CN1730020A - Method for preparing Chinese medicinal formulation for treating tumor - Google Patents
Method for preparing Chinese medicinal formulation for treating tumor Download PDFInfo
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- CN1730020A CN1730020A CNA2005100031513A CN200510003151A CN1730020A CN 1730020 A CN1730020 A CN 1730020A CN A2005100031513 A CNA2005100031513 A CN A2005100031513A CN 200510003151 A CN200510003151 A CN 200510003151A CN 1730020 A CN1730020 A CN 1730020A
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Abstract
The invention relates to a traditional Chinese preparation for treating tumor and process for preparation, wherein the raw materials comprise gen-seng, astragalus root, acanthopanax root and Chinese cantharides through ethanol extracting, passing through macroscopic adsorption resin columns, boiling, ethanol depositing the water extract, adjusting the pH to alkalinity, freezing, adjusting pH of the soup to neutral and depositing again.
Description
Technical field: the present invention relates to a kind of preparation method for the treatment of the Chinese medicine preparation of tumor, belong to the field of medicine technology.
Technical background: the human tumor of finding is existing historical more than 3000.The malignant tumor of epithelium is called cancer, accounts for more than 90% of all malignant tumor.Cancer is a big class disease of serious threat human health, and the patient is in continuous rising, and since 20th century, because development of natural science, fundamental research and The application of new technique, oncology studies has had significant progress.Wherein the applicant has submitted to application number to be on January 3rd, 2003 to Patent Office of the People's Republic of China: 03117114.1; Name is called: the patent of invention of traditional medicine Injectio of treatment tumor and preparation method thereof.In this patent, Mylabris is used water boiling and extraction, makes that the extraction ratio of Mylabris is not high; The alcohol extract of the Radix Astragali, Radix Et Caulis Acanthopanacis Senticosi decocting liquid and Radix Ginseng is refining with stone sulfur method, causes active ingredient in the medicine such as astragaloside, Radix Et Caulis Acanthopanacis Senticosi total glucosides, ginsenoside's loss bigger; Open in addition and just be born on January 5th, 2005 and submitted to application number to be: 200410004443.4 to Patent Office of the People's Republic of China; Name is called: a kind of patent of invention that is used for the treatment of the Chinese medicine lyophilized injectable powder preparation method of tumor.In this patent application, Mylabris is used water extraction, makes that the Mylabris extraction ratio is lower; The Radix Astragali, Radix Et Caulis Acanthopanacis Senticosi ethanol extraction, active constituent content is not high in the medicine.Event is not ideal enough in order to the clinical efficacy of the preparation of top method preparation.
Summary of the invention: the object of the present invention is to provide a kind of preparation method for the treatment of the Chinese medicine preparation of tumor.
The present invention is directed to prior art, Mylabris is used ethanol extraction, and extraction ratio increases, and extracting solution can not only dissolve the oil composition of part after transferring PH to be alkalescence, increases the clarity of medicine, and the effective ingredient in all right salinization medicine increases its dissolubility; The medicinal liquid that reclaims behind the ethanol transfers PH to neutral redeposition, with regard to make in the medicinal liquid can not salinization one-tenth analyze, increase content of effective in the medicine; In addition, Radix Ginseng adopts ethanol extraction, be because the ginsenoside is a main active in the Radix Ginseng, and in the Radix Ginseng extracting method of routine, the content that ethanol reflux extraction extracts Radix Ginseng total saponins is the highest, last macroporous adsorptive resins can effectively be removed impurity such as tannins a large amount of in the medicine, protein, also can reduce the loss rate of effective ingredient Radix Ginseng total saponins in the medicine simultaneously; According to effective ingredient character soluble in water in the Radix Astragali, the Radix Et Caulis Acanthopanacis Senticosi, adopt the decocting cooking method to decoct in addition; Decocting liquid concentrates back ethanol precipitate with ethanol, and it is alkaline that alcohol deposit fluid is transferred PH, and cold preservation again, but the effective ingredient in the salinization medicine like this increase its dissolubility; The medicinal liquid that reclaims behind the ethanol transfers PH to neutral redeposition, with regard to make in the medicinal liquid can not salinization one-tenth analyze, increase content of effective in the medicine.So the preparation with the inventive method preparation can improve the quality of medicine, and can effectively improve the therapeutic effect of clinical drug.
The present invention finishes like this: prepare the Chinese medicine preparation of this treatment tumor with Radix Ginseng 25-100 weight portion, Radix Astragali 50-200 weight portion, Radix Et Caulis Acanthopanacis Senticosi 100-200 weight portion and Mylabris 0.5-5 weight portion, comprise injection, freeze-dried powder, high-capacity injection, oral liquid, capsule, disintegrating tablet, pill or soft capsule.
Get the Mylabris medical material, pulverize, use ethanol extraction, filter, medicinal residues are standby, and extracting solution transfers to pH7-10 with sodium hydroxide solution, decompression recycling ethanol filters thin up, transfer to pH6-8 with hydrochloric acid solution, leave standstill, cold preservation is complete to precipitation, centrifugal filtration, supernatant transfers to pH6～10 with sodium hydroxide solution, and is standby; Get the Radix Ginseng section, use ethanol extraction, filter, medicinal residues are standby, the extracting solution decompression recycling ethanol, and concentrated solution is dissolved in water, and last macroporous adsorbent resin is used ethanol elution, and eluent reclaims ethanol, concentrates, and filters, and is standby; Get the Radix Astragali, Radix Et Caulis Acanthopanacis Senticosi medical material, merge, decoct with water with Radix Ginseng, Mylabris medicinal residues, decocting liquid filters, and concentrates, and filters, supernatant adds ethanol, transfers pH7～11, cold preservation with sodium hydroxide solution, filter, supernatant adds ethanol precipitate with ethanol, cold preservation again, filter, reclaim ethanol, be dissolved in water, transfer pH4～8 with hydrochloric acid solution, add the active carbon boiling decoloring, centrifugal filtration; Supernatant and Radix Ginseng, Mylabris extracting solution merge, and make different preparations with conventional method.
In the product research process, we find that this product prepares according to following parameter, can reach the raising drug quality, increase the purpose of curative effect of medication.So concrete preparation method is: get the Mylabris medical material, pulverize, doubly measure the 30-100% alcohol heating reflux with 5-30 and extract, filter, medicinal residues are standby, and extracting solution transfers to pH7-10 with sodium hydroxide solution, decompression recycling ethanol filters thin up, transfer to pH6-8 with hydrochloric acid solution, leave standstill cold preservation, centrifugal filtration, supernatant transfers to pH7～10 with sodium hydroxide solution, and is standby; Get the Radix Ginseng section, doubly measure the 30-90% alcohol heating reflux with 4-20 and extract, filter, medicinal residues are standby, it is 1-5: 5-1 that extracting solution decompression recycling ethanol, concentrated solution add water to every milliliter of ratio with the every gram of medical material amount of volume, last macroporous adsorbent resin, use the 20-80% ethanol elution, collect eluent, reclaim ethanol, concentrate, filter, standby; Get the Radix Astragali, Radix Et Caulis Acanthopanacis Senticosi medical material, merge, add 5-20 times of water gaging and decoct collecting decoction with Radix Ginseng, Mylabris medicinal residues, filter, being concentrated into every milliliter of ratio with the every gram of medical material amount of volume is 1-5: 5-1, filters, and supernatant adds ethanol, make to contain alcohol amount and reach 40-90%, transfer pH7～10 with sodium hydroxide solution, cold preservation is filtered, supernatant adds ethanol again, makes the alcohol amount of containing reach 45-95%, cold preservation, filter, reclaim ethanol, add water, transfer pH4～7 with hydrochloric acid solution, add the active carbon boiling decoloring, centrifugal filtration; Supernatant and Radix Ginseng, Mylabris extracting solution merge, and make different preparations with conventional method.
In the product research process, we find that when this product prepared according to following parameter, active constituent content was higher in the product, better drug curative effect.So preparation method is more specifically: get the Mylabris medical material, pulverize, doubly measure the 40-90% alcohol heating reflux with 10-20 and extract 1-5 time, each 0.2-5 hour, filter, medicinal residues are standby, merge extractive liquid, transfers to pH7-9 with the 0.5-10% sodium hydroxide solution, decompression recycling ethanol, filter, thin up transfers to pH6-8 with the 5-20% hydrochloric acid solution, leave standstill, cold preservation is complete to precipitation, centrifugal filtration, supernatant transfers to pH7～9 with the 0.5-10% sodium hydroxide solution, and is standby; Get the Radix Ginseng section, doubly measure the 40-85% alcohol heating reflux with 5-15 and extract 1-5 time, each 0.5-5 hour, filter, medicinal residues are standby, merge extractive liquid,, it is 1-3: 3-1 that decompression recycling ethanol, concentrated solution add water to every milliliter of ratio with the every gram of medical material amount of volume, last macroporous adsorbent resin, add water elution 2-10 times column volume, 2-10 times of column volume eluting of reuse 30-70% ethanol collected eluent, reclaim ethanol, concentrate, filter, standby; Get the Radix Astragali, the Radix Et Caulis Acanthopanacis Senticosi medical material is with Radix Ginseng, the Mylabris medicinal residues merge, and add 7-15 times of water gaging and decoct 1-5 time, each 0.5-10 hour, collecting decoction filtered, being concentrated into every milliliter of ratio with the every gram of medical material amount of volume is 1-3: 3-1, filter, supernatant adds ethanol, makes to contain the alcohol amount and reach 50-85%, transfer pH7～10 with the 5-20% sodium hydroxide solution, cold preservation is filtered, and supernatant adds ethanol again, make the alcohol amount of containing reach 50-90%, cold preservation is filtered, and reclaims ethanol, add water to 50-200mL, transfer pH5～7 with the 5-20% hydrochloric acid solution, add 0.05-1% active carbon boiling decoloring 10-60min, centrifugal filtration; Supernatant and Radix Ginseng, Mylabris extracting solution merge, and add adjuvant or do not add adjuvant with conventional method, make injection, freeze-dried powder, high-capacity injection, oral liquid, capsule, disintegrating tablet, pill or soft capsule.
