IV. L A EXISTENCIA DE D IOS Y LA SUMISIÓN DE LA VOLUNTAD
7. Las verdades eternas y la omnipotencia divina
D¡ruharidr¡ consists of dried stem of Berberis
aristata DC. (Fam. Berberidaceae); an erect,
spinous, deciduous shrub, usually 1.8-3.6 m in height found in the Himalayan ranges at an elevation of 1000-3000 m, and in the Nilgiri hills in south India. D¡ruharidr¡ contains not less than 0.4 per cent of berberine when assayed.
Synonyms:
Ka¶a´ka¶er¢, D¡rv¢Other/Regional Language Names:
Bengali: Daruharidra; English: Indian Berberry; Gujarati: Daruharidra, Daruhuladur; Hindi:
Daruhaldi, Darhald; Kannada: Maradarishana, Maradrishina, Daruhaldi; Kashmiri: Ras ashud, Rasvat; Malayalam: Maramannal, Maramanjal;
Marathi: Daruhalad; Oriya: Daruharidra, Daruhalidi; Punjabi: Sumalu; Tamil: Gangeti, Varatiu manjal; Telugu: Manupasupu; Urdu: Darhald
Description:
a) Macroscopic:
Drug available in pieces of variable length and thickness, bark about 0.4-0.8 cm thick, pale yellowish-brown, soft, closely and rather deeply furrowed, rough, brittle, xylem portion yellow, more or less hard, radiate with xylem rays, pith mostly absent, when present small, yellowish- brown when dried, fracture short in bark region, splintery in wood; taste bitter
b) Microscopic:
Stem - Shows rhytidoma with cork consisting of 3-45
rectangular and squarish, yellow coloured, thin-walled cells, arranged radially; sieve elements irregular in shape, thin walled, a few cells containing yellowish- brown contents; phloem fibres arranged in tangential rows, consisting of 1-4 cells, each fibre short thick- walled, spindle-shaped, lignified having wide lumen; half inner portion of rhytidoma traversed by secondary phloem rays; phloem rays run obliquely consisting of radially elongated parenchymatous cells, almost all phloem ray cells having single prismatic crystals of calcium oxalate, a few cells of rhytidoma also contain
prismatic crystals of calcium oxalate; stone cells also found scattered in phloem ray cells in groups, rarely single, mostly elongated, a few rounded; secondary phloem, a broad zone, consisting of sieve elements and phloem fibres, traversed by multiseriate phloem rays; sieve elements arranged in tangential bands and tangentially compressed cells alternating with single to five rows of phloem fibres, secondary xylem broad consisting of xylem vessels, tracheids, xylem fibres and traversed by multi seriate xylem rays; xylem vessels numerous, small to medium sized, distributed throughout xylem region in groups or in singles, groups of vessels usually arranged radially; isolated vessels cylindrical with rounded or projected at one or both ends with spiral thickenings; fibres numerous, lignified, large, thick-walled with wide lumen, and pointed tips; xylem rays quite distinct, straight, multiseriate, consisting of radially arranged rectangular cells, each ray 30-53 cells high, 8-12 cells wide, a few ray cells containing brown contents
Fig. 1: Powdered drug of DËRUHARIDRË (Berberis aristata DC.)
Rf
0.0 0.5 1.0
c) Powder:
Fine powder shows mostly fragments of cork cells, yellow coloured phloem fibres entire or in pieces, stone cells in singles or in groups, numerous prismatic crystals of calcium oxalate, xylem vessels having spiral thickenings, thick-walled, lignified xylem fibres and ray cells (Fig. 1)
Identity, Purity and Strength:
Identification:
Thin-layer chromatography:
Carry out thin-layer chromatography on a precoated silica gel 60F254 plate (Appendix 3.5)
using berberine chloride as a reference standard.
366 nm
RS T
Fig. 2: Thin-Layer Chromatogram of D¡ruharidr¡
RS: Berberine chloride, T: Test solution
Test solution: Extract 0.2 g of substance by
refluxing with 50 ml of methanol for a period of 10-15 min. Filter and concentrate the extract to 25 ml. Standard solution: Dissolve 10 mg of
berberine chloride RS in about 100 ml of methanol. Procedure: Apply 10 l each of the test and standard solutions as bands at a height of 10 mm from the base of a 10 x 5 cm TLC plate and develop up to 8 cm from the base of the plate using the mobile phase : n-butanol : glacial acetic
acid : Water (6.5 : 1.5 : 2.0). Dry the plate in air
and examine under UV 366 nm. The chromatographic profile of the test solution shows a band corresponding to that of the standard solution (Fig. 2).
Quantitative parameters:
Foreign matter: not more than 2.0 per cent
(Appendix 2.1.3); Loss on drying: not more than 12.0 per cent (Appendix 2.1.4); Total ash: not more than 14.0 per cent (Appendix 2.1.5); Acid-
insoluble ash: not more than 5.0 per cent
(Appendix 2.1.7); Alcohol-soluble extractive: not less than 6.0 per cent (Appendix 2.1.8); Water-
soluble extractive: not less than 8.0 per cent
(Appendix 2.1.9)
Other requirements:
Heavy metals:Complies with the prescribed limits, (Appendix 3.1); Microbial contamination: Complies with the prescribed limits, (Appendix 3.2); Pesticide
residues: Complies with the prescribed limits,
(Appendix3.3); Aflatoxins: Complies with the prescribed limits, (Appendix 3.4)
Assay:
Carry out the assay by liquid chromatography (Appendix 3.6). Test solution: Take about 2 g, accurately weighed, of the substance being examined and reflux with methanol (25 ml x 3) on water bath for 15 min each, cool and filter. Combine all the filtrates and transfer to a 100-ml volumetric flask and make up the volume with
methanol. Dilute the solution to match the
standard concentration. Filter through 0.42 m membrane. Standard solution: Take about 10 mg, accurately weighed, berberine chloride RS in a 100 ml volumetric flask and dissolve in about 25 ml of methanol and make up the volume with
methanol. Dilute 5 ml of this solution to 25 ml.
Filter through 0.42 m membrane.
Chromatographic system: High performance
liquid chromatography. Column and stationary
phase: Silica CN (250 mm x 4.6 mm, 5 m). Mobile phase: Filtered and degassed mixture of
35 volumes of acetonitrile and 65 volumes of
water containing 0.3 per cent w/v of orthophosphoric acid. Injection volume: 20 l. Flow rate: 1.5 ml per min. Detection: UV 346 nm. Procedure: Inject 20 l of the standard solution
and record the chromatogram. Inject 20 l of the test solution, record the chromatogram and measure the response for the analyte peak. Calculate the content of berberine in the substance being examined from the peak response of analyte. The test is not valid unless the relative standard deviation for replicate injections is not more than 2.0 per cent.
Fig. 3: HPLC chromatogram of D¡ruharidr¡ with Berberine chloride as RS
Additional requirements:
Storage: Store in well closed container protected
from heat, light, moisture and against attack by insects and rodents.
Labelling: The label states the official name,
followed by the Latin binominal name and the part of the plant contained in the article.
API reference standard:
API Berberine chloride RS