WO2009141835A2

WO2009141835A2 - Novel formulations, herbal medicated threads and process for their preparation.

Info

Publication number: WO2009141835A2
Application number: PCT/IN2009/000276
Authority: WO
Inventors: Syed Mohammad Fazlur Rehman; Ismat Maab Fatima; Nishat Fatima; Syed Habeeb Ahmed; Syed Muaz Ahmad; Syed Mohammad Arqam; Syed Mohammad Salman
Original assignee: Syed Mohammad Fazlur Rehman; Ismat Maab Fatima; Nishat Fatima; Syed Habeeb Ahmed; Syed Muaz Ahmad; Syed Mohammad Arqam; Syed Mohammad Salman
Priority date: 2008-05-19
Filing date: 2009-05-11
Publication date: 2009-11-26
Also published as: WO2009141835A3

Abstract

Formulations and herbal medicated threads made therefrom are provided. The formulations comprise fresh herbal latex and surfactants, wherein constituents of the latex are obtained from latex producing plants. A process for preparing said formulations as well as a process for making herbal medicated threads, and their uses in the treatment of ano-rectal diseases and non-healing lesions of the body are also provided.

Description

NOVEL FORMULATIONS, HERBAL MEDICATED THREADS AND PROCESS

FOR THEIR PREPARATION.

Field of the Invention:

This invention, in general relates to a novel formulation and herbal medicated thread made therefrom for treatment of benign anorectal diseases. In particularly, the present invention provides a novel formulation comprising fresh herbal latex along with surfactant wherein the constituents of the latex are obtained from latex producing plants. Further the invention provides a process for preparing said formulation and uses thereof in the treatment of anorectal diseases particularly a complex fϊstula-in-ano.

Background of the Invention

Hitherto, ailments of fistula were treated by surgery, non-medicated thread(Seton- Hippocrate, 500years B.C.), medicated thread (Kshaara sootra-Sushruta, 600years B.C.), Fibrin glue, Radiofrequency and a new technique with acellular extracellular matrix but these methods still do not provide any certainty on the remission of disease or non occurrence of anal incontinence. Further the treatment period after surgery was long and generally associated with considerable pain to the patient, while use of commercially available Kshaarasootra which is a medicated thread is also associated with intense pain, vertigo and even occurrence of shock to the patient and anal incontinence due to which its use is not widely accepted. Similarly, other diseases like ulcer, cancer, abscess, condyloma, liver diseases, cancer, tumor, asthma etc are not treated effectively with the drugs available in the present scenario.

As mentioned above process for producing a medicated thread using latex for the treatment of benign ano-rectal diseases has been disclosed in the prior art (IN 186243). The process disclosed therein comprises providing plurality of layers of first coating of latex on the thread and drying the latex coated thread, and again providing the plurality of layers of second coating of Achyranthus aspera on said latex coated thread and drying the same and then finally providing the plurality of layers of third coating of Haldi (turmeric) on said coated thread and drying the said coated thread. However, there are several disadvantages are associated with this method. First of all the said process is very cumbersome as it involves several steps to apply multiple of layers of coating consisting of latex, multiple of layers of coatings consisting of Achyranthus aspera, multiple of layers of coatings consisting of Haldi (turmeric) which requires at least 5-10 times repetition of such steps after each coating. Secondly the process used stored latex and requires drying of coated thread at every step which decreases the medicinal properties of the medicated thread. Thirdly, use of such thread still does not provide any certainty on the cure of disease and some patients develop anal incontinence.

In traditional Indian medicinal system there are many plants having medicinal properties like anti-tumor, anti-ulcer, anti-piles etc. The whole plant or a part singularly holds medicinal property. An example is Euphorbia neriifolia a plant used for treating mainly the ailments of ano rectal diseases, Calotropis species used for a variety of disease conditions like leprosy, piles, tumors, ulcer, diseases of abdomen and spleen and strong cytotoxic effect in COLO 320 tumor cells [Smith HF, Woerdenbag HJ, Singh RH, Meulenbeld GJ, Labadie RP, Zwaving JH(1995)]. While Latex of plants belonging to family Moraceae is also useful in the treatment of diarrhoea and dysentery. Certain groups have also worked on anti tumor activity of Calotropis extracts. Whereas no group has worked or applied Calotropis extract for treatment of ano rectal diseases.

