CN1935229A

CN1935229A - Chinese medicine injection preparation and its preparing method

Info

Publication number: CN1935229A
Application number: CN 200610111676
Authority: CN
Inventors: 于文风
Original assignee: Qiyuanyide Medicines Institute Beijing
Current assignee: Qiyuanyide Medicines Institute Beijing
Priority date: 2005-08-22
Filing date: 2006-08-22
Publication date: 2007-03-28

Abstract

The present invention relates to a Chinese medicine injection preparation for raising immunity of body and curing angiocardiopathy and cerebrovascular disease and its preparation method. Said Chinese medicine injection preparation is made up by using ginseng (or red ginseng or pilose asiabell root), ophiopogon tuber and erigeron breviscapus through a certain preparation process. Said Chinese medicine injection preparation can obtain good therapeutic effect for curing the diseases of coronary heart disease, angina pectoris, arrhythmia, cerebral thrombosis and senile dementia, etc.

Description

A kind of traditional medicine Injectio and preparation method thereof

Technical field

The present invention is a kind of traditional medicine Injectio with human body immunity improving power, treatment cardio-cerebrovascular diseases and preparation method thereof, belongs to technical field of Chinese medicine.

Technical background

We's medical application---cardiovascular and cerebrovascular disease, as coronary heart disease, myocardial infarction, rhomboembolia type cerebrovascular etc. is sickness rate height, disability rate height and the also high disease of case fatality rate, with diabetes, tumor etc. is at present the mankind to be threatened maximum three major types disease, and wherein cardiovascular and cerebrovascular disease is positioned at first of this three big disease.There is 2,600,000 people every year in China because of cardiovascular and cerebrovascular disease death at present, so prevention and treatment cardiovascular and cerebrovascular disease have become a necessity and arduous problem.

The medicine that is used for the treatment of at present cardiovascular and cerebrovascular disease clinically is generally Radix Salviae Miltiorrhizae Injection, SHENGMAI ZHUSHEYE, SHENMAI ZHUSHEYE, Breviscapini injection etc., yet these injection curative effects are very not desirable, and the report that untoward reaction is all arranged, the clinical reports of delivering in " clinical misdiagnosis wrong treatment " the 6th phase of calendar year 2001 at the above " giving birth to the untoward reaction of arteries and veins (and ginseng arteries and veins) injection ", Li Lanqing etc. of " Chinese patent medicine " 1999 the 8th phases as Zhuan Zhiquan such as " untoward reaction of Herba Erigerontis injection ".The applicant thinks that the reason that produces this situation may be: 1, the prescription of these preparations and proportioning thereof have much room for improvement, effect such as Breviscapini injection, Radix Salviae Miltiorrhizae Injection is single, can only be to a certain cause of disease pathological changes generation effect of cardiovascular and cerebrovascular disease, so curative effect is undesirable; 2, the processing extraction is impure, and some compositions such as pigment, tannin, starch, protein etc. are remained in the medicinal liquid with colloidal form, thereby untoward reaction takes place.And Chinese medicine is particular about the multicomponent synergism, makes its performance better therapeutic.Therefore, invent a kind of good effect, untoward reaction few, to the cardiovascular and cerebrovascular disease Different types of etiopathogenises produce the medicament composing prescription of synergistic therapeutic action and preparation thereof, technology is necessary.

The applicant drafts prescription: Radix Ophiopogonis, Radix Ginseng, Herba Erigerontis from the medicine of several respects researchs such as Chinese medicine traditional theory, pathomechanism treatment cardiovascular and cerebrovascular disease.From Chinese medicine theoretically, Radix Ginseng QI invigorating reinforcing the heart; Radix Ophiopogonis YIN nourishing and the production of body fluid promoting, Fu Mai; Herba Erigerontis has the effect of dredge the meridian passage, blood circulation promoting and blood stasis dispelling, and three medicine compatibilities are combined into a kind of pharmaceutical preparation that can effectively treat cardiovascular and cerebrovascular disease.From pathomechanism, vascular lesion is the main cause that causes at present known all cardiovascular and cerebrovascular vessel incident, and can be divided into ischemic and hemorrhagic two big classes from lesion nature, and the former sickness rate is far above the latter.In recent years, the free radical mechanism research of ischemic heart and brain damage is very active, has obtained bigger progress in many aspects.Prior art shows the effect that has Herba Erigerontis, Radix Ginseng, Radix Ophiopogonis good removing reactive oxygen free radical.Inventor's process discovers that three's compatibility result of use is better than the single medicine, and through the effective ingredient that extraction process of the present invention prepares, has removed impurity and kept plurality of active ingredients in the medicine, thereby made the effect of preparation better.

Summary of the invention

The object of the present invention is to provide a kind of ejection preparation and preparation method thereof with human body immunity improving power, treatment cardiovascular and cerebrovascular disease; The present invention utilizes the Radix Ginseng strongly invigorating primordial QI, Radix Ophiopogonis YIN nourishing and the production of body fluid promoting, Herba Erigerontis relaxing muscles and tendons to promote blood circulation, analgesic effect are combined into a kind of preparation of effective treatment cardiovascular and cerebrovascular disease.The present invention is directed to prior art, at different medical materials, adopt the mode of separately extracting, both can effectively extract active component, simultaneously can be under the situation that guarantees active component, remove impurity targetedly, sample is made with extra care, the treatment that adds the cardiovascular and cerebrovascular disease acute attack stage is extremely important, and preparation of the present invention is mainly injection, makes medicine performance curative effect fast, the availability height, be fit to the treatment of cardiovascular and cerebrovascular disease, while preparation of the present invention is human body immunity improving power effectively, the generation of prevention and resist the disease.

Technical scheme of the present invention is achieved in that according to parts by weight and calculates, it is made through extracting refining and adding suitable adjuvant by 50～5000 parts of 10～1000 parts of 10～1000 parts of Herba Erigerontiss, Radix Ophiopogonis and Radix Ginsengs, or add the injection that suitable adjuvant is made through extracting the extract that obtains after refining by corresponding weight portion medical material, contain the various saccharides composition in the preparation.Specifically, calculate according to components by weight percent, it is made through extracting refining and adding suitable adjuvant by 50～1000 parts of 10～500 parts of 10～500 parts of Herba Erigerontiss, Radix Ophiopogonis and Radix Ginsengs, or add the injection that suitable adjuvant is made through extracting the extract that obtains after refining by corresponding weight portion medical material, contain various saccharides compositions such as Radix Ophiopogonis polysaccharide and monosaccharide in the preparation.Say exactly, it is made through extracting refining and adding suitable adjuvant by 200～500 parts of 50～200 parts of 50～200 parts of Herba Erigerontiss, Radix Ophiopogonis and Radix Ginsengs, or add the injection that suitable adjuvant is made through extracting the extract that obtains after refining by corresponding weight portion medical material, contain various saccharides compositions such as Radix Ophiopogonis polysaccharide and monosaccharide in the preparation, the total solid that the content of carbohydrate content accounts in the preparation after deduction adjuvant amount and the water quantities is not less than 4%.

Preparation of the present invention is an injection, comprising: be directly used in drug administration by injection injection, need to be used for the concentrated solution for injection of intravenous drip after the dilution, directly for the venous transfusion of intravenous drip and injectable sterile powder and the aseptic block that makes with freeze-drying or spray drying method.

Contain saponin component, polysaccharide composition and flavones ingredient in the traditional medicine Injectio with human body immunity improving power, treatment cardio-cerebrovascular diseases of the present invention, wherein the total solid that accounts in the preparation after deduction adjuvant amount and the water quantities of the content of saponin component is not less than 1%; The total solid that the content of flavones ingredient accounts in the preparation after deduction adjuvant amount and the water quantities is not less than 1%, and the content of polysaccharide composition accounts for that the total solid after the deduction adjuvant amount and water quantities is not less than 3% in the preparation.All the content sums that can survey composition of saponin component in the preparation, polysaccharide composition and flavones ingredient and other account for that the total solid after the deduction adjuvant amount and water quantities is not less than 25% in the preparation.

Preparation method with traditional medicine Injectio of human body immunity improving power, treatment cardio-cerebrovascular diseases of the present invention: Radix Ophiopogonis, people participate in Herba Erigerontis three flavor medical materials and add water or ethanol extraction respectively, extracting solution carry out suitably concentrating crude extract or further adopt one or more methods in alcohol deposition method, water precipitating method, acid-base precipitation method, flocculent precipitation, column chromatography, the solvent extraction be used in combination refining extract, the material of getting it filled is thick to be extracted or refining extract adds different auxiliary material and makes different ejection preparations.

Specifically, the preparation method with traditional medicine Injectio of human body immunity improving power, treatment cardio-cerebrovascular diseases of the present invention is:

A, Radix Ophiopogonis medical material, adding 5～15 times of volume decoctings boils 1～4 time, each 0.5～2.5 hour, merge extractive liquid,, measuring relative density when being concentrated into 60 ℃ is 1.05～1.15, add the ethanol precipitate with ethanol twice, make for the first time that to contain the alcohol amount be 50～70%, make that to contain the alcohol amount be 80～90% for the second time, filter merging filtrate, measuring relative density during decompression recycling ethanol to 60 ℃ is 1.05～1.15, twice precipitation merged the back add 1～4 times of water dissolution, filter, the concentrated solution of filtrate and front merges, measuring relative density when being evaporated to 60 ℃ is 1.05～1.15, the dry Radix Ophiopogonis extract that gets;

B, get the Herba Erigerontis medical material, add 5～15 times of volume 50～80% alcohol reflux 1～4 time, each 0.5～2.5 hour, merge extractive liquid,, measuring relative density when being concentrated into 60 ℃ is 1.05～1.15, dry Herba Erigerontis extract;

C, get the ginseng crude drug, add 5～15 times of volume 50～80% alcohol reflux 1～4 time, each 0.5～2.5 hour, merge extractive liquid,, measuring relative density when being concentrated into 60 ℃ is 1.05～1.15, dry Radix Ginseng extract;

Above-mentioned Radix Ophiopogonis extract, Herba Erigerontis extract and Radix Ginseng extract are merged, add adjuvant and make different ejection preparations.

