GB2387780A

GB2387780A - Herbal composition

Info

Publication number: GB2387780A
Application number: GB0209191A
Authority: GB
Inventors: Chaudhry Zamir Ahmad; Guzanfar Ali; Mohammad Irshad
Original assignee: Individual
Current assignee: Individual
Priority date: 2002-04-23
Filing date: 2002-04-23
Publication date: 2003-10-29
Also published as: GB0209191D0

Abstract

A pharmaceutical composition comprising the herbs Stramoniurn and Nux vomica. Preferably the composition further comprises (i) at least one component selected from Ptychotis Ajowa, Piper Nigrum, Glycyrrhiza Glabra, Zingiber Officinalis, Withania Somnifera, Rauwolfia Serpentina, Pistacia Lentiscun, Silajitu, Musk, Sinapist Juncea or hydrolysed pearls and (ii) at least one of the support herbs Tribulus Terrestris, Balsomdendron Mukal, Rhinocanthus Communis, Ancylus Pyrethrum or Lactuca Satvia. The composition finds use in the treatment of drug addiction, in particular opoids such as heroin. The composition is for oral administration and helps the patient with symptomatic relief from drug craving.

Description

1 2387780

Composition The present invention relates to a composition, particularly, although not exclusively, to a herbal 5 composition for the treatment of drug addiction.

There are a wide number of drugs, both legal and illegal, to which people may become addicted. Of these addictions it is possibly addiction to opioids which is 0 most harmful to both the drug user and society. There are a range of opioids, both natural opiates and synthetic opiates some of which have legitimate medical uses, but heroin (di-acetyl morphine) is a dangerous and addictive drug which is used "recreationally".

Opioid powders can be swallowed or dissolved in water and injected, particularly into a vein, which maximises their effect. When sold for recreational use heroin is likely to have been diluted or cut with a variety of 20 powders having a similar appearance. The main diluent is glucose. However, other substances such as caffeine, flour and talcum powder are often used and present a source of danger to heroin users.

25 Heroin is the most addictive of the opioid derivatives. The principal effects of heroin are significant damping of pain perception along with a modest level of sedation and creation of a sense of euphoria. If a person takes heroin in repeated and frequent doses then 30 they will develop a mild level of tolerance to it. Once a person becomes an habitual heroin user then they develop a moderate tolerance to moderate doses of heroin. At a moderate dose level neuronal adoption develops and the

heroin user will feel normal for short time periods but will also experience "withdrawal sickness" until they take their next dose of heroin. As a result of increased, repeated and frequent doses the heroin user develops a 5 high tolerance. The heroin user thus becomes fully addicted and needs to take heroin to prevent themselves from feeling sick. If the heroin user does not take I heroin for a period of time then withdrawal symptoms, called "abstinence syndrome", appear. These symptoms lo include anxiety and a craving for drugs, yellowing, perspiration, rhinorrhoea and teary eyes. Further symptoms are pupil dilation, tremour(muscle twitching), hot and cold flushes, muscle aches and loss of appetite as well as insomnia, raised blood pressure, high temperature, 5 high pulse rate, restlessness and nausea. In extreme case the intensity of the above symptoms is greater and additional symptoms include vomiting, diarrhoea, weight loss, spontaneous ejaculation or orgasm and increased I blood sugar levels.

A known method of treating heroin addiction comprises weaning the heroin user off their addiction. Generally, the opioid methadone is prescribed to be used in place of heroin. Initially the methadone is prescribed at a 25 relatively high dose and the dosage is then reduced over a period of several months or years. This method of treatment is not ideal as the heroin user remains addicted to opioids and has to continue taking them for a considerable time after their decision to stop taking 30 heroin.

It is an object of the present invention to provide an alternative to methadone for the treatment of heroin addiction. 5 According to a first aspect of the present invention there is provided a composition comprising Stramonium seeds or a derivative or extract thereof (herein "Stramonium component") and Nuxvomica seeds or a derivative or extract thereof (herein "Nuxvomica lo component").

References to derivatives of seeds herein include those produced by comminution, for example by grinding, chopping or powdering seeds.

References to extracts of seeds herein include extracts obtained from the seeds by known extraction methods, for example extracts produced by solvent extraction. Preferably, the Stramonium component comprises a derivative of Stramonium seeds. Preferably, said Stramonium component comprises comminuted, for example, powdered, Stramonium seeds.

