Chinese drug composition for treatment of peptic ulcer and...

Drug – bio-affecting and body treating compositions – Plant material or plant extract of undetermined constitution...

Reexamination Certificate

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C424S774000, C424S779000, C424S474000, C514S925000

Reexamination Certificate

active

06344219

ABSTRACT:

FIELD OF THE INVENTION
The present invention is related to the drug for the treatment of gastric disease especially to a Chinese drug composition for the treatment of peptic ulcer and preparation thereof.
BACKGROUND OF THE INVENTION
Peptic ulcer is a common, frequently-occurring disease with high incidence. The aim of the therapy of peptic ulcer is to eliminate symptoms, promote healing, and to prevent relapse and complications. At present the medicines used in the treatment of peptic ulcer still do not meet the therapeutical demands. The drugs utilizing in the treatment of peptic ulcer at present are all exiting the defects of expensive price, obvious side effects, and high relapse.
In Chinese medicine, peptic ulcer related to the categories of “epigastric pain”, “stomachache caused by the dominant liver-energy” and so on. The mechanism of the disease mostly is concerned with the deficiency of qi in the spleen and stomach, or the stagnation of vital energy caused by cold-evil, or the obstruction of the stomach caused by damp-heat, or the internal stagnation of the blood and so on. The hindrance of functional activities of qi yields the pain, and the stagnation of qi leads to blood stasis, or prolonged diseases involves the collateral, the prolonged blood stasis in the interior changes into heat then the flesh was rotted and the muscles was injured and the ulcer was formed. “NeiJing SuWen: JuTongLun (Plain Question of Canon of Internal Medicine: On the Pain)”: “the cold-evil accumulated between the stomach and intestinal under the half-superficies and half-interior position so that pain was formed due to the blood failed to circulate and the small collateral was blocked”, “the cold-evil accumulated in the stomach and intestinal adversely evolved from upside resulted in pain and vomit”. In clinics, many cases were categorized in cold-evil accumulating in stomach, stagnation of qi leads to blood stasis, Ye Tian-shi of Qing dynasty gave a brilliant exposition on the therapeutical method: “What is the essential of (stomach disease)! The beginning of the disease mentioned above is occurred at the channel then goes into the collateral as a result of prolonged pain, channel is the principal pathogeny and collateral controls the blood, therefore the treatment of qi and blood is abundantly clear”. (“Lin Zheng Zhi Nan Yi An, Wei Wan Tong (Medical Record Guides of clinical Symptoms Epigastric pain)”). Li Dong-huan pointed out in “Nei Wei Shang Pian Huo Lun, Fei Shi Pi Wei Xu Fang (On the recognition of the Nature of internal and traumatic injuries, Formula of the deficiency of Spleen and Stomach due to Lung)”. “Fire has been exhausted and can not be transported and transformed, in addition of the invasion by cold-evil, all of this accumulated as fullness pain. Dispelled it with pungent hot medicine and associated with sweet-bitter ones to use bland flavor drug for clearing up then qi become gentle and stomach become harmony, as a result the pain would be relieved”.
At present, using the drug prepared from two kinds of Chinese medicine indicated as follow for the treatment of peptic ulcer still has not been reported. This two kinds of medicine are:
Chenopodium ambrosioides
(cf. Du Yao Ben Cao (poison Herbs) ed. by Yang Lun-liang pp 925-927. China Chinese Medicine Publish House, Dec. 1993):
Chenopodium ambrosioides
is the total herb with the ear of fruit of the plant of
Chenopodiaceae chenopodium ambrosioides
L. The essential oil (oil of
Chenopodium ambrosiodes
) contained in the total herb is 0.4-1% composing mainly of Ascaridole, p-Cymene, and other terpeniod such as aritasone, limonese etc. possesses the activities of dispelling wind-evil, killing germs, inducing menstruation and relieving pain.
Adina pilulifera
(cf. Zhong Hua Yao Hai (Chinese Medicine Dictionary) ed. by Ran Xian-de p426, Harbin Publish House, Aug. 1993); It is a plant of Rubiaceae, the scientific name is