The preparation method of lyophilized powder of the present invention is: get the Mylabris medical material, pulverize, doubly measure the 30-100% alcohol heating reflux with 5-30 and extract, filter, medicinal residues are standby, and extracting solution transfers to pH7-10 with sodium hydroxide solution, decompression recycling ethanol filters thin up, transfer to pH6-8 with hydrochloric acid, leave standstill cold preservation, centrifugal filtration, supernatant transfers to pH7～10 with sodium hydroxide solution, and is standby; Get the Radix Ginseng section, doubly measure the 30-90% alcohol heating reflux with 4-20 and extract, filter, medicinal residues are standby, it is 1-5: 5-1 that extracting solution decompression recycling ethanol, concentrated solution add water to every milliliter of ratio with the every gram of medical material amount of volume, last macroporous adsorbent resin, use the 20-80% ethanol elution, collect eluent, reclaim ethanol, concentrate, filter, standby; Get the Radix Astragali, Radix Et Caulis Acanthopanacis Senticosi medical material, merge, add 5-20 times of water gaging and decoct collecting decoction with Radix Ginseng, Mylabris medicinal residues, filter, being concentrated into every milliliter of ratio with the every gram of medical material amount of volume is 1-5: 5-1, filters, and supernatant adds ethanol, make to contain alcohol amount and reach 40-90%, transfer pH7～10 with sodium hydroxide, cold preservation is filtered, supernatant adds ethanol again, makes the alcohol amount of containing reach 45-95%, cold preservation, filter, reclaim ethanol, add water, transfer pH4～7 with hydrochloric acid, add the active carbon boiling decoloring, centrifugal filtration; Supernatant and Radix Ginseng, Mylabris extracting solution merge hyperfiltration treatment; Add water to the 300-500 milliliter, filter, add excipient, mixing, packing, lyophilization, gland, promptly.
The preparation method of injection of the present invention is: get the Mylabris medical material, pulverize, doubly measure the 30-100% alcohol heating reflux with 5-30 and extract, filter, medicinal residues are standby, and extracting solution transfers to pH7-10 with sodium hydroxide solution, decompression recycling ethanol filters thin up, transfer to pH6-8 with hydrochloric acid, leave standstill cold preservation, centrifugal filtration, supernatant transfers to pH7～10 with sodium hydroxide solution, and is standby; Get the Radix Ginseng section, doubly measure the 30-90% alcohol heating reflux with 4-20 and extract, filter, medicinal residues are standby, it is 1-5: 5-1 that extracting solution decompression recycling ethanol, concentrated solution add water to every milliliter of ratio with the every gram of medical material amount of volume, last macroporous adsorbent resin, use the 20-80% ethanol elution, collect eluent, reclaim ethanol, concentrate, filter, standby; Get the Radix Astragali, Radix Et Caulis Acanthopanacis Senticosi medical material, merge, add 5-20 times of water gaging and decoct collecting decoction with Radix Ginseng, Mylabris medicinal residues, filter, being concentrated into every milliliter of ratio with the every gram of medical material amount of volume is 1-5: 5-1, filters, and supernatant adds ethanol, make to contain alcohol amount and reach 40-90%, transfer pH7～10 with sodium hydroxide, cold preservation is filtered, supernatant adds ethanol again, makes the alcohol amount of containing reach 45-95%, cold preservation, filter, reclaim ethanol, add water, transfer pH4～7 with hydrochloric acid, add the active carbon boiling decoloring, centrifugal filtration; Supernatant and Radix Ginseng, Mylabris extracting solution merge, and add the injection water to 1000ml, and the adjusting liquid PH value is 3-6, filter, and embedding, sterilization, promptly.
The preparation method of high-capacity injection of the present invention is: get the Mylabris medical material, pulverize, doubly measure the 30-100% alcohol heating reflux with 5-30 and extract, filter, medicinal residues are standby, and extracting solution transfers to pH7-10 with sodium hydroxide solution, decompression recycling ethanol filters thin up, transfer to pH6-8 with hydrochloric acid, leave standstill cold preservation, centrifugal filtration, supernatant transfers to pH7～10 with sodium hydroxide solution, and is standby; Get the Radix Ginseng section, doubly measure the 30-90% alcohol heating reflux with 4-20 and extract, filter, medicinal residues are standby, it is 1-5: 5-1 that extracting solution decompression recycling ethanol, concentrated solution add water to every milliliter of ratio with the every gram of medical material amount of volume, last macroporous adsorbent resin, use the 20-80% ethanol elution, collect eluent, reclaim ethanol, concentrate, filter, standby; Get the Radix Astragali, Radix Et Caulis Acanthopanacis Senticosi medical material, merge, add 5-20 times of water gaging and decoct collecting decoction with Radix Ginseng, Mylabris medicinal residues, filter, being concentrated into every milliliter of ratio with the every gram of medical material amount of volume is 1-5: 5-1, filters, and supernatant adds ethanol, make to contain alcohol amount and reach 40-90%, transfer pH7～10 with sodium hydroxide, cold preservation is filtered, supernatant adds ethanol again, makes the alcohol amount of containing reach 45-95%, cold preservation, filter, reclaim ethanol, add water, transfer pH4～7 with hydrochloric acid, add the active carbon boiling decoloring, centrifugal filtration; Supernatant and Radix Ginseng, Mylabris extracting solution merge, and add osmotic pressure regulator, add the injection water to the 5000-10000 milliliter, and mixing filters through the filter membrane smaller or equal to 0.65um, and fill is in infusion bottle, and sealing promptly gets high-capacity injection after the sterilization.
The preparation method of oral formulations of the present invention is: get the Mylabris medical material, pulverize, doubly measure the 30-100% alcohol heating reflux with 5-30 and extract, filter, medicinal residues are standby, and extracting solution transfers to pH7-10 with sodium hydroxide solution, decompression recycling ethanol filters thin up, transfer to pH6-8 with hydrochloric acid, leave standstill cold preservation, centrifugal filtration, supernatant transfers to pH7～10 with sodium hydroxide solution, and is standby; Get the Radix Ginseng section, doubly measure the 30-90% alcohol heating reflux with 4-20 and extract, filter, medicinal residues are standby, it is 1-5: 5-1 that extracting solution decompression recycling ethanol, concentrated solution add water to every milliliter of ratio with the every gram of medical material amount of volume, last macroporous adsorbent resin, use the 20-80% ethanol elution, collect eluent, reclaim ethanol, concentrate, filter, standby; Get the Radix Astragali, Radix Et Caulis Acanthopanacis Senticosi medical material, merge, add 5-20 times of water gaging and decoct collecting decoction with Radix Ginseng, Mylabris medicinal residues, filter, being concentrated into every milliliter of ratio with the every gram of medical material amount of volume is 1-5: 5-1, filters, and supernatant adds ethanol, make to contain alcohol amount and reach 40-90%, transfer pH7～10 with sodium hydroxide, cold preservation is filtered, supernatant adds ethanol again, makes the alcohol amount of containing reach 45-95%, cold preservation, filter, reclaim ethanol, add water, transfer pH4～7 with hydrochloric acid, add the active carbon boiling decoloring, centrifugal filtration; Supernatant and Radix Ginseng, Mylabris extracting solution merge, and add simple syrup again and make final sugar content 10-35%, add the 0.1%-0.3% sodium benzoate, boil dissolving, add water to 1000ml, stir evenly, filter, and embedding, promptly.
In the above preparation method, adjuvant can be added, also adjuvant can be do not added.
We also find in product research in addition, with the Radix Astragali, Radix Et Caulis Acanthopanacis Senticosi and Radix Ginseng, Mylabris medicinal residues mixed extraction with the Radix Astragali, it is little that Radix Et Caulis Acanthopanacis Senticosi and Radix Ginseng, Mylabris medicinal residues separately extract gained drug quality difference, so the extracting method of the described Radix Astragali, Radix Et Caulis Acanthopanacis Senticosi is:
A, get the Radix Astragali, Radix Et Caulis Acanthopanacis Senticosi medical material, merge with Radix Ginseng, Mylabris medicinal residues, decoct with water, decocting liquid filters, concentrate, filter, supernatant adds ethanol, transfer pH7～11 with sodium hydroxide, cold preservation is filtered, supernatant adds the ethanol precipitate with ethanol again, and cold preservation is filtered, reclaim ethanol, be dissolved in water, transfer pH4～8 with hydrochloric acid, add the active carbon boiling decoloring, centrifugal filtration, promptly.
B, get the Radix Astragali, decoct with water, decocting liquid filters, and concentrates, and filters, and supernatant adds ethanol, transfer pH7～11 with sodium hydroxide, cold preservation is filtered, and supernatant adds the ethanol precipitate with ethanol again, and cold preservation is filtered, reclaim ethanol, be dissolved in water, transfer pH4～8, add the active carbon boiling decoloring with hydrochloric acid, centrifugal filtration, promptly; Get the Radix Et Caulis Acanthopanacis Senticosi medical material, decoct with water, decocting liquid filters, concentrate, filter, supernatant adds ethanol, transfer pH7～11 with sodium hydroxide, cold preservation is filtered, supernatant adds the ethanol precipitate with ethanol again, and cold preservation is filtered, reclaim ethanol, be dissolved in water, transfer pH4～8 with hydrochloric acid, add the active carbon boiling decoloring, centrifugal filtration, promptly; Get Radix Ginseng, Mylabris medicinal residues, decoct with water, decocting liquid filters, concentrate, filter, supernatant adds ethanol, transfer pH7～11 with sodium hydroxide, cold preservation is filtered, supernatant adds the ethanol precipitate with ethanol again, and cold preservation is filtered, reclaim ethanol, be dissolved in water, transfer pH4～8 with hydrochloric acid, add the active carbon boiling decoloring, centrifugal filtration, promptly.