Preferably, the Nuxvomica component comprises a derivative of Nuxvomica seeds. Preferably, said Nuxvomica component comprises comminuted, for example powdered, Nuxvomica seeds.

Preferably, the composition further comprises at least one further component which may comprise a diluent or active ingredient.

Unless otherwise stated, the or each additional component may be a naturally occurring material or a derivative or extract thereof.

Preferably, the composition comprises the Stramonium component and Nuxvomica component in a ratio of between 1:4 and 4:1 by weight, preferably between 1:2 and 2:1, more preferably between 2:3 and 3:2, for example in a lo ratio of between 5:6 and 6:5.

Preferably, the composition comprises between 3 and 12% of Stramonium component by weight, more preferably between 4 and 10%, for example between 5.5 and 6.5%.

Preferably, the composition comprises between 3 and 12% of Nuxvomica component by weight, more preferably between 4 and 10%, for example between 5.5 and 6.5%.

20 Preferably, the composition further comprises supporting herbs, which comprise one or more selected from Tribulus Terrestris extract, Balsomodendron Mukal and Rhinocanthus Comunis.

25 Preferably, the composition further comprises hydrolyzed pearls. Preferably, the composition comprises hydrolyzed pearls and supporting herbs. Preferably, the sum of the amount of hydrolyzed pearls and supporting herbs in the composition is between 3 and 12% of the 30 composition by weight, more preferably between 4 and 10%, for example between 5.5 and 6.5%. Preferably, the supporting herbs represent less than 5% by weight of the composition, more preferably less than 2%, for example

less than 1%. Preferably, the supporting herbs comprise two or more, for example three or more, herbs selected from Tribulus Terrestris extract, Balsomodendron Mukal, Rhinocanthus Comunis, Anacylus Pyrethrum and Lactuca 5 Sativa. Preferably, the supporting herbs comprise Tribulus Terrestris extract, Balsomodendron Mukal and Rhinocanthus Comunis. Preferably, the composition comprises all of the above supporting herbs. i lo Preferably the composition comprises said Stramonium component, said Nuxvomica component and supporting herbs comprising Tribulus Terrestris extract, Balsomodendrom Mukal and Rhinocanthus Comunis.

15 Preferably, the composition further comprises Ptychotis ajowa. Preferably, the composition comprises between 9 and 32% of Ptychotis ajowa by weight, more preferably between 15 and 25%, for example between 17.5 and 19.

20 i Preferably, the composition further comprises Piper -

nigrum. Preferably, the composition comprises between 9 and 25% of Piper nigrum, more preferably between 10 and 15%, for example between 11.5 and 13.

Preferably, the composition comprises said Stramonium component, said Nuxvomica component, Ptychotis ajowa, Piper nigrum, hydrolyzed pearls and supporting herbs together with one or more additional components.

Preferably, the composition comprises Gylcyrrhiza i glabra. Preferably, the composition comprises between 10

and 30% of Gylcyrrhiza glabra by weight, more preferably between 12 and 20%, for example between 14.5 and 16.

Preferably, the composition comprises Zingiber s officinalis. Preferably, the composition comprises between 9 and 25% of Zingiber officinalis by weight, more preferably between 10 and 15%, for example between 11.5 and 13%.

lo Preferably, the composition comprises Withania somnifera. Preferably, the composition comprises between 3 and 12% of Withania somnifera by weight, more preferably between 4 and 10%, for example between 5.5 and 6. 5%.

Preferably, the composition comprises Rauwolfia serpentine. Preferably, the composition comprises between 3 and 12% of Rauwolfia serpentine by weight, more preferably between 4 and 10%, for example between 5.5 and 6. 5%. Preferably, the composition comprises Pistacia lentiscun. Preferably, the composition comprises between 1 and 9% of Pistacia lentiscun by weight, more preferably between 2 and 5%, for example between 2.5 and 3. 5%.

Preferably, the composition comprises Silajitu.

Preferably the Silajitu is dried and ground. Preferably, the composition comprises between 1 and 9% of Silajitu by weight, more preferably between 2 and 5%, for example 30 between 2.5 and 3.5%.

Preferably, the composition comprises Musk.

