Background technology
Leukopenia and agranulocytosis are internal medicine blood system commonly encountered diseases, frequently-occurring disease, and its pathogenic factor can or infect and other disease causes because of chemical factors such as medicine (as benzolism), and partly cause is not clear.Particularly in the therapeutic process of many tumor diseases, need to use chemotherapy or actinotherapy treatment mostly, these two kinds of therapies all can be killed and wounded human leukocytes in a large number, it is the important pathogenesis of primary disease, many tumour patients often can not continue to accept chemotherapy or radiotherapy because of leukopenia causes, so that lose the therapy apparatus meeting, cause the development and the deterioration of tumor.Therefore, the treatment primary disease is particularly treated the leukopenia problem in tumour patient radiotherapy, the chemotherapy process, becomes the key subjects of domestic and international medical circle.
Though modern medicine has had deep understanding for the cause of disease, but in treatment, still lack new means, Therapeutic Method does not have major progress in recent years, generally adopts group vitamins leukocyte increasing (as adenine phosphate), colony stimulating factor and use adrenocortical hormone to reduce the leukocyte that causes because of immunity to destroy.These therapies, curative effect is unsatisfactory, and with some serious adverse comparatively, has limited the clinical scope of application.
The traditional Chinese medical herbal treatment primary disease, general employing determination of treatment based on pathogenesis obtained through differentiation of symptoms and signs, vigorate qi and replenish the blood, grow methods such as anti-tonifying YANG, though some patient is had curative effect preferably, but it is cumbersome with decocting for Chinese herbal medicine, dose is excessive and the time is long, how can influence disadvantages such as appetite, it is very few that the clinical application that has limited tumour patient serves as based on the leukocyte increasing of Chinese medicine to raise variety in the existing market of Chinese medicine preparation of main effect, and generally be compound preparation, and flavour of a drug are many, curative effect is extensively and not special, and especially the effect of leukocyte increasing is slowly and not remarkable.
The objective of the invention is to, the medicine that provides a kind of Chinese medicine and western medicine to unite use, Chinese medicine and Western medicine can be brought into play synergism, reduce the side effect of Western medicine on the one hand, onset rapidly on the other hand.This medicine can be used for various acute and chronic leukopenias or agranulocytosis, is particularly useful for because of the above-mentioned disease due to tumor disease radiotherapy or the chemotherapy.In leukocyte increasing, there is not the toxic and side effects of other similar Western medicine, it is also few that degradation reacts under the appetite due to other Chinese medicine because of taking.
Summary of the invention
This invention compositions realizes as follows: by weight
96 parts of 1 part of Chinese medicine extract of cepharanthine
Wherein Chinese medicine extract prepares according to the method for putting down in writing in the Chinese patent CN1058908A description: 0.15 part of 0.2 part of Radix Salviae Miltiorrhizae of 0.5 part of Fructus Ligustri Lucidi of 1 part of Radix Astragali of Caulis Spatholobi
Earlier Caulis Spatholobi is carried out coarse pulverization, preparing burden in proportion with other three flavors medicine in the back, puts and soaked in the molten device 7-10 hour.Decoct with water respectively then three times, time was respectively 1.5,1,0.5 hours, three fried liquid are merged, slow fire be concentrated into 1: 1 (g: ml) elimination insoluble matter, add 95% ethanol to pure content 80%, left standstill 12 hours, filter, the molten partially recycled ethanol of alcohol gets pure clear paste, is required Chinese medicine extract.
One object of the present invention is to provide the purposes of above-mentioned Pharmaceutical composition in the medicine of preparation promotion leucocyte hyperplasia.
This Chinese medical concrete is called " the described Chinese medicine extract of this paper (or above) " hereinafter.
Above-mentioned composition and mixing acceptable accessories can be made acceptable forms clinically, as tablet, capsule, granule, oral liquid, subcutaneous administration preparation, suppository etc.
Pharmacological research
The main pharmacodynamics of Pharmaceutical composition of the present invention studies confirm that it has the effect that promotes leucocyte hyperplasia more by force, i.e. leukogenic effect.
Cyclophosphamide 120mg/kg/ day is injected in healthy Kunming mouse abdominal cavity continuously, continuous three days, treat that peripheral blood kind leukocyte reduces to 1000/mm3After, begin to take and respectively organize medicine, set up leukopenia model after the mice chemotherapy, carry out the pharmacodynamics test that Pharmaceutical composition of the present invention promotes leucocyte hyperplasia.Each is organized medicine and used 7 days continuously, irritates stomach every day 1 time, 10 of every group of mices.
The test grouping:
1 model control group: after the animal model modeling success, normal physiological saline is irritated stomach;
2 pure Chinese drug-treated group: extractum 0.96g/kg body weight as indicated above
3 cepharanthine groups: the 10mg/kg body weight is irritated stomach
4 compositions groups: 10mg/kg body weight cepharanthine+extractum 0.96g/kg body weight mentioned above is irritated stomach.
| Group | The leukocyte number |
| Group 1 | 1018±107.2/mm3 |
| Group 2 | 1942±111.7/mm3 |
| Group 3 | 2214±185.2/mm3 |
| Group 4 | 3042±196.7/mm3 |
This table shows that all there is significant difference (P＜0.05) in each group (pure Chinese drug-treated group, cepharanthine group, compositions group) of treatment with model control group, and all there are significant difference (P＜0.05) in compositions group and pure Chinese drug-treated group, compositions group and cepharanthine group.Show that there are cooperative effect in cepharanthine and described Chinese medicinal components in the compositions group.
The pharmaceutics test
Can produce the tablet that contains following component in a conventional manner:
ComponentThe Mg/ sheet
Pharmaceutical composition 200-1000 of the present invention
Corn starch 125.0
Pulvis Talci 75.0
Magnesium stearate 1.0
Wherein compositions is made up of with weight ratio cepharanthine and Chinese medicine extract mentioned above at 1: 96.
Can produce the capsule that contains following component in a conventional manner:
ComponentThe Mg/ sheet
Pharmaceutical composition 200-1000 of the present invention
Lactose 10.0
Corn starch 20.0
Talcum 5.0
Wherein compositions is made up of with weight ratio cepharanthine and Chinese medicine extract mentioned above at 1: 96.