CN106511414A - Pharmaceutical composition for treating tumor and preparation method and application thereof - Google Patents
Pharmaceutical composition for treating tumor and preparation method and application thereof Download PDFInfo
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- CN106511414A CN106511414A CN201611143626.3A CN201611143626A CN106511414A CN 106511414 A CN106511414 A CN 106511414A CN 201611143626 A CN201611143626 A CN 201611143626A CN 106511414 A CN106511414 A CN 106511414A
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- 239000008194 pharmaceutical composition Substances 0.000 title claims abstract description 27
- 238000002360 preparation method Methods 0.000 title abstract description 11
- 239000003814 drug Substances 0.000 claims abstract description 22
- 239000002775 capsule Substances 0.000 claims abstract description 19
- 241000269420 Bufonidae Species 0.000 claims description 102
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- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims description 39
- 238000000034 method Methods 0.000 claims description 35
- 210000000481 breast Anatomy 0.000 claims description 34
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- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 29
- 238000000605 extraction Methods 0.000 claims description 26
- 241000125175 Angelica Species 0.000 claims description 25
- 235000001287 Guettarda speciosa Nutrition 0.000 claims description 25
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- IDGUHHHQCWSQLU-UHFFFAOYSA-N ethanol;hydrate Chemical compound O.CCO IDGUHHHQCWSQLU-UHFFFAOYSA-N 0.000 claims description 24
- 239000006286 aqueous extract Substances 0.000 claims description 16
- 235000002639 sodium chloride Nutrition 0.000 claims description 16
- 239000011780 sodium chloride Substances 0.000 claims description 16
- 229960002668 sodium chloride Drugs 0.000 claims description 16
- 238000002604 ultrasonography Methods 0.000 claims description 16
- 238000010992 reflux Methods 0.000 claims description 13
- 239000006228 supernatant Substances 0.000 claims description 10
- 239000002504 physiological saline solution Substances 0.000 claims description 9
- 238000005119 centrifugation Methods 0.000 claims description 8
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- 239000012467 final product Substances 0.000 claims description 4
- 239000000047 product Substances 0.000 claims description 4
- 238000003756 stirring Methods 0.000 claims description 4
- 208000017897 Carcinoma of esophagus Diseases 0.000 claims description 2
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- 239000008187 granular material Substances 0.000 claims description 2
- 201000007270 liver cancer Diseases 0.000 claims description 2
- 208000014018 liver neoplasm Diseases 0.000 claims description 2
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- 208000024891 symptom Diseases 0.000 abstract description 3
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Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/23—Apiaceae or Umbelliferae (Carrot family), e.g. dill, chervil, coriander or cumin
- A61K36/232—Angelica
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
- A61K35/56—Materials from animals other than mammals
- A61K35/65—Amphibians, e.g. toads, frogs, salamanders or newts
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/30—Extraction of the material
- A61K2236/33—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
- A61K2236/331—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using water, e.g. cold water, infusion, tea, steam distillation or decoction
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/30—Extraction of the material
- A61K2236/33—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
- A61K2236/333—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using mixed solvents, e.g. 70% EtOH
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/30—Extraction of the material
- A61K2236/39—Complex extraction schemes, e.g. fractionation or repeated extraction steps
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- Health & Medical Sciences (AREA)
- Natural Medicines & Medicinal Plants (AREA)
- Life Sciences & Earth Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Medicinal Chemistry (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Chemical & Material Sciences (AREA)
- Engineering & Computer Science (AREA)
- Alternative & Traditional Medicine (AREA)
- Biotechnology (AREA)
- Botany (AREA)
- Medical Informatics (AREA)
- Microbiology (AREA)
- Mycology (AREA)
- Medicines Containing Plant Substances (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
Abstract
The present invention provides a pharmaceutical composition for treating tumor and a preparation method thereof, wherein the pharmaceutical composition is prepared from Chinese Angelica and venenum bufonis. The pharmaceutical composition can significantly improve the tumor inhibition rate, and has significantly-improved antitumor activity compared with Antike capsule made from Chinese Angelica and Toad skin. The pharmaceutical composition is suitable for patients with advanced cancer, can be used as an antitumor adjuvant drug, can improve clinical symptoms and improves the quality of life.
