CN101829305A - Antineoplastic Jinsanxiong Chinese medicinal preparation and preparation method thereof - Google Patents
Antineoplastic Jinsanxiong Chinese medicinal preparation and preparation method thereof Download PDFInfo
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Abstract
The invention relates to an antineoplastic Jinsanxiong Chinese medicinal preparation and a preparation method thereof. The antineoplastic Jinsanxiong Chinese medicinal preparation comprises barbed skullcap herb, spreading hedyotis herb, weeping forsythia, baical skullcap root, indigowoad root, gardenia, honeysuckle flower, zedoary oil, pseudoginseng root, scorpion and realgar. The antineoplastic Jinsanxiong Chinese medicinal preparation has the effects of clearing heat and detoxicating, activating blood and dissolving stasis, and resolving hard lump, is suitable for a plurality of cancers caused by qi stagnation and blood stasis and toxic deposit, and can inhibit the development of the tumor, promote the solid tumor regression, and promote apoptosis of the tumor cells; and each raw material of the preparation has the effect of resisting the tumor, and through the combined action of all raw materials, the preparation has accurate, obvious and unique curative effect.
Description
Technical field
The present invention relates to field of traditional Chinese, particularly a kind of antineoplastic Jinsanxiong Chinese medicine preparation and preparation method thereof; Contain Herba Scutellariae Barbatae, Herba Hedyotidis Diffusae, Fructus Forsythiae, Radix Scutellariae, Radix Isatidis, Fructus Gardeniae, Flos Lonicerae, Oleum Curcumae, Radix Notoginseng, Scorpio, Realgar in the described antineoplastic Jinsanxiong Chinese medicine preparation.
Technical background
Over nearly 10 years, the sickness rate of malignant tumor is the situation of high speed development, and the trend of patient's rejuvenation increases the weight of.
The pathogeny of malignant tumor, the whole world are still in exploratory development.
At present, the basic skills of treatment malignant tumor is operative treatment, chemicotherapy etc.; But said method has following side effect: physiological function, the tumor of destroying normal structure and internal organs quickened diffusion, caused misery on the health to the patient.
The treatment by Chinese herbs malignant tumor more and more comes into one's own, and the current research direction in this field is: suppress tumor growth, it is dwindled, form the coexistence of chronic disease and human body, improve patient's immunologic function and survival rate; Thereby avoid and alleviate the side effect of operative treatment, chemicotherapy.
So, need in the clinical treatment a kind of evident in efficacy, the anti-malignant tumor Chinese medicine preparation that side effect is less.
Summary of the invention
The purpose of this invention is to provide a kind of antineoplastic Jinsanxiong Chinese medicine preparation and preparation method; Contain Herba Scutellariae Barbatae, Herba Hedyotidis Diffusae, Fructus Forsythiae, Radix Scutellariae, Radix Isatidis, Fructus Gardeniae, Flos Lonicerae, Oleum Curcumae, Radix Notoginseng, Scorpio, Realgar in the described antineoplastic Jinsanxiong Chinese medicine preparation; The present invention has heat-clearing and toxic substances removing, blood circulation promoting and blood stasis dispelling, the effect of hard masses softening and resolving; Be applicable to that qi stagnation blood stasis, evil poison accumulate the multiple cancer of amassing due to demonstrate,proving.
The objective of the invention is to realize by following technical scheme:
Contain Herba Scutellariae Barbatae, Herba Hedyotidis Diffusae, Fructus Forsythiae, Radix Scutellariae, Radix Isatidis, Fructus Gardeniae, Flos Lonicerae, Oleum Curcumae, Radix Notoginseng, Scorpio, Realgar in the described antineoplastic Jinsanxiong Chinese medicine preparation; The weight ratio of each raw material is in the described antineoplastic Jinsanxiong Chinese medicine preparation:
Herba Scutellariae Barbatae 150～1600
Herba Hedyotidis Diffusae 150～1600
Fructus Forsythiae 150～1600
Radix Scutellariae 60～400
Radix Isatidis 60～400
Fructus Gardeniae 60～400
Flos Lonicerae 60～400
Oleum Curcumae 5～20
Radix Notoginseng 10～120
Scorpio 5～60
Realgar 20～220.
Described antineoplastic Jinsanxiong Chinese medicine preparation is light brown or brown powder, bitter in the mouth.
The dosage form of described antineoplastic Jinsanxiong Chinese medicine preparation can be capsule, tablet, pill, electuary, and usage is: oral meal.
Described antineoplastic Jinsanxiong Chinese medicine preparation function cures mainly:
Heat-clearing and toxic substances removing, blood circulation promoting and blood stasis dispelling, hard masses softening and resolving.Be used for qi stagnation blood stasis, evil poison and accumulate hepatocarcinoma due to the long-pending card, gastric cancer, lymphatic cancer, breast carcinoma, acute and chronic granulocyte type leukemia etc.
Another object of the present invention is achieved through the following technical solutions:
A kind of preparation method of antineoplastic Jinsanxiong Chinese medicine preparation contains Herba Scutellariae Barbatae, Herba Hedyotidis Diffusae, Fructus Forsythiae, Radix Scutellariae, Radix Isatidis, Fructus Gardeniae, Flos Lonicerae, Oleum Curcumae, Radix Notoginseng, Scorpio, Realgar in the described antineoplastic Jinsanxiong Chinese medicine preparation; The weight ratio of each raw material is in the described antineoplastic Jinsanxiong Chinese medicine preparation:
Herba Scutellariae Barbatae 150～1600
Herba Hedyotidis Diffusae 150～1600
Fructus Forsythiae 150～1600
Radix Scutellariae 60～400
Radix Isatidis 60～400
Fructus Gardeniae 60～400
Flos Lonicerae 60～400
Oleum Curcumae 5～20
Radix Notoginseng 10～120
Scorpio 5～60
Realgar 20～220;
The dosage form of described antineoplastic Jinsanxiong Chinese medicine preparation is a capsule, and preparation process is as follows:
I. raw material is handled:
A. Realgar, Radix Notoginseng, Scorpio are handled:
A. described Realgar is carried out water and fly to handle, obtain Realgar superfine powder;
B. described Radix Notoginseng is carried out pulverization process, obtain the Radix Notoginseng fine powder;
C. described Scorpio is cleaned processing, dried, pulverization process successively, obtain the Scorpio fine powder;
B. Oleum Curcumae is handled:
A. will add alcoholic solution in the described Oleum Curcumae, obtain the ethanol volatile oil of Rhizoma Curcumae;
In the ethanol volatile oil of described Rhizoma Curcumae, the volume ratio of described Oleum Curcumae and alcoholic solution is 1: 1～3;
B. the ethanol volatile oil with described Rhizoma Curcumae mixes with beta-schardinger dextrin-solution, carries out stir process, obtains the Oleum Curcumae inclusion complex;
In the described stir process, temperature is 35～40 ℃ and carried out continuously 3～8 hours;
C. described Oleum Curcumae inclusion complex is left standstill processing, filtration treatment, dried, pulverization process, the processing of sieving, obtain Oleum Curcumae inclusion complex fine powder;
Described leaving standstill in the processing, temperature are 15～20 ℃; Time is 12～28 hours;
In the described dried, temperature is 38～40 ℃;
C. Herba Scutellariae Barbatae, Herba Hedyotidis Diffusae, Fructus Forsythiae, Radix Scutellariae, Radix Isatidis, Fructus Gardeniae, Flos Lonicerae are handled:
A. described Herba Scutellariae Barbatae, Herba Hedyotidis Diffusae, Fructus Forsythiae, Radix Scutellariae, Radix Isatidis, Fructus Gardeniae, Flos Lonicerae are carried out pulverization process respectively, obtain the coarse powder of Herba Scutellariae Barbatae, the coarse powder of Herba Hedyotidis Diffusae, the coarse powder of Fructus Forsythiae, the coarse powder of Radix Scutellariae, the coarse powder of Radix Isatidis, the coarse powder of Fructus Gardeniae, the coarse powder of Flos Lonicerae respectively; Again above-mentioned 7 kinds of coarse powder are mixed and obtain coarse powder mixture;
B. described coarse powder mixture is carried out decocting the first time and handles, obtain decocting liquid for the first time and decoct for the first time after medicinal residues;
Described for the first time decoct and to handle, the weight ratio of described coarse powder mixture and water is 1: 6～12; Time is 1～3 hour;
C. the medicinal residues after described first time being decocted carry out decocting second time to be handled, and obtains the medicinal residues behind the decocting liquid and decoction for the second time for the second time;
Described for the second time decoct and to handle, the weight ratio of described coarse powder mixture and water is 1: 6～10, and the time is 1～2 hour;
D. merge described first time of decocting liquid and decocting liquid for the second time, carry out filtration treatment again, obtain mixture filtrate;
E. described mixture filtrate is carried out concentration, obtain the mixture clear paste;
F. with adding alcoholic solution in the described mixture clear paste, obtain containing pure clear paste;
G. contain pure clear paste and leave standstill processing hermetically described, the qinghuo reagent supernatant stays the clear paste residue again; Described leaving standstill in the processing, temperature are room temperature, and the time is 12～48 hours;
H. described clear paste residue is carried out filtration treatment, obtain residue filtrate;
I. described residue filtrate and described clear paste supernatant are merged, carry out concentration, obtain thick paste;
J. with adding starch and mixing in the described thick paste, obtain extract; Again described extract is carried out drying under reduced pressure processing, pulverization process, obtain the extract fine powder;
The percentage by weight that described starch accounts for described extract is 0.02%～0.15%, is preferably 0.1%;
During described drying under reduced pressure was handled, temperature was 60～80 ℃;
D. mix
With described Realgar superfine powder, Radix Notoginseng fine powder, Scorpio fine powder, Oleum Curcumae inclusion complex fine powder, extract fine powder mixing, obtain raw mix;
II. finished product preparation
With described raw mix and magnesium stearate mixing, obtain capsule 's content; The percentage by weight that described magnesium stearate accounts for described capsule 's content is 0.15%～1%; Again described capsule 's content is incapsulated in the housing, promptly get antineoplastic Jinsanxiong Chinese medicinal capsule agent finished product.
