GB2282966A - Compositions with antidecrepit action - Google Patents

Compositions with antidecrepit action Download PDF

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GB2282966A
GB2282966A GB9321945A GB9321945A GB2282966A GB 2282966 A GB2282966 A GB 2282966A GB 9321945 A GB9321945 A GB 9321945A GB 9321945 A GB9321945 A GB 9321945A GB 2282966 A GB2282966 A GB 2282966A
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pharmaceutical composition
mice
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weight ratio
semen
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Wei Jiang
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/23—Apiaceae or Umbelliferae (Carrot family), e.g. dill, chervil, coriander or cumin
    • A61K36/234—Cnidium (snowparsley)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/21—Amaranthaceae (Amaranth family), e.g. pigweed, rockwort or globe amaranth
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
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    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/25—Araliaceae (Ginseng family), e.g. ivy, aralia, schefflera or tetrapanax
    • A61K36/258—Panax (ginseng)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/29—Berberidaceae (Barberry family), e.g. barberry, cohosh or mayapple
    • A61K36/296—Epimedium
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/43—Cuscutaceae (Dodder family), e.g. Cuscuta epithymum or greater dodder
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/48—Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/48—Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
    • A61K36/484—Glycyrrhiza (licorice)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/54—Lauraceae (Laurel family), e.g. cinnamon or sassafras
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/64—Orobanchaceae (Broom-rape family)
    • A—HUMAN NECESSITIES
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    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/88—Liliopsida (monocotyledons)
    • A61K36/896—Liliaceae (Lily family), e.g. daylily, plantain lily, Hyacinth or narcissus
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    • A61K36/88—Liliopsida (monocotyledons)
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    • A61K36/8962—Allium, e.g. garden onion, leek, garlic or chives
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/88—Liliopsida (monocotyledons)
    • A61K36/896—Liliaceae (Lily family), e.g. daylily, plantain lily, Hyacinth or narcissus
    • A61K36/8968—Ophiopogon (Lilyturf)

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Abstract

Compositions with anti-decrepit action contain the alcohol extracts of Male bombycid, Cornu cervi pantotrichum, Genitals of an ass, Radix ginseng, Herba epimedii and Radix achyranthes bidentatae. Composition has therapeutic action on the prostate gland, and activity against presbyopia and other symptoms of "deficiency of Yang (vitality)" caused by decreptitude.

Description

A PwtMLCKUTICAL COMPOSITION HAVING ANTI-DECREPIT ACTION AND A PROCESS FOR PREPARATION TEERBOF This invention relates to a pharmaceutical composition and its preparation, in particular a pharmaceutical composition with anti-decrepit action and its preparation.
Some diseases such as presbyopia, prostatomegaly (hypertrophy of the prostate) are closely concerned with biobody's decrepit. At present, there isn't any drug which can cure presbyopia among the drugs in markets, but there are some drugs such as Qianliekang, tablet Zhulinan which can lysis the symptom of prostatomegaly in addition to operation to cure it.
For a long time, pe-ople have been trying to use traditional Chinese medicines for the treatment of those diseases caused by decreptitude as described above. But because of the inadequate methods for preparing traditional Chinese medicines, for example, using high temperature and high pressure to decoct, the effective constituents of traditional medicines can be destroyed in those conditions,and their activities will be deceased.
An object of the present invention is to overcome the drawbacks of the prior art to provide a pharmaceutical composition with anti-decrepit action to warm blooded mammals and human.
Another object of this invention is to provide a process for preparing the pharmaceutical composition having anti-decrepit action to warm blooded mammals and human.
A further object of this invention is to provide an application of the pharmaceutical composition for treating warm blooded mammals' and human's diseases caused by decrepit of biobody.
The pharmaceutical composition of this invention mainly consist (extractable matter) ing of 60-80% alcohol extractives/of traditional Chinese medicines, which are mainly male bombycid, cornu cervi pantotrichum, genital of ass, radix ginseng, herba epimedii and radix achyranthes bidentatae.