Description
Technical field
The present invention relates to technical field of traditional Chinese medicines, more particularly to a kind of pharmaceutical composition for treating tumour and its preparation side
Method, and application of the pharmaceutical composition in the treatment cancer of the esophagus, cancer of the stomach, the medicine of liver cancer is prepared.
Background technology
Cancer is one of the major disease for endangering human health at present, for cannot impose operation, the danger of chemicotherapy, weight,
Patient with advanced cancer, elderly patient, whole body transfer and secondary patients with recurrent or patient that is insensitive to chemicotherapy or producing resistance,
Traditional Chinese medicine can strengthen body against cancer immunity, control patient's condition, alleviate the state of an illness, mitigate and improve the sings and symptoms of tumor patient
(such as pain, it is weak, become thin, have a fever, apocleisis, Pleural effusions, digestive obstruetion etc.), improve or prevent Advanced Carcinoma Patient dyscrasia
(including MOFE), extend the life cycle of cancer patient to the full extent, lift the life quality of patient.Traditional Chinese medicine
Cancer patient's physique, sublimation of life quality (such as body weight, muscle power, spirit, diet, sleep etc.), and Simultaneous Stabilization can also be strengthened
Knurl body, reduces focus, and promotes people's knurl to balance, and realizes that band knurl is survived.Traditional Chinese medicine can improve carcinous physique and reverse precancerous lesion,
And promoting cancer cell-apoptosis, the benign differentiation of induction cancer cell suppresses tumour cell division, the transfer of prevention of tumor, diffusion and multiple
Send out.
Traditional Chinese medical science Shi Zhirenzhi road and health science, treatment of the traditional Chinese medical science to disease are to safeguard and strong in the case where Doctrines of Maintaining Good Health is instructed
Change the medical practice process that autonomous vitality is its final goal, traditional Chinese medicine focuses on the life movement that adjustment is become estranged in the process
Mode simultaneously promotees self health of its pathology abnormality and lapses to, so as to play the purpose of " controlling in people " and " disease is autonomous ".
Irreplaceability meaning of the traditional Chinese medicine in malignant tumour integral treatment is that by improving carcinous physique, transfer
Itself anticancer potential, recovers body homeostasis and adjusts, and strengthens the autonomous anti-cancer ability of human body comprehensively, and big for the vigour of operation
Impairment of both QI and YIN that wound, radiotherapy cause, in qi-blood deficiency and biological therapy interfering bodies, internal organs yin and yang imbalance has caused by chemotherapy
Protection and repair.
But, the Chinese medicine quantity and curative effect for being clinically used for treating tumour at present is all very limited, therefore, from China's abundant
The medicine that effectively treatment tumour is further developed in traditional Chinese medicine resource has significant meaning.
The content of the invention
The invention provides a kind of pharmaceutical composition for treating tumour, described pharmaceutical composition is made up of Radix Angelicae Sinensis and the dried venom of toads.
Pharmaceutical composition of the invention, Radix Angelicae Sinensis are 1680: 1～1200: 1 with the quality of medicinal material ratio of the dried venom of toads, preferably
1400∶1。
Pharmaceutical composition of the invention, described pharmaceutical composition are capsule；Preferably, the content of the capsule
Thing is medicament composition granule.
Present invention also offers a kind of method for preparing pharmaceutical composition of the present invention, methods described includes following step
Suddenly：
(1) by Radix Angelicae Sinensis cutting, crush, by the angelica powder for obtaining ethanol solution refluxing extraction, filter, obtain Radix Angelicae Sinensis ethanol
Extract and the Radix Angelicae Sinensis dregs of a decoction；By the Radix Angelicae Sinensis dregs of a decoction by water boiling and extraction, Radix Angelicae Sinensis aqueous extract is obtained；
(2) dried venom of toads is ground into into dried venom of toads powder, 0.5%～4.5% sodium chloride for adding concentration to be based on g/ml (similarly hereinafter) is molten
Liquid, grinds to form dried venom of toads breast, is subsequently adding ethanol solution extraction, obtains dried venom of toads extract；
(3) Radix Angelicae Sinensis ethanol extract is well mixed with dried venom of toads extract, is condensed into medicinal extract；
(4) medicinal extract that Radix Angelicae Sinensis aqueous extract is obtained with step (3) is mixed, concentration is obtained final product.