Compared with prior art, Mylabris is used ethanol extraction among the present invention, and extraction ratio is increased, and it is alkalescence that extracting solution is transferred PH, can not only dissolve the oil composition of part, increases the clarity of medicine, and the effective ingredient in all right salinization medicine increases its dissolubility; The medicinal liquid that reclaims behind the ethanol transfers PH to neutral redeposition, make in the medicinal liquid can not salinization one-tenth analyze, increase content of effective in the medicine; Radix Ginseng adopts ethanol extraction, can increase the content of Radix Ginseng total saponins in the medicine, and last macroporous adsorptive resins can not only effectively be removed impurity such as tannins a large amount of in the medicine, protein, also can reduce the loss rate of effective ingredient Radix Ginseng total saponins in the medicine; The Radix Astragali, Radix Et Caulis Acanthopanacis Senticosi adopt decocting to boil, and can improve extraction ratio of effective constituents in the Radix Astragali, the Radix Et Caulis Acanthopanacis Senticosi, and decocting liquid concentrates back ethanol precipitate with ethanol, and it is alkalescence that alcohol deposit fluid is transferred PH, and cold preservation again, but the effective ingredient in the salinization medicine increase its dissolubility; The medicinal liquid that reclaims behind the ethanol transfers PH to neutral redeposition, make in the medicinal liquid can not salinization one-tenth analyze, increase content of effective in the medicine.So the preparation with the inventive method preparation can improve the quality of medicine, and can effectively improve the therapeutic effect of clinical drug.Reached the purpose of invention.For finishing the present invention, we have carried out a series of experiment, research:
Experiment 1: Mylabris is extracted solvent and selects test
| Extract solvent | Concentration | Cantharidin content (%) |
| Water | - | 0.20 |
| Ethanol | 30％ | 0.84 |
| Ethanol | 50％ | 0.97 |
| Ethanol | 60％ | 1.21 |
| Ethanol | 80％ | 1.56 |
| Ethanol | 90％ | 1.35 |
| Ethanol | 100％ | 1.24 |
As seen, the cantharidin content that Mylabris does solvent extraction with ethanol is all than the cantharidin content height that uses water as solvent, and wherein 80% ethanol cantharidin content is the highest.
Experiment 2: the Radix Ginseng process for purification is to the influence of content of ginsenoside
| Process for purification | The Rg1/Re total peak area | The reservation ratio | |
| The D-101 macroporous adsorbent resin | Before crossing post | 2322531 | 91.5％ |
| After crossing post | 2126527 | ||
| Stone sulfur method | Before the processing | 2335468 | 86.1％ |
| After the processing | 2010364 | ||
Experiment 3: the selection test of freeze-dried powder excipient of the present invention
Because after the herb liquid lyophilization of the present invention, the mouldability of goods is good inadequately, thus in medicinal liquid, add excipient, but be not every appearance index that all excipient can both improve freeze-dried products, how to select excipient and consumption thereof, this is known one a big difficulty in the freeze drying technology field.The present invention has determined seven kinds of excipient in numerous adjuvants, experimental selection result is:
| Excipient | Consumption | The lyophilized preparation character | Scoring |
| Glucose | 8% | Have and bubble and the volumetric expansion phenomenon | 61 |
| Sucrose | 8% | Color is more even, but volume has the phenomenon of dwindling | 72 |
| Mannitol | 8% | Color even, constancy of volume, good stability. | 88 |
| Trehalose | 8% | Color is even inadequately, constancy of volume. | 80 |
| Lactose | 8% | Color and luster is even, but viscous preparations is big | 70 |
| Glycine | 8％ | Good moldability, but the lyophilizing solubility is poor | 78 |
| Dextran | 8％ | Constancy of volume, forming, profile is full | 85 |
According to experimental result, the freeze-dried products outward appearance of making excipient with mannitol, dextran, trehalose, glycine all has improvement in various degree, and the freeze-dried products effect of making excipient with mannitol, dextran is better.
| Excipient | Consumption | The lyophilized preparation character | Scoring |
| Mannitol | 5% | Color is even inadequately, constancy of volume, and dissolubility is good inadequately. | 78 |
| Mannitol | 6% | Color even, forming, profile is full, good stability | 95 |
| Mannitol | 7% | Color even, constancy of volume, clarity is good | 87 |
| Mannitol | 8% | Color even, constancy of volume, clarity is good | 85 |
| Mannitol | 9% | Color even, constancy of volume, dissolubility is good | 82 |
| Dextran | 5% | Color even, forming | 81 |
| Dextran | 6% | Color even, forming, dissolubility is good | 87 |
| Dextran | 7% | Color even, forming, profile is full, and clarity is good | 90 |
| Dextran | 8% | Color even, constancy of volume | 80 |
| Dextran | 9% | Color is even inadequately, slightly microdilatancy of volume | 75 |
As seen, the consumption of mannitol is the consumption of 6-9%, dextran when being 5-8%, can effectively improve the quality of lyophilized formulations of the present invention.Optimum amount is mannitol 6%, dextran 7%.
Experiment 4: the screening experiment result to osmotic pressure regulator when the present invention makes the high capacity ejection preparation is:
| Osmotic pressure regulator | Concentration | The result |
| Sodium chloride | 0.9％ | The medicinal liquid clarification, PH is moderate |
| Glucose | 0.9％ | The medicinal liquid clarification, PH is moderate |
| Glycerol | 2.6％ | Influenced by pH value, the medicinal liquid color burn |
According to above experimental result, when selecting sodium chloride and glucose as osmotic pressure regulator for use, medicinal liquid clarity is best, and pH value is more moderate.It below is selection to sodium chloride and glucose consumption.
| Osmotic pressure regulator | Concentration | The result |
| Sodium chloride | 0.45% | PH is on the low side, and the medicinal liquid color is darker |
| Sodium chloride | 0.8% | The medicinal liquid clarification, PH is moderate |
| Sodium chloride | 1.5% | The medicinal liquid clarification, PH is moderate |
| Sodium chloride | 2.5% | The medicinal liquid clarification, PH is moderate |
| Sodium chloride | 2.7% | PH is higher, and the medicinal liquid color burn has pain in the injection process. |
| Glucose | 0.2% | The medicinal liquid clarification, PH is on the low side |
| Glucose | 0.3% | The medicinal liquid clarification, PH is moderate |
| Glucose | 0.5% | The medicinal liquid clarification, PH is moderate |
| Glucose | 0.9% | The medicinal liquid clarification, PH is moderate |
| Glucose | 1.5% | The medicinal liquid clarification, PH is moderate |
| Glucose | 2.0% | The medicinal liquid color burn |
When sodium chloride during as osmotic pressure regulator, conventional amount used is 0.45%-2.7%, and when consumption was 0.8-2.5% among the present invention, quality of liquid medicine was more stable; When the glucose consumption was 0.7-1.5%, quality of liquid medicine was also more stable.So the glucose of selecting the sodium chloride of 0.8-2.5% and 0.3-1.5% among the present invention for use is as osmotic pressure regulator.
Experiment 5: preparation experimental Study on Antitumor Effect of the present invention
One, experiment material: medicine: preparation of the present invention: according to the described method preparation of the application; Medicine A: according to application number be: 03117114.1; Name is called: " traditional medicine Injectio of treatment tumor and preparation method thereof " described method preparation; Medicine B: according to application number be: 200410004443.4; Name is called: " a kind of Chinese medicine lyophilized injectable powder preparation method that is used for the treatment of tumor " described method preparation.
Tumor strain: murine sarcoma S
180, H
22
Animal: Kunming mouse, 18-24g.
Two, method and result
1, to the inhibitory action of animal transplanting tumor: 1. to mice S
180Inhibitory action: getting the tumor source animal of the inoculation 7～10d that goes down to posterity, aseptic condition extracts down ascitic tumor fluid, the right axil subcutaneous vaccination 1 * 10 of every Mus
6Oncocyte, random packet and begin administration behind the 24h, every day, lumbar injection was 1 time, continuous 9～11d.Matched group lumbar injection sterile saline.Next day is put to death mice in drug withdrawal, weighs and peels off the subcutaneous tumors piece, claims tumor heavy, calculates tumour inhibiting rate.The results are shown in Table 1.2. to mice H
22Inhibitory action: method is the same, every Mus inoculation 1 * 10
6H
22Cell the results are shown in Table 2.3. to the inhibitory action of mice EAC solid tumor: extract EAC tumor source mouse ascites, dilution in 1: 3: 5, the right axil subcutaneous vaccination of every Mus 0.2ml, next day random packet and administration, every day, intraperitoneal injection of drugs was 1 time, continuously 10d.Matched group lumbar injection sterile saline.Next day is put to death mice in drug withdrawal, claims tumor re-computation tumour inhibiting rate, the results are shown in Table 3.More than in the experiment, ad pro injection dosage is 30ml/kg; Injection dosage of the present invention is 30m1/kg; Lyophilized powder dosage of the present invention is 1200mg/kg;
Tumour inhibiting rate (%)=[1-(it is heavy that the average tumor of average tumor weight/matched group is organized in treatment)] * 100%
Table 1 couple mice S
180Inhibitory action
| Group | Mus number (only) (beginning/end) | Body weight (g) (beginning/end) | Tumor heavy (g) | Tumour inhibiting rate (%) |
| Normal saline | 20/20 | 20.51/28.41 | 1.58±0.56 | - |
| Medicine A | 20/19 | 21.32/26.35 | 0.71±0.18 | 55.06 |
| Medicine B | 20/20 | 19.53/26.18 | 0.70±0.29 | 55.69 |
| Injection of the present invention | 20/20 | 20.82/27.45 | 0.58±0.44#* | 63.29 |
| Lyophilized powder of the present invention | 20/20 | 19.42/26.67 | 0.60±0.32#* | 62.03 |
| High-capacity injection of the present invention | 20/20 | 20.14/26.87 | 0.61±0.25#* | 61.39 |
Preparation group of the present invention and normal saline group compare, and P＜0.01 has the significance difference opposite sex;
Preparation group of the present invention and medicine A compare, #P＜0.05
Preparation group of the present invention and medicine B compare, * P＜0.05
Table 2 couple mice H
22Inhibitory action
| Group | Mus number (only) (beginning/end) | Body weight (g) (beginning/end) | Tumor heavy (g) | Tumour inhibiting rate (%) |
| Normal saline | 20/19 | 20.41/23.24 | 2.21±0.43 | - |
| Medicine A | 20/20 | 20.52/23.41 | 1.41±0.30 | 36.20 |
| Medicine B | 20/20 | 19.52/22.32 | 1.38±0.10 | 37.56 |
| Injection of the present invention | 20/20 | 21.41/23.25 | 1.19±0.29#* | 46.15 |
| Lyophilized powder of the present invention | 20/20 | 20.54/23.55 | 1.21±0.34#* | 45.25 |
| High-capacity injection of the present invention | 20/20 | 20.36/22.41 | 1.12±0.14#* | 49.32 |
Preparation group of the present invention and normal saline group compare, and P＜0.01 has the significance difference opposite sex;
Preparation group of the present invention and medicine A compare, #P＜0.05
Preparation group of the present invention and medicine B compare, * P＜0.05
The inhibitory action of table 3 pair mice EAC solid tumor
| Group | Mus number (only) (beginning/end) | Body weight (g) (beginning/end) | Tumor heavy (g) | Tumour inhibiting rate (%) |
| Normal saline | 20/20 | 21.57/28.32 | 1.41±0.52 | - |
| Medicine A | 20/19 | 21.14/28.21 | 0.80±0.25 | 43.26 |
| Medicine B | 20/20 | 21.42/27.45 | 0.76±0.24 | 46.10 |
| Injection of the present invention | 20/19 | 20.47/27.15 | 0.58±0.35#* | 58.86 |
| Lyophilized powder of the present invention | 20/20 | 20.23/28.47 | 0.60±0.14#* | 57.45 |
| High-capacity injection of the present invention | 20/20 | 20.25/27.22 | 0.59±0.32#* | 58.16 |
Preparation group of the present invention and normal saline group, P＜0.01 has the significance difference opposite sex;
Preparation group of the present invention and medicine A compare, #P＜0.05
Preparation group of the present invention and medicine B compare, * P＜0.05
Three, conclusion: according to above experimental result, under identical drug dose, preparation antitumor action effect of the present invention is good than medicine A and medicine B.