The weight ratio of the used materials is as follow: Male bombycid (Xiongcan'e) 20-60 Cornu cervi pantotrichum (Lurong) 1-4 Genital of ass (Lushen) 1-4 Radix ginseng (Renshen) 1-6 Herba epimedii (Yinyanghuo) 1-4 Radix achyranthes bidentatae (Niuxi) 1-4 Besides the alcohol extractives of those materials as described above, the pharmaceutical composition of this invention can also contain alcohol extractives of materials as follow (weight ratio): Semen trigonellea (Huluba) 1-5 Rhizoma curculiginis (Xianmao) 1-5 Semen cuscutae (Tusizi) 1-4 Herba cistanches (Roucongrong) 1-4 Fructus cnidii (Shechuangzi) 1-4 or also contains the alcohol extractives of (weight ratio):: Semen trigonellae (Huluba) 1-5 Rhi2oma curculiginis (Xianmao) 1-5 Semen cuscutae (Tusizi) 1-4 Semen allii tuberosi (Jiucaizi) 1-4 Radix ophiopogonis (Maimendong) 1-4 Fructus foeniculi (Xiaohuixiang) 1-4 Cortex cinnamomi (Rougui) 1-4 Radix glycyrrhizae (Gancao) 1-4 In order to prepare the pharmaceutical composition as described above, the process according to the invention comprises the steps of: (1) crushing (weight ratio):: Male bombycid (Xiongcan'e) 20-60 Cornu cervi pantotrichum (Lurong) 1-4 Genital of ass (Lushen) 1-4 Radix ginseng (Renshen) 1-6 into crude powder, and adding 30 to 60% ethanol to moisten the crude powder, allowing the moistened powder to stand in an airtight enclosure for 12 to 36 hours, and percolating the moistened crude powder by using 6 to 90 weight ratio of alcohol, and collecting the percolated solution; (2) refluxing materials consisting of (weight ratio): Herba epimedii (Yinyanghuo) 1-4 Radix achyranthes bidentatae (Niuxi) 1-4 for 2-4 hours by using 60%-80% ethanol which is 5 tines amount of the materials and obtaining the extractive A, filtering the extractive A to obtain filtrate (1) and the residue; refluxing the residue 0.5-1.5 hours by using 60-80% ethanol which is 3 times amount of the residue to obtain extractive B, and filtering the extractive B to obtain filtrate (2)t combining filtrate (1) and (2) to obtain filtrate (3)t (3) evaporating the filtrate (3) under reduced pressure and concentrating the evaporated filtrate (3) to form a dilute extractive with comparative density being 1.15-1.20 at 20-25 degree centigrade; (4) combining the percolate solution in step (1) with the dilute extract in step (3), adding medicinal accepted carrier to obtain the pharmaceutical composition having anti-decrepit action.
The materials in step (2) may also contain (weight ratio): Semen trigonellea (Huluba) 1-5 Rhizoma curculiginis (Xianmao) 1-5 Semen cuscutae (Tusizi) 1-4 Herba cistanches (Roucongrong) 1-4 Pructus cnidii (Shechuangzi) 1-4 or also contains (weight ratio): Semen trigonellae (Huluba) 1-5 Rhizoma curculiginis (Xianmao) 1-5 Semen cuscutae (Tusizi) 1-4 Semen allii tuberosi (Jiucaizi) 1-4 Radix ophiopogonis (Naimendong) 1-4 Fructus foeniculi (Xiaohuixiang) 1-4 Cortex cinnamomi (Rougui) 1-4 Radix glycyrrhizae (Gancao) 1-4 The pharmaceutical ccmposition can be fontulated into the oral solution, capsule, injectable solution, tablet, syrup, pill et al.
Deficiency of vitality is the manifestation of biobody's decreptitude.
Drugs for reinforcing vital function in traditional Chinese medicine are mainly that of reinforcing vital energy or essence of the kidney.
For example, Radix ginseng can greatly reinforce vital energy, promote secretion in the body, and relieve thirst. Cornu cervi pantotrichum can promote reproductive essence, strengthen physique; it mainly cures impotence, lack of strength in loin and knee, spermatorrhea, et al. Herba epimedii can strengthen physique, dispel rheumatism, cure impotence and rheumatic pain.
Genital of ass can invigorate function of kidney and strengthen tendons, cure impotence, weakness, and sour in bones and tendons, spenting of evil heart in both Qi (inner defensive) system and Xue (blood) system, et al. Male bombycid can strengthen vital energy or essence of the kidney by reinforcing the function of the liver, invigorate Yang (vital function) and treat spontaneous seminal emission, cure impotence', emission, leukorrhagia, hematuria, injury, ulcer and scald. Radix achyranthes bidentatae can reinforce the function of liver and kidney, strengthen physique, cure the pain in loin and knee, contracture of the four limbs, et al. Besides, some other medicinal herbs such as Herba cistanches, Semen cuscutae, also have the effect of reinforcing the function of the kidney.