Another object of the present invention is achieved through the following technical solutions:
A kind of preparation method of antineoplastic Jinsanxiong Chinese medicine preparation contains Herba Scutellariae Barbatae, Herba Hedyotidis Diffusae, Fructus Forsythiae, Radix Scutellariae, Radix Isatidis, Fructus Gardeniae, Flos Lonicerae, Oleum Curcumae, Radix Notoginseng, Scorpio, Realgar in the described antineoplastic Jinsanxiong Chinese medicine preparation; The weight ratio of each raw material is in the described antineoplastic Jinsanxiong Chinese medicine preparation:
Herba Scutellariae Barbatae 150～1600
Herba Hedyotidis Diffusae 150～1600
Fructus Forsythiae 150～1600
Radix Scutellariae 60～400
Radix Isatidis 60～400
Fructus Gardeniae 60～400
Flos Lonicerae 60～400
Oleum Curcumae 5～20
Radix Notoginseng 10～120
Scorpio 5～60
Realgar 20～220;
The dosage form of described antineoplastic Jinsanxiong Chinese medicine preparation is a tablet, and preparation process is as follows:
I. raw material is handled:
A. Realgar, Radix Notoginseng, Scorpio are handled:
A. described Realgar is carried out water and fly to handle, obtain Realgar superfine powder;
B. described Radix Notoginseng is carried out pulverization process, obtain the Radix Notoginseng fine powder;
C. described Scorpio is cleaned processing, dried, pulverization process successively, obtain the Scorpio fine powder;
B. Oleum Curcumae is handled:
A. will add alcoholic solution in the described Oleum Curcumae, obtain the ethanol volatile oil of Rhizoma Curcumae;
In the ethanol volatile oil of described Rhizoma Curcumae, the volume ratio of described Oleum Curcumae and alcoholic solution is 1: 1～3;
B. the ethanol volatile oil with described Rhizoma Curcumae mixes with beta-schardinger dextrin-solution, carries out stir process, obtains the Oleum Curcumae inclusion complex;
In the described stir process, temperature is 35～40 ℃, carries out continuously 3～8 hours;
C. described Oleum Curcumae inclusion complex is left standstill processing, filtration treatment, dried, pulverization process, the processing of sieving, obtain Oleum Curcumae inclusion complex fine powder;
Described leaving standstill in the processing, temperature are 15～20 ℃, and the time is 12～28 hours;
In the described dried, temperature is 38～40 ℃;
C. Herba Scutellariae Barbatae, Herba Hedyotidis Diffusae, Fructus Forsythiae, Radix Scutellariae, Radix Isatidis, Fructus Gardeniae, Flos Lonicerae are handled:
A. described Herba Scutellariae Barbatae, Herba Hedyotidis Diffusae, Fructus Forsythiae, Radix Scutellariae, Radix Isatidis, Fructus Gardeniae, Flos Lonicerae are carried out pulverization process respectively, obtain the coarse powder of Herba Scutellariae Barbatae, the coarse powder of Herba Hedyotidis Diffusae, the coarse powder of Fructus Forsythiae, the coarse powder of Radix Scutellariae, the coarse powder of Radix Isatidis, the coarse powder of Fructus Gardeniae, the coarse powder of Flos Lonicerae respectively; Again above-mentioned 7 kinds of coarse powder are mixed and obtain coarse powder mixture;
B. described coarse powder mixture is carried out decocting the first time and handles, obtain decocting liquid for the first time and decoct for the first time after medicinal residues;
Described for the first time decoct and to handle, the weight ratio of described coarse powder mixture and water is 1: 6～12; Time is 1～3 hour;
C. the medicinal residues after described first time being decocted carry out decocting second time to be handled, and obtains the medicinal residues behind the decocting liquid and decoction for the second time for the second time;
Described for the second time decoct and to handle, the weight ratio of described coarse powder mixture and water is 1: 6～10, and the time is 1～2 hour;
D. merge described first time of decocting liquid and decocting liquid for the second time, carry out filtration treatment again, obtain mixture filtrate;
E. described mixture filtrate is carried out concentration, obtain the mixture clear paste;
F. with adding alcoholic solution in the described mixture clear paste, obtain containing pure clear paste
G. contain pure clear paste and leave standstill processing hermetically described, the qinghuo reagent supernatant stays the clear paste residue again; Described leaving standstill in the processing, temperature are room temperature, and the time is 12～48 hours;
H. described clear paste residue is carried out filtration treatment, obtain residue filtrate;
I. described residue filtrate and described clear paste supernatant are merged, carry out concentration, obtain thick paste;
J. described thick paste is carried out drying under reduced pressure processing, pulverization process, obtain the extract fine powder;
During described drying under reduced pressure is handled;
D. mix
With described Realgar superfine powder, Radix Notoginseng fine powder, Scorpio fine powder, Oleum Curcumae inclusion complex fine powder, extract fine powder mixing, obtain raw mix;
II. finished product preparation
A. with described raw mix and microcrystalline Cellulose, carboxymethyl starch sodium mixing, obtain total mixture; Described total mixture is carried out pelletization treatment, dried, obtain tablet mixture;
The percentage by weight that described microcrystalline Cellulose accounts for described total mixture is 0.02～0.05%;
The percentage by weight that described carboxymethyl starch sodium accounts for described total mixture is 0.1～1%;
In the described dried, temperature is 38～40 ℃;
B. with described tablet mixture and magnesium stearate mixing, obtain pressing mixt;
The percentage by weight that described magnesium stearate accounts for described pressing mixt is 0.15%～1%;
Described pressing mixt is carried out compression process, obtain antineoplastic Jinsanxiong Chinese medicinal tablet finished product.
Another object of the present invention is achieved through the following technical solutions:
A kind of preparation method of antineoplastic Jinsanxiong Chinese medicine preparation contains Herba Scutellariae Barbatae, Herba Hedyotidis Diffusae, Fructus Forsythiae, Radix Scutellariae, Radix Isatidis, Fructus Gardeniae, Flos Lonicerae, Oleum Curcumae, Radix Notoginseng, Scorpio, Realgar in the described antineoplastic Jinsanxiong Chinese medicine preparation; The weight ratio of each raw material is in the described antineoplastic Jinsanxiong Chinese medicine preparation:
Herba Scutellariae Barbatae 150～1600
Herba Hedyotidis Diffusae 150～1600
Fructus Forsythiae 150～1600
Radix Scutellariae 60～400
Radix Isatidis 60～400
Fructus Gardeniae 60～400
Flos Lonicerae 60～400
Oleum Curcumae 5～20
Radix Notoginseng 10～120
Scorpio 5～60
Realgar 20～220;
The dosage form of described antineoplastic Jinsanxiong Chinese medicine preparation is a pill, and preparation process is as follows:
I. raw material is handled:
A. Realgar, Radix Notoginseng, Scorpio are handled:
A. described Realgar is carried out water and fly to handle, obtain Realgar superfine powder;
B. described Radix Notoginseng is carried out pulverization process, obtain the Radix Notoginseng fine powder
C. described Scorpio is cleaned processing, dried, pulverization process successively, obtain the Scorpio fine powder;
B. Oleum Curcumae is handled:
A. will add alcoholic solution in the described Oleum Curcumae, obtain the ethanol volatile oil of Rhizoma Curcumae;
In the ethanol volatile oil of described Rhizoma Curcumae, the volume ratio of described Oleum Curcumae and alcoholic solution is 1: 1～3;
B. the ethanol volatile oil with described Rhizoma Curcumae mixes with beta-schardinger dextrin-solution, carries out stir process, obtains the Oleum Curcumae inclusion complex;
In the described stir process, temperature is 35～40 ℃, carries out continuously 3～8 hours;
C. described Oleum Curcumae inclusion complex is left standstill processing, filtration treatment, dried, pulverization process, the processing of sieving, obtain Oleum Curcumae inclusion complex fine powder;
Described leaving standstill in the processing, temperature are 15～20 ℃, and the time is 12～28 hours;
In the described dried, temperature is 38～40 ℃;
C. Herba Scutellariae Barbatae, Herba Hedyotidis Diffusae, Fructus Forsythiae, Radix Scutellariae, Radix Isatidis, Fructus Gardeniae, Flos Lonicerae are handled:
A. described Herba Scutellariae Barbatae, Herba Hedyotidis Diffusae, Fructus Forsythiae, Radix Scutellariae, Radix Isatidis, Fructus Gardeniae, Flos Lonicerae are carried out pulverization process respectively, obtain the coarse powder of Herba Scutellariae Barbatae, the coarse powder of Herba Hedyotidis Diffusae, the coarse powder of Fructus Forsythiae, the coarse powder of Radix Scutellariae, the coarse powder of Radix Isatidis, the coarse powder of Fructus Gardeniae, the coarse powder of Flos Lonicerae respectively; Again above-mentioned 7 kinds of coarse powder are mixed and obtain coarse powder mixture;
B. described coarse powder mixture is carried out decocting the first time and handles, obtain decocting liquid for the first time and decoct for the first time after medicinal residues;
Described for the first time decoct and to handle, the weight ratio of described coarse powder mixture and water is 1: 6～12, and the time is 1～3 hour;
C. the medicinal residues after described first time being decocted carry out decocting second time to be handled, and obtains the medicinal residues behind the decocting liquid and decoction for the second time for the second time;
Described for the second time decoct and to handle, the weight ratio of described coarse powder mixture and water is 1: 6～10, and the time is 1～2 hour;
D. merge described first time of decocting liquid and decocting liquid for the second time, carry out filtration treatment again, obtain mixture filtrate;
E. described mixture filtrate is carried out concentration, obtain the mixture clear paste;
F. with adding alcoholic solution in the described mixture clear paste, obtain containing pure clear paste;
G. contain pure clear paste and leave standstill processing hermetically described, the qinghuo reagent supernatant stays the clear paste residue again; Described leaving standstill in the processing, temperature are room temperature, and the time is 12～48 hours;
H. described clear paste residue is carried out filtration treatment, obtain residue filtrate;
I. described residue filtrate and described clear paste supernatant are merged, carry out concentration, obtain thick paste;
J. described thick paste is carried out drying under reduced pressure processing, pulverization process, obtain the extract fine powder;
During described drying under reduced pressure was handled, temperature was 60～80 ℃;
D. mix
With described Realgar superfine powder, Radix Notoginseng fine powder, Scorpio fine powder, Oleum Curcumae inclusion complex fine powder, extract fine powder mixing, obtain raw mix;
II. finished product preparation
A. with described raw mix and Mel mixing, obtain the pill mixture; The weight ratio of described raw mix and described Mel is 10: 2～7;
B. described pill mixture is carried out mixing and handle, carry out again dried, cold preservation processing, dried, pill processing, promptly get antineoplastic Jinsanxiong medicine pill finished product;
During described mixing was handled, temperature was 20～22 ℃;
During described cold preservation was handled, temperature was 13～20 ℃;
In the described dried, temperature is 35～37 ℃.