Experiment 6: preparation of the present invention is to the influence of tumor-bearing mice immune organ.
1, experiment material: medicine: preparation of the present invention: according to the described method preparation of the application; Medicine A: according to application number be: 03117114.1; Name is called: " traditional medicine Injectio of treatment tumor and preparation method thereof " described method preparation; Medicine B: according to application number be: 200410004443.4; Name is called: " a kind of Chinese medicine lyophilized injectable powder preparation method that is used for the treatment of tumor " described method preparation.
Tumor strain: colorectal cancer cells (L
0V
0Strain).
Animal: 4～5 age in week 40 of SD rats, body weight 112.7 ± 15.7g, male and female dual-purpose.
2, method and result: to the influence of tumor-bearing mice immune organ: choose the 18-20gNIH mice, in the subcutaneous conventional inoculation H22 ascites tumor cell 0.2ml of right front axil, be divided into 7 groups next day at random, respectively by the scheme lumbar injection, every day 1 time, continuous 10d plucked the eyeball sacrificed by exsanguination in 24 hours after the last administration, get thymus, spleen is weighed, and calculates thymus and spleen index.The result shows, CIX group tumor-bearing mice thymus, spleen volume-diminished, weight saving, and thymus, spleen outward appearance and the normal saline group zero difference of preparation group of the present invention and medicine A and medicine b group mice, thymus, index and spleen index all are higher than or near the normal saline group, are good with preparation group of the present invention especially.
| Group | Body weight (g) (beginning/end) | Thymus index | Spleen index |
| Normal saline | 20.15/21.21 | 2.27±0.21 | 6.89±0.44 |
| Medicine A | 21.23/22.32 | 2.70±0.25 | 8.42±0.21 |
| Medicine B | 20.32/21.42 | 2.64±0.41 | 8.49±0.52 |
| Injection of the present invention | 20.41/21.14 | 3.12±0.32#* | 10.31±0.15#* |
| Lyophilized powder of the present invention | 19.58/21.24 | 3.09±0.52#* | 10.23±0.17#* |
| High-capacity injection of the present invention | 20.41/22.51 | 3.07±0.43#* | 10.59±0.18#* |
| Cyclophosphamide | 20.24/18.17 | 1.87±0.84 | 5.42±0.29 |
Preparation group of the present invention and normal saline group and cyclophosphamide group relatively are P＜0.01, have the significance difference opposite sex;
Preparation group of the present invention and medicine A compare, #P＜0.05
Preparation group of the present invention and medicine B compare, * P＜0.05
3, conclusion: show that according to above experimental result the effect of preparation enhancing human body immunity function of the present invention is strong than medicine A and medicine B.
The specific embodiment:
Embodiments of the invention 1: take by weighing: Radix Ginseng 100g, Radix Astragali 200g, Radix Et Caulis Acanthopanacis Senticosi 200g, Mylabris 5g preparation technology are: get the Mylabris medical material, pulverize, use ethanol extraction, filter, medicinal residues are standby, and extracting solution transfers to pH7 with sodium hydroxide solution, decompression recycling ethanol filters thin up, transfer to pH8 with hydrochloric acid, leave standstill, cold preservation is complete to precipitation, centrifugal filtration, supernatant transfers to pH6 with sodium hydroxide solution, and is standby; Get the Radix Ginseng section, use ethanol extraction, filter, medicinal residues are standby, the extracting solution decompression recycling ethanol, and concentrated solution is dissolved in water, and last macroporous adsorbent resin is used ethanol elution, and eluent reclaims ethanol, concentrates, and filters, and is standby; Get the Radix Astragali, Radix Et Caulis Acanthopanacis Senticosi medical material, merge, decoct with water with Radix Ginseng, Mylabris medicinal residues, decocting liquid filters, and concentrates, and filters, supernatant adds ethanol, transfers pH11 with sodium hydroxide, cold preservation, filter, supernatant adds ethanol precipitate with ethanol, cold preservation again, filter, reclaim ethanol, be dissolved in water, transfer pH8 with hydrochloric acid, add the active carbon boiling decoloring, centrifugal filtration.Supernatant and Radix Ginseng, Mylabris extracting solution merge, and are condensed into extractum, cross 120 purpose filter screens, carry out spray drying, and granulate incapsulates, and promptly gets capsule.
Embodiments of the invention 2: take by weighing: Radix Ginseng 25g, Radix Astragali 50g, Radix Et Caulis Acanthopanacis Senticosi 100g, Mylabris 0.5g, Oleum Glycines 150ml, tween 80 90ml, ethyl cellulose 100g
Preparation technology is: get the Mylabris medical material, pulverize, extracted 2 hours with 5ml 85% alcohol heating reflux, filter, medicinal residues are standby, and extracting solution transfers to pH9 with 10% sodium hydroxide solution, decompression recycling ethanol filters, and thin up is to 10ml, transfer to pH6 with 20% hydrochloric acid solution, leave standstill, cold preservation is complete to precipitation, centrifugal filtration, supernatant transfers to pH9 with 10% sodium hydroxide solution, and is standby; Get the Radix Ginseng section, extracted 2 hours, filter with 125ml 85% alcohol heating reflux, medicinal residues are standby, merge extractive liquid,, decompression recycling ethanol, it is 8.3ml that concentrated solution adds water to volume, and last macroporous adsorbent resin adds 2 times of column volumes of water elution, 2 times of column volume eluting of reuse 70% ethanol, collect eluent, reclaim ethanol, concentrate, filter, standby; Get the Radix Astragali, Radix Et Caulis Acanthopanacis Senticosi medical material, merge with Radix Ginseng, Mylabris medicinal residues, add the 2556ml decocting and boiled 3 hours, decocting liquid filters, being concentrated into volume is 56.7ml, filters, and supernatant adds ethanol, makes to contain the alcohol amount and reach 50%, transfer pH7～8 with 5% sodium hydroxide solution, cold preservation is filtered, supernatant adds ethanol again, makes to contain alcohol amount and reach 50%, cold preservation, filter, reclaim ethanol, add water to 50mL, transfer pH5～6 with 5% hydrochloric acid solution, add 0.05% active carbon boiling decoloring 10min, centrifugal filtration; Be concentrated into the thick paste shape, drying is ground into 120 purpose fine powders, gets drug powder.Other gets Oleum Glycines, tween 80, ethyl cellulose mix homogeneously, above-mentioned medicated powder is joined to make in the mixed liquor be uniformly dispersed, and pill promptly gets soft capsule.
Embodiments of the invention 3: take by weighing: Radix Ginseng 50g, Radix Astragali 100g, Radix Et Caulis Acanthopanacis Senticosi 150g, Mylabris 1.5g, refined honey 30g
Preparation technology is: get the Mylabris medical material, pulverize, extract 5 times with 30ml 40% alcohol heating reflux, extraction time is respectively 5h, 2h, 1h, 0.5h, 0.2h, filters, and medicinal residues are standby, merge extractive liquid, transfers to pH7 with 0.5% sodium hydroxide solution, decompression recycling ethanol, filter, thin up transfers to pH8 to 100ml with 5% hydrochloric acid solution, leave standstill, cold preservation is complete to precipitation, centrifugal filtration, supernatant transfers to pH7 with 0.5% sodium hydroxide solution, and is standby; Get the Radix Ginseng section, extract 5 times with 750ml 40% alcohol heating reflux, extraction time is respectively: 5h, 2h, 1h, 0.5h, 0.5h, filter, medicinal residues are standby, merge extractive liquid,, it is 150ml that decompression recycling ethanol, concentrated solution add water to volume, last macroporous adsorbent resin, add 10 times of column volumes of water elution, 10 times of column volume eluting of reuse 30% ethanol are collected eluent, reclaim ethanol, concentrate, filter, standby; Get the Radix Astragali, Radix Et Caulis Acanthopanacis Senticosi medical material, merge, add the 2038ml decocting and boil 5 times with Radix Ginseng, Mylabris medicinal residues, extraction time is respectively: 10h, 5h, 1h, 0.5h, 0.5h, and collecting decoction filters, being concentrated into volume is 873ml, filter, supernatant adds ethanol, makes to contain the alcohol amount and reach 85%, transfer pH9～10 with 20% sodium hydroxide solution, cold preservation is filtered, and supernatant adds ethanol again, make and contain alcohol amount and reach 90%, cold preservation is filtered, and reclaims ethanol, add water to 200mL, transfer pH6～7 with 20% hydrochloric acid solution, add 1% active carbon boiling decoloring 60min, centrifugal filtration; Supernatant and Radix Ginseng, Mylabris extracting solution merge, and are concentrated into the thick paste shape, and spray drying is pulverized, and crosses 150 purpose screen clothes, adds refined honey again and closes medicine, promptly gets pill.