Preferably, the Musk is purified. Preferably, the Musk is

purified by a distillation process. Preferably, the composition comprises between 1 and 9% of Musk by weight, more preferably between 2 and 5t, for example between 2.5 and 3.5%.

Preferably, the composition comprises Sinapist juncea.

Preferably, the composition comprises between 1 and 9% of Sinapist juncea by weight, more preferably between 2 and 5%, for example between 2.5 and 3.5%.

Preferably, the composition comprises said Stramonium component and said Nuxvomica component and one or more components selected from Ptychotis ajowa, Piper nigrum, Gylcyrrihiza glabra, Zingiber officinalis, Withania 15 somnifera, Rauwolfia serpentine, Pistacia lentiscun, Silajitu, Musk, Sinapist juncea, hydrolyzed pearls and supporting herbs comprising one or more of: Tribulus Terrestris extract, Balsomodendron Mukal, Rhinocanthus Communis, Anacylus Pyrethram and Lactuca Sativa.

20 Suitably, the composition may comprise all of the above components. All of the components detailed herein may be readily obtaining by a herbalist from known commercial sources.

According to a second aspect of the present invention, there is further provided a unit dosage form, which can be swallowed by a human, comprising a composition according to said first aspect.

Preferably, the unit dosage form comprises a capsule.

Alternatively, the unit dosage form may comprise a tablet.

Preferably, said unit dosage form includes between 2 and 6 me of composition, more preferably between 3 and 5 mg, for example between 3.5 and 4.5 mg. The balance may be made up of pharmaceutically acceptable carriers or 5 diluents or the like.

According to a third aspect of the present invention there is further provided a composition comprising Stramonium seeds or a derivative or extract thereof lo (herein "Stramonium component") and Nuxvomica seeds or a derivative or extract thereof (herein "Nuxvomica component"), for use in treating drug addiction.

Preferably, the Stramonium component comprises a derivative of Stramonium seeds. Preferably, said Stramonium component comprises comminuted, for example powdered, Stramonium seeds.

Preferably, the Nuxvomica component comprises a 20 derivative of Nuxvomica seeds. Preferably, said Nuxvomica component comprises comminuted, for example powdered, Nuxvomica seeds.

Preferably, the drug addiction is an addiction to 25 opioids, for example to heroin.

Preferably, the composition further comprises one or more components selected from Ptychotis ajowa, Piper nigrum, Gylcyrrhiza glabra, Zingiber officinalis, Withania 30 somnifera, Rauwolfia serpentine, Pistacia lentiscun, Silajitu, Musk, Sinapist juncea, hydrolyzed pearls and supporting herbs comprising one or more of: Tribulus

Terrestris extract, Balsomodendron Mukal, Rhinocanthus Comunis, Anacylus Pyrethrum and Lactuca Sativa.

Preferably, the composition comprises a composition 5 according to said first aspect.

According to a fourth aspect of the present invention there is further provided the use of a composition comprising Stramonium seeds or a derivative or extract lo thereof (herein "Stramonium component") and Nuxvomica seeds or a derivative or extract thereof (herein "Nuxvomica component"), for the manufacture of a medicament for treatment of drug addiction.

15 Preferably, the Stramonium component comprises a derivative of Stramonium seeds. Preferably, said Stramonium component comprises comminuted, for example powdered, Stramonium seeds.

20 Preferably, the Nuxvomica component comprises a derivative of Nuxvomica seeds. Preferably, said Nuxvomica component comprises comminuted, for example powdered, Nuxvomica seeds.

25 Preferably, the drug addiction is an addiction to opioids, for example to heroin.

Preferably, the composition further comprises one or more components selected from Ptychotis ajowa, Piper 30 nigrum, Gylcyrrhiza glabra, Zingiber officinalis, Withania somnifera, Rauwolfia serpentine, Pistacia lentiscun, Silajitu, Musk, Sinapist juncea, hydrolyzed pearls and supporting herbs comprising one or more of: Tribulus

Preferably, a person suffering from a drug addiction is initially given between 2 and 4 unit dosage forms as described according to said second aspect.

Preferably, said dosage forms are taken together with a glass of milk, for example half a pint (284ml) of milk.