Another object of the present invention is achieved through the following technical solutions:
A kind of preparation method of antineoplastic Jinsanxiong Chinese medicine preparation contains Herba Scutellariae Barbatae, Herba Hedyotidis Diffusae, Fructus Forsythiae, Radix Scutellariae, Radix Isatidis, Fructus Gardeniae, Flos Lonicerae, Oleum Curcumae, Radix Notoginseng, Scorpio, Realgar in the described antineoplastic Jinsanxiong Chinese medicine preparation; The weight ratio of each raw material is in the described antineoplastic Jinsanxiong Chinese medicine preparation:
Herba Scutellariae Barbatae 150～1600
Herba Hedyotidis Diffusae 150～1600
Fructus Forsythiae 150～1600
Radix Scutellariae 60～400
Radix Isatidis 60～400
Fructus Gardeniae 60～400
Flos Lonicerae 60～400
Oleum Curcumae 5～20
Radix Notoginseng 10～120
Scorpio 5～60
Realgar 20～220;
The dosage form of described antineoplastic Jinsanxiong Chinese medicine preparation is an electuary, and preparation process is as follows:
I. raw material is handled:
A. Realgar, Radix Notoginseng, Scorpio are handled:
A. described Realgar is carried out water and fly to handle, obtain Realgar superfine powder;
B. described Radix Notoginseng is carried out pulverization process, obtain the Radix Notoginseng fine powder;
C. described Scorpio is cleaned processing, dried, pulverization process successively, obtain the Scorpio fine powder;
B. Oleum Curcumae is handled:
A. will add alcoholic solution in the described Oleum Curcumae, obtain the ethanol volatile oil of Rhizoma Curcumae;
In the ethanol volatile oil of described Rhizoma Curcumae, the volume ratio of described Oleum Curcumae and alcoholic solution is 1: 1～3;
B. the ethanol volatile oil with described Rhizoma Curcumae mixes with beta-schardinger dextrin-solution, carries out stir process, obtains the Oleum Curcumae inclusion complex;
In the described stir process, temperature is 35～40 ℃, carries out continuously 3～8 hours;
C. described Oleum Curcumae inclusion complex is left standstill processing, filtration treatment, dried, pulverization process, the processing of sieving, obtain Oleum Curcumae inclusion complex fine powder;
Described leaving standstill in the processing, temperature are 15～20 ℃, and the time is 12～28 hours;
In the described dried, temperature is 38～40 ℃;
C. Herba Scutellariae Barbatae, Herba Hedyotidis Diffusae, Fructus Forsythiae, Radix Scutellariae, Radix Isatidis, Fructus Gardeniae, Flos Lonicerae are handled:
A. described Herba Scutellariae Barbatae, Herba Hedyotidis Diffusae, Fructus Forsythiae, Radix Scutellariae, Radix Isatidis, Fructus Gardeniae, Flos Lonicerae are carried out pulverization process respectively, obtain the coarse powder of Herba Scutellariae Barbatae, the coarse powder of Herba Hedyotidis Diffusae, the coarse powder of Fructus Forsythiae, the coarse powder of Radix Scutellariae, the coarse powder of Radix Isatidis, the coarse powder of Fructus Gardeniae, the coarse powder of Flos Lonicerae respectively; Again above-mentioned 7 kinds of coarse powder are mixed and obtain coarse powder mixture;
B. described coarse powder mixture is carried out decocting the first time and handles, obtain decocting liquid for the first time and decoct for the first time after medicinal residues;
Described for the first time decoct and to handle, the weight ratio of described coarse powder mixture and water is 1: 6～12, and the time is 1～3 hour;
C. the medicinal residues after described first time being decocted carry out decocting second time to be handled, and obtains the medicinal residues behind the decocting liquid and decoction for the second time for the second time;
Described for the second time decoct and to handle, the weight ratio of described coarse powder mixture and water is 1: 6～10, and the time is 1～2 hour;
D. merge described first time of decocting liquid and decocting liquid for the second time, carry out filtration treatment again, obtain mixture filtrate;
E. described mixture filtrate is carried out concentration, obtain the mixture clear paste;
F. with adding alcoholic solution in the described mixture clear paste, obtain containing pure clear paste;
G. contain pure clear paste and leave standstill processing hermetically described, the qinghuo reagent supernatant stays the clear paste residue again; Described leaving standstill in the processing, temperature are room temperature, and the time is 12～48 hours;
H. described clear paste residue is carried out filtration treatment, obtain residue filtrate;
I. described residue filtrate and described clear paste supernatant are merged, carry out concentration, obtain thick paste;
J. described thick paste is carried out drying under reduced pressure processing, pulverization process, obtain the extract fine powder;
During described drying under reduced pressure was handled, temperature was 60～80 ℃;
D. mix
With described Realgar superfine powder, Radix Notoginseng fine powder, Scorpio fine powder, Oleum Curcumae inclusion complex fine powder, extract fine powder mixing, obtain raw mix;
II. finished product preparation:
With described raw mix and glucose, sucrose mixing, obtain the electuary mixture, be antineoplastic Jinsanxiong Chinese medicine electuary finished product;
The weight ratio of described raw mix and described glucose, sucrose is 10: 1～4: 1～6.
Beneficial effect of the present invention is:
1. the invention belongs to heat-clearing and toxic substances removing, blood circulation promoting and blood stasis dispelling, hard masses softening and resolving class Chinese medicine, can suppress tumor development, impel entity tumor to dwindle, promote apoptosis of tumor cells;
2. each raw material of the present invention all has the antineoplastic function, various raw material synergy, determined curative effect, remarkable, unique.
The specific embodiment
Embodiment 1:
A kind of antineoplastic Jinsanxiong Chinese medicine preparation contains Herba Scutellariae Barbatae, Herba Hedyotidis Diffusae, Fructus Forsythiae, Radix Scutellariae, Radix Isatidis, Fructus Gardeniae, Flos Lonicerae, Oleum Curcumae, Radix Notoginseng, Scorpio, Realgar in the described antineoplastic Jinsanxiong Chinese medicine preparation; The weight ratio of each raw material is in the described antineoplastic Jinsanxiong Chinese medicine preparation:
Herba Scutellariae Barbatae 150～1600
Herba Hedyotidis Diffusae 150～1600
Fructus Forsythiae 150～1600
Radix Scutellariae 60～400
Radix Isatidis 60～400
Fructus Gardeniae 60～400
Flos Lonicerae 60～400
Oleum Curcumae 5～20
Radix Notoginseng 10～120
Scorpio 5～60
Realgar 20～220.
Described antineoplastic Jinsanxiong Chinese medicine preparation is light brown or brown powder, bitter in the mouth.
The dosage form of described antineoplastic Jinsanxiong Chinese medicine preparation is a capsule, hermetically storing; Usage is: oral meal.
The dosage form of described antineoplastic Jinsanxiong Chinese medicine preparation also can be tablet, pill, electuary, hermetically storing; Usage is: oral meal.
Described antineoplastic Jinsanxiong Chinese medicine preparation function cures mainly:
Heat-clearing and toxic substances removing, blood circulation promoting and blood stasis dispelling, hard masses softening and resolving.Be used for qi stagnation blood stasis, evil poison and accumulate hepatocarcinoma due to the long-pending card, gastric cancer, lymphatic cancer, breast carcinoma, acute and chronic granulocyte type leukemia etc.
The theoretical basis of the above-mentioned raw materials that present embodiment is selected for use is:
A.. the Realgar of present embodiment (is led and contains As
2S
2) can be heated is oxidized to extremely toxic substance As
2O
3, its antitumor action mechanism is: inducing apoptosis of tumour cell, suppress growth of tumor; Suppressing tumor cell proliferation and blood capillary generates; Suppress telomerase activation, the apoptosis of inducing cell; The dna replication dna of sudden change or damage is reduced, suppress the generation of tumor.
This extremely toxic substance As
2O
3Be applied to clinical treatment at home and abroad: domestic, arsenous acid injection (the accurate word H20030347 of traditional Chinese medicines) in 1999 is produced by National Drug Administration's approval, is used for the treatment of leukemia; Considerable university (containing Hong Kong), hospital and scientific research institution have carried out As
2O
3Clinical application research has all been obtained better effects.Abroad, 1910, the specific drug Arsaminol that Paul Ehrlich has developed treatment syphilis and african trypanosomiasis (contained As
2O
3) and obtain Nobel Prize; 1992 to 1997, doctor's clinical verification of countries such as the U.S., Britain, Italy, Iran, India " arsenization " be treatment acute promyelocytic leukemia unique the best way; 2002 to 2008, U.S. Clinical Oncology association, American Society for Hematology reported, have obtained success with " arsenization " treatment bone marrow cancer, hepatocarcinoma etc.Select the main As that contains in the raw material of present embodiment for use
2S
2Realgar, embodied the treatment thinking of " treating the poisonous disease with poisonous drugs ", have novelty.
B. present embodiment Oleum Curcumae, Herba Scutellariae Barbatae, Herba Hedyotidis Diffusae, Scorpio etc. record all that " Chinese pharmacopoeia 2010 editions has antiviral, antitumor action.
C. the present embodiment function is heat-clearing and toxic substances removing, blood circulation promoting and blood stasis dispelling, hard masses softening and resolving with the characteristics that cure mainly.
Heat-clearing and detoxifying herb can suppress tumor development; Activating blood herbs can change the cytomorphosis ability, improve tumor patient whole blood stickiness, increase vascular permeability, microcirculation improvement, impel that entity tumor dwindles, apoptosis of tumor cells, meet " the tumor Chinese traditional medical diagnose guide " basic principle in (on January 7th, 2009), embodied in the classic of TCM " disease when clothes, Radix Aconiti Lateralis Preparata, Radix Et Rhizoma Rhei, arsenicum all are most valuable treasures; The improper clothes of disease, ginseng, stilbene, Cornu Cervi Pantotrichum, Fructus Lycii all are arsenicum " reasonable recipe, determination of treatment based on pathogenesis obtained through differentiation of symptoms and signs." Japan hanako materia medica ": " Realgar, logical red bright person be last, test can worm the dead for true, foul smell is few, chews carefully that to contain the sharp peppery person of soup in the mouth general.”
Select one or more the practical application statistical result of the decoction of making in above-mentioned 11 kinds of raw materials to be:
Case load is totally 465 people.According to the Western medicine diagnose standard, include case in: treatment mid and late liver cancer patient is totally 117 people, and survival rate reaches 38.5% more than 5 years, the tumor person of dwindling 72%, and the inhibition of pain effective percentage reaches 87.3%; Treatment middle and advanced stage patients with gastric cancer (cooperating operation, chemotherapy) is totally 98 people, and survival rate reaches 49.1%, 8 annual survival rate, 2 examples more than 5 years; Treatment II phase, III phase lymphatic cancer (cooperating operation, chemotherapy) 8 annual survival rates reach 55.2%; Treatment patient with breast cancer (cooperating operation, chemotherapy) is totally 112 people, and 8 annual survival rates reach 72.2%; Treat acute and chronic granulocyte type leukaemic (combined with chemotherapy) totally 48 people, remission rate is more than 93%, do not recur 9 examples in 8 years.Patient's constitution status all is significantly improved or improves.This statistical result shows, selects one or more the decoction of making in above-mentioned 11 kinds of raw materials to be applied to malignant tumor patient, determined curative effect, safety.
But this decoction needs to consider patient's individual variation in actual applications, different prescriptions need be used for different patients; So the adaptive surface of above decoction is narrower, can not makes Chinese patent medicine at large and be used for numerous patients.And in the present embodiment, the various prescriptions of comprehensive above decoction are handled above-mentioned 11 kinds of raw materials through scientific procedure, are prepared into determined curative effect, stable, safety, adapt to the antineoplastic Jinsanxiong Chinese medicine preparation of face width, have novelty.