Adina pilulifera
(Lam Franch). Its leaves contain the admixture of acidic saponin which gave quinovic acid and acetate thereof aftwr hydrolysis, it also contains beta-sitosterol, and its stern contains quinovic acid, beta-sitosterol and the admixture of saponin which yields quinovic acid, betulic acid and cinchoninic acid after hydrolisis. The fraction of saccharide contains mainly glucuronate. It exhibits the effect of clearing away heat and dampness, removing blood stasis and relieving pain, arresting blood and promoting the regeneration of tissues and so on.
The object of the invention is to overcome the deficiency of the prior art and to provide a Chinese drug composition comprising mainly of the active components of
chenopodium ambrosioides
and
adina pilulifera
for the treatment of peptic ulcer.
The another object of the present invention is to provide a method for preparing said Chinese drug composition.
The still another object of the present invention is to provide a capsule preparation comprising said Chinese drug composition.
The further object of the present invention is to provide a use of said Chinese drug composition in the preparation of drug for the treatment of peptic ulcer.
SUMMARY OF THE INVENTION
The present invention provides a Chinese drug composition for the treatment of peptic ulcer which comprises the oil of
Chenopodium abrosioides
and the oil of
Adina pilulifera,
in a ratio of oil of
Chenopodium ambrosiodes:
oil of
Adina pilulifera
being 18-70:0.5-5 (by weight).
The Chinese drug composition of this invention was prepared according to the following procedure, that is:
Chenopodium ambrosioides
and
Adina pilulifera
(50-70:30-50 by weight) were steam distilled for extracting the essential oil, and collecting the oil obtained.
The preparation containing the Chinese drug composition of this invention can be administered with any oral preparations preferable is capsules, its preparative method may be the regular method known in the existing art.
The Chinese drug composition of present invention possesses good therapeutic effect on peptic ulcer and is provided with significant inhibitory action to pyloric spirillum.
DETAILED DESCRIPTION OF THE INVENTION
The Chinese drug composition of this invention is the active components extracted from
Chenopodium ambrosioides
(Chenopodiaceae) and
Adina pilulifera
(Rubiaceae) which were the essential oils obtained by steam distillation of
Chenopodium ambrosioides
and
Adina pilulifera
in a ratio of 50-70:30-50 by weight. The essential oil obtained was a mixture comprising the oil of
Chenopodium ambrosioides
and oil of
Adina pilulifera
oil of
Chenopodium ambrosioides:
oil of
Adina pilulifera
therein is 18-70:0.5-5 (by weight).
The source of the medicines of this invention is spread in everywhere, and the price of the medicines is cheap. The preparative procedure is simple and easy to conduct which is advantageous to decrease the product cost.
The results of animal tests indicated that the Chinese drug composition of present invention possesses good protective effect to the ulcer of stress, pyloric ligation, acetic acid burn, and Reserpine, Indomethacin and Histamine induced peptic ulcer (details are shown in experiments 1-1 to 1-6 thereinafter).
The generally accepted mechanism of peptic ulcer was the “balance theory” suggested by Shay which meant that the defending factors and the attacking factors were in a state of imbalance. Anti-ulcer agents showed the therapeutic effect through promoting the defending factors or by retarding the attacking factors.
The stress ulcer is generally considered as an acute ulcer caused by the disorder of central nerve system and automatic nerve system function and the disorder of gastrointestinal peristalsis and secretion.
The mechanism of pyloric ligation ulcer is considered to be the result of the accumulation of acid and pepsin. The ulcer induced by Reserpine is related to the stimulation of vagus and the increase of gastric secretion.
The increased secretion of gastric juice with high acidity induced by Histamine is probably an important factor of ulcer occurrence. The medicine of the pre

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