Preferably, a person suffering from a drug addiction is given an initial treatment of 2 unit dosage forms, as described, two hours before a time at which they would ordinarily take drugs, on the first day of treatment. If the person does not crave drugs it will indicate the dosage is correct and the person may start a course of 20 treatment on the following (second) day. If the person craves drugs they may be given 2 unit dosage forms at each drug craving during the first day of treatment.

Preferably, after an initial day of treatment, the person will undertake a course of treatment. Preferably, the 25 person will take 2 unit dosage forms each morning and 2 unit dosage forms each night. The person may take an additional 2 unit dosage forms during the day, for example at lunchtime, if this is necessary to control their craving for drugs. Preferably, the person will continue 30 this treatment for at least 8 days.

Preferably, the person will not take more than 10 unit dosage forms in a 24 hour period.

According to the present invention there is further provided the use of a composition comprising Stramonium seeds or a derivative or extract thereof (herein 5 "Stramonium component") and Nuxvomica seeds or a derivative or extract thereof (herein "Nuxvomica component"), for the manufacture of a medicament for treatment of one or more of rheumatoid arthritis, general weakness, asthenia, geriatric problems and impotency.

Preferably, the composition further comprises one or more components selected from Ptychotis ajowa, Piper nigrum, Gylcyrrhiza glabra, Zingiber officinalis, Withania somnifera, Rauwolfia serpentine, Pistacia lentiscun, 25 Silajitu, Musk, Sinapist juncea, hydrolyzed pearls and supporting herbs comprising one or more of: Tribulus Terrestris extract, Balsomodendron Mukal, Rhinocanthus Comunis, Anacylus Pyrethrum and Lactuca Sativa.

30 Preferably, the composition comprises a composition according to said first aspect.

According to the present invention there is further provided an assembly, for example a receptacle or other package, comprising two or more unit dosage forms wherein each unit dosage form comprises substantially equal 5 amounts of a composition according to said first aspect.

According to the present invention there is further provided a method of providing a composition comprising Stramonium seeds or a derivative or extract thereof lo (herein "Stramonium component") and Nuxvomica seeds or a derivative or extract thereof (herein "Nuxvomica component"), wherein said method comprises contacting said Stramonium component, said Nuxvomica component and supporting herbs comprising Tribulus Terrestris extract, 5 Balsomodendron Mukal and Rhinocanthus Comunis to produce a first mixture.

Preferably, the Stramonium component comprises a derivative of Stramonium seeds. Preferably, said 20 Stramonium component comprises comminuted, for example powdered, Stramonium seeds.

Preferably, the Nuxvomica component comprises a derivative of Nuxvomica seeds. Preferably, said Nuxvomica 25 component comprises comminuted, for example powdered, Nuxvomica seeds.

Preferably, the supporting herbs are dried and ground.

30 Preferably, a second mixture is prepared by contacting hydrolyzed pearls with supporting herbs comprising Anacylus Pyrethrum and Lactuca Sativa and the mixture may be contacted with the first mixture.

Preferably, a third mixture is prepared for later combination with the first mixture. Preferably, the third mixture is prepared by separately drying and grinding 5 Ptychotis ajowa, Piper nigrum, Gylcyrrhiza glabra, Zingiber officinalis, Withania somnifera, Rauwolfia serpentine, Pistacia lentiscun and Sinapist juncea, which are then contacted together.

0 Preferably, a fourth mixture is prepared for later combination with the first mixture. Preferably, the fourth mixture is prepared by contacting processed Silajitu and purified Musk.

15 Preferably, the final composition is produced by contacting the third and fourth mixtures with the first mixture (which has preferably already been combined with the second mixture).

20 Once all the mixtures have been contacted they are preferably mixed to produce the composition and may then all be ground together. The composition may then be purified and capsulated.

25 Specific embodiments of the invention will now be described by way of example.

Example 1 - preparation of composition.