A kind of preparation method of antineoplastic Jinsanxiong Chinese medicine preparation, the dosage form of described antineoplastic Jinsanxiong Chinese medicine preparation is a capsule, preparation process is as follows:
I. raw material is handled:
A. Realgar, Radix Notoginseng, Scorpio are handled:
A. described Realgar is carried out water and fly to handle, obtain Realgar superfine powder;
B. described Radix Notoginseng is carried out pulverization process, obtain the Radix Notoginseng fine powder;
C. described Scorpio is cleaned processing, dried, pulverization process successively, obtain the Scorpio fine powder; In the described clean processing, adopt 75% alcoholic solution;
B. Oleum Curcumae is handled:
A. will add alcoholic solution in the described Oleum Curcumae, obtain the ethanol volatile oil of Rhizoma Curcumae;
The concentration of described alcoholic solution is 95%; In the ethanol volatile oil of described Rhizoma Curcumae, the volume ratio of described Oleum Curcumae and alcoholic solution is 1: 1～3, is preferably 1: 2;
B. the ethanol volatile oil with described Rhizoma Curcumae mixes with beta-schardinger dextrin-solution, carries out stir process, obtains the Oleum Curcumae inclusion complex;
In the described stir process, temperature is 35～40 ℃, is preferably 37 ℃; Carried out continuously 3～8 hours, and be preferably 5 hours;
The compound method of described beta-schardinger dextrin-solution is: add entry to beta-schardinger dextrin-, heating makes its dissolving, stirs and be cooled to 35 ℃, obtains described beta-schardinger dextrin-solution; The weight ratio of described beta-schardinger dextrin-and water is 1: 100; Described Oleum Curcumae and described beta-schardinger dextrin-and w/v (w/v) be 1: 8;
C. described Oleum Curcumae inclusion complex is left standstill processing, filtration treatment, dried, pulverization process, the processing of sieving, obtain Oleum Curcumae inclusion complex fine powder;
Described leaving standstill in the processing, temperature is 15～20 ℃, is preferably 17 ℃; Time is 12～28 hours, is preferably 24 hours;
In the described filtration treatment, adopt common filter paper, the aperture of this filter paper is 5～7 microns;
In the described dried, temperature is 38～40 ℃, is preferably 39 ℃; Exsiccant degree is for till reaching standard until the moisture detector detection;
In the described processing of sieving, adopt 60 mesh sieves;
C. Herba Scutellariae Barbatae, Herba Hedyotidis Diffusae, Fructus Forsythiae, Radix Scutellariae, Radix Isatidis, Fructus Gardeniae, Flos Lonicerae are handled:
A. described Herba Scutellariae Barbatae, Herba Hedyotidis Diffusae, Fructus Forsythiae, Radix Scutellariae, Radix Isatidis, Fructus Gardeniae, Flos Lonicerae are carried out pulverization process respectively, obtain the coarse powder of Herba Scutellariae Barbatae, the coarse powder of Herba Hedyotidis Diffusae, the coarse powder of Fructus Forsythiae, the coarse powder of Radix Scutellariae, the coarse powder of Radix Isatidis, the coarse powder of Fructus Gardeniae, the coarse powder of Flos Lonicerae respectively; Again above-mentioned 7 kinds of coarse powder are mixed and obtain coarse powder mixture;
B. described coarse powder mixture is carried out decocting the first time and handles, obtain decocting liquid for the first time and decoct for the first time after medicinal residues;
Described for the first time decoct and to handle, the weight ratio of described coarse powder mixture and water is 1: 6～12; Be preferably 1: 10; Time is 1～3 hour, is preferably 2 hours;
C. the medicinal residues after described first time being decocted carry out decocting second time to be handled, and obtains the medicinal residues behind the decocting liquid and decoction for the second time for the second time;
Described for the second time decoct and to handle, the weight ratio of described coarse powder mixture and water is 1: 6～10, is preferably 1: 8, and the time is 1～2 hour, is preferably 1.5 hours;
D. merge described first time of decocting liquid and decocting liquid for the second time, carry out filtration treatment again, obtain mixture filtrate; In the described filtration treatment, adopt 300 order mesh screens;
E. described mixture filtrate is carried out concentration, obtain the mixture clear paste; The relative density of described mixture clear paste is 1.15 (80 ℃);
F. with adding alcoholic solution in the described mixture clear paste, obtain containing pure clear paste; Described containing in the pure clear paste, containing the alcohol amount is 65%～70%; The weight percent concentration of described alcoholic solution is 98% o'clock, and the weight ratio of described clear paste and described alcoholic solution is 4～5: 10;
G. contain pure clear paste and leave standstill processing hermetically described, the qinghuo reagent supernatant stays the clear paste residue again; Described leaving standstill in the processing, temperature are room temperature, and the time is 12～48 hours, are preferably 36 hours;
H. described clear paste residue is carried out filtration treatment, obtain residue filtrate; In the described filtration treatment, adopt 300 order mesh screens;
I. described residue filtrate and described clear paste supernatant are merged, carry out concentration, obtain thick paste; The density of described thick paste is 1.35～1.38 (60 ℃);
J. with adding starch and mixing in the described thick paste, obtain extract; Again described extract is carried out drying under reduced pressure processing, pulverization process, obtain the extract fine powder;
The percentage by weight that described starch accounts for described extract is 0.02%～0.15%, is preferably 0.1%;
During described drying under reduced pressure was handled, temperature was 60～80 ℃, is preferably 75 ℃;
D. mix
With described Realgar superfine powder, Radix Notoginseng fine powder, Scorpio fine powder, Oleum Curcumae inclusion complex fine powder, extract fine powder mixing, obtain raw mix;
II. finished product preparation
With described raw mix and magnesium stearate mixing, obtain capsule 's content; The percentage by weight that described magnesium stearate accounts for described capsule 's content is 0.15%～1%, is preferably 0.5%;
Again described capsule 's content is incapsulated in the housing, promptly get antineoplastic Jinsanxiong Chinese medicinal capsule agent finished product;
Described capsule housing is the hard capsule housing, and described antineoplastic Jinsanxiong Chinese medicinal capsule agent finished product is a hard capsule; Described capsule housing also can be the soft capsule shell body, and described antineoplastic Jinsanxiong Chinese medicinal capsule agent finished product is for being soft capsule.
In the present embodiment, the consumption of each raw material in the described antineoplastic Jinsanxiong Chinese medicine preparation can be in the ratio range that provides flexible combination, do not enumerate one by one at this;
In the present embodiment, the unit of weight of each raw material in the described antineoplastic Jinsanxiong Chinese medicine preparation is a gram, also can be kilogram;
In the present embodiment, each raw material in the described antineoplastic Jinsanxiong Chinese medicine preparation is a conventional products, all can be in market and associated mechanisms buy and obtain;
In the present embodiment, used equipment was conventional equipment during described pulverization process, dried, drying under reduced pressure were handled, and all can buy to obtain on market.
In the present embodiment, the overall process of described preparation method is carried out in medicine GMP workshop.
Embodiment 2:
Present embodiment is the another kind of preferred version on embodiment 1 basis, is when the dosage form of described antineoplastic Jinsanxiong Chinese medicine preparation is tablet, the preparation method of employing.
The dosage form of described antineoplastic Jinsanxiong Chinese medicine preparation is a tablet, and preparation process is as follows:
I. raw material is handled:
A. Realgar, Radix Notoginseng, Scorpio are handled:
A. described Realgar is carried out water and fly to handle, obtain Realgar superfine powder;
B. described Radix Notoginseng is carried out pulverization process, obtain the Radix Notoginseng fine powder;
C. described Scorpio is cleaned processing, dried, pulverization process successively, obtain the Scorpio fine powder; In the described clean processing, adopt 75% alcoholic solution;
B. Oleum Curcumae is handled:
A. will add alcoholic solution in the described Oleum Curcumae, obtain the ethanol volatile oil of Rhizoma Curcumae;
The concentration of described alcoholic solution is 95%; In the ethanol volatile oil of described Rhizoma Curcumae, the volume ratio of described Oleum Curcumae and alcoholic solution is 1: 1～3, is preferably 1: 2;
B. the ethanol volatile oil with described Rhizoma Curcumae mixes with beta-schardinger dextrin-solution, carries out stir process, obtains the Oleum Curcumae inclusion complex;
In the described stir process, temperature is 35～40 ℃, is preferably 37 ℃; Carried out continuously 3～8 hours, and be preferably 5 hours;
The compound method of described beta-schardinger dextrin-solution is: add entry to beta-schardinger dextrin-, heating makes its dissolving, stirs and be cooled to 35 ℃, obtains described beta-schardinger dextrin-solution; The weight ratio of described beta-schardinger dextrin-and water is 1: 100; Described Oleum Curcumae and described beta-schardinger dextrin-and w/v (w/v) be 1: 8;
C. described Oleum Curcumae inclusion complex is left standstill processing, filtration treatment, dried, pulverization process, the processing of sieving, obtain Oleum Curcumae inclusion complex fine powder;
Described leaving standstill in the processing, temperature is 15～20 ℃, is preferably 17 ℃; Time is 12～28 hours, is preferably 24 hours;
In the described filtration treatment, adopt common filter paper, the aperture of this filter paper is 5～7 microns;
In the described dried, temperature is 38～40 ℃, is preferably 39 ℃; Exsiccant degree is for till reaching standard until the moisture detector detection;
In the described processing of sieving, adopt 60 mesh sieves;
C. Herba Scutellariae Barbatae, Herba Hedyotidis Diffusae, Fructus Forsythiae, Radix Scutellariae, Radix Isatidis, Fructus Gardeniae, Flos Lonicerae are handled:
A. described Herba Scutellariae Barbatae, Herba Hedyotidis Diffusae, Fructus Forsythiae, Radix Scutellariae, Radix Isatidis, Fructus Gardeniae, Flos Lonicerae are carried out pulverization process respectively, obtain the coarse powder of Herba Scutellariae Barbatae, the coarse powder of Herba Hedyotidis Diffusae, the coarse powder of Fructus Forsythiae, the coarse powder of Radix Scutellariae, the coarse powder of Radix Isatidis, the coarse powder of Fructus Gardeniae, the coarse powder of Flos Lonicerae respectively; Again above-mentioned 7 kinds of coarse powder are mixed and obtain coarse powder mixture;
B. described coarse powder mixture is carried out decocting the first time and handles, obtain decocting liquid for the first time and decoct for the first time after medicinal residues;
Described for the first time decoct and to handle, the weight ratio of described coarse powder mixture and water is 1: 6～12; Be preferably 1: 10; Time is 1～3 hour, is preferably 2 hours;
C. the medicinal residues after described first time being decocted carry out decocting second time to be handled, and obtains the medicinal residues behind the decocting liquid and decoction for the second time for the second time;
Described for the second time decoct and to handle, the weight ratio of described coarse powder mixture and water is 1: 6～10, is preferably 1: 8, and the time is 1～2 hour, is preferably 1.5 hours;
D. merge described first time of decocting liquid and decocting liquid for the second time, carry out filtration treatment again, obtain mixture filtrate; In the described filtration treatment, adopt 300 order mesh screens;
E. described mixture filtrate is carried out concentration, obtain the mixture clear paste; The relative density of described mixture clear paste is 1.15 (80 ℃);
F. with adding alcoholic solution in the described mixture clear paste, obtain containing pure clear paste; Described containing in the pure clear paste, containing the alcohol amount is 65%～70%; The weight percent concentration of described alcoholic solution is 98% o'clock, and the weight ratio of described clear paste and described alcoholic solution is 4～5: 10;
G. contain pure clear paste and leave standstill processing hermetically described, the qinghuo reagent supernatant stays the clear paste residue again; Described leaving standstill in the processing, temperature are room temperature, and the time is 12～48 hours, are preferably 36 hours;
H. described clear paste residue is carried out filtration treatment, obtain residue filtrate; In the described filtration treatment, adopt 300 order mesh screens;
I. described residue filtrate and described clear paste supernatant are merged, carry out concentration, obtain thick paste; The density of described thick paste is 1.35～1.38 (60 ℃);
J. described thick paste is carried out drying under reduced pressure processing, pulverization process, obtain the extract fine powder;
During described drying under reduced pressure was handled, temperature was 60～80 ℃, is preferably 75 ℃;
D. mix
With described Realgar superfine powder, Radix Notoginseng fine powder, Scorpio fine powder, Oleum Curcumae inclusion complex fine powder, extract fine powder mixing, obtain raw mix;
II. finished product preparation
A. with described raw mix and microcrystalline Cellulose, carboxymethyl starch sodium mixing, obtain total mixture; Described total mixture is carried out pelletization treatment, dried, obtain tablet mixture;
The percentage by weight that described microcrystalline Cellulose accounts for described total mixture is 0.02～0.05%, is preferably 0.35%;
The percentage by weight that described carboxymethyl starch sodium accounts for described total mixture is 0.1～1%, is preferably 0.6%;
In the described dried, temperature is 38～40 ℃, is preferably 39 ℃;
B. with described tablet mixture and magnesium stearate mixing, obtain pressing mixt;
The percentage by weight that described magnesium stearate accounts for described pressing mixt is 0.15%～1%, is preferably 0.5%;
Described pressing mixt is carried out compression process, obtain antineoplastic Jinsanxiong Chinese medicinal tablet finished product;
Described antineoplastic Jinsanxiong Chinese medicinal tablet finished product can be plain sheet; Can coated again processing back be coated tablet also, the coating of described coated tablet be sugar-coat or film-coat.