Freeze-dried powder is preparation like this in the injection of the present invention:

A, get medical material Radix Ophiopogonis, adding 10 times of volume decoctings boils 3 times, each 1.5 hours, merge extractive liquid,, measuring relative density when being concentrated into 60 ℃ is 1.05～1.15, add the ethanol precipitate with ethanol twice, make for the first time that to contain the alcohol amount be 60%, make that to contain the alcohol amount be 85% for the second time, filter merging filtrate, measuring relative density during decompression recycling ethanol to 60 ℃ is 1.05～1.15, twice precipitation merged the back add 2 times of water dissolutioies, filter, the concentrated solution of filtrate and front merges, measuring relative density when being evaporated to 60 ℃ is 1.05～1.15, the dry Radix Ophiopogonis extract that gets;

B, get the Herba Erigerontis medical material, add 10 times of volume 70% alcohol reflux 3 times, each 1 hour, merge extractive liquid,, measuring relative density when being concentrated into 60 ℃ is 1.05～1.15, dry Herba Erigerontis extract;

C, get the ginseng crude drug, add 10 times of volume 70% alcohol reflux 3 times, each 1 hour, merge extractive liquid,, measuring relative density when being concentrated into 60 ℃ is 1.05～1.15, dry Radix Ginseng extract.

Above-mentioned Radix Ophiopogonis extract, Herba Erigerontis extract are merged, add an amount of water for injection dissolving, by volume add 0.1%～1.5% active carbon, boil, keep little 10～60min that boils, cold slightly filtration, filtrate adds the injection water to ormal weight, transfers pH value 5.5～7.5, boils, spend the night coarse filtration, fine straining 1～8 ℃ of cold preservation.Mannitol is added the injection water be mixed with 50～150mg/ml solution,, filter packing with above-mentioned filtrate mixing, temperature-55～-45 ℃, pre-freeze time 8～12h, the beginning evacuation, and be warming up to-43～-37 ℃, keep 6～10h, be warming up to-33～-27 ℃ again, keep 6～10h; Be warming up to-23～-17 ℃, keep 6～10h, be warming up to-13～-7 ℃, keep 4～6h, be warming up to-3～3 ℃, keep 4～6h, be warming up to 7～13 ℃, keep 1～3h, be warming up to 17～23 ℃, keep 1～3h, promptly get freeze-dried powder.

Injection with small volume of the present invention or concentrated solution for injection prepare like this:

Above-mentioned Radix Ophiopogonis extract, Herba Erigerontis extract and Radix Ginseng extract are merged, add an amount of water for injection dissolving, by volume add 0.1%～1.5% active carbon, boil, keep little 10～60min that boils, cold slightly filtration, filtrate adds the injection water to ormal weight, transfer pH value 5.5～7.5, boil, spend the night 1～8 ℃ of cold preservation, coarse filtration, fine straining, dividing to install in the ampoule bottle, is 100～110 ℃ in vapor (steam) temperature, and actual pressure is at 100～120kN/m ³Pressure sterilizing is 40～60 minutes under the condition, promptly gets the injection with small volume or the concentrated solution for injection that are directly used in drug administration by injection.

Glucose intravenous infusion agent of the present invention prepares like this:

C, get the ginseng crude drug, add 10 times of volume 70% alcohol reflux 3 times, each 1 hour, merge extractive liquid,, measuring relative density when being concentrated into 60 ℃ is 1.05～1.15, dry Radix Ginseng extract;

Above-mentioned Radix Ophiopogonis extract, Herba Erigerontis extract and Radix Ginseng extract are merged, add an amount of water for injection dissolving, add the glucose of ormal weight again, by volume add 0.1%～1.5% active carbon, boil, keep little 10～60min that boils, cold slightly filtration, filtrate add the injection water to ormal weight, transfer pH value 5.5～7.5, boil, spend the night coarse filtration, fine straining 1～8 ℃ of cold preservation, add the injection water, packing is under 105～125 ℃ of conditions, sterilized 20～60 minutes, and promptly got the glucose intravenous infusion agent.

Sodium chloride intravenous infusion agent of the present invention prepares like this:

B, Herba Erigerontis medical material add 10 times of volume 70% alcohol reflux 3 times, and each 1 hour, merge extractive liquid,, measuring relative density when being concentrated into 60 ℃ is 1.05～1.15, the dry Herba Erigerontis extract that gets;

Above-mentioned Radix Ophiopogonis extract, Herba Erigerontis extract and Radix Ginseng extract are merged, add an amount of water for injection dissolving, add the sodium chloride of ormal weight again, by volume add 0.1%～1.5% active carbon, boil, keep little 10～60min that boils, cold slightly filtration, filtrate add the injection water to ormal weight, transfer pH value 5.5～7.5, boil, spend the night coarse filtration, fine straining 1～8 ℃ of cold preservation, add the injection water, packing is under 105～125 ℃ of conditions, sterilized 20～60 minutes, and promptly got the sodium chloride intravenous infusion agent.

The preparation like this of freeze dry sterile powder of the present invention end:

Above-mentioned Radix Ophiopogonis extract, Herba Erigerontis extract and Radix Ginseng extract are merged, add an amount of water for injection dissolving, by volume add 0.1%～1.5% active carbon, boil, keep little 10～60min that boils, cold slightly filtration, filtrate adds the injection water to ormal weight, transfers pH value 5.5～7.5, boils, spend the night 1～8 ℃ of cold preservation, coarse filtration, fine straining divide to install in the enamel tray, temperature-55～-45 ℃, pre-freeze time 8～12h, the beginning evacuation, and be warming up to-43～-37 ℃, keep 6～10h, be warming up to-33～-27 ℃ again, keep 6～10h; Be warming up to-23～-17 ℃, keep 6～10h, be warming up to-13～-7 ℃, keep 4～6h, be warming up to-3～3 ℃, keep 4～6h, be warming up to 7～13 ℃, keep 1～3h, be warming up to 17～23 ℃, keep 1～3h, under aseptic condition, divide to install to promptly to get the freeze dry sterile powder end in the cillin bottle.

Spray drying sterilized powder of the present invention prepares like this:

Above-mentioned Radix Ophiopogonis extract, Herba Erigerontis extract and Radix Ginseng extract are merged, add an amount of water for injection dissolving, by volume add 0.1%～1.5% active carbon, boil, keep little 10～60min that boils, cold slightly filtration, filtrate adds the injection water to ormal weight, transfer pH value 5.5～7.5, boil, spend the night 1～8 ℃ of cold preservation, coarse filtration, fine straining, in inlet temperature is 140～160 ℃, and leaving air temp is 60～80 ℃, and air velocity is 16～20ms ^-1Condition under spray drying get powder, packing promptly gets the spray drying sterilized powder.

The adjuvant that is adopted in the preparation of the present invention comprises one or more in mannitol, galactose, glycine, glucose, sodium chloride, dextran, glycerol, ethanol, propylene glycol, Polyethylene Glycol, sorbitol, tween, the poloxamer.The Radix Ginseng that the present invention relates to can also be the Radix Ginseng Rubra or the Radix Codonopsis of equivalent.

Compared with prior art, salience progress of the present invention is:

The applicant filters out optimum prescription in conjunction with aspects such as traditional Chinese medicine theory, cardiovascular and cerebrovascular disease pathomechanism, each effective ingredient site of actions; make it possess effects such as the blood vessel of expansion, brain protection, anticoagulant, the healing of promotion myocardial damage; and respectively each flavor Effective Components of Chinese Herb is extracted; be prepared into compound preparation, pharmacodynamics test proves that this compound preparation has stronger curative effect to cardiovascular and cerebrovascular disease than other preparations and single medicinal substances extract.The three herbal medicine rational and effective prescription proportionings that the present invention filters out, can many-sided effect in the vascular lesion position, and enhancing human body immunity power had better effect.Find that simultaneously Herba Erigerontis, Radix Ophiopogonis, compatibility Radix Ginseng Rubra, Radix Codonopsis also had certain curative effect.

Each medical material of this prescription adopts and extracts separately and suitable process for refining, avoids occurring the complicated component that mixed extraction may cause, and the pigment that remove impurity does not totally cause, tannin, protein etc. remain in the medium problem of medicinal liquid.

The applicant finds that in injection with small volume or concentrated solution for injection molding research the effective ingredient breviscapine dissolubility of Herba Erigerontis is low, and chemical stability problems appears in preparation easily.Through repetition test; we adopt the ethanol extraction Herba Erigerontis of higher concentration; and the medicinal liquid pH value is adjusted to 5.5～7.5; this moment, medicinal liquid was relatively stable; do not produce microgranule or any cosmetic variation; index components scutellarin content does not have too big variation, has effectively solved the problem of Herba Erigerontis stability.

Lyophilized formulations provided by the invention because main component is saponin, flavone, polysaccharide material, situations such as spray bottle, lyophilizing are incomplete occurred in freezing dry process, may be because composition is more, and contain the cause of polysaccharide material.Through our repetition test, adopt rational freeze-dry process, preferably resolve this difficult problem.The inventor finds that in research process most of adjuvant all can be made into freeze-dried powder, but solubility angle integrated survey from yield rate, molding situation and sample, use the effect of mannitol to be better than other several adjuvants separately, both can satisfy the every requirement of injection, and reduce simultaneously as far as possible and add too much adjuvant.

Experimentation shows, the prescription side effect that the applicant screened is little, cardiovascular and cerebrovascular disease is had tangible curative effect; The selected preparation technology of the present invention extracts the medical material effective ingredient when removing impurity; The selected moulding process of the present invention is rationally controlled, and the formulation products that obtains is the good medicine of human body immunity improving power, treatment cardiovascular and cerebrovascular disease.

The applicant has carried out a series of experiments, can prove that safety of medicine provided by the invention is effective, process stabilizing, quality controllable.

Experimental example 1: drug effectiveness research

The pharmacological research conclusion

Pilot project	Of the present invention group	The Herba Erigerontis injection group
Pilot project	Of the present invention group	The Herba Erigerontis injection group	Improve the rheology test of blood stasis model rat blood	Effect is remarkable, and effect strengthens	Effect is general
The antiplatelet aggregation test	Effect is remarkable, and effect strengthens	Effect is obvious	Improve the rheology test of blood stasis model rat blood	Effect is remarkable, and effect strengthens	Effect is general
The antiplatelet aggregation test	Effect is remarkable, and effect strengthens	Effect is obvious	Anti-mouse tail thrombotest	Effect is remarkable, and effect strengthens	Effect is general
The rabbit fibrin solubility test	Effect is obvious, and effect strengthens	Effect is general	Anti-mouse tail thrombotest	Effect is remarkable, and effect strengthens	Effect is general
The rabbit fibrin solubility test	Effect is obvious, and effect strengthens	Effect is general	The white mice anti-fatigue test	Effect is remarkable	DeGrain

From above-mentioned test as can be seen, the combination preparation therapeutic effect is significantly better than single preparation group.