The pharmaceutical composition of this invention involves the choice of same medicines as described above which have the effect of reinforcing vitality, and to provide combination recipe in a reasonable or convenient manner. The process of the invention involves the use of a satisfactory process to prepare the pharmaceutical coMposition which has the effect of strengthening the vital functions by reinforcing vital energy or essence of kidney, adjusting the blood system, strengthen physique, increasing essence and narrow. This pharmaceutical composition has better effect for old people's prostatomegaly and presbyopia.
The mentioned process of preparation of the pharmaceutical composition of this invention uses an alcohol solution to percolate and extract.
This avoids the conventional high temperature and high pressure, and preserves the effective constituents of the materials of traditional Chinese medicines to a great extent.
The above mentioned beneficial effects are described in detail for better understanding in the following Examples.
Examples 1-3 Preparation of percolate Preparation: recipes of percolate of different concentration as follow: Material Examples (gram) 1 2 3 Hale bombycid 500 1000 1500 Cornu cervi pantotrichum 100 25 25 Radix ginseng (Red ginseng) 1000 150 25 Genital of ass 100 50 25 The materials as described above were combined and crushed into crude powder. 30 degree white spirit was added to moisten the crude powder. The moistened crude powder was allowed to stand in airtight enclosure then it was percolated by 38 degree white spirit and 2000 ul percolate was collected. Details are shown in table 1.
Table 1 Examples 1 2 3 T e (standing in airtight enclosure) (hours) 18 24 36 Examples 4-6 Preparation of Dilute Extract Preparing dilute extracts using three kinds of constituents, the recipes being as follows: Materials Examples (gram) 4 5 6 Herba epimedii 100 50 25 Radix achyranthes bidentatae 50 100 25 Semen trigonellae 125 80 25 Rhizoma curculiginis (spirit treatment) 125 80 50 Semen cuscutae 25 50 100 Herba cistanches 25 25 25 Fructus cnidii 25 25 100 Semen allii tuberosi / 50 25 Radix ophiopogonis / 75 25 Fructus foeniculi (salt treatment) / 25 100 Cortex cinnamomi / 50 100 Radix glycyrrhizae / 25 50 After they were crushed respectively, semen cuscutae, fructus cnidii, semen allii tuberosi and fructus foeniculi together with other materials were combined according to the arnunts as described above. The combined mixtures were ref fluxed with ethanol in accordance with table 2. Filtrates were combined and evaporated under reduced pressure with recollection of ethanol, and with concentration of filtrates to dilute extract which had a comparative density of 1.15-1.20 ( measured at 20 degrees centigrade).
Table 2 Examples 4 5 6 Ethanol concentration for reflux 65 70 75 The 1st reflux amount of ethanol (ml) 2400 3000 3250 time of reflux (hour) 2.0 3.0 4.0 The'2nd reflux amount of ethanol (ml) 1400 2000 2000 time of reflux (hour) 0.5 1.0 1.5 The comparative density of dilute 1.15 1.20 1.19 extract after concentrating (20 C) Examples 7-9 Preparing Oral Solution The percolates were combined to the dilute extracts according to the following: Examples 7 8 9 percolate prepared in example 1 2 3 dilute extract prepared in example 4 5 6 The combined mixtures were diluted by adding 3500 ml of water, filtered to obtain filtrates to provide the oral solutions of the pharmaceutical composition of the present invention.
Example 10 The percolate produced in example 2 was combined with the dilute extract of example 5, and a powder was produced vacuum drying the containing the composition mixture. Capsules/were made by using the techniques well-known in the art.
Example 11 The percolate produced in example 3 was combined with the dilute extract of example 6, and obtained powder by vacuum drying the mixture. An injectable solution was made by usuing the techniques well-known in the art.
Experiment 1-4 Materials Drugs: 1. The pharmaceutical composition, made in example 7, was concentrated on a water bath to evaporate alcohol.
An aqueous solution of the required concentration was prepared just before using.
2. Qianliekang was made in Hexi Pharmaceutical Factory, China.
In the experiment, it was ground into fine powder in a mortar together with water. A turbid solution of the experimental material needing concentration was prepared.
3. Testosterone propionate, manufactured by East-northern No.6 pharmaceutical factory, was prepared as a solution of the experimental concentration by using ethyl oleate.
4. Jinkuishengiwan, manufactured by Liaoning Traditional Chinese Medical College Pharmaceutical Factory, was prepared into solution turbid.
5. Hydroxy urea, provided by Shanghai Institute of Biochemistry, Chinese Academy of Sciences.
Animals: The mice of Kunming strain, either sex were used, were provided by the animal laboratory of Shenyang Pharmaceutical College.
