbent for the fluorescence quenching. Solvents taken toluene-hexane, ether, ethyl acetate, methanol, butanol, and water (8).

2. The use of compounds and marker making of fingerprints for identification and standardization of botanical drugs: – Chemical and chromatographic techniques can be used to help in the identification of a herbal material or extract. chromatographic technique such as HPLC, TLC, GC and capillary electrophoresis and spectroscopic methods as IR, NMR, and UV rays can also be used for fingerprinting. DNA fingerprinting has been widely used in many species, for example, DNA fingerprints of Panax species and their adulterants. (9) marker compounds can be used to help identify herbal materials, materials specifications, standardize botanical preparations in all aspects of manufacturing processes and obtaining stability profiles (10).

3. Chromatography thin layer densitometric determination of escin in a herbal medicine containing Asculum and Vitis dry extract: – A method is developed TLC to analyze the total saponin content, also known as the content of escin, a herbal medicine that contains two capsules dry. After a purification step using C (18) solid phase extraction, samples were analyzed by HPTLC silica gel plate with the top layer of a mixture of acid acetic acid-water-butanol (10/40/50v/v/v) as mobile phase. The spots are visualized by spraying with anisaldehyde reagent and heating the plate for 5-10 min. (100-105oC) and measured at a wavelength of 535 nm (11).

4. Determination of stigmasterol, beta – sitosterol and stigmastanol in oral dosage forms by HPLC with evaporative light scattering – A validated and reproducible HPLC method with the dispersion evaporative light line was developed for the analysis of two sterols, sitosterol stegmasterol, beta-and stanol one turned out to be common in many formulations herbal and health supplements. This method was used to test commercially available products formulated as oral dosage forms intended to contain potato African and associated sterols and stanols. (12)

5. Elemental analysis of herbal preparations for traditional medicines through neutron activation analysis with the standard method KO: – herbal preparations prescribed for specific treatment purposes were purchased markets and by neutron activation analysis with normalization kO. 500 to 700 mg of each sample was palletized at a pressure of six tones and irradiated together with monitors for alpha and neutron flux determination ratio of about 6 hours in a heat flux of 2.29 x 10 (12) n/cm2/s (13).

6. Liquid chromatography-UV determination and liquid chromatography chemical characterization of atmospheric pressure mass spectrometry ionization mass sitosterol and stigmasterol in soybean oil: – A narrow bore HPLC-UV method was developed for the analysis of two of the more phytosterols abundant naturally in vegetable oils: sitosterol and stigmasterol. The method allowed the detection of compounds at a concentration of 0.42 μ / ml and quantification of the concentration of 0.52 and 0.54 μ / ml for sitosterol and stigmasterol, respectively (14).

7. Simultaneous determination of cinnamaldehyde, eugenol and paeonol in traditional Chinese medicine preparations by capillary GC-FID: – A capillary GC method was established for the simultaneous determination of cinnamaldehyde (NCDM), eugenol (EL) and paeonol (PL) in two preparations of traditional Chinese herbal medicine, Weitongding compressed (WTDT) and pill Guifu Dihuang (GDHP). The tests are based on a temperature programmed GC on a 30 mx 0.53 mm capillary column with nitrogen as carrier and an FID detector. Good linearity was obtained in the range of 0.45 to 0452 mg / l NCDM, 0.31 to 0.625 mg / l and 0.30 to 610 mg / l PL, respectively. (15)

8. HPTLC fingerprinting of commercial formulation containing Shankhpushpi: – These are important Ayurvedic formulations used for perinatal care the mother and child. Standardization of churn conducted the study taste, phytochemical analysis, qualitative analysis of organic and inorganic TLC, UV-visible spectrophotometer and HPLC fingerprint studies. Organic qualitative analysis of both the churna revealed the presence of alkaloids, steroids, phenols, tannins, glycosides, resins, saponins and flavonoids (16).