Experimental example 2: extraction process Study on Conditions

2.1 Radix Ophiopogonis Study on Preparation

2.1.1 Radix Ophiopogonis, the water extraction condition was investigated

Main active component is polysaccharide and saponins in Radix Ophiopogonis, and the two all has fine solubility in water, therefore takes into account both extractions, and preliminary definite extraction solvent is a water.The Chinese medicine preparation curative effect depends primarily on extraction, and extraction effect is subjected to extracting the influence of factors such as solvent, extraction time and time.Extract to such an extent that each factor is investigated to influence.

2.1.1.1 water absorption rate is investigated

Medical material is a dry product when decocting for the first time, and itself will absorb moisture, and for preventing the influence of medical material suction to amount of water, the spy makes water absorption rate and investigates, and adds corresponding water absorption when decocting for the first time.

Get 200g medical material Radix Ophiopogonis during investigation and add 10 times of water gagings, be dipped to the heart, filter, recording water absorption rate is 230%.

2.1.1.2 extract the solvent load screening Radix Ophiopogonis

Experimental technique and data: take by weighing three parts Radix Ophiopogonis medical material, every part of 300g adds different water gagings respectively and decocts 2 times, each 1 hour, merge decoction liquor, filter, it is 1.05～1.15 (60 ℃) that filtrate is concentrated into relative density, drying is weighed.Measure in the precipitation total polysaccharides content Radix Ophiopogonis.

The solvent load screening

The experiment number	Medical material amount (g)	Solvent load (times medical material amount)	Extractum amount (g)	Total polysaccharides content (%)	The total polysaccharides rate of transform (%)
The experiment number	Medical material amount (g)	Solvent load (times medical material amount)	Extractum amount (g)	Total polysaccharides content (%)	The total polysaccharides rate of transform (%)	1 2 3	300 300 300	8 10 12	90.38 93.28 94.12	23.86 24.88 24.62	83.88 90.27 90.12

Annotate: total polysaccharides content 8.57% in the Radix Ophiopogonis medical material.

As can be known from the results, respectively with 8 times, 10 times, 12 times water extraction, wherein the content of 8 times of water extraction total polysaccharidess and the rate of transform are minimum, 10 times of water and 12 times of water extraction total polysaccharides content and the rate of transform are higher, and total polysaccharides content and the rate of transform are more or less the same under these two kinds of conditions, take all factors into consideration, selecting the extraction solvent load of Radix Ophiopogonis is 10 times of water.

2.1.1.3 the screening of extraction time, extraction time

Experimental technique and data: take by weighing 300g medical material Radix Ophiopogonis, adding 10 times of water gagings decocts 5 times, each extraction time is 1 hour, each extracting solution filters respectively, it is 1.05～1.15 (60 ℃) that filtrate is concentrated into relative density, drying is weighed, and is that index is investigated the water boiling and extraction number of times with the extractum amount.

The extraction time screening

Extraction time	Extraction time (h)	Extractum amount (g)
Extraction time	Extraction time (h)	Extractum amount (g)	1	1	72.58
2	1	17.28	1	1	72.58
2	1	17.28	3	1	4.12
4	1	0.60	3	1	4.12
4	1	0.60	5	1	0.25

Have the result as can be known, the extract amount seldom there is no need to proceed to extract again after the water boiling and extraction three times, is 3 times so select the water boiling and extraction number of times.

2.1.1.4 extraction time screening

Experimental technique and data: take by weighing 300g medical material Radix Ophiopogonis, nominal is got 3 parts, add 10 times of water gagings and decoct extraction 3 times, extract with different extraction times respectively, extracting solution filters, and it is 1.05～1.15 (60 ℃) that filtrate is concentrated into relative density, drying, weighing, is that index is investigated the water boiling and extraction time with the content of total polysaccharides in extractum amount and the extractum.

The extraction time screening

The experiment number	Solvent load (times medical material amount)	Extraction time	Each extraction time (h)	Extractum amount (g)	Total polysaccharides content (%)
The experiment number	Solvent load (times medical material amount)	Extraction time	Each extraction time (h)	Extractum amount (g)	Total polysaccharides content (%)	1	10	3	1	88.76	23.92
2	10	3	1.5	93.29	24.37	1	10	3	1	88.76	23.92
2	10	3	1.5	93.29	24.37	3	10	3	2	94.87	24.05

By experimental result as can be known, under the situation that extraction solvent load, extraction time are all determined, the total polysaccharides content difference is few in the extract that three kinds of extraction times obtain, but to extract the extract that obtained in 1 hour minimum at every turn, and to extract the extract amount that obtained in 1.5 hours and 2 hours all more and be more or less the same at every turn, selects each the extraction 1.5 hours for raising the efficiency.

2.1.2 impurity removal process is investigated

Owing to contain a large amount of impurity in the water extract Radix Ophiopogonis, can't satisfy the requirement of preparations shaping, therefore need carry out purification to it.Because extract is a water extract, the water impurity dissolubility that contains is stronger, therefore adopts ethanol precipitation to make medicinal liquid obtain purification contamination precipitation; Simultaneously because polysaccharide dissolubility in alcohol is relatively poor, thus polysaccharide loss when adding ethanol precipitation, so water extracts polysaccharide from precipitate behind precipitate with ethanol.And these two tests, the consumption of solvent and concentration of alcohol have considerable influence to result of the test, therefore with Radix Ophiopogonis total polysaccharides content be index, investigate precipitate with ethanol condition and amount of water.

2.1.2.1 the precipitate with ethanol condition is investigated

Experimental technique and data: take by weighing medical material 1500g Radix Ophiopogonis, add 10 times of water gagings and decoct 3 times, each 1.5 hours, merge decoction liquor, filter, it is 1.05～1.15 (60 ℃) that filtrate is concentrated into relative density, is divided into three parts, respectively precipitate with ethanol operation carrying out purification in the according to the form below, alcohol deposit fluid is filtered, filtrate decompression concentrates, and drying is weighed.Precipitation oven dry is weighed, and measures in the precipitation total polysaccharides content Radix Ophiopogonis.

The investigation of precipitate with ethanol condition

The experiment number	The precipitate with ethanol operation	Precipitation heavy (g)	Total polysaccharides content (%)	The rate of transform (%)
The experiment number	The precipitate with ethanol operation	Precipitation heavy (g)	Total polysaccharides content (%)	The rate of transform (%)	1	The ethanol precipitate with ethanol once, the alcohol amount of containing is 80%	91.08	34.48	73.28
2	Ethanol precipitate with ethanol twice makes for the first time that to contain the alcohol amount be 60%, makes that to contain the alcohol amount be 85% for the second time	106.25	34.43	85.38	1		91.08	34.48	73.28
2		106.25	34.43	85.38	3	Ethanol precipitate with ethanol three times, make for the first time that to contain the alcohol amount be 60%, make for the second time that to contain the alcohol amount be 80 %, make for the third time that to contain the alcohol amount be 85%	105.08	35.32	86.62

From top result as can be seen, when adopting ethanol precipitation twice, most of precipitation is separated out, so, take all factors into consideration, select the precipitate with ethanol condition to be: ethanol precipitate with ethanol twice, make that to contain the alcohol amount be 60% for the first time, make that to contain the alcohol amount be 85% for the second time.

2.1.2.2 amount of water is investigated

Experimental technique and data: take by weighing medical material 3000g Radix Ophiopogonis, add 10 times of water gagings and decoct each 1.5 hours 3 times, merge decoction liquor, filter, it is 1.05～1.15 (60 ℃) that filtrate is concentrated into relative density, be divided into three parts, ethanol precipitate with ethanol twice makes for the first time that to contain the alcohol amount be 60%, makes that to contain the alcohol amount be 85% for the second time, cold preservation (4 ℃) is spent the night, filter, filtrate decompression is concentrated into 60 ℃ of mensuration relative densities and is 1.05～1.15, and is standby.Precipitation oven dry adds different volumes water, stirs, and leaves standstill, and filters, and the concentrated solution of filtrate filtrate and front merges, and measuring relative density when being evaporated to 60 ℃ is 1.05～1.15, and dry Radix Ophiopogonis extract calculates the rate of transform of total polysaccharides Radix Ophiopogonis in precipitating.

The precipitation amount of water is investigated

The experiment number	Medical material weight (g)	Amount of water (times precipitation capacity)	The precipitation hydrotrope heavy (g)	The total polysaccharides rate of transform (%)
The experiment number	Medical material weight (g)	Amount of water (times precipitation capacity)	The precipitation hydrotrope heavy (g)	The total polysaccharides rate of transform (%)	1	1000	2	38.20	75.36
2	1000	3	41.08	83.72	1	1000	2	38.20	75.36
2	1000	3	41.08	83.72	3	1000	4	41.54	84.26

Experimental result shows, the precipitate with ethanol postprecipitation adds 2 times of water can guarantee that polysaccharide can fully transfer in the solution, and further strengthens water consumption and can not obviously improve stripping polysaccharide amount, is 2 times so select amount of water.

2.2 Herba Erigerontis Study on Preparation

Through above analysis and investigation, determined preparation technology's basic technology route.This test will be investigated the principal element that influences flavones ingredient extraction effect in the Herba Erigerontis, as extracting solvent, extraction time etc., to determine the preferred process condition.

2.2.1 the investigation of concentration of alcohol

According to the EXPERIMENTAL DESIGN of extraction process, Different concentrations of alcohol is carried out preferably.Design is respectively with 30%, 50% in the test, and 70%, 80% ethanol is as extracting solvent, serves as to investigate index with the rate of transform of scutellarin in the extract, in conjunction with the content of scutellarin, different extraction solvents investigated simultaneously.

Test method: take by weighing 4 parts of Herba Erigerontiss, every part of 200g adds the different solvents of 15 times of volumes, reflux, extract, 3 times, each 1 hour respectively.Respectively extracting solution is filtered, decompression filtrate recycling ethanol (60 ℃) concentrates, vacuum drying (60 ℃ ,-0.09Mpa).Measure the content of scutellarin.

The investigation table of concentration of alcohol

Concentration of alcohol (%)	Medical material weight (g)	Cream heavy (g)	Scutellarin content (%)	The rate of transform (%)
Concentration of alcohol (%)	Medical material weight (g)	Cream heavy (g)	Scutellarin content (%)	The rate of transform (%)	30	200	14.38	3.57	68.27
50	200	15.42	4.06	83.25	30	200	14.38	3.57	68.27
50	200	15.42	4.06	83.25	70	200	10.87	6.27	90.63
80	200	11.05	6.12	89.93	70	200	10.87	6.27	90.63

Annotate: scutellarin content 0.376% in the medical material

The result shows, during with 70% ethanol extraction, the scutellarin content and the rate of transform all are higher than the ethanol of other concentration.So the ethanol of selection 70% is as extracting solvent.

