Title of Invention	A HERBAL PHARMACEUTICAL PREPARATION FOR THE TREATMENT OF LEUCODERMA
Abstract	A pharmaceutical preparation for the treatment of leucoderma comprising 5 to 9 gms of a mixture of tyrosine and a diluent and optionally 1 to 5 gms of a mixture of methionine and a diluent and 1 gm of an inorganic salt of zinc.

Full Text

FIELD OF THE INVENTION The present invention relates to a pharmaceutical preparation for the treatment of leucoderma. BACKGROUND OF THE INVENTION Leucoderma or vitiligo is a disease commonly associated with failure of pigmentation of the skin. Para-aminobenzoic acid, panthothenic acid and biotin are alleged to function in the process dealing with pigmentation of the skin. It is true that gray-haired condition has been produced in rats, dogs, guinea- pigs and silver faxes on certain types of deficient diets: but it seems a far cry from this experimental procedure to the process of aging as it occurs in human being. An enzyme tyrosinase converts Tyrosine into melanin, a brownish black pigment present in skin and hair. The mechanism by which this transformation is accomplished is not known. According to Raper, a hydroxy lotion of benzene nucleus possibly takes place, followed by ring closure whereby indole derivatives are formed. Para-aminobenzDic acid modifies the formation of melanin. In the Tyrosine-tyrosinase reaction, a typical red stage 1 is reached before the black precipitate of melanin is obtained. In the presence of the acid, the red stage is not seen and in the place of the black melanin precipitate, a brownish product is obtained. It has also been claimed that melanophore hormone of the pituitary accelerates the tyrosine-tyrosinase reaction. There are different degrees and forms of the disease and the cure mainly depends on the extent of manifestation. This is due to the shortage or complete absence of tyrosinase in the system. Several ayurvedic preparations are known to be prescribed for vitiligo such as a composition comprising Psoralia Coryfolia, commonly known as buchkidana and Pavonia Odorata, commonly known as udicha. Another commonly prescribed composition is a mixture of Plumbago Rosea Linn. (Raktachita) and Mussaenda frondosa Lin (Nagballi). However, presently no cure is known for the disease, particularly in its advanced stages. OBJECTS OF THE INVENTION It is therefore an object of this invention to propose a pharmaceutical preparation for the treatment of leucoderma. It is a further object of this invention to propose a pharmaceutical preparation for the treatment of leucoderma which is cheap and can be made easily available. Another object of this invention is to propose a pharmaceutical preparation for the treatment of leucoderma which is efficient even for advanced stages of the disease. DESCRIPTION OF THE INVENTION According to this invention, there is provided a pharmaceutical preparation for the treatment of leucoderma comprising tyrosine, a diluent and optionally methionine and an inorganic salt of zinc . According to this invention, there is further provided a process for the preparation of a pharmaceutical composition for the treatment of leucoderma comprising mixing tyrosinase with a diluent to obtain a first mixture, mixing the first mixture with a zinc salt and optional additives to obtain the pharmaceutical composition, optionally preparing a second mixture of methionine and the diluent and adding the second mixture to the first mixture, before adding the zinc salt thereto. The pharmaceutical preparation is in the form of an oral formu- lation or a topical formulation. The topical formulation comprises tyrosine and a diluent in a carreir such as water. About 1 to 3 gms of the mixture of tyrosine and the diluent is dissolved in about 45 to 135 ml distilled water and 5 to 15 ml of a preservative such as 90% rectified spirit is added to it to obtain the topical formulation. The oral formulation comprises tyrosine, methionine, diluent and an inorganic salt of zinc. In accordance with this invention, the oral formulation is prepared by thoroughly mixing tyrosine with a diluent and slowly increasing the proportion of the diluent to obtain a mixture of tyrosine and the diluent. Thereafter, methionine is mixed with the diluent and the dilution is slowly increased by increasing the proportion of sugar to obtain a mixture of methionine and the diluent. The two mixtures are then mixed thorouqly and zinc sulphate is added to it, followed by a further mixing. Thereafter, optional additives are added to the mixture obtained to obtain the oral formulation. About 5 to 9 gms of the mixture of tyrosine and the diluent is mixed with 1 to 5 gms of methionine mixture and about 1 gm of the inorganic salt of zinc is mixed together to obtain the oral formulation. The inorganic salt of zinc, is any salt of zinc, preferably a sulphate. The diluent used is a sugar such as lactose, fructose, sucrose, glucose, etc., preferably