Embodiments of the invention 4: take by weighing: Radix Ginseng 25g, Radix Astragali 200g, Radix Et Caulis Acanthopanacis Senticosi 100g, Mylabris 0.5g, mannitol 50g
Preparation technology is: get the Mylabris medical material, pulverize, extract 3 times with 6ml 50% alcohol heating reflux, extraction time is respectively: 2h, 1h, 0.5h, filter, and medicinal residues are standby, extracting solution transfers to pH7 with 5% sodium hydroxide solution, and decompression recycling ethanol filters, thin up transfers to pH7-8 to 10ml with 14% hydrochloric acid solution, leaves standstill, cold preservation, centrifugal filtration, supernatant transfers to pH7-8 with 5% sodium hydroxide solution, and is standby; Get the Radix Ginseng section, extract 2 times, extract 1h respectively with 300ml 70% alcohol heating reflux, filter, medicinal residues are standby, the extracting solution decompression recycling ethanol, it is 100ml that concentrated solution adds water to volume, and last macroporous adsorbent resin adds 6 times of column volumes of water elution, 6 times of column volume eluting of reuse 50% ethanol, collect eluent, reclaim ethanol, concentrate, filter, standby; Get the Radix Astragali, Radix Et Caulis Acanthopanacis Senticosi medical material, merge, add the 5447ml decocting and boil 3h, collecting decoction with Radix Ginseng, Mylabris medicinal residues, filter, being concentrated into volume is 641ml, filters, and supernatant adds ethanol, make to contain alcohol amount and reach 70%, transfer pH9 with 10% sodium hydroxide solution, cold preservation, filtration, supernatant adds ethanol again, makes to contain alcohol amount and reach 70%, cold preservation, filter, reclaim ethanol, add water to 140ml, transfer pH5-6 with 14% hydrochloric acid solution, add 0.4% active carbon boiling decoloring 50min, centrifugal filtration; Supernatant and Radix Ginseng, Mylabris extracting solution merge hyperfiltration treatment.Add water to 300ml, filter, add mannitol, mixing, packing, lyophilization, gland promptly gets freeze-dried powder preparation.
Embodiments of the invention 5: take by weighing: Radix Ginseng 100g, Radix Astragali 50g, Radix Et Caulis Acanthopanacis Senticosi 150g, Mylabris 1g, dextran 30g
Preparation technology is: get the Mylabris medical material, pulverize, extract 4 times with 25ml 60% alcohol heating reflux, extraction time is respectively: 3h, 2h, 1h, 0.2h, filter, and medicinal residues are standby, extracting solution transfers to pH8 with 60% sodium hydroxide solution, and decompression recycling ethanol filters, thin up transfers to pH7 to 50ml with 16% hydrochloric acid solution, leaves standstill, cold preservation, centrifugal filtration, supernatant transfers to pH8-9 with 6% sodium hydroxide solution, and is standby; Get the Radix Ginseng section, extract 3 times with 1800ml 75% alcohol heating reflux, extraction time is respectively: 1h, 0.5h, 0.5h, filter, medicinal residues are standby, the extracting solution decompression recycling ethanol, it is 200ml that concentrated solution adds water to volume, and last macroporous adsorbent resin adds 7 times of column volumes of water elution, 7 times of column volume eluting of reuse 60% ethanol, collect eluent, reclaim ethanol, concentrate, filter, standby; Get Milkvetch Root, add the 900ml decocting and boil 2 times, extract 1h respectively, decocting liquid filters, being concentrated into volume is 13ml, filters, and supernatant adds ethanol, makes to contain the alcohol amount and reach 80%, transfer pH8-9 with 15% sodium hydroxide solution, cold preservation is filtered, supernatant adds ethanol again, makes to contain alcohol amount and reach 80%, cold preservation, filter, reclaim ethanol, add water to 150ml, transfer pH6-7 with 16% hydrochloric acid solution, add 0.5% active carbon boiling decoloring 35min, centrifugal filtration; Get the Radix Et Caulis Acanthopanacis Senticosi medical material, add the 2700ml decocting and boil 2 times, extract 1h respectively, decocting liquid filters, being concentrated into volume is 37.5ml, filters, and supernatant adds ethanol, makes to contain the alcohol amount and reach 80%, transfer pH8-9 with 15% sodium hydroxide solution, cold preservation is filtered, supernatant adds ethanol again, makes to contain alcohol amount and reach 80%, cold preservation, filter, reclaim ethanol, add water to 150ml, transfer pH6-7 with 16% hydrochloric acid solution, add 0.5% active carbon boiling decoloring 35min, centrifugal filtration; Get Radix Ginseng, Mylabris medicinal residues, add the 1454ml decocting and boil 2 times, extract 1h respectively, decocting liquid filters, being concentrated into volume is 20ml, filters, and supernatant adds ethanol, makes to contain the alcohol amount and reach 80%, transfer pH8-9 with 15% sodium hydroxide solution, cold preservation is filtered, supernatant adds ethanol again, makes to contain alcohol amount and reach 80%, cold preservation, filter, reclaim ethanol, add water to 150ml, transfer pH6-7 with 16% hydrochloric acid solution, add 0.5% active carbon boiling decoloring 35min, centrifugal filtration; Supernatant and Radix Ginseng, Mylabris extracting solution merge hyperfiltration treatment.Add water to 500ml, filter, add dextran, mixing, packing, lyophilization, gland promptly gets freeze-dried powder preparation.
Embodiments of the invention 6: take by weighing: Radix Ginseng 60g, Radix Astragali 80g, Radix Et Caulis Acanthopanacis Senticosi 180g, Mylabris 5g
Preparation technology is: get the Mylabris medical material, pulverize, extract 5 times with 40ml 100% alcohol heating reflux, extraction time is respectively: 2h, 1h, 0.5h, 0.5h, 0.5h, filter, and medicinal residues are standby, extracting solution transfers to pH8-9 with 4% sodium hydroxide solution, and decompression recycling ethanol filters, thin up transfers to pH6-7 to 100ml with 12% hydrochloric acid solution, leaves standstill, cold preservation, centrifugal filtration, supernatant transfers to pH8-9 with 4% sodium hydroxide solution, and is standby; Get the Radix Ginseng section, extract 3h, filter with 480ml 60% alcohol heating reflux, medicinal residues are standby, and it is 15ml that extracting solution decompression recycling ethanol, concentrated solution add water to volume, last macroporous adsorbent resin, add 5 times of column volumes of water elution, 5 times of column volume eluting of reuse 80% ethanol are collected eluent, reclaim ethanol, concentrate, filter, standby; Get the Radix Astragali, Radix Et Caulis Acanthopanacis Senticosi medical material, merge, add the 2496ml decocting and boil 5 times with Radix Ginseng, Mylabris medicinal residues, extraction time is respectively: 3h, 2h, 1h, 0.5h, 0.5h, and collecting decoction filters, being concentrated into volume is 156ml, filter, supernatant adds ethanol, makes to contain the alcohol amount and reach 60%, transfer pH7 with 7% sodium hydroxide solution, cold preservation is filtered, and supernatant adds ethanol again, make and contain alcohol amount and reach 60%, cold preservation is filtered, and reclaims ethanol, add water to 120ml, transfer pH4～5 with 12% hydrochloric acid solution, add 0.3% active carbon boiling decoloring 40min, centrifugal filtration; Supernatant and Radix Ginseng, Mylabris extracting solution merge, and add the injection water to 1000ml, and regulating liquid PH value is 3, filters, and embedding, sterilization promptly get ejection preparation.
Embodiments of the invention 7: take by weighing: Radix Ginseng 80g, Radix Astragali 150g, Radix Et Caulis Acanthopanacis Senticosi 120g, Mylabris 2.5g preparation technology are: get the Mylabris medical material, pulverize, extracted 3 hours with 45ml 80% alcohol heating reflux, filter, medicinal residues are standby, and extracting solution transfers to pH9-10 with 7% sodium hydroxide solution, decompression recycling ethanol filters, and thin up is to 100ml, transfer to pH8 with 18% hydrochloric acid solution, leave standstill cold preservation, centrifugal filtration, supernatant transfers to pH9-10 with 7% sodium hydroxide solution, and is standby; Get the Radix Ginseng section, extract 4 times with 480ml 80% alcohol heating reflux, extraction time is respectively: 2h, 1h, 0.5h, 0.5h, filter, medicinal residues are standby, the extracting solution decompression recycling ethanol, it is 80ml that concentrated solution adds water to volume, and last macroporous adsorbent resin adds 9 times of column volumes of water elution, 9 times of column volume eluting of reuse 70% ethanol, collect eluent, reclaim ethanol, concentrate, filter, standby; Get Milkvetch Root, add the 2400ml decocting and boil 3 times, extract 2h respectively, collecting decoction, filter, being concentrated into volume is 600ml, filters, and supernatant adds ethanol, make to contain alcohol amount and reach 65%, transfer pH10 with 16% sodium hydroxide solution, cold preservation, filtration, supernatant adds ethanol again, makes to contain alcohol amount and reach 75%, cold preservation, filter, reclaim ethanol, add water to 100ml, transfer pH7 with 18% hydrochloric acid solution, add 0.8% active carbon boiling decoloring 55min, centrifugal filtration; Get the Radix Et Caulis Acanthopanacis Senticosi medical material, add the 1920ml decocting and boil 3 times, extract 2h respectively, collecting decoction, filter, being concentrated into volume is 480ml, filters, and supernatant adds ethanol, make to contain alcohol amount and reach 65%, transfer pH10 with 16% sodium hydroxide solution, cold preservation, filtration, supernatant adds ethanol again, makes to contain alcohol amount and reach 75%, cold preservation, filter, reclaim ethanol, add water to 100ml, transfer pH7 with 18% hydrochloric acid solution, add 0.8% active carbon boiling decoloring 55min, centrifugal filtration; Get Radix Ginseng, Mylabris medicinal residues, add the 1056ml decocting and boil 3 times, extract 2h respectively, collecting decoction, filter, being concentrated into volume is 264ml, filters, and supernatant adds ethanol, make to contain alcohol amount and reach 65%, transfer pH10 with 16% sodium hydroxide solution, cold preservation, filtration, supernatant adds ethanol again, makes to contain alcohol amount and reach 75%, cold preservation, filter, reclaim ethanol, add water to 100ml, transfer pH7 with 18% hydrochloric acid solution, add 0.8% active carbon boiling decoloring 55min, centrifugal filtration; Supernatant and Radix Ginseng, Mylabris extracting solution merge, and add the injection water to 1000ml, and regulating liquid PH value is 6, filters, and embedding, sterilization promptly get ejection preparation.