2.2.2 the screening of ethanol consumption

After the extraction solvent is determined, its consumption is carried out.Take by weighing 4 parts of Herba Erigerontiss, every part of 200g adds the solvent of different volumes, reflux, extract, 3 times, each 1 hour respectively.Respectively extracting solution is filtered, decompression filtrate recycling ethanol (60 ℃) concentrates, vacuum drying (60 ℃ ,-0.09Mpa).Measure the content of scutellarin.The result is as follows:

The screening of ethanol consumption

Ethanol consumption (times medical material amount)	Medical material weight (g)	Cream heavy (g)	Scutellarin content (%)	The rate of transform (%)
Ethanol consumption (times medical material amount)	Medical material weight (g)	Cream heavy (g)	Scutellarin content (%)	The rate of transform (%)	6	200	12.34	3.46	56.78
8	200	12.68	5.18	87.34	6	200	12.34	3.46	56.78
8	200	12.68	5.18	87.34	10	200	10.86	6.32	91.27
12	200	10.98	6.28	91.69	10	200	10.86	6.32	91.27

Annotate: scutellarin content 0.376% in the medical material

By experimental result as can be known, adopt the highest and rate of transform of 10 times of medical material amounts, 70% ethanol extraction scutellarin content and differ very little with 12 times of amounts, therefore selecting the ethanol consumption is 10 times of medical material amounts.

2.2.3 extraction time screening

Extract solvent and extract consumption determine after, extraction time is investigated.Take by weighing 3 parts of Herba Erigerontiss, every part of 200g adds the solvent of 10 times of medical material amounts respectively, the reflux, extract, different time, and every part is extracted 3 times.Respectively extracting solution is filtered, decompression filtrate recycling ethanol (60 ℃) concentrates, vacuum drying (60 ℃ ,-0.09Mpa).Measure the content of scutellarin.The result is as follows:

Extraction time is investigated

Tested number	Medical material weight (g)	Extraction time	Extraction time (h)	Cream heavy (g)	Scutellarin content (%)	The rate of transform (%)
Tested number	Medical material weight (g)	Extraction time	Extraction time (h)	Cream heavy (g)	Scutellarin content (%)	The rate of transform (%)	1	200	1	0.5
2	0.5	10.75	5.05	72.15					1	0.5
2	0.5	10.75	5.05	72.15	3	0.5
2	200	1	1		3	0.5
		1	1		2	1	12.32	5.55	90.86
		3	1		2	1	12.32	5.55	90.86
		3	1		3	200	1	1.5
2	1.5	13.08	5.24	91.12			1	1.5
2	1.5	13.08	5.24	91.12			3	1.5

As seen from the experiment, though it is the highest to extract 1.5 hours scutellarin rates of transform, extract 1 hour scutellarin rate of transform and differ very little with it, and content is higher, consider simultaneously to save time, the selective extraction time is 1 hour.

2.3 Radix Ginseng Study on Preparation

This test will be investigated the principal element that influences total soap former times extraction effect in the Radix Ginseng, as extracting solvent, solvent load, extraction time etc., to determine the preferred process condition.

2.3.1 the investigation of concentration of alcohol

According to the EXPERIMENTAL DESIGN of extraction process, Different concentrations of alcohol is carried out preferably.Design is respectively with 20%, 40% in the test, and 60%, 80% ethanol is as extracting solvent, serves as to investigate index with the rate of transform of total saponins in the extract, and different extraction solvents is investigated.

Test method: take by weighing 4 parts of Radix Ginsengs, every part of 200g adds the different solvents of 15 times of volumes, reflux, extract, 3 times, each 1 hour respectively.Respectively extracting solution is filtered, decompression filtrate recycling ethanol (60 ℃) concentrates, vacuum drying (60 ℃ ,-0.09Mpa).Measure the content of Radix Ginseng Rubra total saponins.

The investigation table of concentration of alcohol

Concentration of alcohol (%)	Medical material weight (g)	Cream heavy (g)	Total saponin content (%)	The rate of transform (%)
Concentration of alcohol (%)	Medical material weight (g)	Cream heavy (g)	Total saponin content (%)	The rate of transform (%)	30	200	43.28	3.10	82.82
50	200	33.02	4.26	86.83	30	200	43.28	3.10	82.82
50	200	33.02	4.26	86.83	70	200	25.83	5.78	92.16
80	200	24.64	5.72	87.00	70	200	25.83	5.78	92.16

Annotate: Radix Ginseng Rubra total saponins content 0.81% in the medical material

The result shows, during with 70% ethanol extraction, the total saponin content and the rate of transform all are higher than the ethanol of other concentration.So the ethanol of selection 70% is as extracting solvent.

2.3.2 extract the investigation of solvent load

Test method: take by weighing 4 parts of Radix Ginsengs, every part of 200g adds 70% ethanol of different volumes, reflux, extract, 3 times, each 1 hour respectively.Respectively extracting solution is filtered, decompression filtrate recycling ethanol (60 ℃) concentrates, vacuum drying (60 ℃ ,-0.09Mpa).Measure the content of Radix Ginseng total saponins.

The screening of ethanol consumption

Ethanol consumption (times medical material amount)	Medical material weight (g)	Cream heavy (g)	Total saponin content (%)	The rate of transform (%)
Ethanol consumption (times medical material amount)	Medical material weight (g)	Cream heavy (g)	Total saponin content (%)	The rate of transform (%)	6	300	28.34	3.46	56.78
8	300	12.68	5.18	87.34	6	300	28.34	3.46	56.78
8	300	12.68	5.18	87.34	10	300	10.86	6.32	91.27
12	300	10.98	6.28	91.69	10	300	10.86	6.32	91.27

As seen from the experiment, extract with 10 times and 12 times of medical material amounts, the extract total saponin content and the rate of transform are higher and be more or less the same, and are 10 times of medical material amounts for saving solvent selective extraction quantity of solvent.

2.3.3 extraction time screening

Test method: take by weighing 3 parts of Radix Ginsengs, every part of 200g adds 70% ethanol of 10 times of medical material amounts, reflux, extract, 3 times respectively.Respectively extracting solution is filtered, decompression filtrate recycling ethanol (60 ℃) concentrates, vacuum drying (60 ℃ ,-0.09Mpa).Measure the content of Radix Ginseng total saponins.

Extraction time is investigated

Tested number	Medical material weight (g)	Extraction time	Extraction time (h)	Cream heavy (g)	Total saponin content (%)	The rate of transform (%)
Tested number	Medical material weight (g)	Extraction time	Extraction time (h)	Cream heavy (g)	Total saponin content (%)	The rate of transform (%)	1	300	1	0.5
2	0.5	34.38	5.38	76.15					1	0.5
2	0.5	34.38	5.38	76.15	3	0.5
2	300	1	1		3	0.5
		1	1		2	1	36.52	6.14	92.26
		3	1		2	1	36.52	6.14	92.26
		3	1		3	300	1	1.5
2	1.5	37.08	6.05	92.28			1	1.5
2	1.5	37.08	6.05	92.28			3	1.5

The result shows, extraction time be each 1 hour best, the total saponin content and the total saponins rate of transform are the highest in its extract, increase extraction time can not significantly improve the total saponins rate of transform and owing to proposed more impurity total saponin content is reduced on the contrary, and be each 1 hour so select extraction time.

Experimental example 3: injection with small volume or concentrated solution for injection molding research

3.1 activated carbon dosage is investigated

Injection owing to solvent, raw material, container etc. have the pyrogen material, reduces the safety of injection in the process of producing, and therefore needs to remove the pyrogen material in the process of preparation injection.The method of depyrogenation mainly contains high temperature method, acid-base method, ultrafiltration and absorption method at present, active carbon adsorption not only can heat of adsorption originality composition, the effect that also has filter of helping and decolouring, when removing pyrogen, can improve the appearance character of preparation, therefore we select the active carbon adsorption depyrogenation for use, and its consumption investigated, the results are shown in following table.

The activated carbon dosage investigation table

Activated carbon dosage (%)	Cream heavy (g)	The rate of transform (%)	Outward appearance
Activated carbon dosage (%)	Cream heavy (g)	The rate of transform (%)	Outward appearance	0.1	8.63	56.35	Reddish brown
1	8.39	54.33	Red	0.1	8.63	56.35	Reddish brown
1	8.39	54.33	Red	1.5	7.98	50.41	Red

From the medicinal liquid outward appearance, select activated carbon dosage be 1% and 1.5% proper; But judge that from the rate of transform 0.1% consumption and 1% consumption are slightly better, the three all can satisfy the related request of injection, but takes all factors into consideration above factor, so that be the best with the activated carbon decolorizing of medicine liquid volume 1%.

The bleaching time investigation table

Time (minute)	Cream heavy (g)	The rate of transform (%)	Outward appearance
Time (minute)	Cream heavy (g)	The rate of transform (%)	Outward appearance	10	8.63	53.25	Reddish brown
30	8.27	52.13	Red	10	8.63	53.25	Reddish brown
30	8.27	52.13	Red	60	8.04	49.68	Pale red

From top test as can be seen, along with the color of the prolongation medicinal liquid of time is thin out, but above-mentioned factor is taken all factors into consideration in the also corresponding minimizing of the rate of transform of effective ingredient, selects for use and boils 30 minutes for best.

3.2 pH value of solution is investigated

For adapting to the Human Physiology needs, also to consider the character of each constituents in the medicinal liquid simultaneously, when dosing, need suitably adjust the pH value of medicinal liquid.Select scutellarin content as evaluation index.