Accordingly the present invention not only provides a novel formulation but also a herbal medicated thread for treatment of benign ano-rectal diseases, which can avoid the problem associated with prior arts and completely ensures a complication free remission without recurrence of disease. The present also proposes to provide a simple non cumbersome single step process to prepare the medicated thread which is very economical and cost effective and also at the same time produces a medicated thread which is most effective in curing the disease completely thereby avoiding the pains and anal incontinence occurred during surgery or with other procedures. Summary of the Invention

In accordance with one aspect of the present invention, there is provided a novel formulation for non-malignant ano-rectal diseases comprising fresh herbal latex along with surfactant of the kind as herein described wherein the constituents of the latex are from plants of family asclepdiaceae, moraceae, euphorbiaceae and caricaceae and said latex is mixed with surfactant in a ratio range of 1:0.10 to 1:10.00.

In accordance with another aspect of the present invention, there is provided a novel formulation for benign ano-rectal diseases, wherein said formulation is prepared by a process comprising obtaining a fresh milky sap and exudates from the part of plant employing hygienic method of wild collection in an sterilized glass container having with surfactant of the kind as herein described.

In accordance with one other aspect of the present invention, there is provided a herbal medicated thread used in ano-rectal diseases having a single or plurality of layers of coating of the novel formulation comprising fresh herbal latex along with surfactant wherein the constituents of the latex are from plants of family asclepdiaceae, moraceae, euphorbiaceae and caricaceae. j

Detailed Description of the Invention

While this specification concludes with claims particularly pointing out and distinctly claiming that, which is regarded as the invention, it is anticipated that the invention can be more readily understood through reading the following detailed description of the invention and study of the included examples which are given for the purpose of illustration only which should, in no way, be understood to limit the scope of the invention. Therefore other embodiments which may be possible within the scope of the invention but not described herein are not excluded,

The present invention provides a novel formulation for benign ano-rectal disease, ulcer, fistula, abscess, sinus, wart, condyloma etc.

According to the present invention, there is provided a novel formulation for benign ano-rectal diseases comprising fresh herbal latex along with surfactant of the kind as herein described in a ratio range of 1 :0.10 to 1 : 10.00, wherein the constituents of the latex are from plants of family asclepdiaceae, moraceae, euphorbiaceae and caricaceae, wherein the latex and exudates of the plant contain active ingredient having healing/protective property against many diseases.

According to present invention, the formulation as herein described, could also be advantageously used in making suitable forms like solution, spray, lotions, ointments, gels, suppositories, injections, capsules, tablets, surgical sutures, syrup, emulsions etc. for use in other diseases like asthma, ulcer, Fistula, abscess, sinus, wart, condyloma, cancer, rheumatoid and other inflammatory diseases etc. It can also be used in cosmetics, dietary and for dressing material for non-healing ulcers with assured results. It could also be successfully used as a spermicidal agent directly or indirectly by irrigating the distal part of vas deferens in cases of vasectomy to make the operation instantaneously effective without the need of further use of contraceptive post operatively. Further, the formulation is advantageous in reducing the recurrence of the disease compared to surgery and other methods including commercially available Kshaarasootra and other techniques.

The process for preparing the formulation disclosed herein according to the present invention, comprises obtaining a fresh milky sap and exudates from the part of plant employing hygienic method of wild collection in an sterilized graduated glass container having surfactant in a ratio range of 1 :0.10 to 10.00 and mixing the same by continuous shaking the container throughout the process of latex collection. Wherein the hygienic method of wild collection of fresh milky sap and exudates from the part of plant includes thorough washing of the portion of plant from where the fresh latex and exudates are to be collected, by the use of water and surfactant already sterilized by boiling and then proceeding further by partly cutting, piercing or incising the cleaned portion of the plant with sterile surgical blade and by using the disposable sterile gloves and then collecting the flowing latex in an sterilized graduated glass container having surfactant.