Embodiments of the invention 8: take by weighing: Radix Ginseng 40g, Radix Astragali 180g, Radix Et Caulis Acanthopanacis Senticosi 140g, Mylabris 4g, sodium chloride 45g
Preparation technology is: get the Mylabris medical material, pulverize, extract 4 times with 20ml 30% alcohol heating reflux, extraction time is respectively: 2h, 0.5h, 0.5h, 0.2h, 0.2h, filter, and medicinal residues are standby, extracting solution transfers to pH7-8 with 3% sodium hydroxide solution, and decompression recycling ethanol filters, thin up transfers to pH6-7 to 20ml with 8% hydrochloric acid solution, leaves standstill, cold preservation, centrifugal filtration, supernatant transfers to pH7～8 with 8% sodium hydroxide solution, and is standby; Get the Radix Ginseng section, extract 4 times with 800ml 90% alcohol heating reflux, extraction time is respectively: 3h, 2h, 1h, 0.5h, filter, medicinal residues are standby, the extracting solution decompression recycling ethanol, it is 200ml that concentrated solution adds water to volume, and last macroporous adsorbent resin adds 5 times of column volumes of water elution, 5 times of column volume eluting of reuse 80% ethanol, collect eluent, reclaim ethanol, concentrate, filter, standby; Get the Radix Astragali, Radix Et Caulis Acanthopanacis Senticosi medical material, merge, add the 7104ml decocting and boil 4 times with Radix Ginseng, Mylabris medicinal residues, extraction time is respectively: 5h, 4h, 3h, 1h, and collecting decoction filters, being concentrated into volume is 1776ml, filter, supernatant adds ethanol, makes to contain the alcohol amount and reach 90%, transfer pH9-10 with 8% sodium hydroxide solution, cold preservation is filtered, and supernatant adds ethanol again, make and contain alcohol amount and reach 95%, cold preservation is filtered, and reclaims ethanol, add water to 80ml, transfer pH6-7 with 10% hydrochloric acid solution, add 0.7% active carbon boiling decoloring 30min, centrifugal filtration; Supernatant and Radix Ginseng, Mylabris extracting solution merge, and add the sodium chloride dissolving, add the injection water to 5000ml, mixing, and through the filter membrane filtration of 0.65um, fill is in infusion bottle, and sealing promptly gets high-capacity injection after the sterilization.
Embodiments of the invention 9: take by weighing: Radix Ginseng 30g, Radix Astragali 120g, Radix Et Caulis Acanthopanacis Senticosi 160g, Mylabris 3g, glucose 90g
Preparation technology is: get the Mylabris medical material, pulverize, extract 2 times with 66ml 65% alcohol heating reflux, extraction time is respectively: 5h, 1h, filter, and medicinal residues are standby, extracting solution transfers to pH7-8 with 8% sodium hydroxide solution, and decompression recycling ethanol filters, thin up transfers to pH7 to 50ml with 6% hydrochloric acid solution, leaves standstill, cold preservation, centrifugal filtration, supernatant transfers to pH7-8 with 8% sodium hydroxide solution, and is standby; Get the Radix Ginseng section, extract 5h, filter with the 390ml55% alcohol heating reflux, medicinal residues are standby, and it is 20ml that extracting solution decompression recycling ethanol, concentrated solution add water to volume, last macroporous adsorbent resin, add 6 times of column volumes of water elution, 6 times of column volume eluting of reuse 50% ethanol are collected eluent, reclaim ethanol, concentrate, filter, standby; Get Milkvetch Root, add the 720ml decocting and boil 4 times, extraction time is respectively: 5h, 1h, 1h, 0.5h, collecting decoction, filter, being concentrated into volume is 180ml, filters, and supernatant adds ethanol, make to contain alcohol amount and reach 45%, transfer pH7-8 with 18% sodium hydroxide solution, cold preservation, filtration, supernatant adds ethanol again, makes to contain alcohol amount and reach 80%, cold preservation, filter, reclaim ethanol, add water to 180ml, transfer pH5-6 with 17% hydrochloric acid solution, add 0.9% active carbon boiling decoloring 45min, centrifugal filtration; Get the Radix Et Caulis Acanthopanacis Senticosi medical material, add the 960ml decocting and boil 4 times, extraction time is respectively: 5h, 1h, 1h, 0.5h, collecting decoction, filter, being concentrated into volume is 240ml, filters, and supernatant adds ethanol, make to contain alcohol amount and reach 45%, transfer pH7-8 with 18% sodium hydroxide solution, cold preservation, filtration, supernatant adds ethanol again, makes to contain alcohol amount and reach 80%, cold preservation, filter, reclaim ethanol, add water to 180ml, transfer pH5-6 with 17% hydrochloric acid solution, add 0.9% active carbon boiling decoloring 45min, centrifugal filtration; Get Radix Ginseng, Mylabris medicinal residues, add the 158ml decocting and boil 4 times, extraction time is respectively: 5h, 1h, 1h, 0.5h, collecting decoction, filter, being concentrated into volume is 40ml, filters, and supernatant adds ethanol, make to contain alcohol amount and reach 45%, transfer pH7-8 with 18% sodium hydroxide solution, cold preservation, filtration, supernatant adds ethanol again, makes to contain alcohol amount and reach 80%, cold preservation, filter, reclaim ethanol, add water to 180ml, transfer pH5-6 with 17% hydrochloric acid solution, add 0.9% active carbon boiling decoloring 45min, centrifugal filtration; Supernatant and Radix Ginseng, Mylabris extracting solution merge, and add the glucose dissolving, add the injection water to 10000ml, mixing, and through the filter membrane filtration of 0.45um, fill is in infusion bottle, and sealing promptly gets high-capacity injection after the sterilization.
Embodiments of the invention 10: take by weighing: Radix Ginseng 80g, Radix Astragali 60g, Radix Et Caulis Acanthopanacis Senticosi 180g, Mylabris 2g, sodium benzoate 1g, simple syrup 100g
Preparation technology is: get the Mylabris medical material, pulverize, extract 3 times with 60ml 90% alcohol heating reflux, extraction time is respectively 2h, 1h, 1h, filters, and medicinal residues are standby, extracting solution transfers to pH9-10 with 1% sodium hydroxide solution, and decompression recycling ethanol filters, thin up transfers to pH7-8 to 100ml with 15% hydrochloric acid solution, leaves standstill, cold preservation, centrifugal filtration, supernatant transfers to pH9～10 with 1% sodium hydroxide solution, and is standby; Get the Radix Ginseng section, extract 3 times with 320ml 30% alcohol heating reflux, extraction time is respectively: 2h, 1h, 1h, filter, medicinal residues are standby, the extracting solution decompression recycling ethanol, the ratio that concentrated solution adds water to volume and medical material amount is about 16ml, and last macroporous adsorbent resin adds 3 times of column volumes of water elution, 3 times of column volume eluting of reuse 20% ethanol, collect eluent, reclaim ethanol, concentrate, filter, standby; Get the Radix Astragali, Radix Et Caulis Acanthopanacis Senticosi medical material, merge, add the 1526ml decocting and boil 3 times with Radix Ginseng, Mylabris medicinal residues, extraction time is respectively: 8h, 6h, 4h, and collecting decoction filters, being concentrated into volume is 60ml, filter, supernatant adds ethanol, makes to contain the alcohol amount and reach 40%, transfer pH7-8 with 6% sodium hydroxide solution, cold preservation is filtered, and supernatant adds ethanol again, make and contain alcohol amount and reach 45%, cold preservation is filtered, and reclaims ethanol, add water to 100ml, transfer pH4～5 with 8% hydrochloric acid solution, add 0.1% active carbon boiling decoloring 25min, centrifugal filtration; Supernatant and Radix Ginseng, Mylabris extracting solution merge, and add simple syrup, sodium benzoate again, boil dissolving, add water to 1000ml, stir evenly, and filter, and embedding promptly gets oral liquid.
Embodiments of the invention 11: take by weighing: Radix Ginseng 90g, Radix Astragali 80g, Radix Et Caulis Acanthopanacis Senticosi 200g, Mylabris 0.5g, sodium benzoate 3g, simple syrup 350g
Preparation technology is: get the Mylabris medical material, pulverize, extract with 14ml 70% alcohol heating reflux, filter, medicinal residues are standby, and extracting solution transfers to pH8-9 with sodium hydroxide solution, decompression recycling ethanol filters, and thin up is to 20ml, transfer to pH7 with hydrochloric acid solution, leave standstill cold preservation, centrifugal filtration, supernatant transfers to pH8 with sodium hydroxide solution, and is standby; Get the Radix Ginseng section, extract with 990ml 65% alcohol heating reflux, filter, medicinal residues are standby, the extracting solution decompression recycling ethanol, it is 135ml that concentrated solution adds water to volume, and last macroporous adsorbent resin is used 60% ethanol elution, collects eluent, reclaim ethanol, concentrate, filter, standby; Get the Radix Astragali, Radix Et Caulis Acanthopanacis Senticosi medical material, merge, add the 4224ml decocting and boil collecting decoction with Radix Ginseng, Mylabris medicinal residues, filter, being concentrated into volume is 352ml, filters, and supernatant adds ethanol, make to contain alcohol amount and reach 75%, transfer pH8-9 with sodium hydroxide solution, cold preservation is filtered, supernatant adds ethanol again, makes to contain alcohol amount and reach 85%, cold preservation, filter, reclaim ethanol, add water, transfer pH6-7 with hydrochloric acid solution, add the active carbon boiling decoloring, centrifugal filtration; Supernatant and Radix Ginseng, Mylabris extracting solution merge, and add simple syrup, sodium benzoate again, boil dissolving, add water to 1000ml, stir evenly, and filter, and embedding promptly gets oral liquid.