In the present embodiment, used equipment was conventional equipment during described pulverization process, dried, drying under reduced pressure were handled, and all can buy to obtain on market.
In the present embodiment, the overall process of described preparation method is carried out in medicine GMP workshop.
Embodiment 3:
Present embodiment is that present embodiment is the another kind of preferred version on embodiment 1 basis, is when the dosage form of described antineoplastic Jinsanxiong Chinese medicine preparation is pill, the preparation method of employing.
A kind of preparation method of antineoplastic Jinsanxiong Chinese medicine preparation, the dosage form of described antineoplastic Jinsanxiong Chinese medicine preparation is a pill, preparation process is as follows:
I. raw material is handled:
A. Realgar, Radix Notoginseng, Scorpio are handled:
A. described Realgar is carried out water and fly to handle, obtain Realgar superfine powder;
B. described Radix Notoginseng is carried out pulverization process, obtain the Radix Notoginseng fine powder;
C. described Scorpio is cleaned processing, dried, pulverization process successively, obtain the Scorpio fine powder; In the described clean processing, adopt 75% alcoholic solution;
B. Oleum Curcumae is handled:
A. will add alcoholic solution in the described Oleum Curcumae, obtain the ethanol volatile oil of Rhizoma Curcumae;
The concentration of described alcoholic solution is 95%; In the ethanol volatile oil of described Rhizoma Curcumae, the volume ratio of described Oleum Curcumae and alcoholic solution is 1: 1～3, is preferably 1: 2;
B. the ethanol volatile oil with described Rhizoma Curcumae mixes with beta-schardinger dextrin-solution, carries out stir process, obtains the Oleum Curcumae inclusion complex;
In the described stir process, temperature is 35～40 ℃, is preferably 37 ℃; Carried out continuously 3～8 hours, and be preferably 5 hours;
The compound method of described beta-schardinger dextrin-solution is: add entry to beta-schardinger dextrin-, heating makes its dissolving, stirs and be cooled to 35 ℃, obtains described beta-schardinger dextrin-solution; The weight ratio of described beta-schardinger dextrin-and water is 1: 100; Described Oleum Curcumae and described beta-schardinger dextrin-and w/v (w/v) be 1: 8;
C. described Oleum Curcumae inclusion complex is left standstill processing, filtration treatment, dried, pulverization process, the processing of sieving, obtain Oleum Curcumae inclusion complex fine powder;
Described leaving standstill in the processing, temperature is 15～20 ℃, is preferably 17 ℃; Time is 12～28 hours, is preferably 24 hours;
In the described filtration treatment, adopt common filter paper, the aperture of this filter paper is 5～7 microns;
In the described dried, temperature is 38～40 ℃, is preferably 39 ℃; Exsiccant degree is for till reaching standard until the moisture detector detection;
In the described processing of sieving, adopt 60 mesh sieves;
C. Herba Scutellariae Barbatae, Herba Hedyotidis Diffusae, Fructus Forsythiae, Radix Scutellariae, Radix Isatidis, Fructus Gardeniae, Flos Lonicerae are handled:
A. described Herba Scutellariae Barbatae, Herba Hedyotidis Diffusae, Fructus Forsythiae, Radix Scutellariae, Radix Isatidis, Fructus Gardeniae, Flos Lonicerae are carried out pulverization process respectively, obtain the coarse powder of Herba Scutellariae Barbatae, the coarse powder of Herba Hedyotidis Diffusae, the coarse powder of Fructus Forsythiae, the coarse powder of Radix Scutellariae, the coarse powder of Radix Isatidis, the coarse powder of Fructus Gardeniae, the coarse powder of Flos Lonicerae respectively; Again above-mentioned 7 kinds of coarse powder are mixed and obtain coarse powder mixture;
B. described coarse powder mixture is carried out decocting the first time and handles, obtain decocting liquid for the first time and decoct for the first time after medicinal residues;
Described for the first time decoct and to handle, the weight ratio of described coarse powder mixture and water is 1: 6～12; Be preferably 1: 10; Time is 1～3 hour, is preferably 2 hours;
C. the medicinal residues after described first time being decocted carry out decocting second time to be handled, and obtains the medicinal residues behind the decocting liquid and decoction for the second time for the second time;
Described for the second time decoct and to handle, the weight ratio of described coarse powder mixture and water is 1: 6～10, is preferably 1: 8, and the time is 1～2 hour, is preferably 1.5 hours;
D. merge described first time of decocting liquid and decocting liquid for the second time, carry out filtration treatment again, obtain mixture filtrate; In the described filtration treatment, adopt 300 order mesh screens;
E. described mixture filtrate is carried out concentration, obtain the mixture clear paste; The relative density of described mixture clear paste is 1.15 (80 ℃);
F. with adding alcoholic solution in the described mixture clear paste, obtain containing pure clear paste; Described containing in the pure clear paste, containing the alcohol amount is 65%～70%; The weight percent concentration of described alcoholic solution is 98% o'clock, and the weight ratio of described clear paste and described alcoholic solution is 4～5: 10;
G. contain pure clear paste and leave standstill processing hermetically described, the qinghuo reagent supernatant stays the clear paste residue again; Described leaving standstill in the processing, temperature are room temperature, and the time is 12～48 hours, are preferably 36 hours;
H. described clear paste residue is carried out filtration treatment, obtain residue filtrate; In the described filtration treatment, adopt 300 order mesh screens;
I. described residue filtrate and described clear paste supernatant are merged, carry out concentration, obtain thick paste; The density of described thick paste is 1.35～1.38 (60 ℃);
J. described thick paste is carried out drying under reduced pressure processing, pulverization process, obtain the extract fine powder;
During described drying under reduced pressure was handled, temperature was 60～80 ℃, is preferably 75 ℃;
D. mix
With described Realgar superfine powder, Radix Notoginseng fine powder, Scorpio fine powder, Oleum Curcumae inclusion complex fine powder, extract fine powder mixing, obtain raw mix;
II. finished product preparation
A. with described raw mix and Mel mixing, obtain the pill mixture; The weight ratio of described raw mix and described Mel is 10: 2～7, is preferably 10: 3;
B. described pill mixture is carried out mixing and handle, carry out again dried, cold preservation processing, dried, pill processing, promptly get antineoplastic Jinsanxiong medicine pill finished product; And will store behind this antineoplastic Jinsanxiong medicine pill finished product packing.
During described mixing was handled, temperature was 20～22 ℃, is preferably 21 ℃;
During described cold preservation was handled, temperature was 13～20 ℃, is preferably 15 ℃;
In the described dried, temperature is 35～37 ℃, is preferably 36 ℃;
Described pill is handled and is carried out according to relevant regulations.
In the present embodiment, used equipment was conventional equipment during described pulverization process, dried, drying under reduced pressure were handled, and all can buy to obtain on market.
In the present embodiment, the overall process of described preparation method is carried out in medicine GMP workshop.
Embodiment 4:
Present embodiment is the another kind of preferred version on embodiment 1 basis, is when the dosage form of described antineoplastic Jinsanxiong Chinese medicine preparation is electuary, the preparation method of employing.
