WO1994023704A1

WO1994023704A1 - Herbal extract composition

Info

Publication number: WO1994023704A1
Application number: PCT/US1994/003949
Authority: WO
Inventors: Xuhui Wang; Sophie Fan
Original assignee: International Medical Research Inc
Current assignee: International Medical Research Inc
Priority date: 1993-04-19
Filing date: 1994-04-11
Publication date: 1994-10-27
Anticipated expiration: 1995-10-19
Also published as: AU6631094A

Abstract

A composition comprising a selected combination of herbs and their extracts. Properties of the composition include dietary supplement, appetite stimulant, analgesic and mood elevation utilities, particularly advantageous for broad spectrum improvement in quality of life for terminally ill individuals. This supplement is found to profoundly improve patient's appetites and immune system. It can also largely reduce patient's pain and thus improve patient's mood.

Description

HERBAL EXTRACT COMPOSITION

Background of the Invention

The vast majority of terminally-ill individuals require dietary supplement, appetite stimulation, significant analgesia and/or mood elevation to optimize the quality of the duration of their survival prognosis.

The principal major analgesics belong to the morphine opioids. This class of drugs acts by blocking the central nervous system. Non-opioid drugs that are used are nonsteroid antiinflammation drugs (NSAIDS), such as aspirin. This latter class of drugs inhibits prostaglandin synthesis and thus reduces the pain transmitted by somatic nerves. None of these are entirely ideal due to the addictive effect of the first class of drugs and the often limited efficacy of the second class of drugs. Neither have ever been shown to exhibit appetite stimulant properties in the absence of dependence risk. Summary of the Invention

In accordance with the present invention, the inventor have provided a composition comprising a preparation of eac of the following components: Cheng-min chou, Mou-hui Tou, Stephania Sinica Diels, Stephania Delavayi Diels, Zanthoxylem Nitidum, Corydalis Bulbosa, Lycoris Radiata, an Agrimonia Pilosa Ledeb. Most preferred is the above composition further comprising a preparation of each of the following components: Pyrola Rotundifolia L. , Rabdosia Rubescens, Ganoderma Japonicum, Flower Pollen, Panax Ginseng, Cervus Nippon Tem inck, and Glycyrrhiza.

The above combination of herbs and their extracts is useful as a food or nutritional supplement and has been observed to profoundly improve individuals appetites and stimulate their immune system responsiveness. It also significantly reduces pain in individuals receiving it and thus improves these patients' mood.

Brief Description of the Drawings

Figure 1 graphically illustrates the comparative voltage outputs at each time interval as the mean observed for each series of animals tested in Example 2. The degree of twitching response in control series 1 was defined as 100%. Preparation A (used at 12x the morphine concentration) resulted in a more pronounced inhibition than even the morphine-treated series displayed. Preparation B (series 2) animals demonstrated less pronounced inhibition than either Preparation A or the morphine group animals.

Figure 2 graphically illustrates the comparative levels of analgesic effect of Preparation A and morphine as tested -3-

in Example 3 over time. While the effect of morphine declined continuously from day 2 until day 7, the effect of the preparation of the invention remained undiminished throughout the observation period of 7 days.

Detailed Description

A principal aspect of the present invention is a composition of a preparation (e.g. dried, cut herbs or extracts thereof) from each of the following components: Cheng-min chou, Mou-hui Tou, Stephania Sinica Diels, Stephania Delavayi Diels, Zanthoxylem Nitidum, Corydalis Bulbosa, Lycoris Radiata, and Agrimonia Pilosa Ledeb. Most preferred is the above composition further comprising a preparation of each of the following components: Pyrola Rotundifolia L. , Rabdosia Rubescens, Ganoderma Japonicum, Flower Pollen, Panax Ginseng, Cervus Nippon Temminck, and Glycyrrhiza.

Certain of the individual extracts in this composition are new compositions of matter in and of themselves. They are extracts and other therapeutically effective preparations of Cheng-min chou and, independently, of Mou-hui Tou.