Test method and result: after feeding intake and handle by recipe quantity,, filter with the concentrated solution mix homogeneously by above-mentioned condition, add water to 1000ml, adjust pH is when the different pH value that reaches shown in the following table, boil the back standing over night, observe the variation of appearance character under different pH condition.Experimental result sees Table:

The investigation of dosing pH value

Sequence number	1 2 3	4 5 6 7	8 9
Sequence number	1 2 3	4 5 6 7	8 9	Dosing pH	4.5 5.0 5.5	6.0 6.5 7.0 7.5	8.0 8.5
Boil pH	4.1 4.7 5.3	5.7 6.2 6.6 7.2	7.6 8.2	Dosing pH	4.5 5.0 5.5	6.0 6.5 7.0 7.5	8.0 8.5
Boil pH	4.1 4.7 5.3	5.7 6.2 6.6 7.2	7.6 8.2	Outward appearance	Precipitation appears	No significant change	Color burn

The result shows, the medicinal liquid pH value boils the back at the sample below 5.5 and precipitation occurs, and pH value is obviously deepened in the color sample more than 7.5, and pH value is that 5.5～7.5 medicinal liquid is relatively stable, and outward appearance does not have significant change.Below its scutellarin content is measured, be the results are shown in Table:

The situation of change table of index components before and after pH value is regulated

Sequence number	Dosing pH	Content during dosing (%)	Boil back pH	Boil back content (%)
Sequence number	Dosing pH	Content during dosing (%)	Boil back pH	Boil back content (%)	1	5.5	3.62	5.3	3.40
2	6.0	3.62	5.7	3.49	1	5.5	3.62	5.3	3.40
2	6.0	3.62	5.7	3.49	3	6.5	3.62	6.2	3.55
4	7.0	3.62	6.6	3.43	3	6.5	3.62	6.2	3.55
4	7.0	3.62	6.6	3.43	5	7.5	3.62	7.2	3.42

As seen from table, medicinal liquid is being adjusted the pH value front and back, the not too big variation of index components scutellarin content.The appearance character of comprehensive above-mentioned medicinal liquid and the changes of contents of scutellarin, the pH value of medicinal liquid is transferred between 5.5～7.5 when determining dosing.

Experimental example 4: the investigation of lyophilized formulations moulding process

4.1 the screening of caffolding agent kind

The caffolding agent kind influences the molding of freeze-dried powder, so at first this is screened.Taking liquid mixes with caffolding agent mannitol, glucose and lactose solution respectively, 0.22 μ m membrane filtration postlyophilization, every XiLin bottle-packaging solution 3ml.Freeze dryer: Edwards SNL-3200 freezer dryer (the thermoelectric Thermo of the U.S.).Lyophilisation condition :-45 ℃, behind the pre-freeze 8h, the beginning evacuation, and be warming up to-40 ℃, keep 10h; Be warming up to-30 ℃, keep 10h; Be warming up to-20 ℃, keep 10h; Be warming up to-10 ℃, keep 5h; Be warming up to 0 ℃, keep 5h; Be warming up to 15 ℃, keep 3h; Be warming up to 25 ℃, keep 3h, the result is as showing:

The screening of caffolding agent kind

The caffolding agent kind	Caffolding agent: medicinal liquid (V: V)	Solubility	The finished product outward appearance
The caffolding agent kind	Caffolding agent: medicinal liquid (V: V)	Solubility	The finished product outward appearance	Glucose	3∶2	Good	Part is subsided
Galactose	3∶2	Generally	Molding	Glucose	3∶2	Good	Part is subsided
Galactose	3∶2	Generally	Molding	Mannitol	3∶2	Good	Molding
Glycine	3∶2	Good	Molding, frangible	Mannitol	3∶2	Good	Molding
Glycine	3∶2	Good	Molding, frangible	Dextran	3∶2	Generally	Molding
Mannitol, propylene glycol	3∶2	Good	Molding	Dextran	3∶2	Generally	Molding
Mannitol, propylene glycol	3∶2	Good	Molding	Glycine, Polyethylene Glycol	3∶2	Good	Molding, frangible
Dextran, sorbitol, tween	3∶2	Good	Molding	Glycine, Polyethylene Glycol	3∶2	Good	Molding, frangible
Dextran, sorbitol, tween	3∶2	Good	Molding	Blank medicinal liquid	3ml		Atrophy

As seen from table, in the adjuvant that is screened, under the identical situation of other conditions, most of adjuvant all can be made into freeze-dried powder, but solubility angle integrated survey from yield rate, molding situation and sample, use the effect of mannitol to be better than other several adjuvants separately, can satisfy the every requirement of injection, reduce simultaneously as far as possible and add too much adjuvant.

4.2 caffolding agent consumption screening

The mannitol solution (40mg/ml, 100mg/ml and 160mg/ml) of variable concentrations is mixed in varing proportions with medicinal liquid, filter, every cillin bottle loading amount is 3ml, lyophilization.Lyophilisation condition :-45 ℃, behind the pre-freeze 8h, the beginning evacuation, and be warming up to-40 ℃, keep 10h; Be warming up to-30 ℃, keep 10h; Be warming up to-20 ℃, keep 10h; Be warming up to-10 ℃, keep 5h; Be warming up to 0 ℃, keep 5h; Be warming up to 15 ℃, keep 3h; Be warming up to 25 ℃, keep 3h.The result is as showing:

The screening of mannitol consumption

Numbering	Mannitol concentration (mg/ml)	Mannitol: medicinal liquid (v: v)	Color and luster	Profile	Solubility	Clarity
Numbering	Mannitol concentration (mg/ml)	Mannitol: medicinal liquid (v: v)	Color and luster	Profile	Solubility	Clarity	1	40	2∶1	Yellowish-brown	Part is subsided	Good	Up to specification
2	100	2∶1	Yellow	Intact	Good	Up to specification	1	40	2∶1	Yellowish-brown	Part is subsided	Good	Up to specification
2	100	2∶1	Yellow	Intact	Good	Up to specification	3	160	2∶1	Yellowish	Intact	Good	Up to specification

As seen from table, when the ratio of caffolding agent consumption and medicinal liquid is 3: 2, the sample character is that the sample of 100mg/ml and 160mg/ml is relatively good with the mannitol concentration, the sample of 40mg/ml has part to subside, but major part still is molding, but take all factors into consideration the consumption and the clinical dose of adjuvant, the optimum selection mannitol concentration is 100mg/ml, and the volume ratio of mannitol solution and medicinal liquid is 3: 2.

4.3 lyophilization conditional filtering

Lyophilization is a veryer long dry run, needs to consume a large amount of energy.An ideal lyophilisation condition not only can be saved a large amount of energy, can also shorten man-hour simultaneously, so we are optimized screening to existing lyophilisation condition.The actual conditions screening sees Table:

The lyophilization conditional filtering

Time (h)

Condition I condition II condition III cold-trap

Temperature (℃)

-45 (pre-freezes) 10-8

-40 (pre-freeze)-8-

-40 (evacuation) 8-10

-35 (evacuation)-10-

-30 (evacuation) 8-10 keeps

-25 (evacuation)-8--70 ℃

-20 (evacuation) 8-7

-15 (evacuation)-6-

-10 (evacuation) 5-5

0 (evacuation) 565

10 (evacuation) 223

20 (evacuation) 123

Experimental result shows: finished product appearance character that condition I, II and III make and the equal conformance with standard of moisture.But comparatively speaking, condition II yield rate is low slightly, and condition III power consumption is bigger, considers the practical situation of production, short condition I of finally selected overall time spent, i.e. and lyophilization condition is: pre-freeze temperature-45 ℃, pre-freeze time 10h;-40 ℃ of evacuation keep 8h; Be warming up to-30 ℃ again, keep 8h; Be warming up to-20 ℃, keep 8h; Be warming up to-10 ℃, keep 5h; Be warming up to 0 ℃, keep 5h; Be warming up to 10 ℃, keep 2h; Be warming up to 20 ℃, keep 1h, get product.

Experimental example 5: spray drying conditional filtering

Spray drying technology can make sample dry rapidly under the situation of atomizing, and the protection effective ingredient can make the water content of sample reduce simultaneously, helps stability of formulation.It is bigger that but the air temperature and current speed that spray-dired effect is imported and exported influences, so we are that evaluation index is investigated these three factors with the loss of active ingredients rate.

Spray drying condition investigation table

Inlet temperature (℃)	Outlet temperature (℃)	Air velocity (ms ^-1)	Loss rate (%)
Inlet temperature (℃)	Outlet temperature (℃)	Air velocity (ms ^-1)	Loss rate (%)	140	60	16	4.16
150	70	18	3.91	140	60	16	4.16
150	70	18	3.91	160	80	20	4.32

From above-mentioned result of the test as can be seen, three kinds of conditions all can obtain material preferably, but are 150 ℃ with inlet temperature by contrast, and outlet temperature is 70 ℃, and air velocity is 18 ms ^-1Condition be best.

Concrete embodiment

(part is represented weight portion, as: kilogram, gram etc.)

Embodiment 1: 350 parts of Herba Erigerontis 120 parts of Radix Ginsengs, 120 parts of Radix Ophiopogonis

Above-mentioned Radix Ophiopogonis extract, Herba Erigerontis extract are merged, add an amount of water for injection dissolving, by volume add 1% active carbon, boil, keep little 30min that boils, cold slightly filtration, filtrate adds the injection water to ormal weight, and regulating pH value is 6.5, boil, spend the night coarse filtration, fine straining 4 ℃ of cold preservations.Mannitol is added the injection water be mixed with 100mg/ml solution,, filter, packing, pre-freeze temperature-45 ℃, pre-freeze time 10h with above-mentioned filtrate mixing;-40 ℃ of evacuation keep 8h; Be warming up to-30 ℃ again, keep 8h; Be warming up to-20 ℃, keep 8h; Be warming up to-10 ℃, keep 5h; Be warming up to 0 ℃, keep 5h; Be warming up to 10 ℃, keep 2h; Be warming up to 20 ℃, keep 1h, get product.After testing: Radix Ophiopogonis polysaccharide content accounts in the preparation 15% of total solid after deduction adjuvant amount and the water quantities; The content of saponin component accounts in the preparation 7% of total solid after deduction adjuvant amount and the water quantities; The content of flavones ingredient accounts in the preparation 10% of total solid after deduction adjuvant amount and the water quantities; The total solid that three's sum accounts in the preparation after deduction adjuvant amount and the water quantities is 32%.

Embodiment 2: 350 parts of Herba Erigerontis 120 parts of Radix Ginsengs, 120 parts of Radix Ophiopogonis

Above-mentioned Radix Ophiopogonis extract, Herba Erigerontis extract and Radix Ginseng extract are merged, add an amount of water for injection dissolving, by volume add 1.0% active carbon, boil, keep little 30min that boils, cold slightly filtration, filtrate adds the injection water to ormal weight, regulating pH value is 6, boils, and spends the night 4 ℃ of cold preservations, coarse filtration, fine straining, dividing to install in the ampoule bottle, is 110 ℃ in vapor (steam) temperature, and actual pressure is at 120kN/m ³Pressure sterilizing is 60 minutes under the condition, promptly gets the injection with small volume or the concentrated solution for injection that are directly used in drug administration by injection.After testing: Radix Ophiopogonis polysaccharide content accounts in the preparation 14% of total solid after deduction adjuvant amount and the water quantities; The content of saponin component accounts in the preparation 10% of total solid after deduction adjuvant amount and the water quantities; The content of flavones ingredient accounts in the preparation 5% of total solid after deduction adjuvant amount and the water quantities; The total solid that three's sum accounts in the preparation after deduction adjuvant amount and the water quantities is 29%.