I. raw material is handled:
A. Realgar, Radix Notoginseng, Scorpio are handled:
A. described Realgar is carried out water and fly to handle, obtain Realgar superfine powder;
B. described Radix Notoginseng is carried out pulverization process, obtain the Radix Notoginseng fine powder;
C. described Scorpio is cleaned processing, dried, pulverization process successively, obtain the Scorpio fine powder; In the described clean processing, adopt 75% alcoholic solution;
B. Oleum Curcumae is handled:
A. will add alcoholic solution in the described Oleum Curcumae, obtain the ethanol volatile oil of Rhizoma Curcumae;
The concentration of described alcoholic solution is 95%; In the ethanol volatile oil of described Rhizoma Curcumae, the volume ratio of described Oleum Curcumae and alcoholic solution is 1: 1～3, is preferably 1: 2;
B. the ethanol volatile oil with described Rhizoma Curcumae mixes with beta-schardinger dextrin-solution, carries out stir process, obtains the Oleum Curcumae inclusion complex;
In the described stir process, temperature is 35～40 ℃, is preferably 37 ℃; Carried out continuously 3～8 hours, and be preferably 5 hours;
The compound method of described beta-schardinger dextrin-solution is: add entry to beta-schardinger dextrin-, heating makes its dissolving, stirs and be cooled to 35 ℃, obtains described beta-schardinger dextrin-solution; The weight ratio of described beta-schardinger dextrin-and water is 1: 100; Described Oleum Curcumae and described beta-schardinger dextrin-and w/v (w/v) be 1: 8;
C. described Oleum Curcumae inclusion complex is left standstill processing, filtration treatment, dried, pulverization process, the processing of sieving, obtain Oleum Curcumae inclusion complex fine powder;
Described leaving standstill in the processing, temperature is 15～20 ℃, is preferably 17 ℃; Time is 12～28 hours, is preferably 24 hours;
In the described filtration treatment, adopt common filter paper, the aperture of this filter paper is 5～7 microns;
In the described dried, temperature is 38～40 ℃, is preferably 39 ℃; Exsiccant degree is for till reaching standard until the moisture detector detection;
In the described processing of sieving, adopt 60 mesh sieves;
C. Herba Scutellariae Barbatae, Herba Hedyotidis Diffusae, Fructus Forsythiae, Radix Scutellariae, Radix Isatidis, Fructus Gardeniae, Flos Lonicerae are handled:
A. described Herba Scutellariae Barbatae, Herba Hedyotidis Diffusae, Fructus Forsythiae, Radix Scutellariae, Radix Isatidis, Fructus Gardeniae, Flos Lonicerae are carried out pulverization process respectively, obtain the coarse powder of Herba Scutellariae Barbatae, the coarse powder of Herba Hedyotidis Diffusae, the coarse powder of Fructus Forsythiae, the coarse powder of Radix Scutellariae, the coarse powder of Radix Isatidis, the coarse powder of Fructus Gardeniae, the coarse powder of Flos Lonicerae respectively; Again above-mentioned 7 kinds of coarse powder are mixed and obtain coarse powder mixture;
B. described coarse powder mixture is carried out decocting the first time and handles, obtain decocting liquid for the first time and decoct for the first time after medicinal residues;
Described for the first time decoct and to handle, the weight ratio of described coarse powder mixture and water is 1: 6～12; Be preferably 1: 10; Time is 1～3 hour, is preferably 2 hours;
C. the medicinal residues after described first time being decocted carry out decocting second time to be handled, and obtains the medicinal residues behind the decocting liquid and decoction for the second time for the second time;
Described for the second time decoct and to handle, the weight ratio of described coarse powder mixture and water is 1: 6～10, is preferably 1: 8, and the time is 1～2 hour, is preferably 1.5 hours;
D. merge described first time of decocting liquid and decocting liquid for the second time, carry out filtration treatment again, obtain mixture filtrate; In the described filtration treatment, adopt 300 order mesh screens;
E. described mixture filtrate is carried out concentration, obtain the mixture clear paste; The relative density of described mixture clear paste is 1.15 (80 ℃);
F. with adding alcoholic solution in the described mixture clear paste, obtain containing pure clear paste; Described containing in the pure clear paste, containing the alcohol amount is 65%～70%; The weight percent concentration of described alcoholic solution is 98% o'clock, and the weight ratio of described clear paste and described alcoholic solution is 4～5: 10;
G. contain pure clear paste and leave standstill processing hermetically described, the qinghuo reagent supernatant stays the clear paste residue again; Described leaving standstill in the processing, temperature are room temperature, and the time is 12～48 hours, are preferably 36 hours;
H. described clear paste residue is carried out filtration treatment, obtain residue filtrate; In the described filtration treatment, adopt 300 order mesh screens;
I. described residue filtrate and described clear paste supernatant are merged, carry out concentration, obtain thick paste; The density of described thick paste is 1.35～1.38 (60 ℃);
J. described thick paste is carried out drying under reduced pressure processing, pulverization process, obtain the extract fine powder;
During described drying under reduced pressure was handled, temperature was 60～80 ℃, is preferably 75 ℃;
D. mix
With described Realgar superfine powder, Radix Notoginseng fine powder, Scorpio fine powder, Oleum Curcumae inclusion complex fine powder, extract fine powder mixing, obtain raw mix;
II. finished product preparation:
A. with described raw mix and glucose, sucrose mixing, obtain the electuary mixture, be antineoplastic Jinsanxiong Chinese medicine electuary finished product; And will store behind this antineoplastic Jinsanxiong Chinese medicine electuary finished product packing.
The weight ratio of described raw mix and described glucose, sucrose is 10: 1～4: 1～6, is preferably 10: 2: 3; Described sucrose is become fine powder by pulverization process.
In the present embodiment, used equipment was conventional equipment during described pulverization process, dried, drying under reduced pressure were handled, and all can buy to obtain on market.
In the present embodiment, the overall process of described preparation method is carried out in medicine GMP workshop.
Embodiment 5:
Present embodiment is the preferred version on embodiment 1 basis, and the quality of raw materials used (component) is identical with embodiment 1, and the weight ratio of each raw material is in the described antineoplastic Jinsanxiong Chinese medicine preparation:
Herba Scutellariae Barbatae 810
Herba Hedyotidis Diffusae 810
Fructus Forsythiae 810
Radix Scutellariae 220
Radix Isatidis 220
Fructus Gardeniae 220
Flos Lonicerae 220
Oleum Curcumae 13
Radix Notoginseng 63
Scorpio 28
Realgar 64.
In the present embodiment, the unit of weight of each raw material in the described antineoplastic Jinsanxiong Chinese medicine preparation is a gram, also can be kilogram.
When the dosage form of present embodiment was capsule, preparation method was referring to embodiment 1; When the dosage form of present embodiment was tablet, preparation method was referring to embodiment 2; When the dosage form of present embodiment was pill, preparation method was referring to embodiment 3; When the dosage form of present embodiment was electuary, preparation method was referring to embodiment 4.
Embodiment 6:
Present embodiment is the preferred version on embodiment 1 basis, and the quality of raw materials used (component) is identical with embodiment 1, and the weight ratio of each raw material is in the described antineoplastic Jinsanxiong Chinese medicine preparation:
Herba Scutellariae Barbatae 420
Herba Hedyotidis Diffusae 420
Fructus Forsythiae 420
Radix Scutellariae 105
Radix Isatidis 105
Fructus Gardeniae 105
Flos Lonicerae 105
Oleum Curcumae 6
Radix Notoginseng 31
Scorpio 18
Realgar 97.
In the present embodiment, the unit of weight of each raw material in the described antineoplastic Jinsanxiong Chinese medicine preparation is a gram, also can be kilogram.
When the dosage form of present embodiment was capsule, preparation method was referring to embodiment 1; When the dosage form of present embodiment was tablet, preparation method was referring to embodiment 2; When the dosage form of present embodiment was pill, preparation method was referring to embodiment 3; When the dosage form of present embodiment was electuary, preparation method was referring to embodiment 4.
Embodiment 7:
Present embodiment is the preferred version on embodiment 1 basis, and the quality of raw materials used (component) is identical with embodiment 1, and the weight ratio of each raw material is in the described antineoplastic Jinsanxiong Chinese medicine preparation:
Herba Scutellariae Barbatae 1570
Herba Hedyotidis Diffusae 1570
Fructus Forsythiae 1570
Radix Scutellariae 380
Radix Isatidis 380
Fructus Gardeniae 380
Flos Lonicerae 380
Oleum Curcumae 19
Radix Notoginseng 117
Scorpio 69
Realgar 210.
In the present embodiment, the unit of weight of each raw material in the described antineoplastic Jinsanxiong Chinese medicine preparation is a gram, also can be kilogram.
When the dosage form of present embodiment was capsule, preparation method was referring to embodiment 1; When the dosage form of present embodiment was tablet, preparation method was referring to embodiment 2; When the dosage form of present embodiment was pill, preparation method was referring to embodiment 3; When the dosage form of present embodiment was electuary, preparation method was referring to embodiment 4.
Embodiment 8:
Present embodiment is the preferred version on embodiment 1 basis, and the quality of raw materials used (component) is identical with embodiment 1, and the weight ratio of each raw material is in the described antineoplastic Jinsanxiong Chinese medicine preparation:
Herba Scutellariae Barbatae 153
Herba Hedyotidis Diffusae 160
Fructus Forsythiae 157
Radix Scutellariae 63
Radix Isatidis 65
Fructus Gardeniae 67
Flos Lonicerae 70
Oleum Curcumae 6
Radix Notoginseng 13
Scorpio 8
Realgar 22.
In the present embodiment, the unit of weight of each raw material in the described antineoplastic Jinsanxiong Chinese medicine preparation is a gram, also can be kilogram.
When the dosage form of present embodiment was capsule, preparation method was referring to embodiment 1; When the dosage form of present embodiment was tablet, preparation method was referring to embodiment 2; When the dosage form of present embodiment was pill, preparation method was referring to embodiment 3; When the dosage form of present embodiment was electuary, preparation method was referring to embodiment 4.
Claims (10)
1. an antineoplastic Jinsanxiong Chinese medicine preparation is characterized in that: contain Herba Scutellariae Barbatae, Herba Hedyotidis Diffusae, Fructus Forsythiae, Radix Scutellariae, Radix Isatidis, Fructus Gardeniae, Flos Lonicerae, Oleum Curcumae, Radix Notoginseng, Scorpio, Realgar in the described antineoplastic Jinsanxiong Chinese medicine preparation; The weight ratio of each raw material is in the described antineoplastic Jinsanxiong Chinese medicine preparation:
Herba Scutellariae Barbatae 150～1600
Herba Hedyotidis Diffusae 150～1600
Fructus Forsythiae 150～1600
Radix Scutellariae 60～400
Radix Isatidis 60～400
Fructus Gardeniae 60～400
Flos Lonicerae 60～400
Oleum Curcumae 5～20
Radix Notoginseng 10～120
Scorpio 5～60
Realgar 20～220.
2. antineoplastic Jinsanxiong Chinese medicine preparation according to claim 1 is characterized in that: the dosage form of described antineoplastic Jinsanxiong Chinese medicine preparation is capsule, tablet, pill, electuary.
3. antineoplastic Jinsanxiong Chinese medicine preparation according to claim 1 and 2 is characterized in that: the weight ratio of each raw material is in the described antineoplastic Jinsanxiong Chinese medicine preparation:
Herba Scutellariae Barbatae 810
Herba Hedyotidis Diffusae 810
Fructus Forsythiae 810
Radix Scutellariae 220
Radix Isatidis 220
Fructus Gardeniae 220
Flos Lonicerae 220
Oleum Curcumae 13
Radix Notoginseng 63
Scorpio 28
Realgar 64.
4. antineoplastic Jinsanxiong Chinese medicine preparation according to claim 1 and 2 is characterized in that: the weight ratio of each raw material is in the described antineoplastic Jinsanxiong Chinese medicine preparation:
Herba Scutellariae Barbatae 420
Herba Hedyotidis Diffusae 420
Fructus Forsythiae 420
Radix Scutellariae 105
Radix Isatidis 105
Fructus Gardeniae 105
Flos Lonicerae 105
Oleum Curcumae 6
Radix Notoginseng 31
Scorpio 18
Realgar 97.
5. antineoplastic Jinsanxiong Chinese medicine preparation according to claim 1 and 2 is characterized in that: the weight ratio of each raw material is in the described antineoplastic Jinsanxiong Chinese medicine preparation:
Herba Scutellariae Barbatae 1570
Herba Hedyotidis Diffusae 1570
Fructus Forsythiae 1570
Radix Scutellariae 380
Radix Isatidis 380
Fructus Gardeniae 380
Flos Lonicerae 380
Oleum Curcumae 19
Radix Notoginseng 117
Scorpio 69
Realgar 210.