Example 1 Preparation of Extract Compositions

Preparation Components

As used herein, Preparation A contains material from each of the following: Cheng-min chou, Mou-hui Tou, Stephania Sinica Diels, Stephania Delavayi Diels, Zanthoxylem Nitidum, Corydalis Bulbosa, Lycoris Radiata, an Agrimonia Pilosa Ledeb and a preparation of each of the following components: Pyrola Rotundifolia L. , Rabdosia Rubescens, Ganoderma Japonicum, Flower Pollen, Panax Ginseng, Cervus Nippon Temminck, and Glycyrrhiza. Preparation B contains material from each of the following: Cheng-min chou, Mou-hui Tou, Stephania Sinica Diels, Stephania Delavayi Diels, Zanthoxylem Nitidum, Corydalis Bulbosa, Lycoris Radiata, and Agrimonia Pilosa Ledeb.

Extract Preparation: The procedure used for preparing extracts of each of the components was as follows: A cut, dried portion (lOOg) of each of the above ingredients was individually finely chopped by blender, the chopped preparation was soaked in water (300-500 ml) for a minimum of 1 hour, boiled for 20-50 minutes; and allowed to cool to ambient temperature.

The solid residue of the above was filtered through a 1.0 L Buchner funnel lined with Whatman filter paper. Volumes of ethanol equal to each sample filtrate volume wer added to the flask and the mixture was vigorously stirred until precipitation was complete. The filter residue was discarded and the aqueous phase eluate lyophilized. The resultant material was used as is. The components prepared as described above were combined by addition to a powder mixer (Won-Nen Mixer, Model 8L-K-III, Shanghai). The weight of Lycoris Radiata used was defined as 1, the relative weights of the rest of the ingredients were 0.5 to 2, except Cervus Nippon Temminck which was between 0.01 to 0.2.

Example 2 Analgesic Effect of the Compositions)

Four series of Wistar White rats (8 rats per series; 300 g avg. body weight) were treated as follows.

Series 1: Abdominal injection of 1 ml saline solution (0.9% NaCl) - control group

Series 2: Abdominal injection of 1 ml Preparation B (4.5 mg)

Series 3: Abdominal injection of 1 ml Preparation A (9 mg)

Series 4: Abdominal injection of 1 ml morphine (0.75 mg)

Each rat received an abdominal injection consistent with the series to which it had. been assigned and was then placed into a mechanical restraint. The restraint devices were provided with electrodes that produced a mild electric shock sufficient to cause twitching of the tails of the rats. The degree of response in each of the rats in each series was recorded as the length of time required to interrupt the circuit at time intervals after injection of 0 (substantially immediately upon restraint), 15, 30, 45, 60, 75, 90 and 105 minutes.

Figure 1 graphically summarizes the comparative responses at each time interval as the mean observed for each series. The twitching response delay time in control series 1 was defined as 100%. Preparation A of series 3 (used at 12x the morphine concentration) resulted in a more pronounced inhibition (long delay time) than even the morphine-treated series (series 4) displayed.

Example 3 Duration of Analgesic Effect

Three groups of Wistar White rats (8 rats per group) were used in this study and treated as follows. The experimental procedures used were the same as those described in the Example 2, except as follows.

Series 1: Abdominal injection of 2 ml of saline solution (0.9% NaCl) - control group

Series 2: Abdominal injection of 2 ml of Preparation (20 mg)

Series 3: Abdominal injection of 2 ml of morphine (3 mg)

The animals were each injected once daily for seven consecutive days. Response in each animal was recorded 10 minutes after injection on each day. Figure 2 graphically illustrates the comparative levels of analgesic effect of Preparation A and morphine over time. While the effect of morphine declined continuously from day 2 until day 7, the effect of Preparation A remained undiminished throughout the observation period of 7 days.

Example 4 Comparative Addictive Effect

Experiment 1

Three groups of Chinese Kun-Min mice (10 mice per group; 19 ± lg each) were used in this study. The first group was injected with 1 ml of saline solution (0.9% NaCl), the second group with 1 ml of morphine (0.5 mg), the third group with 1 ml of Preparation A (6 mg) . The animals were injected abdominally, twice daily (8 hours apart) for four consecutive days. The dosage for the last injection was doubled. Behavior of the mice was observed on day four. Group 1 and Group 3 showed normal generally tranquil behavior, while the mice in Group 2 displayed an abnormal excited state.

Experiment 2

Two groups of Wistar White rats (10 rats per group) were treated as follows. The first group was injected with 1 ml of morphine (0.75 mg) and the second group was injecte with 1 ml of Preparation A (10 mg) . After the abdominal injections, the stiffness of the tails were monitored for 1 minutes. The first group showed a very stiff tail which could be manipulated to any shape, while the second group showed a normal relaxed tail.