Experiment 1 Restraining action on prostatomegaly of the mice Fifty-five mice, male, weighting 19-25 g, were used and randomly divided into 5 groups. The mice in the control group were administered with ethyl oleate Sml/kg by hypodermic injection. The mice in other four groups were all administered with testosterone propionate 5m1/kg by hypodermic injection. Then, the mice in both the ethyl oleate group and the testosterone propionate group were administered equal volume normal saline by p.o.. The mice in both the small dose group and the big dose group, were respectively administered p.o. with the pharmaceutical composition of the present invention 2g/kg and 4g/kg. The mice in the positive coMparative drug were administered with Qianliekang 2g/kg by p.o. Administered for 10 days continuously one time per day.On the eleventh day, the mice were killed and anatanized to take off the prostate. The prostates were weighed and the prostate index was calculated (mg per gram of weight). A statistical T examination was done to compare the data of each group. Results were shown in table 3.
Table 3. Restraining action on the mice's prostatomegaly caused by testosterone propionate (xSD).
Group Number Dose Weight of Prostate index of mice (g/kg) prostate (mg) mg/kg Ethyl oleate + equal + normal saline 11 volume 29.57.0 0.950.20 Testosterone propionate equal + normal saline 11 volume 43.45.6### 1.570.23### P.C. + Testosterone propionate 11 2.00.005 34.84.6***+ 1.140.34***+ P.C. + Testosterone propionate 11 4.00.005 36.94.0***+ 1.220.07***++ Qianliekang + Testosterone propionate 11 2.0+0.005 38.3+4.0** 1.340.17** Note: P.C.: Pharmaceutical composition of the present invention III : P < 0.01, comparing with the ethyl oleate group ** : P < 0.05, *** : P < 0.01, comparing with the testosterone propionate = : P > 0.05, ++ : P < 0.05 comparing with the group of healthy prostate The results in table 3 showed that both the mice's prostate weight and prostate index in the testosterone propionate group were significantly bigger than that of the mice in the ethyl oleate group, which indicated that testosterone propionate could cause prostatauxe of mouse.In the pharmaceutical composition of the invention's small dose group (2g/kg), big dose group (4g/kg), and Qianliekang group (2g/kg), the prostate weight and the prostate index of mice were significantly smaller than that of the testosterone propionate group, which indicated that the two dose of the pharmaceutical composition of the invention were not significantly different to compare with that of the mice in the Qianliekang group, which indicated that the doses of the two medicines were equal and the actions were similar.
Experiment 2 Effect on the function of the "deficiency of vitality" mice caused by hydroxy urea Fifty-five mice, weighing 18-22 g, with either sex, were weighed and the temperatures of the mice's tail skin were measured before the experiment. The mice were randomly divided into five groups.
The mice in the control group received p.o. normal saline. The mice in the "deficiency of vitality" model group received p.o.
hydroxy urea 300 mg/kg. The mice in the two groups of the pharmaceutical composition of the invention received respectively p.o.
2.0g/kg and 4.Og/kg. The mice in the positive comparative group received p.o. Jinkuishenqiwan 4.Og/kg. Hydroxy urea was given to the mice in the hydroxy urea group, the two groups of the pharmaceutical composition of the invention, and the Jinkuishenqiwan group every morning and the pharmaceutical composition of the invention and Jinkuishenqiwan were given every afternoon. Medi cines were given continuously for 7 days. On the eighth day, after weight was weighed and skin temperature was measured, the mice were killed and dissected to take their spleens. These spleens were weighed and spleen indices calculated. T examination of each group data was done and the result was shown in table 4.
Table 4. Effect on weight, skin temperature, spleen weight, spleen index of the mice of "deficiency of vitality" caused by hydroxy urea (xSD) Group Number Dose Weight Skin Spleen Spleen of (g/kg) temp. Weight index mice (g) ( C) (mg) (mg/g) Normal b. ad. 19.7+1.5 31.80.7 saline ------ 10 e.v.
a. ad. 25.1+1.7 27.5+0.4 144.926.9 5.75+0.81 H.U. b. ad. 19.81.6 32.10.7 10 0.3 & um; & um; & um; & um; & um; & um; & um; & um, & um; & um; & um; & um; a. ad. 19.2+2.0 26.8+0.3 61.0+25.7 3.15+1.3 P.C.+ b. ad. 2.0 19.71.5 32.30.5 H.U. ------ 10 + & um; & um; & um;* *** & um; & um; & um; & um;* & um; & um; & um;* a. ad. 0.3 18.6+1.2 27.5+0.3 58.8+22.0 3.13+1.0 P.C.+ b. ad. 4.0 19.61.4 32.50.5 H.U. ------ 10 + & um; & um; & um;* *** & um; & um; & um; & um;* & um; & um; & um;* a. ad. 0.3 18.7+2.0 27.6+0.3 71.2+21.3 3.79+1.0 JKSQW+ b. ad. 4.0 20.01.6 32.60.3 H.U. ------ 10 + & um; & um; & um;* & um; & um; & um;*** & um; & um; & um;* & um; & um; & um;* a. ad. 0.3 19.1+2.4 28.2+0.4 75.1+30.6 3.91+1.51 H.U.: Hydroxy urea P.C.: the Pharmaceutical Composition of the invention JKSQW: Jinkuishenqiwan b.ad.: before administered a.ad.: after administered t : P > 0.05, & um; & um; & um; : P < 0.01, comparing with the normal saline group.