6. antineoplastic Jinsanxiong Chinese medicine preparation according to claim 1 and 2 is characterized in that: the weight ratio of each raw material is in the described antineoplastic Jinsanxiong Chinese medicine preparation:
Herba Scutellariae Barbatae 153
Herba Hedyotidis Diffusae 160
Fructus Forsythiae 157
Radix Scutellariae 63
Radix Isatidis 65
Fructus Gardeniae 67
Flos Lonicerae 70
Oleum Curcumae 6
Radix Notoginseng 13
Scorpio 8
Realgar 22;
7. the preparation method of an antineoplastic Jinsanxiong Chinese medicine preparation is characterized in that: contain Herba Scutellariae Barbatae, Herba Hedyotidis Diffusae, Fructus Forsythiae, Radix Scutellariae, Radix Isatidis, Fructus Gardeniae, Flos Lonicerae, Oleum Curcumae, Radix Notoginseng, Scorpio, Realgar in the described antineoplastic Jinsanxiong Chinese medicine preparation; The weight ratio of each raw material is in the described antineoplastic Jinsanxiong Chinese medicine preparation:
Herba Scutellariae Barbatae 150～1600
Herba Hedyotidis Diffusae 150～1600
Fructus Forsythiae 150～1600
Radix Scutellariae 60～400
Radix Isatidis 60～400
Fructus Gardeniae 60～400
Flos Lonicerae 60～400
Oleum Curcumae 5～20
Radix Notoginseng 10～120
Scorpio 5～60
Realgar 20～220;
The dosage form of described antineoplastic Jinsanxiong Chinese medicine preparation is a capsule, and preparation process is as follows:
I. raw material is handled:
A. Realgar, Radix Notoginseng, Scorpio are handled:
A. described Realgar is carried out water and fly to handle, obtain Realgar superfine powder;
B. described Radix Notoginseng is carried out pulverization process, obtain the Radix Notoginseng fine powder;
C. described Scorpio is cleaned processing, dried, pulverization process successively, obtain the Scorpio fine powder;
B. Oleum Curcumae is handled:
A. will add alcoholic solution in the described Oleum Curcumae, obtain the ethanol volatile oil of Rhizoma Curcumae;
In the ethanol volatile oil of described Rhizoma Curcumae, the volume ratio of described Oleum Curcumae and alcoholic solution is 1: 1～3;
B. the ethanol volatile oil with described Rhizoma Curcumae mixes with beta-schardinger dextrin-solution, carries out stir process, obtains the Oleum Curcumae inclusion complex;
In the described stir process, temperature is 35～40 ℃ and carried out continuously 3～8 hours;
C. described Oleum Curcumae inclusion complex is left standstill processing, filtration treatment, dried, pulverization process, the processing of sieving, obtain Oleum Curcumae inclusion complex fine powder;
Described leaving standstill in the processing, temperature are 15～20 ℃; Time is 12～28 hours;
In the described dried, temperature is 38～40 ℃;
C. Herba Scutellariae Barbatae, Herba Hedyotidis Diffusae, Fructus Forsythiae, Radix Scutellariae, Radix Isatidis, Fructus Gardeniae, Flos Lonicerae are handled:
A. described Herba Scutellariae Barbatae, Herba Hedyotidis Diffusae, Fructus Forsythiae, Radix Scutellariae, Radix Isatidis, Fructus Gardeniae, Flos Lonicerae are carried out pulverization process respectively, obtain the coarse powder of Herba Scutellariae Barbatae, the coarse powder of Herba Hedyotidis Diffusae, the coarse powder of Fructus Forsythiae, the coarse powder of Radix Scutellariae, the coarse powder of Radix Isatidis, the coarse powder of Fructus Gardeniae, the coarse powder of Flos Lonicerae respectively; Again above-mentioned 7 kinds of coarse powder are mixed and obtain coarse powder mixture;
B. described coarse powder mixture is carried out decocting the first time and handles, obtain decocting liquid for the first time and decoct for the first time after medicinal residues;
Described for the first time decoct and to handle, the weight ratio of described coarse powder mixture and water is 1: 6～12; Time is 1～3 hour;
C. the medicinal residues after described first time being decocted carry out decocting second time to be handled, and obtains the medicinal residues behind the decocting liquid and decoction for the second time for the second time;
Described for the second time decoct and to handle, the weight ratio of described coarse powder mixture and water is 1: 6～10, and the time is 1～2 hour;
D. merge described first time of decocting liquid and decocting liquid for the second time, carry out filtration treatment again, obtain mixture filtrate;
E. described mixture filtrate is carried out concentration, obtain the mixture clear paste;
F. with adding alcoholic solution in the described mixture clear paste, obtain containing pure clear paste;
G. contain pure clear paste and leave standstill processing hermetically described, the qinghuo reagent supernatant stays the clear paste residue again; Described leaving standstill in the processing, temperature are room temperature, and the time is 12～48 hours;
H. described clear paste residue is carried out filtration treatment, obtain residue filtrate;
I. described residue filtrate and described clear paste supernatant are merged, carry out concentration, obtain thick paste;
J. with adding starch and mixing in the described thick paste, obtain extract; Again described extract is carried out drying under reduced pressure processing, pulverization process, obtain the extract fine powder;
The percentage by weight that described starch accounts for described extract is 0.02%～0.15%, is preferably 0.1%;
During described drying under reduced pressure was handled, temperature was 60～80 ℃;
D. mix
With described Realgar superfine powder, Radix Notoginseng fine powder, Scorpio fine powder, Oleum Curcumae inclusion complex fine powder, extract fine powder mixing, obtain raw mix;
II. finished product preparation
With described raw mix and magnesium stearate mixing, obtain capsule 's content; The percentage by weight that described magnesium stearate accounts for described capsule 's content is 0.15%～1%; Again described capsule 's content is incapsulated in the housing, promptly get antineoplastic Jinsanxiong Chinese medicinal capsule agent finished product.
8. the preparation method of an antineoplastic Jinsanxiong Chinese medicine preparation is characterized in that: contain Herba Scutellariae Barbatae, Herba Hedyotidis Diffusae, Fructus Forsythiae, Radix Scutellariae, Radix Isatidis, Fructus Gardeniae, Flos Lonicerae, Oleum Curcumae, Radix Notoginseng, Scorpio, Realgar in the described antineoplastic Jinsanxiong Chinese medicine preparation; The weight ratio of each raw material is in the described antineoplastic Jinsanxiong Chinese medicine preparation:
Herba Scutellariae Barbatae 150～1600
Herba Hedyotidis Diffusae 150～1600
Fructus Forsythiae 150～1600
Radix Scutellariae 60～400
Radix Isatidis 60～400
Fructus Gardeniae 60～400
Flos Lonicerae 60～400
Oleum Curcumae 5～20
Radix Notoginseng 10～120
Scorpio 5～60
Realgar 20～220;
The dosage form of described antineoplastic Jinsanxiong Chinese medicine preparation is a tablet, and preparation process is as follows:
I. raw material is handled:
A. Realgar, Radix Notoginseng, Scorpio are handled:
A. described Realgar is carried out water and fly to handle, obtain Realgar superfine powder;
B. described Radix Notoginseng is carried out pulverization process, obtain the Radix Notoginseng fine powder;
C. described Scorpio is cleaned processing, dried, pulverization process successively, obtain the Scorpio fine powder;
B. Oleum Curcumae is handled:
A. will add alcoholic solution in the described Oleum Curcumae, obtain the ethanol volatile oil of Rhizoma Curcumae;
In the ethanol volatile oil of described Rhizoma Curcumae, the volume ratio of described Oleum Curcumae and alcoholic solution is 1: 1～3;
B. the ethanol volatile oil with described Rhizoma Curcumae mixes with beta-schardinger dextrin-solution, carries out stir process, obtains the Oleum Curcumae inclusion complex;
In the described stir process, temperature is 35～40 ℃, carries out continuously 3～8 hours;
C. described Oleum Curcumae inclusion complex is left standstill processing, filtration treatment, dried, pulverization process, the processing of sieving, obtain Oleum Curcumae inclusion complex fine powder;
Described leaving standstill in the processing, temperature are 15～20 ℃, and the time is 12～28 hours;
In the described dried, temperature is 38～40 ℃;
C. Herba Scutellariae Barbatae, Herba Hedyotidis Diffusae, Fructus Forsythiae, Radix Scutellariae, Radix Isatidis, Fructus Gardeniae, Flos Lonicerae are handled:
A. described Herba Scutellariae Barbatae, Herba Hedyotidis Diffusae, Fructus Forsythiae, Radix Scutellariae, Radix Isatidis, Fructus Gardeniae, Flos Lonicerae are carried out pulverization process respectively, obtain the coarse powder of Herba Scutellariae Barbatae, the coarse powder of Herba Hedyotidis Diffusae, the coarse powder of Fructus Forsythiae, the coarse powder of Radix Scutellariae, the coarse powder of Radix Isatidis, the coarse powder of Fructus Gardeniae, the coarse powder of Flos Lonicerae respectively; Again above-mentioned 7 kinds of coarse powder are mixed and obtain coarse powder mixture;
B. described coarse powder mixture is carried out decocting the first time and handles, obtain decocting liquid for the first time and decoct for the first time after medicinal residues;
Described for the first time decoct and to handle, the weight ratio of described coarse powder mixture and water is 1: 6～12; Time is 1～3 hour;
C. the medicinal residues after described first time being decocted carry out decocting second time to be handled, and obtains the medicinal residues behind the decocting liquid and decoction for the second time for the second time;
Described for the second time decoct and to handle, the weight ratio of described coarse powder mixture and water is 1: 6～10, and the time is 1～2 hour;
D. merge described first time of decocting liquid and decocting liquid for the second time, carry out filtration treatment again, obtain mixture filtrate;
E. described mixture filtrate is carried out concentration, obtain the mixture clear paste;
F. with adding alcoholic solution in the described mixture clear paste, obtain containing pure clear paste
G. contain pure clear paste and leave standstill processing hermetically described, the qinghuo reagent supernatant stays the clear paste residue again; Described leaving standstill in the processing, temperature are room temperature, and the time is 12～48 hours;
H. described clear paste residue is carried out filtration treatment, obtain residue filtrate;
I. described residue filtrate and described clear paste supernatant are merged, carry out concentration, obtain thick paste;
J. described thick paste is carried out drying under reduced pressure processing, pulverization process, obtain the extract fine powder;
During described drying under reduced pressure is handled;
D. mix
With described Realgar superfine powder, Radix Notoginseng fine powder, Scorpio fine powder, Oleum Curcumae inclusion complex fine powder, extract fine powder mixing, obtain raw mix;
II. finished product preparation
A. with described raw mix and microcrystalline Cellulose, carboxymethyl starch sodium mixing, obtain total mixture; Described total mixture is carried out pelletization treatment, dried, obtain tablet mixture;
The percentage by weight that described microcrystalline Cellulose accounts for described total mixture is 0.02～0.05%;
The percentage by weight that described carboxymethyl starch sodium accounts for described total mixture is 0.1～1%;
In the described dried, temperature is 38～40 ℃;
B. with described tablet mixture and magnesium stearate mixing, obtain pressing mixt;
The percentage by weight that described magnesium stearate accounts for described pressing mixt is 0.15%～1%;
Described pressing mixt is carried out compression process, obtain antineoplastic Jinsanxiong Chinese medicinal tablet finished product.