According to the present invention there is a provided process for producing Herbal Medicated Threads, gel and lotions (direct or in spray form) for treatment of ano rectal diseases, ulcer, fistula, abscess, sinus, wart, condyloma, asthma, etc., comprising providing a preparation of a solution of fresh latex and exudates of any part, under aseptic condition, of the particular plant in a preferably non ionic surfactant in isolation or in different combinations and permutations.

In accordance with this invention the Herbal Medicated Thread is first treated with the said composition so that it is receptive to coating thereon. The thread should have sufficient tensile strength, as the solution of latex applied thereon is rich in enzymes and other active substances, which would normally destroy the thread to a certain extent. By way of example, the thread comprises a strong cotton thread such as Lenin No.l 0, 20, 40 etc available commercially. Instead of cotton, a synthetic thread having good tensile strength like polyamide or polyester threads do not have suitable absorbency and/or binding property. Thus for this purpose, it is preferred that the thread employed for absorbing the solution of latex and exudates should be of cotton having the required strength.

The first step of the process of preparation of Herbal Medicated Thread consists of applying a prepared solution of latex and exudates, namely of plants like Calotropis gigantea, Euphorbia neriifolia, Carica papaya, Ficus reiigiosa, Calotropis procera of family: Euphorbiaceae, Caricaceae, Asclepdiaceae and/or Moraceae with either of the nonionic surfactants like Alkyl phenol ethoxylate, Sorbitan ester surfactants and Alcohol ethoxylates. Different formulations can be used depending upon the need of specific disease condition, stage and type of disease presentation in a particular patient e.g., in the case of low fistula in ano if it is of anal (submucoustype)only local use of gel or lotion or emulsion could be enough. But in case of high (complex) fistula in-ano, the use of Herbal Medicated Thread becomes mandatory since beginning.For Herbal Medicated Thread, the cotton thread already sterilized by autoclave is passed through a bath containing the aforesaid solution of latex and exudates collected in non-ionic surfactant and then dried. Such a process of impregnation of cotton thread with the solution is repeated several times to ensure that the solution is absorbed into the pores of the thread and further have sufficient adhesive properties. Such a step is repeated multiple times, preferably at least seven to eleven times, and after coating the thread is subjected to the step of drying. Hot air blower at the temperature below fifty degree Celsius could also be used for drying purpose.

The final step of storage of the Herbal Medicated Thread, lotion, emulsion and gel could only be of a sterilized dark glass container kept at cool and dry place until it is used.

Several distinct advantages are associated with use of Herbal Medicated Thread. One such advantage is that a non-toxic nonionic surfactant is used, (which are already in human use for more than 25-years) for encapsulation(micro or nano) of active herbal ingredients of live plants for strolled delivery at the diseased site. Another advantage is that, this Herbal Medicated Thread is most tolerated with minimum pain and shortest healing time of 7 to 14 days. Yet another advantage is that the cure rate of patient is almost 100% without recurrence of disease. A further advantage is that such herbal medicated thread is not harmful to human and normal tissue and does not cause anal incontinence.

Our experiences of treating benign ano-rectal diseases and non-healing ulcers during preceding five years yielded excellent results. The patients suffering with complex fistula in- ano are frequently referred to me by colleague surgeons for the treatment with herbal medicated thread and none of these patients who received this treatment has returned with recurrence or complication till date. The formulations used to treat these patients are as follows;

Formulation -1

The formulation was prepared by mixing 5.00 gms of freshly taken Latex of Eurphobia neriifolia plant with 5.00 Gms of Nonyl phenol ethoxylate (Alphox-100) as surfactant and emulsion resulted from aforesaid formulation was used to impregnate the 10-meterlength of No.20 autoclaved cotton thread of brand Barbours' thread) to prepare the herbal medicated thread.