Embodiment 3: 350 parts of Herba Erigerontis 120 parts of Radix Ginsengs, 120 parts of Radix Ophiopogonis

Above-mentioned Radix Ophiopogonis extract, Herba Erigerontis extract and Radix Ginseng extract are merged, add an amount of water for injection dissolving, add the glucose of ormal weight again, by volume add 1.0% active carbon, boil, keep little 30min that boils, cold slightly filtration, filtrate add the injection water to ormal weight, and regulating pH value is 7, boil, spend the night coarse filtration, fine straining 4 ℃ of cold preservations, add the injection water, packing is under 110 ℃ of conditions, sterilized 40 minutes, and promptly got the glucose intravenous infusion agent.After testing: Radix Ophiopogonis polysaccharide content accounts in the preparation 12% of total solid after deduction adjuvant amount and the water quantities; The content of saponin component accounts in the preparation 8% of total solid after deduction adjuvant amount and the water quantities; The content of flavones ingredient accounts in the preparation 11% of total solid after deduction adjuvant amount and the water quantities; The total solid that three's sum accounts in the preparation after deduction adjuvant amount and the water quantities is 31%.

Embodiment 4: 350 parts of Herba Erigerontis 120 parts of Radix Ginsengs, 120 parts of Radix Ophiopogonis

Above-mentioned Radix Ophiopogonis extract, Herba Erigerontis extract and Radix Ginseng extract are merged, add an amount of water for injection dissolving, by volume add 1.0% active carbon, boil, keep little 30min that boils, cold slightly filtration, filtrate adds the injection water to ormal weight, adjust pH is 6.5, boils, and spends the night 4 ℃ of cold preservations, coarse filtration, fine straining, in inlet temperature is 150 ℃, and leaving air temp is 70 ℃, and air velocity is 18ms ^-1Condition under spray drying get powder, packing promptly gets the spray drying sterilized powder.After testing: Radix Ophiopogonis polysaccharide content accounts in the preparation 13% of total solid after deduction adjuvant amount and the water quantities; The content of saponin component accounts in the preparation 9% of total solid after deduction adjuvant amount and the water quantities; The content of flavones ingredient accounts in the preparation 12% of total solid after deduction adjuvant amount and the water quantities; The total solid that three's sum accounts in the preparation after deduction adjuvant amount and the water quantities is 34%.

Embodiments of the invention 5: 5000 parts of Herba Erigerontis 1000 parts of Radix Ginsengs, 1000 parts of Radix Ophiopogonis

A, get medical material Radix Ophiopogonis, adding 15 times of volume decoctings boils 4 times, each 2.5 hours, merge extractive liquid,, measuring relative density when being concentrated into 60 ℃ is 1.05～1.15, add the ethanol precipitate with ethanol twice, make for the first time that to contain the alcohol amount be 70%, make that to contain the alcohol amount be 90% for the second time, filter merging filtrate, measuring relative density during decompression recycling ethanol to 60 ℃ is 1.05～1.15, twice precipitation merged the back add 4 times of water dissolutioies, filter, the concentrated solution of filtrate and front merges, measuring relative density when being evaporated to 60 ℃ is 1.05～1.15, the dry Radix Ophiopogonis extract that gets;

B, get the Herba Erigerontis medical material, add 15 times of volume 80% alcohol reflux 4 times, each 2.5 hours, merge extractive liquid,, measuring relative density when being concentrated into 60 ℃ is 1.05～1.15, dry Herba Erigerontis extract;

C, get the ginseng crude drug, add 15 times of volume 80% alcohol reflux 4 times, each 2.5 hours, merge extractive liquid,, measuring relative density when being concentrated into 60 ℃ is 1.05～1.15, dry Radix Ginseng extract;

Above-mentioned Radix Ophiopogonis extract, Herba Erigerontis extract and Radix Ginseng extract are merged, add an amount of water for injection dissolving, by volume add 1% active carbon, boil, keep little 30min that boils, cold slightly filtration, filtrate adds the injection water to ormal weight, and adjust pH 7.5 boils, spend the night coarse filtration, fine straining 4 ℃ of cold preservations.Mannitol is added the injection water be mixed with 100mg/ml solution,, filter, packing, temperature-45 ℃, pre-freeze time 10h with above-mentioned filtrate mixing;-40 ℃ of evacuation keep 8h; Be warming up to-30 ℃ again, keep 8h; Be warming up to-20 ℃, keep 8h; Be warming up to-10 ℃, keep 5h; Be warming up to 0 ℃, keep 5h; Be warming up to 10 ℃, keep 2h; Be warming up to 20 ℃, keep 1h, promptly get freeze-dried powder.After testing: Radix Ophiopogonis polysaccharide content accounts in the preparation 43% of total solid after deduction adjuvant amount and the water quantities; The content of saponin component accounts in the preparation 19% of total solid after deduction adjuvant amount and the water quantities; The content of flavones ingredient accounts in the preparation 28% of total solid after deduction adjuvant amount and the water quantities; The total solid that three's sum accounts in the preparation after deduction adjuvant amount and the water quantities is 90%.

Embodiments of the invention 6: 50 parts of Herba Erigerontis 10 parts of Radix Ginsengs, 10 parts of Radix Ophiopogonis

A, get medical material Radix Ophiopogonis, adding 5 times of volume decoctings boiled 1 time 0.5 hour, merge extractive liquid,, measuring relative density when being concentrated into 60 ℃ is 1.05～1.15, add the ethanol precipitate with ethanol twice, make for the first time that to contain the alcohol amount be 50%, make for the second time that to contain the alcohol amount be 80%, filter merging filtrate, measuring relative density during decompression recycling ethanol to 60 ℃ is 1.05～1.15, will twice precipitation merges the back and adds 1 times of water dissolution, filter, the concentrated solution of filtrate and front merges, and measuring relative density when being evaporated to 60 ℃ is 1.05～1.15, the dry Radix Ophiopogonis extract that gets;

B, get the Herba Erigerontis medical material, added 5 times of volumes, 50% alcohol reflux 1 time 0.5 hour, merge extractive liquid,, measuring relative density when being concentrated into 60 ℃ is 1.05～1.15, dry Herba Erigerontis extract;

C, get the ginseng crude drug, added 5 times of volumes, 50% alcohol reflux 1 time 0.5 hour, merge extractive liquid,, measuring relative density when being concentrated into 60 ℃ is 1.05～1.15, dry Radix Ginseng extract;

Above-mentioned Radix Ophiopogonis extract, Herba Erigerontis extract and Radix Ginseng extract are merged, add an amount of water for injection dissolving, by volume add 0.1% active carbon, boil, keep little 60min that boils, cold slightly filtration, filtrate adds the injection water to ormal weight, adjust pH is 7.5, boils, and spends the night 8 ℃ of cold preservations, coarse filtration, fine straining, dividing to install in the ampoule bottle, is 100 ℃ in vapor (steam) temperature, and actual pressure is at 100kN/m ³Pressure sterilizing is 20 minutes under the condition, promptly gets the injection with small volume or the concentrated solution for injection that are directly used in drug administration by injection.After testing: Radix Ophiopogonis polysaccharide content accounts in the preparation 21% of total solid after deduction adjuvant amount and the water quantities; The content of saponin component accounts in the preparation 3% of total solid after deduction adjuvant amount and the water quantities; The content of flavones ingredient accounts in the preparation 1% of total solid after deduction adjuvant amount and the water quantities; The total solid that three's sum accounts in the preparation after deduction adjuvant amount and the water quantities is 25%.

Embodiments of the invention 7: 500 parts of Herba Erigerontis 200 parts of Radix Ginseng Rubra, 200 parts of Radix Ophiopogonis

A, get medical material Radix Ophiopogonis, adding 10 times of volume decoctings boiled 1 time 2 hours, merge extractive liquid,, measuring relative density when being concentrated into 60 ℃ is 1.05～1.15, add the ethanol precipitate with ethanol twice, make for the first time that to contain the alcohol amount be 60%, make for the second time that to contain the alcohol amount be 90%, filter merging filtrate, measuring relative density during decompression recycling ethanol to 60 ℃ is 1.05～1.15, will twice precipitation merges the back and adds 3 times of water dissolutioies, filter, the concentrated solution of filtrate and front merges, and measuring relative density when being evaporated to 60 ℃ is 1.05～1.15, the dry Radix Ophiopogonis extract that gets;

B, get the Herba Erigerontis medical material, get the Herba Erigerontis medical material, added 5 times of volumes, 60% alcohol reflux 1 time 2.5 hours, merge extractive liquid,, measuring relative density when being concentrated into 60 ℃ is 1.05～1.15, dry Herba Erigerontis extract;

C, get the Radix Ginseng Rubra medical material, added 5 times of volumes, 60% alcohol reflux 1 time 0.5 hour, merge extractive liquid,, measuring relative density when being concentrated into 60 ℃ is 1.05～1.15, dry Radix Ginseng Rubra extract;

Above-mentioned Radix Ophiopogonis extract, Herba Erigerontis extract and Radix Ginseng Rubra extract are merged, add an amount of water for injection dissolving, add the glucose of ormal weight again, by volume add 0.1% active carbon, boil, keep little 10min that boils, cold slightly filtration, filtrate add the injection water to ormal weight, and adjust pH is 7.5, boil, spend the night coarse filtration, fine straining 1 ℃ of cold preservation, add the injection water, packing is under 105 ℃ of conditions, sterilized 20 minutes, and promptly got the glucose intravenous infusion agent.After testing: the content of carbohydrate content accounts in the preparation 4% of total solid after deduction adjuvant amount and the water quantities.

Embodiments of the invention 8: 300 parts of Herba Erigerontis 60 parts of Radix Ginsengs, 110 parts of Radix Ophiopogonis

A, get medical material Radix Ophiopogonis, add 6 times of volume decoctings and boiled 1 time 0.5 hour, merge extractive liquid,, measuring relative density when being concentrated into 60 ℃ is 1.05～1.15, dry Radix Ophiopogonis extract;

B, get the Herba Erigerontis medical material, add 7 times of volume 50% alcohol reflux 2 times, each 1 hour, merge extractive liquid,, measuring relative density when being concentrated into 60 ℃ is 1.05～1.15, dry Herba Erigerontis extract;

C, get the ginseng crude drug, added 5 times of volumes, 70% alcohol reflux 1 time 0.5 hour, merge extractive liquid,, measuring relative density when being concentrated into 60 ℃ is 1.05～1.15, dry Radix Ginseng extract;

Above-mentioned Radix Ophiopogonis extract, Herba Erigerontis extract and Radix Ginseng extract are merged, add an amount of water for injection dissolving, add the sodium chloride of ormal weight again, by volume add 1% active carbon, boil, keep little 30min that boils, cold slightly filtration, filtrate add the injection water to ormal weight, and adjust pH is 5.5, boil, spend the night coarse filtration, fine straining 4 ℃ of cold preservations, add the injection water, packing is under 115 ℃ of conditions, sterilized 30 minutes, and promptly got the sodium chloride intravenous infusion agent.