A composition was prepared according to the following formulation: l TABLE 1 l

1 1

COMPONENT % OF FORMULATION BY

WEIGHT

1 1 Ptychotis ajowa 18.18 Piper nigrum 12.12 Stramonium seeds 06.06 Nuxvomica seeds 06.06 Gylcyrrhiza glabra 15.15 Zingiber officinalis 12.13 Withania somnifera 06.06 Rauwolfia serpentine 06.06 Pistacia lentiscun 03. 03 Silajitu 03.03 Musk (purified) 03.03 Sinapist juncea 03.03 Hydrolyzed pearls & supporting 06.06 herbs: (i) Tribulus Terrestris extract (ii) Balsomodendron Mukal (iii) Rhinocanthus Comunis (iv) Anacylus Pyrethrum (v) Lactuca Sativa

The composition was prepared by the following process: 1. Stramonium seeds and Nuxvomica seeds were processed by being inserted into a mixing unit on 5 a primary processing line and to these were added dried and ground supporting herbs comprising Tribulus Terrestri extract, Balsomodendron Mukal and Rhinocanthus Comunis. In the next stage hydrolyzed Pearls and supporting herbs comprising 0 Anacylus Pyrethrum and Lactuca Sativa were mixed together and added into the mixing unit.

2. On another processing line Ptychotis ajowa, Piper nigrum, Gylcyrrhiza glabra, Zingiber officinalis, 5 Witania somnifera, Rauwolfia seprentin, Pistacia lentiscun, and Sinapist juncea were dried and ground separately and then subjected to a quality check and lab test after which they were mixed together. 3. At the same time Silajitu and Musk (purified) were mixed and tested for their quality.

4. All the ingredients were then mixed together on 25 the primary processing line to form the composition. Once mixing was complete the mixture was transferred to a grinding plant and once ground and purified was filled into capsules.

Example 2 - treatment of addiction using composition.

A composition comprising Ptychotis ajowa, Piper nigrum, powdered Stramonium seeds, powdered Nuxvomica 5 seeds, Gylcyrrhiza glabra, Zingiber officinalis, Withania somnifera, Rauwolfia serpentine, Pistacia lentiscun, Silajitu, Musk (purified), Sinapist juncea, Hydrolyzed pearls and supporting herbs: Tribulus Terrestris extract, Balsomodendron Mukal, Rhinocanthus Comunis, Anacylus lo Pyrethrum, and Lactuca Sativa was used in the treatment of a trial group of patients addicted to drugs and was also given to a control group having no addiction.

Patients were initially treated with 2-3 capsules, 15 each containing 4 mg of composition, at every drug craving, up to a maximum of lo capsules, during the first day of treatment and after settlement of their craving they were treated with 2 capsules twice a day for eight days. If necessary, patients were given an additional 2 20 capsules during the day.

The results of the trial are summarised in the following table and show the success of the composition in the treatment of drug addiction.

l TABLE 2

l. PATIENT TOTAL NUMBER UNDERWENT RESULT SIDE EFFECTS

CONDITION I.. FULL TRIAL l Normal 12 12 100 as 10 none before 2 had minor side effects Addicted 32 32 100%no 19 none (Excluding longer13 had minor heroin) taking drugs side effects Addicted 142 135 (7 after 100% no 79 none (heroin) feeling free longer 63 had minor from demand taking drugs side effects stopped using medicine) All those patients who took the composition together with a glass of milk did not develop any side effects.

Out of the 142 patients who were addicted to heroin prior to the trial 6 tried to use opiates again but started vomiting. However, it is not known whether this will be applicable to all patients after treatment.

Twenty one of the patients who were addicted prior to the trial developed an urge to use drugs within 6 months of the trial end but consulted their doctors and were prescribed two capsules a day for four days after which 15 they did not revert to taking drugs.

The composition thus provides an alternative to methadone for use in the treatment of heroin. In addition, the composition may have beneficial effects for

patients suffering from other ailments, for example rheumatoid arthritis.

The reader's attention is directed to all papers and 5 documents which are filed concurrently with or previous to this specification in connection with this application and

which are open to public inspection with this specification, and the contents of all such papers and

documents are incorporated herein by reference.

All of the features disclosed in this specification

(including any accompanying claims, abstract and drawings), and/or all of the steps of any method or process so disclosed, may be combined in any combination, except combinations where at least some of such features and/or steps are mutually exclusive.

Each feature disclosed in this specification

(including any accompanying claims, abstract and 20 drawings), may be replaced by alternative features serving the same, equivalent or similar purpose, unless expressly stated otherwise. Thus, unless expressly stated otherwise, each feature disclosed is one example only of a generic series of equivalent or similar features.