lactose. The binder is a compound such as carboxymethyl cellulose; the disintegrant used is starch 5 the glidant used is such as aerosil; magnesium stearate. The lubricant used is a compound such as talcum powder and the preservative is a paraben compound such as methyl paraben, propyl paraben, etc.. The carrier used for the topical formulation is a solvent such as water. The invention will now be explained in greater detail with the help of the following non-limiting examples. EXAMPLE 1 About 1 gm of tyrosine is thoroughly mixed with about 9 gms of lactose (80-100 mesh) placed in a mortar and the mixture is macerated for 60 mins.. Every 5 mins. of maceration is followed by mixing for 1 min.. This process is repeated 10 times. The mixture is transferred in a bigger mortar and fresh lactose of 90 gms is mixed with it for about 10 mins.. It is again macerated for 5 mins. and mixed for a minute. This process is repeated 10 times. Fresh lactose, 900 gms is taken in a big mortar and the mixture obtained earlier is poured over it, followed by thorough mixing for about 10 mins.. This is again followed by maceration for 5 mins. and mixing for a min., 10 times to obtain the tyrosine mixture of 1000 dilution. In a similar way, about 300 mg of methionine is mixed with 2.7 gms of lactose for about 5 mins.. This is followed by maceration for 5 mins. and mixing for a min., 10 times to obtain a mixture. In another mortar, about 27 gms lactose is taken and the mixture is poured over it and mixed thoroughly. It is macerated for 5 mins. and mixed for a min., 10 times to obtain a mixture, which is again mixed with about 270 gms of lactose. This is again followed by maceration for 5 mins. and mixing for 1 min., 10 times to obtain the methionine mixture of 1000 dilution. TOPICAL FORMULATION. About 2 gms of the tyrosine mixture is dissolved in about 90 ml distilled water and to this solution, about 10 ml 90V. rectified spirit is added and the mixture is shaken to obtain the topical formulation. ORAL FORMULATION About 7 gms of tyrosine mixture and 3 gms of methionine are mixed thoroughly for about 20 mins. and 100 mgs or 0.1 gms zinc sulphate, pulverised to a very fine mesh size added to the mixture with thorough mixing. EXAMPLE 2 For the preparation of caplets, tyrosine and methionine are diluted separately with lactose (80~100mesh) as per homoeopathic method of dilution to 1000 times. Both the diluted forms of tyrosine and methionine are well mixed. Zinc sulphate is pulverised to very fine mesh. Powder obtained, ie. mixture of tyrosine + methionine are mixed geometrically with zinc sulphate powder. So all the three active ingredients are well mixed with lactose. This mixed powder is the starting for tablet (cap let) manufacture. These ingredients except talcum powder are mixed together thoroughly in tablet mixing drum for 45 mins.. The powder is then slugged, ie,, they are preliminary compression of fine powder into rough tablets or slugs followed by their grinding into granular particles. The granules are separated, mixed with lubricants, ie. talcum powder and compressed in suitable tablet punching machine. CAPSULE MAKING Powder of the three active ingredients for 50,000 capsules = 50.05 kgs. are mixed with 1.5 kgs. light Mag. Carb. and 0.5 kgs. Aerosil and mixed thoroughly. Total weight terms to 52.05 kgs. Average weight of content of each capsule = 1.041 gms. approx.. The powder is now filed in number "000" capsules. The preparation according to the invention has been administered to a number of patients and the results have been quite encoura- ging. The treatment is based on administering the preparation in daily doses with very low concentration of the constituents) alongwith application of the topical formulation. Application of the topical formulation on the affected area is fallowed by exposure to sunlight. The preparation works on the principle of Arndt., ie. weak stimuli excite-physiologic activity, moderately strong ones favour it, strong ones retard it and very strong ones arrest it. The results of the chemical trials is as follows: The preparation has been successfully used for treating vitiligo and has been particularly successful when the disease is detected in the early stages. Cure is passible within 15 days to 1m. If detected xn the late stages, ie. from a year to about 6 years old, cure is passible within 1 to 3 years. Extreme cases have so far not been cured. I CLAIM: 1. A pharmaceutical preparation for the treatment of 1encoderma comprising 5 to 9 gms of a mixture of tyrosinc and a diluent and optionally 1 to 5 gms of a mixture of methionine and a diluent and 1 gm of an inorganic salt of zinc 2. The pharmaceutical preparation for the treatment of leucoderma as claimed in claim 1, wherein said mixture of tyrosine and diluent is obtained by mixing thoroughly 1 gm of tyrosine and 9 gms diluent, followed by mixing and adding 90 gms, diluent thereto, followed by mixing and adding a further 900 gms diluent, to obtain the tyrosine mixture of 1000 dilution. 