Embodiments of the invention 9: 200 parts of Herba Erigerontis 50 parts of Radix Ginseng Rubra, 50 parts of Radix Ophiopogonis

A, add 10 times of volumes, 70% alcohol reflux Radix Ophiopogonis 3 times, each 1.5 hours, merge extractive liquid,, measuring relative density when being concentrated into 60 ℃ is 1.05～1.15, add the dissolving of 3 times of amount water for injection, filter merging filtrate, measuring relative density when being evaporated to 60 ℃ is 1.05～1.15, and medicinal residues add 5 times of volume decoctings and boil 2 times, merge extractive liquid,, concentrating and measuring relative density when adding to 60 ℃ is 1.05～1.15, adds ethanol precipitate with ethanol twice, makes that to contain the alcohol amount be 60% for the first time, make for the second time that to contain the alcohol amount be 90%, filter merging filtrate, measuring relative density during decompression recycling ethanol to 60 ℃ is 1.05～1.15, will twice precipitation merges the back and adds 2 times of water dissolutioies, filter, the concentrated solution of filtrate and front merges, and measuring relative density when being evaporated to 60 ℃ is 1.05～1.15, the dry Radix Ophiopogonis extract that gets;

B, get the Herba Erigerontis medical material, add 12 times of volume 80% alcohol reflux 1 time, each 1 hour, merge extractive liquid,, measuring relative density when being concentrated into 60 ℃ is 1.05～1.15, dry Herba Erigerontis extract;

C, get the Radix Ginseng Rubra medical material, adding 8 times of volume decoctings boils 3 times, each 1 hour, measuring relative density when merge extractive liquid, is concentrated into 60 ℃ is 1.05～1.15, add the ethanol precipitate with ethanol twice, make for the first time that to contain the alcohol amount be 50%, make for the second time that to contain the alcohol amount be 85%, filter merging filtrate, measuring relative density during decompression recycling ethanol to 60 ℃ is 1.05～1.15, will twice precipitation merges the back and adds 3 times of water dissolutioies, filter, the concentrated solution of filtrate and front merges, and measuring relative density when being evaporated to 60 ℃ is 1.05～1.15, the dry Radix Ginseng Rubra extract that gets;

Above-mentioned Radix Ophiopogonis extract, Herba Erigerontis extract and Radix Ginseng Rubra extract are merged, add an amount of water for injection dissolving, by volume add 0.1%～1.5% active carbon, boil, keep little 10～60min that boils, cold slightly filtration, filtrate adds the injection water to ormal weight, adjust pH is 6.5, boils, and spends the night 8 ℃ of cold preservations, coarse filtration, fine straining, divide to install in the enamel tray temperature-45 ℃, pre-freeze time 12h;-37 ℃ of evacuation keep 10h; Be warming up to-27 ℃ again, keep 10h; Be warming up to-17 ℃, keep 10h; Be warming up to-7 ℃, keep 6h; Be warming up to 3 ℃, keep 6h; Be warming up to 13 ℃, keep 3h; Be warming up to 23 ℃, keep 3h, under aseptic condition, divide to install to promptly to get the freeze dry sterile powder end in the cillin bottle.After testing: Radix Ophiopogonis polysaccharide content accounts in the preparation 9% of total solid after deduction adjuvant amount and the water quantities; The content of saponin component accounts in the preparation 10% of total solid after deduction adjuvant amount and the water quantities.

Embodiments of the invention 10: 1000 parts of Herba Erigerontis 500 parts of Radix Codonopsis, 500 parts of Radix Ophiopogonis

A, get medical material Radix Ophiopogonis, adding 12 times of volume decoctings boils 2 times, each 1.5 hours, merge extractive liquid,, measuring relative density when being concentrated into 60 ℃ is 1.05～1.15, add the ethanol precipitate with ethanol twice, make for the first time that to contain the alcohol amount be 55%, make that to contain the alcohol amount be 85% for the second time, filter merging filtrate, measuring relative density during decompression recycling ethanol to 60 ℃ is 1.05～1.15, twice precipitation merged the back add 2 times of water dissolutioies, filter, the concentrated solution of filtrate and front merges, measuring relative density when being evaporated to 60 ℃ is 1.05～1.15, the dry Radix Ophiopogonis extract that gets;

B, get the Herba Erigerontis medical material, add 10 times of volume 50% alcohol reflux 3 times, each 1 hour, merge extractive liquid,, measuring relative density when being concentrated into 60 ℃ is 1.05～1.15, dry Herba Erigerontis extract;

C, get codonopsis pilosula, added 8 times of volumes, 70% alcohol reflux 1 time 1 hour, merge extractive liquid,, measuring relative density when being concentrated into 60 ℃ is 1.05～1.15, dry Radix Codonopsis extract;

Above-mentioned Radix Ophiopogonis extract, Herba Erigerontis extract and Radix Codonopsis extract are merged, add an amount of water for injection dissolving, by volume add 0.8% active carbon, boil, keep little 40min that boils, cold slightly filtration, filtrate adds the injection water to ormal weight, adjust pH is 6.5, boils, and spends the night 6 ℃ of cold preservations, coarse filtration, fine straining, in inlet temperature is 160 ℃, and leaving air temp is 80 ℃, and air velocity is 20ms ^-1Condition under spray drying get powder, packing promptly gets the spray drying sterilized powder.After testing: the total solid that the content of saponin component accounts in the preparation after deduction adjuvant amount and the water quantities is 1%; The total solid that the content of flavones ingredient accounts in the preparation after deduction adjuvant amount and the water quantities is 1%, and the content of polysaccharide composition accounts for that the total solid after the deduction adjuvant amount and water quantities is 3% in the preparation.

Embodiments of the invention 11: 300 parts of Herba Erigerontis 100 parts of Radix Ginseng Rubra, 80 parts of Radix Ophiopogonis

A, get medical material Radix Ophiopogonis, adding 6 times of volume decoctings boiled 1 time 1.5 hours, merge extractive liquid,, measuring relative density when being concentrated into 60 ℃ is 1.05～1.15, adds ethanol precipitate with ethanol twice, makes that to contain the alcohol amount be 65% for the first time, make for the second time that to contain the alcohol amount be 90%, filter merging filtrate, measuring relative density during decompression recycling ethanol to 60 ℃ is 1.05～1.15, dry Radix Ophiopogonis extract;

B, get the Herba Erigerontis medical material, added 7 times of volumes, 50% alcohol reflux 1 time 1.5 hours, merge extractive liquid,, measuring relative density when being concentrated into 60 ℃ is 1.05～1.15, dry Herba Erigerontis extract;

C, get the Radix Ginseng Rubra medical material, added 8 times of volumes, 60% alcohol reflux 1 time 1.5 hours, merge extractive liquid,, measuring relative density when being concentrated into 60 ℃ is 1.05～1.15, dry Radix Ginseng Rubra extract;

Above-mentioned Radix Ophiopogonis extract, Herba Erigerontis extract and Radix Ginseng Rubra extract are merged, add an amount of water for injection dissolving, by volume add 0.1% active carbon, boil, keep little 60min that boils, cold slightly filtration, filtrate adds the injection water to ormal weight, and adjust pH is 7.5, boils, spend the night 8 ℃ of cold preservations, coarse filtration, fine straining divide to install in the ampoule bottle, are 110 ℃ in vapor (steam) temperature, actual pressure pressure sterilizing 60 minutes under the 120kN/m3 condition promptly gets the injection with small volume or the concentrated solution for injection that are directly used in drug administration by injection.After testing: Radix Ophiopogonis polysaccharide content accounts in the preparation 3.1% of total solid after deduction adjuvant amount and the water quantities.

Embodiments of the invention 12: 400 parts of Herba Erigerontis 50 parts of Radix Ginsengs, 60 parts of Radix Ophiopogonis

A, get medical material Radix Ophiopogonis, adding 10 times of volume decoctings boils 3 times, each 2 hours, merge extractive liquid,, merge extractive liquid,, filter, filtrate is crossed ZTC-1 type macroporous adsorptive resins with the speed of 0.5ml/g medical material .min, water with 5 times of resin volumes washes with the speed of 0.7ml/g medical material .min earlier, and 15% ethanol of 3 times of resin volumes of reuse is used the speed eluting of 70% ethanol of 5 times of resin volumes with 0.8ml/g medical material .min at last with the speed eluting impurity of 1.2ml/g medical material .min, collect stripping liquid, reclaim ethanol, measuring relative density when being evaporated to 60 ℃ is 1.05～1.15, the dry Radix Ophiopogonis extract that gets;

B, get the Herba Erigerontis medical material, add 8 times of volume 75% alcohol reflux 3 times, each 1 hour, merge extractive liquid,, measuring relative density when being concentrated into 60 ℃ is 1.05～1.15, dry Herba Erigerontis extract;

C, get the ginseng crude drug, add 12 times of volume 70% alcohol reflux 3 times, each 1 hour, merge extractive liquid,, measuring relative density during decompression recycling ethanol to 60 ℃ is 1.05～1.15, the water dissolution that adds 3 times of medical material volumes, filter, filtrate is crossed ZTC-1 type macroporous adsorbent resin with the speed of 0.5ml/g medical material .min, use 6 times of resinite hydrops and 5 times of resin volume 10% alcohol flushing impurity successively, use 60% alcohol desorption of 5 times of resin volumes then, collect stripping liquid, measuring relative density during decompression recycling ethanol to 60 ℃ is 1.05～1.15, dry Radix Ginseng extract;

Above-mentioned Radix Ophiopogonis extract, Herba Erigerontis extract and Radix Ginseng extract are merged, add an amount of water for injection dissolving, by volume add 1.5% active carbon, boil, keep little 50min that boils, cold slightly filtration, filtrate adds the injection water to ormal weight, adjust pH is 6, boils, and spends the night 8 ℃ of cold preservations, coarse filtration, fine straining, divide to install in the enamel tray temperature-45 ℃, pre-freeze time 10h;-40 ℃ of evacuation keep 8h; Be warming up to-30 ℃ again, keep 8h; Be warming up to-20 ℃, keep 8h; Be warming up to-10 ℃, keep 5h; Be warming up to 0 ℃, keep 5h; Be warming up to 10 ℃, keep 2h; Be warming up to 20 ℃, keep 2h, under aseptic condition, divide to install to promptly to get the freeze dry sterile powder end in the cillin bottle.After testing: carbohydrate content content accounts in the preparation 4.2% of total solid after deduction adjuvant amount and the water quantities.