9. the preparation method of an antineoplastic Jinsanxiong Chinese medicine preparation is characterized in that: contain Herba Scutellariae Barbatae, Herba Hedyotidis Diffusae, Fructus Forsythiae, Radix Scutellariae, Radix Isatidis, Fructus Gardeniae, Flos Lonicerae, Oleum Curcumae, Radix Notoginseng, Scorpio, Realgar in the described antineoplastic Jinsanxiong Chinese medicine preparation; The weight ratio of each raw material is in the described antineoplastic Jinsanxiong Chinese medicine preparation:
Herba Scutellariae Barbatae 150～1600
Herba Hedyotidis Diffusae 150～1600
Fructus Forsythiae 150～1600
Radix Scutellariae 60～400
Radix Isatidis 60～400
Fructus Gardeniae 60～400
Flos Lonicerae 60～400
Oleum Curcumae 5～20
Radix Notoginseng 10～120
Scorpio 5～60
Realgar 20～220;
The dosage form of described antineoplastic Jinsanxiong Chinese medicine preparation is a pill, and preparation process is as follows:
I. raw material is handled:
A. Realgar, Radix Notoginseng, Scorpio are handled:
A. described Realgar is carried out water and fly to handle, obtain Realgar superfine powder;
B. described Radix Notoginseng is carried out pulverization process, obtain the Radix Notoginseng fine powder
C. described Scorpio is cleaned processing, dried, pulverization process successively, obtain the Scorpio fine powder;
B. Oleum Curcumae is handled:
A. will add alcoholic solution in the described Oleum Curcumae, obtain the ethanol volatile oil of Rhizoma Curcumae;
In the ethanol volatile oil of described Rhizoma Curcumae, the volume ratio of described Oleum Curcumae and alcoholic solution is 1: 1～3;
B. the ethanol volatile oil with described Rhizoma Curcumae mixes with beta-schardinger dextrin-solution, carries out stir process, obtains the Oleum Curcumae inclusion complex;
In the described stir process, temperature is 35～40 ℃, carries out continuously 3～8 hours;
C. described Oleum Curcumae inclusion complex is left standstill processing, filtration treatment, dried, pulverization process, the processing of sieving, obtain Oleum Curcumae inclusion complex fine powder;
Described leaving standstill in the processing, temperature are 15～20 ℃, and the time is 12～28 hours;
In the described dried, temperature is 38～40 ℃;
C. Herba Scutellariae Barbatae, Herba Hedyotidis Diffusae, Fructus Forsythiae, Radix Scutellariae, Radix Isatidis, Fructus Gardeniae, Flos Lonicerae are handled:
A. described Herba Scutellariae Barbatae, Herba Hedyotidis Diffusae, Fructus Forsythiae, Radix Scutellariae, Radix Isatidis, Fructus Gardeniae, Flos Lonicerae are carried out pulverization process respectively, obtain the coarse powder of Herba Scutellariae Barbatae, the coarse powder of Herba Hedyotidis Diffusae, the coarse powder of Fructus Forsythiae, the coarse powder of Radix Scutellariae, the coarse powder of Radix Isatidis, the coarse powder of Fructus Gardeniae, the coarse powder of Flos Lonicerae respectively; Again above-mentioned 7 kinds of coarse powder are mixed and obtain coarse powder mixture;
B. described coarse powder mixture is carried out decocting the first time and handles, obtain decocting liquid for the first time and decoct for the first time after medicinal residues;
Described for the first time decoct and to handle, the weight ratio of described coarse powder mixture and water is 1: 6～12, and the time is 1～3 hour;
C. the medicinal residues after described first time being decocted carry out decocting second time to be handled, and obtains the medicinal residues behind the decocting liquid and decoction for the second time for the second time;
Described for the second time decoct and to handle, the weight ratio of described coarse powder mixture and water is 1: 6～10, and the time is 1～2 hour;
D. merge described first time of decocting liquid and decocting liquid for the second time, carry out filtration treatment again, obtain mixture filtrate;
E. described mixture filtrate is carried out concentration, obtain the mixture clear paste;
F. with adding alcoholic solution in the described mixture clear paste, obtain containing pure clear paste;
G. contain pure clear paste and leave standstill processing hermetically described, the qinghuo reagent supernatant stays the clear paste residue again; Described leaving standstill in the processing, temperature are room temperature, and the time is 12～48 hours;
H. described clear paste residue is carried out filtration treatment, obtain residue filtrate;
I. described residue filtrate and described clear paste supernatant are merged, carry out concentration, obtain thick paste;
J. described thick paste is carried out drying under reduced pressure processing, pulverization process, obtain the extract fine powder; During described drying under reduced pressure was handled, temperature was 60～80 ℃;
D. mix
With described Realgar superfine powder, Radix Notoginseng fine powder, Scorpio fine powder, Oleum Curcumae inclusion complex fine powder, extract fine powder mixing, obtain raw mix;
II. finished product preparation
A. with described raw mix and Mel mixing, obtain the pill mixture; The weight ratio of described raw mix and described Mel is 10: 2～7;
B. described pill mixture is carried out mixing and handle, carry out again dried, cold preservation processing, dried, pill processing, promptly get antineoplastic Jinsanxiong medicine pill finished product;
During described mixing was handled, temperature was 20～22 ℃;
During described cold preservation was handled, temperature was 13～20 ℃;
In the described dried, temperature is 35～37 ℃.
10. the preparation method of an antineoplastic Jinsanxiong Chinese medicine preparation is characterized in that: contain Herba Scutellariae Barbatae, Herba Hedyotidis Diffusae, Fructus Forsythiae, Radix Scutellariae, Radix Isatidis, Fructus Gardeniae, Flos Lonicerae, Oleum Curcumae, Radix Notoginseng, Scorpio, Realgar in the described antineoplastic Jinsanxiong Chinese medicine preparation; The weight ratio of each raw material is in the described antineoplastic Jinsanxiong Chinese medicine preparation:
Herba Scutellariae Barbatae 150～1600
Herba Hedyotidis Diffusae 150～1600
Fructus Forsythiae 150～1600
Radix Scutellariae 60～400
Radix Isatidis 60～400
Fructus Gardeniae 60～400
Flos Lonicerae 60～400
Oleum Curcumae 5～20
Radix Notoginseng 10～120
Scorpio 5～60
Realgar 20～220;
The dosage form of described antineoplastic Jinsanxiong Chinese medicine preparation is an electuary, and preparation process is as follows:
I. raw material is handled:
A. Realgar, Radix Notoginseng, Scorpio are handled:
A. described Realgar is carried out water and fly to handle, obtain Realgar superfine powder;
B. described Radix Notoginseng is carried out pulverization process, obtain the Radix Notoginseng fine powder;
C. described Scorpio is cleaned processing, dried, pulverization process successively, obtain the Scorpio fine powder;
B. Oleum Curcumae is handled:
A. will add alcoholic solution in the described Oleum Curcumae, obtain the ethanol volatile oil of Rhizoma Curcumae;
In the ethanol volatile oil of described Rhizoma Curcumae, the volume ratio of described Oleum Curcumae and alcoholic solution is 1: 1～3;
B. the ethanol volatile oil with described Rhizoma Curcumae mixes with beta-schardinger dextrin-solution, carries out stir process, obtains the Oleum Curcumae inclusion complex;
In the described stir process, temperature is 35～40 ℃, carries out continuously 3～8 hours;
C. described Oleum Curcumae inclusion complex is left standstill processing, filtration treatment, dried, pulverization process, the processing of sieving, obtain Oleum Curcumae inclusion complex fine powder;
Described leaving standstill in the processing, temperature are 15～20 ℃, and the time is 12～28 hours;
In the described dried, temperature is 38～40 ℃;
C. Herba Scutellariae Barbatae, Herba Hedyotidis Diffusae, Fructus Forsythiae, Radix Scutellariae, Radix Isatidis, Fructus Gardeniae, Flos Lonicerae are handled:
A. described Herba Scutellariae Barbatae, Herba Hedyotidis Diffusae, Fructus Forsythiae, Radix Scutellariae, Radix Isatidis, Fructus Gardeniae, Flos Lonicerae are carried out pulverization process respectively, obtain the coarse powder of Herba Scutellariae Barbatae, the coarse powder of Herba Hedyotidis Diffusae, the coarse powder of Fructus Forsythiae, the coarse powder of Radix Scutellariae, the coarse powder of Radix Isatidis, the coarse powder of Fructus Gardeniae, the coarse powder of Flos Lonicerae respectively; Again above-mentioned 7 kinds of coarse powder are mixed and obtain coarse powder mixture;
B. described coarse powder mixture is carried out decocting the first time and handles, obtain decocting liquid for the first time and decoct for the first time after medicinal residues;
Described for the first time decoct and to handle, the weight ratio of described coarse powder mixture and water is 1: 6～12, and the time is 1～3 hour;
C. the medicinal residues after described first time being decocted carry out decocting second time to be handled, and obtains the medicinal residues behind the decocting liquid and decoction for the second time for the second time;
Described for the second time decoct and to handle, the weight ratio of described coarse powder mixture and water is 1: 6～10, and the time is 1～2 hour;
D. merge described first time of decocting liquid and decocting liquid for the second time, carry out filtration treatment again, obtain mixture filtrate;
E. described mixture filtrate is carried out concentration, obtain the mixture clear paste;
F. with adding alcoholic solution in the described mixture clear paste, obtain containing pure clear paste;
G. contain pure clear paste and leave standstill processing hermetically described, the qinghuo reagent supernatant stays the clear paste residue again; Described leaving standstill in the processing, temperature are room temperature, and the time is 12～48 hours;
H. described clear paste residue is carried out filtration treatment, obtain residue filtrate;
I. described residue filtrate and described clear paste supernatant are merged, carry out concentration, obtain thick paste;
J. described thick paste is carried out drying under reduced pressure processing, pulverization process, obtain the extract fine powder;
During described drying under reduced pressure was handled, temperature was 60～80 ℃;
D. mix
With described Realgar superfine powder, Radix Notoginseng fine powder, Scorpio fine powder, Oleum Curcumae inclusion complex fine powder, extract fine powder mixing, obtain raw mix;
II. finished product preparation:
With described raw mix and glucose, sucrose mixing, obtain the electuary mixture, be antineoplastic Jinsanxiong Chinese medicine electuary finished product; The weight ratio of described raw mix and described glucose, sucrose is 10: 1～4: 1～6.
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104224959A (en) * | 2014-09-29 | 2014-12-24 | 淄博市食品药品检验所 | Medicament composition for treating leukemia and preparation method of medicament composition |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104224959A (en) * | 2014-09-29 | 2014-12-24 | 淄博市食品药品检验所 | Medicament composition for treating leukemia and preparation method of medicament composition |
| CN104224959B (en) * | 2014-09-29 | 2016-04-06 | 淄博市食品药品检验所 | One is used for the treatment of leukemic pharmaceutical composition and preparation method thereof |
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Application publication date: 20100915 |