Formulation -2

The formulation was prepared by mixing 4.00 gms of freshly taken Latex of Calotropis procera plant with 8.00 Gms of Nonyl phenol ethoxylate (Alphox-200) as surfactant and emulsion resulted from aforesaid formulation was -used to impregnate the 10-meter length of No.20 autoclaved and pre-soaked cotton thread of brand Barbours' thread with the fresh gel of the plant Aloevera barbedensis to prepare the herbal medicated thread.

While this invention has been described in detail with reference to certain preferred embodiments, it should be appreciated that the present invention is not limited to those precise embodiments rather, in view of the present disclosure, which describes the current best mode for practicing the invention, many modifications and variations, would present themselves to those skilled in the art without departing from the scope and spirit of this invention. This invention is susceptible to considerable variation in its practice within the spirit and scope of the appended claims.

Claims

We Claim:

1. A novel formulation comprising fresh herbal latex along with surfactant of the kind as herein described in a ratio range of 1 :0.10 to 1 :10.00 wherein the constituents of the latex used are freshly obtained from the plants of family Asclepdiaceae, Moraceae, Euphorbiaceae and Caricaceae.

2. The novel formulation as claimed in claim 1, wherein said latex is a fresh milky sap with exudates procured by a hygienic method of wild collection from the parts of plants.

3. The formulation as claimed in claim 1, wherein the plants are preferably Calotropis gigantea, Calotropis procera, Ficus religiosa, Euphorbia neriifolia and Carica papaya.

4. The formulation as claimed in claim 1, wherein said surfactant is preferably a non-ionic surfactant.

5. The formulation as claimed in claim 4, wherein said non-ionic surfactant is selected from Alkyl phenol ethoxylate, Sorbitan ester surfactants or Alcohol ethoxylates.

6. The formulation as claimed in claim 1, wherein said formulation is solution, spray, lotion, ointment, gel, suppository, injection, capsule, tablet, surgical suture, syrup, emulsion or any other pharmaceutically suitable forms.

7. A process for preparing the novel formulation as claimed in claim 1 wherein said process comprising obtaining a fresh milky sap , and exudates from the part of plant latex employing hygienic method of wild collection in an sterilized and graduated glass container having surfactant of the kind as herein described in a ratio of 1 :0.10 to 1 : 10 & preferably of 1 : 1 and 1 :2.

8. The process as claimed in claim 7, wherein the formulation is micro and/or nano dispersion and/or encapsulation of latex component in surfactant or vice versa.

9. The formulation according to claim 1 , wherein said formulation is used to prepare herbal medicated thread, gel, lotion or suppository for treatment of benign anό-rectal- diseases, ulcer, fistula, abscess, sinus, wart, condyloma etc.

10. A herbal medicated thread for treatment of benign ano-rectal diseases having a single or plurality of layers of coating the autoclaved cotton thread with a novel formulation comprising fresh herbal latex along with surfactant as herein described in a ratio range of 1 :0.10 to 1 : 10.00 wherein the constituents of the latex are from plants of family Asclepdiaceae, Moraceae, Euphorbiaceae and Caricaceae.

1 1. A herbal medicated thread as claimed in claim 10 wherein the said autoclaved cotton thread be preferably be soaked with fresh gel of plant Aloevera barbedensis.

12. A herbal medicated thread as claimed in claim 10, wherein said thread is optionally being coated about seven to eleven layers and said thread is being dried after each step of coating.

13. A herbal medicated thread as claimed in claim 10, wherein the herbal medicated thread is advantageously used in benign ano-rectal diseases especially of the complex type of fistula-in-ano

14. A novel formulation and herbal medicated thread useful for the treatment of ano rectal disease substantially as herein described.

15. A process for preparing the novel formulation and herbal medicated thread useful for the treatment of ano rectal disease substantially as herein described.