EVALUATION OF DRUG / herbal

1: Biological. Parameter (bioassay) – is well established that the biological activity of the herbal components is due to not one, but a mixture of bioactive components of plants and related properties of a single bioactive compound can vary from one batch to another, while maintaining biological activity within desirable. (1) Some examples are: _

a. Evaluation of the activity profile of herbal preparation adaptogenic: – adaptogens help the body to rise to stress and improve overall health and performance. AVM is an herbal formulation. Composition-Emblica officinalis, Withania somnifera, Asparagus racemosus, Ocimum sanctum, Piper longum and tribulus terrestris. AVM shows significant stress, activities immunomodulatory and anabolic steroids in animal models to test a promising adaptogen. (17)

b. Assessment antioxidant activity of herbal products: – A new test method for measuring the antioxidant power of herbal products based on spectrophptometry tetrabenzo using solid phase-b, f, j, n, l, 5, 9, 13 – tetraazacy-clohexadecin-Cu (II) immobilized on silica gel is proposed. The method represents an alternative the most common waste collection capacity tests. The method was adopted in the analysis of herbal drinks and drugs most popular echinacea determined spectrophotometrically (18).

c. Assessment of the reduction of microbial contamination of plants through the technological process of decoction and spray dry: – The technological process of the raw material has many stages, usually negative for microbial growth, but complete elimination depends on the initial condition and the work used. The aim of this study was to assess the microbial contamination extraction solution, such as (SE) and dry spray (PSA) to evaluate the reduction of pollution after cooking and drying spray. Microbiological testing of products was performed by plate count and coliform MPN. (19)

d. Evaluation Nitric oxide uptake activity of certain medicinal plants used in inflammatory diseases: – Four traditional medicinal plants, namely Ventilago Gaertn madraspatana cordifolia. Blonde, Linn., Lanatana camara Linn. And Morinda citrifolia Linn. Were selected for a study on the inhibition of nitric oxide (NO) a key mediator in the phenomenon of inflammation, which means the actual presence of anti-inflammatory components in it. Plant samples were extracted with different solvents for evaluation of inhibitory activity of NO produced in vitro from sodium nitroprusside, and in LPS activated murine peritoneal macrophages, ex-vivo (20).

e. The inhibitory activity of lipid peroxidation: – The reaction mixture contained mice liver homogenate (0.2 ml, 10% w / v) in 0.15 KCl, KCl (0.1 ml, 150 / m), Tris (0.4 ml, pH 7.5) and different concentrations of test extracts. In vitro lipid peroxidation was initiated by the addition of FeSO4.7H2O (0.1 ml, 10 microns). The reaction mixture was incubated at 37 for 1 h. After incubation period, the reaction was terminated by the addition of thiobarbituric acid (TBA-2 ml, 0.8%) and heating the contents of 15 min. development color complex. The tubes were centrifuged at 4000 rpm for 10 min. and cooled. The% inhibition of lipid peroxidation was determined by comparing the results of the test compound with untreated control extracts by monitoring the color intensity at 532 nm. Gallic acid was used as control positive. (21)

2. Antidiabetic marketing assessment using biomarkers formulatios polyherbal charantin: – Charantin is one of those present in Momordica charantia phytoconstituents. It is well known for having antihyperglycaemia, anti-cholesterol, immunosuppressive activities, gastroprotective, Antispermatogenic and androgenic. HPTLC method is rapid, accurate, sensitive and reproducible with good recoveries for the standardization of formulations polyherbal. The recovery values were found charantin about 98.89%. (2)

3. In vivo and in vitro in the evaluation of hair growth potential of the flower of the shoe: – The leaves and flowers of Hibiscus rosa-sinensis are used as promoters hair growth and aids in healing of ulcers. petroleum ether extract of leaves and flowers of the plant was assessed in vivo growth potential and in vitro methods. In vivo, 1% extract of leaves and flowers in the liquid was applied topically to the shaved skin of albino rats and monitoring and evaluation for 30 days. Hair length and the different cyclic phases of hair follicles, as anagen and telogen phases were determined at different periods time. In vitro, the hair follicles of albino rat neonates were isolated and cultured in DMEM supplemented with 0.01 mg / ml of petroleum ether extract leaves and flowers. We conclude that the leaf extract, compared with the flower extract, exhibits more power on hair growth. (22)

4. The clinical evaluation to assess the safety and efficacy of herbal medicine code "Dysmo-off" against allopathic medicine "Diclofenac Sodium" for the treatment of primary dysmenorrhea: – The clinical study on primary dysmenorrhea to comparatively examine the development coded herbal drug "Dysmo-off" with authentic allopathic medicine "Diclofenac sodium." A randomized controlled clinical trial was conducted. These assessments were based on the verbal rating scale to determine the rate of analgesic effects on pain dysmenorrhoeic. Patients were randomly assigned to the ratio of 1:2 for controlled treatment with drugs (NSAIDs) (n = 40) received Diclofenac sodium tablets twice daily for 4 days (50 mg a day before and three days after menstruation), and treatment of Dysmo-off test (n = 80) received Dysmo-off powder twice a day for 4 days (5 g day before and three days after menstruation). The treatment lasted for four consecutive menstrual cycles. Hemoglobin, ESR and ultrasonography were measured at baseline during the study. All subjects were studied clinically (23).