Example 5 Study on Human Volunteers

Twenty-two individuals who had been diagnosed to be in the terminal stages of cancer and were being treated with chemotherapy agents such as Piminodinum, Dolantinum and Dihydroetorphine volunteered for this study. The types of cancers diagnosed in the volunteer population were as follows:

Hepatoma patients - 6

Metastatic Leukemia patients - 4

Lung cancer patients - 4

Colon cancer patients 3

Esophogus cancer patients 1

Stomach cancer patients 2

Breast cancer patients 1

Pancreas cancer patients 1 By consent, chemotherapy treatment was discontinued and thereafter each patient was given 600-1800 mg of Preparatio A daily for 7 consecutive days. At the end of one day of treatment with Preparation A, the patients responded to the questions summarized in Table 1.

Table 1

Questions Degree of pain (scale 0-10)

Day 0 Day

Worst pain in the past 24 hours 6-9 0-3

Average pain at the present time 3-5 0-3 How much interference in your daily activities due to discomfort 6-9 0-3

The responses appearing in Table 1 are the range of response to each question from the 22 patients. This clearly demonstrates that patients who received Preparation A experienced a profound reduction in the pain associated with their condition.

At day 7, the erythrocyte sedimentation rate (ESR) of each patient was measured and compared with that patient's ESR at Day 0. At day 21, the total white cell count of eac patient was measured and compared to that patient's WBC count at Day 0. The range of results are set forth in Tabl 2. Table 2

Parameters Day 0 Day 7/Day 21

ESR 35-120 < 30 (Day 7)

WBC counts 3000-3500/nm³ 5500-7500/nm³

As is evident from the results reported in Table 2, a clear improvement in the white blood cell counts and in red cell sedimentation rate was observed.

Claims

What is Claimed Is:

1. A composition comprising a preparation of each of the following components: Cheng-min chou, Mou-hui Tou, Stephania Sinica Diels, Stephania Delavayi Diels, Zanthoxylem Nitidum, Corydalis Bulbosa, Lycoris Radiata, and Agrimonia Pilosa Ledeb.

2. The composition of claim 1 which further comprises a preparation of each of the following components: Pyrola Rotundifolia L., Rabdosia Rubescens, Ganoderma Japonicum, Flower Pollen, Panax Ginseng, Cervus Nippon Temminck, and Glycyrrhiza.

3. The composition of claim 2, wherein the preparation of each such component is an ethanol extract of dried, cut plant parts.

4. The composition of claim 2 wherein the Lycoris Radiata, Cervus Nippon Temminck and each of the other components are present in a dried, weight-to-weight range of ratio of about 1:0.01-0.2:0.5-2.

5. A food additive composition comprising a dietary supplementing amount of the composition of claim 2 in an ingestible form.

6. The food additive composition of claim 5 wherein the ingestible form is selected from a powder, capsule or tablet.

7. A food additive composition comprising a dietary supplementing amount of the composition of claim 4 in an ingestible form.

8. An appetite stimulant composition comprising an appetite stimulating amount of the composition of claim 2 in an ingestible form.

9. The appetite stimulant composition of claim 8 wherein the ingestible form is selected from a powder, capsule or tablet.

10. An appetite stimulant composition comprising an appetite stimulating amount of the composition of claim 4 in an ingestible form.

11. The composition of claim 10 which is in an ingestible or injectable form.

12. A pharmaceutical composition comprising the composition of claim 2 in an analgesically effective amount in a pharmaceutically acceptable carrier.

13. A pharmaceutical composition comprising the composition of claim 2 in a mood elevant amount in a pharmaceutically acceptable carrier.

14. A pharmaceutical composition comprising the composition of claim 4 in a mood elevant amount in a pharmaceutically acceptable carrier.

15. An extract preparation of Cheng-min Chou.

16. An extract preparation of Mou-hui Tou.

17. A method of supplementing the diet of an individual in need thereof which comprises administering a dietary supplementing amount of the composition of claim 5.

18. A method of stimulating the appetite of an individual in need thereof which comprises administering an appetite stimulating amount of the composition of claim 8.

19. A method of treating pain in an individual thereof which comprises administering an analgesically effective amount of the composition of claim 12.

20. A method of elevating the mood of an individual in need thereof which comprises administering to said individual a mood elevating amount of the composition of claim 13.