* : P > 0.05, *** P < 0.01, comparing with the hydroxy urea group.
The results in table 4 indicated that the weight, skin temperature, spleen weight, spleen index of the mice in the hydroxy urea group were all significantly lower than that of the mice in the control group (P < O.O1), which indicated that the model of "deficiency of vitality" caused by hydroxy urea had already been formed. The skin temperature of all the mice in the pharmaceutical composition of the invention small dose group, big dose group, and the Jinkuishenqiwan group was higher than that of the hydroxy urea group (P < 0.01), and was not significantly different to compare with that of the normal saline group (P > 0.05), which indicated that the pharmaceutical composition of the invention had the action of preventing decrease of the skin temperature of the "deficiency of vitality" mice caused by hydroxy urea.The weight, spleen weight and spleen index of the mice in the pharmaceutical composition of the invention small dose group, big dose group and the Jinkuishenqiwan group were not significantly different to compare with that of the mice in the hydroxy group (P > 0.05), which indicated that the pharmaceutical composition of the invention had no effect on decrease of the mice's weight, spleen weight and spleen index caused by hydroxy urea,when using the dose of the composition of this invention in this experiment.
Experiment 3 Anti-inflammatory action on the mice of "deficiency of vitality" caused by hydroxy urea Sixty-nine mice weighing 18-22 g and of either sex were used and randomly divided into seven groups. They were divided into two batches for experiment. After measured the volume of the behindright foot of the mice in each group, the mice in the control group were administered p.o. equal volume normal saline, the mice in the "deficiency of vitality" model group, the pharmaceutical composition of the invention small dose group, big dose group and the Jinkuishenqiwan group were administered p.o. hydroxy urea 300 mg/kg for 7 days continuously. On the eighth day, equal volume normal saline was administered p.o. to the mice in the control group and the model of "deficiency of vitality" group.The pharmaceutical composition of the invention 2.Og/kg, 4.Og/kg were administered p.o. to the mice in the two groups of the pharmaceutical composition of the invention. Jinkuishenqiwan 4.0gig was administered p.o. to the mice in the positive medicine comparative group. After thirty minutes, each mouse was injected subcutaneously 1% carrageenan 0.1 ml at the ankle to cause inflammation. During 4 hours after causing inflammation, the mice in each /fOOt group were measured foot volume. The difference of the foot volume between after and before causing inflammation was used to express the degree of swelling. The results were shown in table 5.
Table 5. Anti-inflammatory action on the mice of "deficiency of vitality" caused by hydroxy urea (xSD) Group Number Dose Degree of foot swelling (cm) of mice (g/kg) lh 2h 3h 4h Normal urea 10 e.v. 0.0840.029 0.099+0.042 0.103+0.042 0.990.031 Hydroxy * ** ** *** urea 10 0.3 0.073+0.025 0.0600.023 0.059+0.037 0.0520.024 P.C.+ 2.0 & um;* & um; & um;* & um;** & um; & um;*** H.U. 10 +0.3 0,0850.026 0.0900.025 0.068+0.029 0.030+0.018 P.C. + 4.0 & um;* & um;* & um; & um;*** & um;*** H.U. 10 +0.3 0.0880.029 0.068+0.038 0.0290.016 0.034+0.021 Normal Saline 10 e.v. 0.1250.015 0.1290.019 0.1190.039 0.092*0.027 Hydroxy * *** * * urea 9 0.3 0.1000.034 0.078*0.024 0.102*0.042 0.1030.038 JKSQW 4.0 *** & um; & um;* & um;* & um;* +H.U. 10 +0.3 0.0980.031 0.1110.039 0.097+0.024 0.0730.028 P.C.: the pharmaceutical composition of the invention H.U.: Hydroxy urea JKSQW: Jinkuishenqiwan *p > 0.05, **p < 0.05, *** p < 0.01 comparing with normal saline group & um;p > 0.05, & um; & um;p < 0.05, comparing with hydroxy urea group The results in the table 5 indicated that the degree of swelling of the foot of the mice in the hydroxy urea group (2,3,4 hours), the small dose of the pharmaceutical composition of the invention group (3,4 hours) and the Jinkuishenqiwan group (1 hour) were smaller than that of the mice in the normal saline group a t certain time ( p < 0.05-0.01) indicated that hydroxy urea had the action of restraining foot swelling of mice caused by carrageenan.The degree of foot swell of the mice in the two groups of the pharmaceutical composition of the invention (the small dose 2 hours, the big dose 3 hours) was smaller than that the mice in the hydroxy urea group, which indicated that the pharmaceutical composition of the invention had anti-inflanatory action on the "deficiency of fatality" mice. But it couldn't demonstrated that Jinkuishenqiwan had this action.