The invention is not restricted to the details of the foregoing embodiment(s). The invention extends to any novel one, or any novel combination, of the features disclosed in this specification (including any

30 accompanying claims, abstract and drawings), or to any novel one, or any novel combination, of the steps of any i method or process so disclosed.

Claims

CLAIMS:

1. A composition including the herbs Stramonium seeds and Nux vomica seeds, or extracts thereof.

2. A composition according to claim I further including the herbs Tribulus Terrestris Extract. and Balsomodendron Mukal, or extract thereof.

3. A composition according to claim I or 2 further including the herb Rhinocanthus Comunisand or Anacylus Pyrethrum and or Lactuca Sativa, or extract thereof.

4. A composition according to claim 1,2 or 3 further including one or more of the herb Ptychotis ajowa, Piper nigrum, Gylcyrrhiza glabra and Zingiber officinalis, or extract thereof.

5. A composition according to any one of claims 1-4 further including one or more of Withania somnifera Rauwolfia serpentine Pistacia lentiscun, and Sinapist juncea, or extracts thereof.

6. A composition according to any one of claims 1-5 further including one or more of Silajitu, Musk and Pearls or extracts thereof.

7. A composition according to claim 6 including Ptychotis ajowa 09% - 32%, Piper nigrum 09% - 25%, Stramonium seeds 03% - 12%, Nuxvomica seeds 03% 12%, Gylcyrrhiza glabralO / 30%, Zingiber officinalis 09% - 25%, Withania somnifera 03% -12%, Rauwolfia serpentine 03% - 12%, Pistacia lentiscun 01% - 09%, Silajitu 01% - 09%, Musk (purified) 01% - 09%, Sinapist junceaO1% -

09% any one, some or all of the Hydrolyzed pearls, Tribulus Terrestris Extract.,Balsomodendron Mukal, Rhinocanthus Comunis, nacylus Pyrethrum, Lactuca Sativa 03% - 12%, or extracts thereof.

8. A composition according to any one of claims 1 to 7, wherein the composition is in the form of a liquid.

9. A composition according to any one of claims 1 to 7, wherein the composition is in the form of a powder.

10. A composition according to any one of claims 1 to 7, wherein the composition is in the form of a paste.

11. A composition according to any one of claims 1 to 7, wherein the composition is in the form of a capsule.

12. A composition according to any one of claims 1 to 7, wherein the composition is in the form of a tablet.

13. A method of preparing a medicinal composition for treating drug addiction Stramonium seeds and Nux vomica seeds processed by inserting into a mixing unit on a primary processing line, dried and ground supporting herbs comprising

Tribulus Terrestris extract., Balsomodendron Mukal and Rhinocanthus Comunis to be added. In the next stage Hydrolyzed Pearls and supporting herbs comprising Anacylus Pyrethrum and Lactuca Sativa mixed together and added into mixing unit. On the other processing line Ptychotis ajowa, Piper nigrum, Gylcyrrhiza glabra, Zingiber offcinalis, Withania somnifera, Rauwolfia serpentine, Pistacia lentiscun, Sinapist juncea being dried and ground separately and then subjected to quality check and lab test after which they are all mixed together. At the same time Silajitu and Musk (purified) being mixed and tested for their quality. All the ingredients then mixed together on the processing line to form the composition.

Once mixing is complete the mixture is to transfer to grinding plant to produce a dry powder.

14. A method according to claim 13 further including placing said powder into a capsule. 15. A method according to claim 14 wherein said capsule contains 0.3g - 0.9g of said powder.

16. A method according to claim 13 further including the steps of adding water to said powder to produce a paste.

17. A method according to claim 16 further including placing said paste into a capsule. 18. A method according to claim 17 wherein said capsule contains 0.3g ^ 0.9g of said paste.

19. A medicament for the treatment of drug addiction, the medicament including an effective amount of a composition according to any one of claims 1 to 7.

20. A method for treating drug addiction in a patient including administering to said patient an effective amount of a composition according to any one of claims 1 to 7. 21. A method of treatment for drug addiction as claimed in claim 19, wherein the herbal composition is administered to the patient orally in three equivalent dosages which are one third of the amount of a total daily dosage, each dosage being administered in succession in approximately even intervals of about 8 hours each throughout a day, each dosage being 2-4 capsules.

27. Use of a composition according to any one of claims 1 to 7 for the manufacture of a medicament for treatment of drug addiction.