Embodiments of the invention 13: 200 parts of 200 parts of Radix Ginsengs of Herba Erigerontis 200 parts of Radix Ophiopogonis

A, get medical material Radix Ophiopogonis, adding 10 times of volume decoctings boils 3 times, each 1.5 hours, merge extractive liquid,, merge extractive liquid,, filter, filtrate is crossed ZTC-1 type macroporous adsorptive resins with the speed of 0.4ml/g medical material .min, water with 6 times of resin volumes washes with the speed of 0.7ml/g medical material .min earlier, and 15% ethanol of 4 times of resin volumes of reuse is used the speed eluting of 70% ethanol of 4 times of resin volumes with 0.8ml/g medical material .min at last with the speed eluting impurity of 1.2ml/g medical material .min, collect stripping liquid, reclaim ethanol, measuring relative density when being evaporated to 60 ℃ is 1.05～1.15, the dry Radix Ophiopogonis extract that gets;

B, get the Herba Erigerontis medical material, add 8 times of volume 70% alcohol reflux 3 times, each 1 hour, merge extractive liquid,, measuring relative density during decompression recycling ethanol to 60 ℃ is 1.05～1.15, the water heating for dissolving that adds 4 times of medical material volumes, filter, filtrate is crossed AB-8 type macroporous adsorbent resin with the speed of 0.5ml/g medical material .min, use 8 times of resinite hydrops and 6 times of resin volume 10% alcohol flushing impurity successively, use 40% alcohol desorption of 5 times of resin volumes then, collect stripping liquid, measuring relative density during decompression recycling ethanol to 60 ℃ is 1.05～1.15, dry Herba Erigerontis extract;

C, get the ginseng crude drug, add 10 times of volume 70% alcohol reflux 2 times, each 1.5 hours, merge extractive liquid,, measuring relative density during decompression recycling ethanol to 60 ℃ is 1.05～1.15, the water dissolution that adds 4 times of medical material volumes, filter, filtrate is crossed ZTC-1 type macroporous adsorbent resin with the speed of 0.5ml/g medical material .min, use 7 times of resinite hydrops and 5 times of resin volume 10% alcohol flushing impurity successively, use 60% alcohol desorption of 5 times of resin volumes then, collect stripping liquid, measuring relative density during decompression recycling ethanol to 60 ℃ is 1.05～1.15, dry Radix Ginseng extract;

Above-mentioned Radix Ophiopogonis extract, Herba Erigerontis extract and Radix Ginseng extract are merged, add an amount of water for injection dissolving, by volume add 0.1% active carbon, boil, keep little 10min that boils, cold slightly filtration, filtrate adds the injection water to ormal weight, adjust pH is 6, boils, and spends the night 1 ℃ of cold preservation, coarse filtration, fine straining, divide to install in the enamel tray temperature-45 ℃, pre-freeze time 10h;-40 ℃ of evacuation keep 8h; Be warming up to-30 ℃ again, keep 8h; Be warming up to-20 ℃, keep 8h; Be warming up to-10 ℃, keep 5h; Be warming up to 0 ℃, keep 5h; Be warming up to 10 ℃, keep 2h; Be warming up to 20 ℃, keep 2h, under aseptic condition, divide to install to promptly to get the freeze dry sterile powder end in the cillin bottle.After testing: it is 36% that the content of flavones ingredient accounts for the total solid of deducting adjuvant amount and water quantities in the preparation, and it is 42% that the content of saponin component accounts for the total solid of deducting adjuvant amount and water quantities in the preparation.

Claims

1, a kind of traditional medicine Injectio with human body immunity improving power, treatment cardiovascular and cerebrovascular disease, it is characterized in that: calculate according to components by weight percent, it is made through extracting refining and adding suitable adjuvant by 50～5000 parts of 10～1000 parts of 10～1000 parts of Herba Erigerontiss, Radix Ophiopogonis and Radix Ginsengs, or add the injection that suitable adjuvant is made through extracting the extract that obtains after refining by corresponding weight portion medical material, contain the various saccharides composition in the preparation.

2, according to the described traditional medicine Injectio of claim 1 with human body immunity improving power, treatment cardiovascular and cerebrovascular disease, it is characterized in that: calculate according to components by weight percent, it is made through extracting refining and adding suitable adjuvant by 50～1000 parts of 10～500 parts of 10～500 parts of Herba Erigerontiss, Radix Ophiopogonis and Radix Ginsengs, or add the injection that suitable adjuvant is made through extracting the extract that obtains after refining by corresponding weight portion medical material, contain various saccharides compositions such as Radix Ophiopogonis polysaccharide and monosaccharide in the preparation.

3, describedly has human body immunity improving power according to claim 1 or 2, the traditional medicine Injectio of treatment cardiovascular and cerebrovascular disease, it is characterized in that: calculate according to components by weight percent, it is by 50～200 parts of Herba Erigerontiss, 200～500 parts of 50～200 parts of Radix Ophiopogonis and Radix Ginsengs are made through extracting refining and adding suitable adjuvant, or add the injection that suitable adjuvant is made through extracting the extract that obtains after refining by corresponding weight portion medical material, contain various saccharides compositions such as Radix Ophiopogonis polysaccharide and monosaccharide in the preparation, the total solid that the content of carbohydrate content accounts in the preparation after deduction adjuvant amount and the water quantities is not less than 4%.

4, according to any described traditional medicine Injectio with human body immunity improving power, treatment cardiovascular and cerebrovascular disease of claim 1～3, it is characterized in that: injection comprises: be directly used in drug administration by injection injection, need to be used for the concentrated solution for injection of intravenous drip after the dilution, directly for the venous transfusion of intravenous drip and injectable sterile powder and the aseptic block that makes with freeze-drying or spray drying method.

5, according to the described traditional medicine Injectio of claim 4 with human body immunity improving power, treatment cardiovascular and cerebrovascular disease, it is characterized in that: contain saponin component, polysaccharide composition and flavones ingredient in the preparation, wherein the content of saponin component is not less than in the preparation 1% of total solid after deduction adjuvant amount and the water quantities; The content of flavones ingredient is not less than in the preparation 1% of total solid after deduction adjuvant amount and the water quantities, and the content of polysaccharide composition is not less than 3% of the total solid after the deduction adjuvant amount and water quantities in the preparation.

6, according to the described traditional medicine Injectio with human body immunity improving power, treatment cardiovascular and cerebrovascular disease of claim 5, it is characterized in that: all the content sums that can survey composition of the saponin component in the preparation, polysaccharide composition and flavones ingredient and other account for that the total solid after the deduction adjuvant amount and water quantities is not less than 25% in the preparation.

7, the preparation method with traditional medicine Injectio of human body immunity improving power, treatment cardiovascular and cerebrovascular disease as claimed in claim 4, it is characterized in that: Radix Ophiopogonis, people participate in Herba Erigerontis three flavor medical materials and add water or ethanol extraction respectively, extracting solution carry out suitably concentrating crude extract or further adopt one or more methods in alcohol deposition method, water precipitating method, acid-base precipitation method, flocculent precipitation, column chromatography, the solvent extraction be used in combination refining extract, get it filled material crude extract or refining extract add different auxiliary material and make different ejection preparations.

8, the preparation method with traditional medicine Injectio of human body immunity improving power, treatment cardiovascular and cerebrovascular disease as claimed in claim 7 is characterized in that:

A, get medical material Radix Ophiopogonis, adding 5～15 times of volume decoctings boils 1～4 time, each 0.5～2.5 hour, merge extractive liquid,, measuring relative density when being concentrated into 60 ℃ is 1.05～1.15, add ethanol precipitate with ethanol twice, make that to contain the alcohol amount be 50～70% for the first time, make that to contain the alcohol amount be 80～90% for the second time, filter merging filtrate, measuring relative density during decompression recycling ethanol to 60 ℃ is 1.05～1.15, will twice precipitation merges the back and adds 1～4 times of water dissolution, filters, the concentrated solution of filtrate and front merges, measuring relative density when being evaporated to 60 ℃ is 1.05～1.15, dry Radix Ophiopogonis extract, and this technology has been extracted the polysaccharide composition in medical material Radix Ophiopogonis;

Above-mentioned Radix Ophiopogonis extract, Herba Erigerontis extract, Radix Ginseng extract are merged, add adjuvant and make different ejection preparations.

9, according to the described preparation method of claim 8, it is characterized in that with traditional medicine Injectio of human body immunity improving power, treatment cardiovascular and cerebrovascular disease:

10, according to the described preparation method with traditional medicine Injectio of human body immunity improving power, treatment cardiovascular and cerebrovascular disease of claim 9, it is characterized in that: aseptic block is preparation like this:

Above-mentioned Radix Ophiopogonis extract, Herba Erigerontis extract, Radix Ginseng extract are merged, add an amount of water for injection dissolving, by volume add 1.0% active carbon, boil, keep little 30min that boils, cold slightly filtration, filtrate adds the injection water to ormal weight, and adjust pH 5.5～7.5 boils, at 4 ℃ of cold preservations 12 hours, coarse filtration, fine straining.With suitable adjuvant aqueous solution, with above-mentioned filtrate mixing, filter, packing, temperature-45 ℃, pre-freeze time 10h, the beginning evacuation, and in 12～72 hours differential gradient increased temperature to 10 ℃ progressively, keep 2h, be warming up to 20 ℃, keep 2h, promptly.

11, according to any described preparation method with traditional medicine Injectio of human body immunity improving power, treatment cardiovascular and cerebrovascular disease in the claim 7～10, it is characterized in that: the adjuvant that is adopted in the preparation comprises one or more in mannitol, galactose, glycine, glucose, sodium chloride, dextran, glycerol, ethanol, propylene glycol, Polyethylene Glycol, sorbitol, tween, the poloxamer.

12, according to any described traditional medicine Injectio with human body immunity improving power, treatment cardiovascular and cerebrovascular disease in the claim 1～10, it is characterized in that: Radix Ginseng can also be the Radix Ginseng Rubra or the Radix Codonopsis of equivalent.