Experiment 4 Analgesic action on the mice of "deficiency of vitality" caused by hydroxy urea Forty- nine mice weighing 18-22 g and of either sex were used and randomly divided into five groups. Equal volume normal saline was administered p.o. to the mice in the control group. Hydroxy urea 300mg/kg was administered p.o. to all the mice in the "deficiency of vitality" model group. The two dose groups of the pharmaceutical composition of the invention and the Jinkuishenqiwan group for seven days continuously. On the seventh day, equal volume normal saline was administered p.o. to the mice in both the control group and the "deficiency of vitality" model group.
The pharmaceutical composition of the present invention 2.Og/kg and 4.Og/kg were respectively administered p.o. to the mice in the two dose groups of the pharmaceutical composition of the invention. Jinkuishenqiwan 4.0g/kg was administered p.o. to the mice in the positive medicinal comparative group. At 30 minutes after administered, the mice in each group were injected abdominally 0.6% acetic acid solution O.lml/lOg. The action of body's swing (writhing) and the times of body's swing during 30 minutes were noted.
The obtained data were analysed with statistical methods. The results are shown in table 6.
Table 6: Analgesic action on the mice of "deficiency of vitality caused by hydroxy urea Group Number Dose Latent period of Time of body's swing of mice (g/kg) body's swing during 30 minutes (min) (times) Normal saline 10 e.q. 3.2+1.2 66.7+20.1 * Hydroxy urea 9 0.3 4.1+1.1 37.9ll.7*** P.C.+ H.U. 10 2.0+0.3 3.20.8* & um; & um; 55.428.5* & um; P.C.+ H.U. 10 4.0+0.3 5.41.2*** & um; & um; 50,217.8* & um; JKSQW + H.U. 10 4.0+0.3 4.31.9* & um; 50.821.5* & um; P.C.: the pharmaceutical composition of the invention H.U.: Hydroxy urea JKSQW:Jinkuishenqiwan *p > 0.05, ***p < O.01 comparing with the normal saline group & um;p > 0,05, tOp < O.05 comparing with the hydroxy urea group The results in table 6 indicated that the times of body's swing of the mice in the hydroxy urea group and the latent period of body's swing of the mice in the big dose of the pharmaceutical composition of the invention group were smaller than that of the mice in the normal saline group, which indicated that hydroxy urea had the action of restraining body's swing of the mice caused by acetic acid.The latent period of body's swing of the mice in the big dose of the pharmaceutical composition of the invention group was significantly longer than that of the mice in the hydroxy urea group (p < 0.05), which indicated that the pharmaceutical composition of the invention had analgesic action on the mice of "deficiency of vitality". But it couldn't be demonstrated that the Jinkuishenqi pill had this action.
The results of experiments 1-4 indicated: 1. The pharmaceutical composition of the invention had restraining action on prostatauxe caused by testosterone propionate.
2. The pharmaceutical composition of the invention had the protective action on decrease of the skin's temperature of the mice of "deficiency of vitality" caused by hydroxy urea.
3. The pharmaceutical composition of the invention had antiinflammatory action on the mice of "deficiency of vitality" caused by hydroxy urea.
4. The pharmaceutical composition of the invention had analgesic action on the mice of "deficiency of vitality" caused by hydroxy urea.
Experiment 5 The therapeutical action on the old people's prostatauxe /were chosen 407 male patients who had the disease of prostatauxe and were in the age range 46 to 87 years. They were randomly divided into two groups. Group A had 198 men. They had been continuously taking the pharmaceutical composition of the invention (20ml/day which was made in example t for three months. Group B had 209 men They had been continuously taking Ginseng Royal Jelly 5ml which was made in Fushun Qingfeng Pharmaceutical Factory for three months, 2 times a day. All of the 407 men did not take any other medi cine relating to the treatment of prostatauxe and did not accept treatment during the three months' therapeutic period.