5. Assessment Thermal: – In this study, the authors used thermography to evaluate the effects of herbal formulations on the basis of "Sho" scientifically. In cases that were suitable for Keishibukuryogan, called Keishibukuryogan Sho, an increase of significant skin temperature was observed in the upper half the body after intake Keishibukuryogan. In a case that was suitable for Hochuekkito, a marked rise in skin temperature spread across the upper trunk. Suggested that thermography is useful for an objective assessment of Sho in Kampo medicine, and to identify the site of action of the formulation Herbal (24).

6. Biochemical assessment: – Most herbal medicines are a mixture of various ingredients. Their cumulative effect increases the effectiveness of the drug in curing diseases. Muthu Marunthu is a herbal formulation comprising of eight different plant ingredients, and claims that have anticancer effects. It was noted that the growth rate in rats was normal and there was no change in blood parameters such as glucose, urea, protein, cholesterol and also in the activities of pathophysiological enzymes such as lactate dehydrogenase (LDH), gluconate oxaloacetate transaminase (GOT), the glutamate pyruvate transaminase (GPT), alkaline and acid phosphatase after Muthu Marunthu administration. The tumor weight was found to be reduced in methylcholanthrene fibrosarcoma induced rats after Muthu Marunthu treatment. (25)

7. Evaluation of alkaloids Kutaj-Ghanavati principles: – Kutaj-Ghanavati is a reputed Ayurvedic preparation used in dysentery and diarrhea. Contains water extract of bark Kurchi dust and fine roots of aconite. Was evaluated quantitatively TLC and quality employment and the volumetric method. TLC study any interference from Kurchi aconite alkaloids and with each other in their respective solvent systems. The formulation was found to contain all Kurchi and Aconitum alkaloids. (26)

8. Organoleptic Evaluation: – Evaluation organoleptic food plays an important role to judge the acceptability of censure or no food on the market. Effect of various treatments (blanching, stinging, and treatment with bleach), the concentration of sugar (50%, 60%, 70%) and storage in color scores, scores flavor, texture scores of intermediate moisture apricots. The general acceptability of the products was significantly higher in sugar syrup 70% but these results decreased as the period advanced storage. (27)

CONCLUSION: - The issue of standardization of herbal medicines is massively wide and deep. There is much to know and so seemingly contradictory theories on the subject of herbal medicine and its relationship to human physiology and mental function.

For the purposes of research on the standardization of herbal formulations and a thorough knowledge of the herbs that can be found in India and widely used in Ayurvedic formulation is of paramount importance. (6)

Even if the chemical composition of an extract of the plant is known, pharmacologically active fraction can not be. Environment, climate, and growth of the membership to influence the conditions, as well as the specific the plant and its maturity. Monographs detail standardization of active ingredients would improve the market. Even if an herbal product is standardized, for example, 4% of a component, the remaining 96% of ingredients are not standardized and can affect the solubility of the product, bioavailability, stability, efficacy and toxicity. So as controlled trials are needed to establish the safety and efficacy, manufacturing standards are required to ensure product quality (28).

Now a day the new and advanced methods are available for standardization of herbal drugs such as fluorescence quenching, the combination chromatographic and spectrophotometric methods, bioassays, the use of biomarkers in fingerprinting, etc. may play a role bioassay important in the standardization of herbal medicines and can also become an important method of quality control and stability testing appropriate product (4).

India can emerge as the leading country and play a leading role in the production of the standard formulation, ayurveda therapeutically effective. India needs to explore the medicinally important plants. This can be achieved only if herbal products are evaluated and analyzed using standardization sophisticated modern techniques such as UV-visible, TLC, HPLC, HPTLC, GC-MS, and other spectrofluorimetric methods (6).

References

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About the Author

M.Pharm.(Pharmacognosy)
Lecturer at BN Girls college of Pharmacy, Udaipur-INDIA

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