Embodiments of the invention 12: take by weighing: Radix Ginseng 100g, Radix Astragali 200g, Radix Et Caulis Acanthopanacis Senticosi 200g, Mylabris 5g, low-substituted hydroxypropyl cellulose 40g, microcrystalline Cellulose 300g, sucrose 200g, Mentholum 20g
Preparation technology is: get the Mylabris medical material, pulverize, extract 2 times with 75ml 50% alcohol heating reflux, each 1 hour, filter, medicinal residues are standby, merge extractive liquid, transfers to pH7-8 with 2% sodium hydroxide solution, decompression recycling ethanol, filter, thin up transfers to pH6-7 to 200ml with 10% hydrochloric acid solution, leave standstill, cold preservation is complete to precipitation, centrifugal filtration, supernatant transfers to pH7～8 with 2% sodium hydroxide solution, and is standby; Get the Radix Ginseng section, extract 2 times, extracted respectively 1 hour with 1000ml 50% alcohol heating reflux, filter, medicinal residues are standby, merge extractive liquid,, it is 50ml that decompression recycling ethanol, concentrated solution add water to volume, last macroporous adsorbent resin, add 4 times of column volumes of water elution, 4 times of column volume eluting of reuse 40% ethanol are collected eluent, reclaim ethanol, concentrate, filter, standby; Get Milkvetch Root, add the 2000ml decocting and boil 2 times, extraction time is respectively: 10h, 2h, collecting decoction, filter, being concentrated into volume is 133ml, filters, and supernatant adds ethanol, make to contain alcohol amount and reach 55%, transfer pH8 with 10% sodium hydroxide solution, cold preservation, filtration, supernatant adds ethanol again, makes to contain alcohol amount and reach 55%, cold preservation, filter, reclaim ethanol, add water to 60mL, transfer pH6 with 6% hydrochloric acid solution, add 0.08% active carbon boiling decoloring 20min, centrifugal filtration; Get the Radix Et Caulis Acanthopanacis Senticosi medical material, add the 2000ml decocting and boil 2 times, extraction time is respectively: 10h, 2h, collecting decoction, filter, being concentrated into volume is 133ml, filters, and supernatant adds ethanol, make to contain alcohol amount and reach 55%, transfer pH8 with 10% sodium hydroxide solution, cold preservation, filtration, supernatant adds ethanol again, makes to contain alcohol amount and reach 55%, cold preservation, filter, reclaim ethanol, add water to 60mL, transfer pH6 with 6% hydrochloric acid solution, add 0.08% active carbon boiling decoloring 20min, centrifugal filtration; Get Radix Ginseng, Mylabris medicinal residues, add the 840ml decocting and boil 2 times, extraction time is respectively: 10h, 2h, collecting decoction, filter, being concentrated into volume is 56ml, filters, and supernatant adds ethanol, make to contain alcohol amount and reach 55%, transfer pH8 with 10% sodium hydroxide solution, cold preservation, filtration, supernatant adds ethanol again, makes to contain alcohol amount and reach 55%, cold preservation, filter, reclaim ethanol, add water to 60mL, transfer pH6 with 6% hydrochloric acid solution, add 0.08% active carbon boiling decoloring 20min, centrifugal filtration; Supernatant and Radix Ginseng, Mylabris extracting solution merge, and concentrating under reduced pressure becomes extractum, and drying is ground into 200 purpose powder, and with low-substituted hydroxypropyl cellulose, microcrystalline Cellulose, sucrose, Mentholum mix homogeneously, tabletting promptly gets oral cavity disintegration tablet.
Claims (11)
1, a kind of preparation method for the treatment of the Chinese medicine preparation of tumor prepares with Radix Ginseng 25-100 weight portion, Radix Astragali 50-200 weight portion, Radix Et Caulis Acanthopanacis Senticosi 100-200 weight portion and Mylabris 0.5-5 weight portion; It is characterized in that: get the Mylabris medical material, pulverize, use ethanol extraction, filter, medicinal residues are standby, and extracting solution transfers to pH7-10 with sodium hydroxide solution, decompression recycling ethanol filters thin up, transfer to pH6-8 with hydrochloric acid solution, leave standstill, cold preservation is complete to precipitation, centrifugal filtration, supernatant transfers to pH6～10 with sodium hydroxide solution, and is standby; Get the Radix Ginseng section, use ethanol extraction, filter, medicinal residues are standby, the extracting solution decompression recycling ethanol, and concentrated solution is dissolved in water, and last macroporous adsorbent resin is used ethanol elution, and eluent reclaims ethanol, concentrates, and filters, and is standby; Get the Radix Astragali, Radix Et Caulis Acanthopanacis Senticosi medical material, merge, decoct with water with Radix Ginseng, Mylabris medicinal residues, decocting liquid filters, and concentrates, and filters, supernatant adds ethanol, transfers pH7～11, cold preservation with sodium hydroxide solution, filter, supernatant adds ethanol precipitate with ethanol, cold preservation again, filter, reclaim ethanol, be dissolved in water, transfer pH4～8 with hydrochloric acid solution, add the active carbon boiling decoloring, centrifugal filtration; Supernatant and Radix Ginseng, Mylabris extracting solution merge, and make different preparations with conventional method.
2, according to the preparation method of the Chinese medicine preparation of the described treatment tumor of claim 1, it is characterized in that: get the Mylabris medical material, pulverize, doubly measure the 30-100% alcohol heating reflux with 5-30 and extract, filter, medicinal residues are standby, extracting solution transfers to pH7-10 with sodium hydroxide solution, and decompression recycling ethanol filters, thin up transfers to pH6-8 with hydrochloric acid solution, leaves standstill, cold preservation, centrifugal filtration, supernatant transfers to pH7～10 with sodium hydroxide solution, and is standby; Get the Radix Ginseng section, doubly measure the 30-90% alcohol heating reflux with 4-20 and extract, filter, medicinal residues are standby, it is 1-5: 5-1 that extracting solution decompression recycling ethanol, concentrated solution add water to every milliliter of ratio with the every gram of medical material amount of volume, last macroporous adsorbent resin, use the 20-80% ethanol elution, collect eluent, reclaim ethanol, concentrate, filter, standby; Get the Radix Astragali, Radix Et Caulis Acanthopanacis Senticosi medical material, merge, add 5-20 times of water gaging and decoct collecting decoction with Radix Ginseng, Mylabris medicinal residues, filter, being concentrated into every milliliter of ratio with the every gram of medical material amount of volume is 1-5: 5-1, filters, and supernatant adds ethanol, make to contain alcohol amount and reach 40-90%, transfer pH7～10 with sodium hydroxide solution, cold preservation is filtered, supernatant adds ethanol again, makes the alcohol amount of containing reach 45-95%, cold preservation, filter, reclaim ethanol, add water, transfer pH4～7 with hydrochloric acid solution, add the active carbon boiling decoloring, centrifugal filtration; Supernatant and Radix Ginseng, Mylabris extracting solution merge, and make different preparations with conventional method.
3, according to the preparation method of the Chinese medicine preparation of claim 1 or 2 described treatment tumors, it is characterized in that: get the Mylabris medical material, pulverize, doubly measure the 40-90% alcohol heating reflux with 10-20 and extract 1-5 time, each 0.2-5 hour, filter, medicinal residues are standby, merge extractive liquid, transfers to pH7-9 with the 0.5-10% sodium hydroxide solution, decompression recycling ethanol, filter, thin up transfers to pH6-8 with the 5-20% hydrochloric acid solution, leaves standstill, cold preservation is complete to precipitation, centrifugal filtration, supernatant transfers to pH7～9 with the 0.5-10% sodium hydroxide solution, and is standby; Get the Radix Ginseng section, doubly measure the 40-85% alcohol heating reflux with 5-15 and extract 1-5 time, each 0.5-5 hour, filter, medicinal residues are standby, merge extractive liquid,, it is 1-3: 3-1 that decompression recycling ethanol, concentrated solution add water to every milliliter of ratio with the every gram of medical material amount of volume, last macroporous adsorbent resin, add water elution 2-10 times column volume, 2-10 times of column volume eluting of reuse 30-70% ethanol collected eluent, reclaim ethanol, concentrate, filter, standby; Get the Radix Astragali, the Radix Et Caulis Acanthopanacis Senticosi medical material is with Radix Ginseng, the Mylabris medicinal residues merge, and add 7-15 times of water gaging and decoct 1-5 time, each 0.5-10 hour, collecting decoction filtered, being concentrated into every milliliter of ratio with the every gram of medical material amount of volume is 1-3: 3-1, filter, supernatant adds ethanol, makes to contain the alcohol amount and reach 50-85%, transfer pH7～10 with the 5-20% sodium hydroxide solution, cold preservation is filtered, and supernatant adds ethanol again, make the alcohol amount of containing reach 50-90%, cold preservation is filtered, and reclaims ethanol, add water to 50-200mL, transfer pH5～7 with the 5-20% hydrochloric acid solution, add 0.05-1% active carbon boiling decoloring 10-60min, centrifugal filtration; Supernatant and Radix Ginseng, Mylabris extracting solution merge, and add adjuvant or do not add adjuvant with conventional method, make injection, freeze-dried powder, high-capacity injection, oral liquid, capsule, disintegrating tablet, pill or soft capsule.