Before and after taking itedicine for three months, they were examined by the rectal touch method. The result was determined according to "Rule of diagnosis and criterions of cure or taking a favorable turn of clinical disease", which was published by the People's Army Medical Press. There were 101 patients taking a favorable turn1 48 patients being cured among the 149 patients in the pharmaceutical composition of the invention group after taking the composition for three months. The total effective examples were 149 and the total effective rate was 75.3%. The ineffective examples were 49 which is 24.7% of the total sample. In 209 examples which the patients took Ginseng Royal Jelly, after taking it for three months, 23 men had taking a favorable turn, 3 nen were cured. The total effective examples were 26, the total effective rate was 12.4%. The ineffective examples were 183 with the ineffective rate was 87.6*. Coxparative results showed as table 7.
Table 7 Group Number Effect Cured Ineffect Total effective of rate Examples ----------------------------------------- No. % No. % No. % No. % A 198 101 51.0 48 24.2 49 24.8 149 75.3* B 209 23 11.0 3 1.4 163 87.6 26 12.4 * Comparing with the Ginseng Royal Jelly group p < O.05.
The dxperimental results in table 7 indicated that the clinical therapeutic effect on prostatauxe of the pharmaceutical composition of the invention was significantly better than that of Ginseng Royal Jelly.
Experiment 6 390 patients with equal sex who had presbyopia and were 46-87 years old were chosen. They were randomly divided into two groups. Group A had 186 examples with the patients continuously taking the pharmaceutical composition of the invention 20ml made in example 9 per day for three months. Group B had 204 examples the patients continuously taking Ginseng Royal Jelly 5ml made in Fushun Qingfeng Pharmaceutical Factory 2 times per day for three months. All of the 390 examples with the patients not taking any medicine for treatment of presbyopia and operating treatment during the three months' therapeutic period.
After taking medicinal for three months, the patients were examined. The result was determined according to "Rule of diagnosis and criterions of cured or taking a favorable turn of clinical diseases" published by the People's Army Medical Press. Among the presbyopia patients of group A, there were 79 patients whose symptom of presbyopia was improved and 53 patients were cured.
The total effective examples was 132. Total effective rate was 70.9%. The ineffective examples was 54. In the group B, there were 31 examples that the patients symptom of presbyopia was improved, and 4 examples that the patients were cured. The total effective example was 35, total effective rate was 17.2%. The ineffective examples were 169. The results showed as Table 8.
Table 8 Group Number Effect Cured Ineffect Total effective of rate Examples No. % No. % No. % No. % A 186 79 42.5 53 28.5 54 29.0 132 70.9* B 204 31 15.2 4 1.9 169 82.8 35 17.2 * Comparing with the Ginseng Royal Jelly group p < O.05.
The results in table 8 indicated that the clinical therapeutical the effectiveness of /pharmaceutical composition of the invention was significantly better than that of the Ginseng Royal Jelly.

Claims (8)

CLAIMS :
1. A pharmaceutical composition having anti-decrepit action, comprising extractives of traditional Chinese medicines with weight ratio: Male bombycid (Xiongcan'e) 20-60 Cornu cervi pantotrichum (Lurong) 1-4 Genital of ass (Lushen) 1-4 Radix ginseng (Renshen) 1-6 Herba epimedii (Yinyanghuo) 1-4 Radix achyranthes bidentatae (Niuxi) 1-4 said extractives being those which are extractable using a solution of 60 to 80% alcohol.
2. A pharmaceutical composition according to claim 1, characterized in that the pharmaceutical composition also conq?rises the alcohol extractives of traditional Chinese medicines with weight ratio: Semen trigonellea (Huluba) 1-5 Rhizoma curculiginis (Xianmao) 1-5 Semen cuscutae (Tusizi) 1-4 Herba cistanches (Roucongrong) 1-4 Fructus cnidii (Shechuangzi) 1-4
3. A pharmaceutical composition according to claim 1, characterized in that the pharmaceutical composition also comprises the alcohol extractives of traditional Chinese medicines with weight ratio: Semen trigonellae (Huluba) 1-5 Rhizoma curculiginis (Xianmao) 1-5 Semen cuscutae (Tusizi) 1-
4 Semen allii tuberosi (Jiucaizi) 1-4 Radix ophiopogonis (Maimendong) 1-4 Fructus foeniculi (Xiaohuixiang) 1-4 Cortex cinnamomi (Rougui) 1-4 Radix glycyrrhizae (Gancao) 1-4 4.A process for preparing a pharmaceutical composition having anti-decrepit action comprising the steps of: (a). crushing (weight ratio): Male bombycid (Xiongcan'e) 20-60 Cornu cervi pantotrichum (Lurong) 1-4 Genital of ass (Lushen) 1-4 Radix ginseng (Renshen) 1-6 into crude powder and adding 30 to 60% ethanol to moisten the powder, allowing the moistened powder to stand in an airtight enclosure for 12 to 36 hours, percolating the moistened crude powder by using 6 to 90 weight ratio of alcohol, and collecting the percolated solution.