3. The preparation as claimed in claim 1 wherein the mixture of methionine is a composition of 300 mg of methionine and 2.7 gms of diluent thoroughly mixed and followed by maceration, 27 gms diluent is added to the said composition and mixed thoroughly and maceration) further 270 gms of diluentand again is added to the last composition and the same steps are followed to obtain a mixture of 1000 dilution. 4. The preparation as claimed in claim 1 in the form of a topical for mulation and an oral formulation. 5. The preparation as claimed in claim 1 optionally comprising additives such as carriers, binders, disintegrants, glidants, anti—adhesives, lubricants and preservatives. 6. The preparation as claimed in claim 1 wherein the zinc salt is zinc sulphate. 7. The preparation as claimed in claims 4,5 wherein the diluent for the oral formulation is a sugar such as glucose, lactose, sucrose, fructose and the like* preferably lactose. 8. The preparation as claimed in claims 4,5 wherein the carrier for the topical formula is water. 9. The preparation as claimed in claim 9 wherein the binder is a compound such as carboxy—methyl cellulose. 10. The preparation as claimed in claim S wherein the disintegrant used is starch. 11. The preparation as claimed in claim 5 wherein the glidant used is selected from aerosil* magnesium stearate. 12. The preparation as claimed in claim S wherein the lubricant used is such as talcum powder. 13. The preparation as claimed in claim 5 wherein the preservative used is a paraben compound such as methyl paraben, propyl paraben. 14. The preparation am claimed in claim 1 wherein the preservative for the topical formulation is art alcohol much am rectified spirit. 15. The preparation am claimed in claim 5 wherein the oral formulation is in the form of tablets and capsules. 16. A process for the preparation of a pharmaceutical composition for the treatment of leucoderma comprising mixing tyrosinase with a diluent to obtain a first mixture* mixing the first mixture with a zinc malt and optional additives to obtain the pharmaceutical composition, optionally preparing a second mixture of methionine and the diluent and adding the second mixture to the first mixture, before adding the zinc salt thereto. 17. The process as claimed in claim 16 wherein said pharma- ceutical composition is in the form of an oral or topical formulation. 18. The process as claimed in claim 16 wherein maid optional additives are carriers, binders, disintegrants, glidants, anti- adhesives, lubricants and preservatives. 19. The process as claimed in claim 16 wherein 5-9 gms of the first mixture, 1-5 gms of the second mixture and 1 gm of line salt is used for the oral formulation. 20. The process as claimed in claim 16 wherein during the step of mixing tyrosine or methionine with the diluent, the proportion of diluent is slowly increased in the mixture. 21. The process as claimed in claim 16 wherein said first mixture is mixed with a carrier such as water, and preservative such as rectified spirit for the topical formulation. 22. The process as claimed in claim 16 wherein the diluent is pulverised to 80-100 mesh size. 23. The process as claimed in claim 16 wherein the zinc salt is zinc sulphate. 24. The process as claimed in claims 17*18 wherein the diluent for the oral formulation is a sugar such glucose* lactose, sucrose, fructose and the like, preferably lactose. 25. The process as claimed in claims 17, 18 wherein the carrier for the topical formulation is water. 26. The process as claimed in claim 16 wherein the binder is a compound such as carboxy-methyl cellulose. 27. The process as claimed in claim 18 wherein the disintegrant used is such starch. 28. The process as claimed in claim 18 wherein the glidant used is such as aerosil, magnesium stearate. 29. The process as claimed in claim 18 wherein the lubricant used is such as talcum powder. 30. The process as claimed in claim 18 wherein the preservative used is a paraben compound such as methyl paraben, propyl paraben. 31. The process as claimed in dim 18 wherein the oral formulation is in the form of tablets and capsules. A pharmaceutical preparation for the treatment of leucoderma comprising 5 to 9 gens of a mixture of tyrosine and a diluent and optionally 1 to 5 gms of a mixture of methionine and a diluent and 1 gm of an inorganic salt of zinc

Documents:

460-cal-2002-granted-abstract.pdf

460-cal-2002-granted-claims.pdf

460-cal-2002-granted-correspondence.pdf

460-cal-2002-granted-description (complete).pdf

460-cal-2002-granted-form 1.pdf

460-cal-2002-granted-form 18.pdf

460-cal-2002-granted-form 2.pdf

460-cal-2002-granted-form 3.pdf

460-cal-2002-granted-letter patent.pdf

460-cal-2002-granted-pa.pdf

460-cal-2002-granted-reply to examination report.pdf

460-cal-2002-granted-specification.pdf