4, according to the preparation method of the Chinese medicine preparation of claim 1 or 2 described treatment tumors, it is characterized in that: the preparation method of lyophilized powder of the present invention is: get the Mylabris medical material, pulverize, doubly measure the 30-100% alcohol heating reflux with 5-30 and extract, filter, medicinal residues are standby, extracting solution transfers to pH7-10 with sodium hydroxide solution, and decompression recycling ethanol filters, thin up transfers to pH6-8 with hydrochloric acid, leaves standstill, cold preservation, centrifugal filtration, supernatant transfers to pH7～10 with sodium hydroxide solution, and is standby; Get the Radix Ginseng section, doubly measure the 30-90% alcohol heating reflux with 4-20 and extract, filter, medicinal residues are standby, it is 1-5: 5-1 that extracting solution decompression recycling ethanol, concentrated solution add water to every milliliter of ratio with the every gram of medical material amount of volume, last macroporous adsorbent resin, use the 20-80% ethanol elution, collect eluent, reclaim ethanol, concentrate, filter, standby; Get the Radix Astragali, Radix Et Caulis Acanthopanacis Senticosi medical material, merge, add 5-20 times of water gaging and decoct collecting decoction with Radix Ginseng, Mylabris medicinal residues, filter, being concentrated into every milliliter of ratio with the every gram of medical material amount of volume is 1-5: 5-1, filters, and supernatant adds ethanol, make to contain alcohol amount and reach 40-90%, transfer pH7～10 with sodium hydroxide, cold preservation is filtered, supernatant adds ethanol again, makes the alcohol amount of containing reach 45-95%, cold preservation, filter, reclaim ethanol, add water, transfer pH4～7 with hydrochloric acid, add the active carbon boiling decoloring, centrifugal filtration; Supernatant and Radix Ginseng, Mylabris extracting solution merge hyperfiltration treatment; Add water to the 300-500 milliliter, filter, add excipient, mixing, packing, lyophilization, gland, promptly.
5, according to the preparation method of the Chinese medicine preparation of the described treatment tumor of claim 4, it is characterized in that: with the dextran of the mannitol of 6-9% or 5-8% excipient as freeze-dried powder.
6, according to the preparation method of the Chinese medicine preparation of claim 1 or 2 described treatment tumors, it is characterized in that: the preparation method of injection of the present invention is: get the Mylabris medical material, pulverize, doubly measure the 30-100% alcohol heating reflux with 5-30 and extract, filter, medicinal residues are standby, extracting solution transfers to pH7-10 with sodium hydroxide solution, and decompression recycling ethanol filters, thin up transfers to pH6-8 with hydrochloric acid, leaves standstill, cold preservation, centrifugal filtration, supernatant transfers to pH7～10 with sodium hydroxide solution, and is standby; Get the Radix Ginseng section, doubly measure the 30-90% alcohol heating reflux with 4-20 and extract, filter, medicinal residues are standby, it is 1-5: 5-1 that extracting solution decompression recycling ethanol, concentrated solution add water to every milliliter of ratio with the every gram of medical material amount of volume, last macroporous adsorbent resin, use the 20-80% ethanol elution, collect eluent, reclaim ethanol, concentrate, filter, standby; Get the Radix Astragali, Radix Et Caulis Acanthopanacis Senticosi medical material, merge, add 5-20 times of water gaging and decoct collecting decoction with Radix Ginseng, Mylabris medicinal residues, filter, being concentrated into every milliliter of ratio with the every gram of medical material amount of volume is 1-5: 5-1, filters, and supernatant adds ethanol, make to contain alcohol amount and reach 40-90%, transfer pH7～10 with sodium hydroxide, cold preservation is filtered, supernatant adds ethanol again, makes the alcohol amount of containing reach 45-95%, cold preservation, filter, reclaim ethanol, add water, transfer pH4～7 with hydrochloric acid, add the active carbon boiling decoloring, centrifugal filtration; Supernatant and Radix Ginseng, Mylabris extracting solution merge, and add the injection water to 1000ml, and the adjusting liquid PH value is 3-6, filter, and embedding, sterilization, promptly.
7, according to the preparation method of the Chinese medicine preparation of claim 1 or 2 described treatment tumors, it is characterized in that: the preparation method of high-capacity injection of the present invention is: get the Mylabris medical material, pulverize, doubly measure the 30-100% alcohol heating reflux with 5-30 and extract, filter, medicinal residues are standby, extracting solution transfers to pH7-10 with sodium hydroxide solution, and decompression recycling ethanol filters, thin up transfers to pH6-8 with hydrochloric acid, leaves standstill, cold preservation, centrifugal filtration, supernatant transfers to pH7～10 with sodium hydroxide solution, and is standby; Get the Radix Ginseng section, doubly measure the 30-90% alcohol heating reflux with 4-20 and extract, filter, medicinal residues are standby, it is 1-5: 5-1 that extracting solution decompression recycling ethanol, concentrated solution add water to every milliliter of ratio with the every gram of medical material amount of volume, last macroporous adsorbent resin, use the 20-80% ethanol elution, collect eluent, reclaim ethanol, concentrate, filter, standby; Get the Radix Astragali, Radix Et Caulis Acanthopanacis Senticosi medical material, merge, add 5-20 times of water gaging and decoct collecting decoction with Radix Ginseng, Mylabris medicinal residues, filter, being concentrated into every milliliter of ratio with the every gram of medical material amount of volume is 1-5: 5-1, filters, and supernatant adds ethanol, make to contain alcohol amount and reach 40-90%, transfer pH7～10 with sodium hydroxide, cold preservation is filtered, supernatant adds ethanol again, makes the alcohol amount of containing reach 45-95%, cold preservation, filter, reclaim ethanol, add water, transfer pH4～7 with hydrochloric acid, add the active carbon boiling decoloring, centrifugal filtration; Supernatant and Radix Ginseng, Mylabris extracting solution merge, and add osmotic pressure regulator, add the injection water to the 5000-10000 milliliter, and mixing filters through the filter membrane smaller or equal to 0.65um, and fill is in infusion bottle, and sealing promptly gets high-capacity injection after the sterilization.
8, according to the preparation method of the Chinese medicine preparation of the described treatment tumor of claim 7, it is characterized in that: select the osmotic pressure regulator of the glucose of the sodium chloride of 0.8-2.5% or 0.3-1.5% for use as high-capacity injection.
9, according to the preparation method of the Chinese medicine preparation of claim 1 or 2 described treatment tumors, it is characterized in that: the preparation method of oral formulations of the present invention is: get the Mylabris medical material, pulverize, doubly measure the 30-100% alcohol heating reflux with 5-30 and extract, filter, medicinal residues are standby, extracting solution transfers to pH7-10 with sodium hydroxide solution, and decompression recycling ethanol filters, thin up transfers to pH6-8 with hydrochloric acid, leaves standstill, cold preservation, centrifugal filtration, supernatant transfers to pH7～10 with sodium hydroxide solution, and is standby; Get the Radix Ginseng section, doubly measure the 30-90% alcohol heating reflux with 4-20 and extract, filter, medicinal residues are standby, it is 1-5: 5-1 that extracting solution decompression recycling ethanol, concentrated solution add water to every milliliter of ratio with the every gram of medical material amount of volume, last macroporous adsorbent resin, use the 20-80% ethanol elution, collect eluent, reclaim ethanol, concentrate, filter, standby; Get the Radix Astragali, Radix Et Caulis Acanthopanacis Senticosi medical material, merge, add 5-20 times of water gaging and decoct collecting decoction with Radix Ginseng, Mylabris medicinal residues, filter, being concentrated into every milliliter of ratio with the every gram of medical material amount of volume is 1-5: 5-1, filters, and supernatant adds ethanol, make to contain alcohol amount and reach 40-90%, transfer pH7～10 with sodium hydroxide, cold preservation is filtered, supernatant adds ethanol again, makes the alcohol amount of containing reach 45-95%, cold preservation, filter, reclaim ethanol, add water, transfer pH4～7 with hydrochloric acid, add the active carbon boiling decoloring, centrifugal filtration; Supernatant and Radix Ginseng, Mylabris extracting solution merge, and add simple syrup again and make final sugar content 10-35%, add the 0.1%-0.3% sodium benzoate, boil dissolving, add water to 1000ml, stir evenly, filter, and embedding, promptly.
10, according to the preparation method of the Chinese medicine preparation of any described treatment tumor among the claim 1-9, it is characterized in that: the extracting method of the described Radix Astragali, Radix Et Caulis Acanthopanacis Senticosi is: get the Radix Astragali, Radix Et Caulis Acanthopanacis Senticosi medical material, merge with Radix Ginseng, Mylabris medicinal residues, decoct with water, decocting liquid filters, concentrate, filter, supernatant adds ethanol, transfer pH7～11 with sodium hydroxide, cold preservation is filtered, and supernatant adds the ethanol precipitate with ethanol again, cold preservation, filter, reclaim ethanol, be dissolved in water, transfer pH4～8 with hydrochloric acid, add the active carbon boiling decoloring, centrifugal filtration, promptly.
11, according to the preparation method of the Chinese medicine preparation of any described treatment tumor among the claim 1-10, it is characterized in that: the extracting method of the described Radix Astragali, Radix Et Caulis Acanthopanacis Senticosi is: get the Radix Astragali, decoct with water, decocting liquid filters, concentrate, filter, supernatant adds ethanol, transfer pH7～11 with sodium hydroxide, cold preservation is filtered, supernatant adds the ethanol precipitate with ethanol again, and cold preservation is filtered, reclaim ethanol, be dissolved in water, transfer pH4～8 with hydrochloric acid, add the active carbon boiling decoloring, centrifugal filtration, promptly; Get the Radix Et Caulis Acanthopanacis Senticosi medical material, decoct with water, decocting liquid filters, concentrate, filter, supernatant adds ethanol, transfer pH7～11 with sodium hydroxide, cold preservation is filtered, supernatant adds the ethanol precipitate with ethanol again, and cold preservation is filtered, reclaim ethanol, be dissolved in water, transfer pH4～8 with hydrochloric acid, add the active carbon boiling decoloring, centrifugal filtration, promptly; Get Radix Ginseng, Mylabris medicinal residues, decoct with water, decocting liquid filters, concentrate, filter, supernatant adds ethanol, transfer pH7～11 with sodium hydroxide, cold preservation is filtered, supernatant adds the ethanol precipitate with ethanol again, and cold preservation is filtered, reclaim ethanol, be dissolved in water, transfer pH4～8 with hydrochloric acid, add the active carbon boiling decoloring, centrifugal filtration, promptly.
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| CN101084983B (en) * | 2006-06-08 | 2011-06-08 | 天津天士力之骄药业有限公司 | Traditional Chinese medicine powder injection for treating tumor and its preparation process |
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| CN106581639A (en) * | 2017-02-07 | 2017-04-26 | 张艳飞 | Dendrobium extract-containing drink for preventing haze damages |
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