(b). ref fluxing materials comprising of (weight ratio): Herba epimedii (Yinyanghuo) 1-4 Radix achyranthes bidentatae (Niuxi) 1-4 for /2-4 hours by using 60-80% ethanol which is 5 times amount of the materials and obtaining the extractive A, filtering the extractive A to obtain filtrate (1) and the residue; ref fluxing the residue 0.5-1.5 hours by using 60-80% ethanol which is 3 times amount of the residue to obtain extractive B, and filtering the extractive B to obtain filtrate (2); combining filtrate (1) and (2) to obtain filtrate (3); (c). evaporating the filtrate 3 under reduced pressure and concentrating the evaporated filtrate (3) to form a dilute extractive with a comparative density of 1.15-1.20 at 20-25 degree centigrade; (d). combining the percolate solution in step (a) with said dilute extractive in step (c), adding medicinally acceptable carrier to obtain the pharmaceutical composition having anti-decrepit action.
5. A process for preparing a pharmaceutical composition having anti-decrepit action according to claim 4, characterized in that the materials in step (b) may also contain (weight ratio): Semen trigonellea (Huluba) 1-5 Rhizoma curculiginis (Xianmao) 1-5 Semen cuscutae (Tusizi) 1-4 Herba cistanches (Roucongrong) 1-4 Fructus cnidii (Shechuangzi) 1-4
6. A process for preparing a pharmaceutical composition having anti-decrepit action according to claim 4, characterized in that the materials in step (b) may also contain (weight ratio): Semen trigonellae (Huluba) 1-5 Rhizoma curculiginis (Xianmao) 1-5 Semen cuscutae (Tusizi) 1-4 Semen allii tuberosi (Jiucaizi) 1-4 Radix ophiopogonis (Maimendong) 1-4 Fructus foeniculi (Xiaohuixiang) 1-4 Cortex cinnamomi (Rougui) 1-4 Radix glycyrrhizae (Gancao) 1-4
7. A process for preparing a pharmaceutical composition having anti-decrepit action according to one of claims4 to 6, characterized in that the pharmaceutical composition is the form of oral solution, injectable solution, capsule or tablet.
8. A pharmaceutical composition as claimed in claim 1, substantially as described in anyone of the examples hereinbefore set forth.
GB9321945A 1993-10-25 1993-10-25 A pharmaceutical composition having anti-decrepit action and a process for preparation thereof Expired - Fee Related GB2282966B (en)

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HK98100905A HK1002139A1 (en) 1993-10-25 1998-02-06 A pharmaceutical composition having anti-decrepit action and a process for preparation thereof

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GB2282966A true GB2282966A (en) 1995-04-26
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Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2001001996A1 (en) * 1999-06-29 2001-01-11 University Of Western Australia Compositions and methods for treating or preventing osteoporosis
GB2402062A (en) * 2003-03-28 2004-12-01 Nuliv Biomedicine Inc Pharmaceutical composition for the prophylaxis or treatment of osteoporosis
WO2008113118A1 (en) * 2007-03-16 2008-09-25 Medcina Group Pty Ltd Compositions and methods for treating male infertility
CN103230458A (en) * 2013-05-09 2013-08-07 武汉市健恒药业有限公司 Method for preparing prostate Longbitong tablet

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2001001996A1 (en) * 1999-06-29 2001-01-11 University Of Western Australia Compositions and methods for treating or preventing osteoporosis
GB2402062A (en) * 2003-03-28 2004-12-01 Nuliv Biomedicine Inc Pharmaceutical composition for the prophylaxis or treatment of osteoporosis
WO2008113118A1 (en) * 2007-03-16 2008-09-25 Medcina Group Pty Ltd Compositions and methods for treating male infertility
CN103230458A (en) * 2013-05-09 2013-08-07 武汉市健恒药业有限公司 Method for preparing prostate Longbitong tablet

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Publication number Publication date
HK1002139A1 (en) 1998-07-31
GB9321945D0 (en) 1993-12-15
GB2282966B (en) 1997-08-13

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