In the method for the invention, the concentration used in step (2) is that 0.5%～4.5% sodium chloride solution is imitated
Fluid environment, is more beneficial for the dissolving and dispersion of dried venom of toads breast.Compared with water, dried venom of toads breast has higher in sodium chloride solution
Decentralization.Meanwhile, by way of the mixing in using step (3) and step (4), it is possible to reduce alcohol insoluble matter composition it is heavy
Form sediment and separate out, so as to be conducive to improving the quality of medicine.
Preferably, the step of the method for the invention in (1), the ethanol solution refluxing extraction is：To in angelica powder
Add based on angelica powder quality 3～8 times of quality 45～90% ethanol solutions, refluxing extraction 1～5 time, every time extract 0.5～
3.5 hour.Throughout the present invention, the concentration of ethanol solution is represented with volume fraction.
It is highly preferred that the step of the method for the invention in (1), the alcohol reflux is extracted as：Add in angelica powder
Enter 70% ethanol solution of 5 times of quality based on angelica powder quality, refluxing extraction 2 times is extracted 1.5 hours every time.
Preferably, the step of the method for the invention in (1), the water boiling and extraction is：Add to the Radix Angelicae Sinensis dregs of a decoction and press
The water of Radix Angelicae Sinensis dregs of a decoction quality 1～8 times of quality of meter, decocts 2～5 times, decocts 0.5～4.5 hour every time；It is highly preferred that the water
Decoction is extracted as：The water of 3 times of quality based on Radix Angelicae Sinensis dregs of a decoction quality is added to the Radix Angelicae Sinensis dregs of a decoction, is decocted 2 times, decocted 1 hour every time.
According to an embodiment of the method for the invention, in step (2), the dried venom of toads is ground into into dried venom of toads powder, is added
Based on dried venom of toads powder quality 10～45 times of quality physiological saline (in physiological saline the concentration of sodium chloride can be 0.65～0.9%,
G/ml), dried venom of toads breast is ground to form, 45～95% ethanol solutions by dried venom of toads breast matter 55～100 times of quality of gauge is subsequently adding, 30
Stirring at a temperature of～80 DEG C is extracted 2～5 times, is extracted 2～8 hours every time, is filtered, obtain dried venom of toads extract.
According to another embodiment of the method for the invention, in step (2), the dried venom of toads is ground into into dried venom of toads powder, plus
Enter the physiological saline of 30 times of quality based on dried venom of toads powder quality, grind to form dried venom of toads breast, be subsequently adding by 70 times of matter of dried venom of toads breast matter gauge
95% ethanol solution of amount, stirs at a temperature of 50～60 DEG C and extracts 2 times, extract 4 hours every time, filter, obtain the dried venom of toads and carry
Take liquid.
Preferably, in an embodiment of the method for the invention, in step (2), the dried venom of toads is ground into into the dried venom of toads
Powder, adds the concentration of 10～45 times of quality based on dried venom of toads powder quality for the sodium chloride solution of 0.5%～4.5% (g/ml), grinding
Into dried venom of toads breast.The dried venom of toads breast that grinding is obtained is heated to into 25～45 DEG C, 40 DEG C are preferably heated to, 20～30min is ground, is preferably ground
Mill 30min, is subsequently adding 45～95% ethanol solutions of 55～100 times of quality by dried venom of toads breast matter gauge, at 25～45 DEG C, excellent
20～40min of ultrasound at a temperature of 40 DEG C is selected, preferably ultrasound 30min；Then insulated and stirred extraction 2～8 hours, preferably 4 hours,
Centrifugation, collects supernatant, and 45～95% ethanol solutions of 55～100 times of quality for pressing dried venom of toads breast matter gauge are added in precipitation,
At 25～45 DEG C, 20～40min of ultrasound at a temperature of preferably 40 DEG C, preferably ultrasound 30min, then insulated and stirred extraction 2～8 is little
When, preferably 4 hours, supernatant was collected in centrifugation；Merge extract twice.In the present embodiment, ultrasound can reduce particle and gather
Collect, advantageously in the dissolution of effective ingredient.
Preferably, the method for the invention also includes：Enriched product that step (4) is obtained is spray-dried to make medicine
Powder, is then prepared into capsule.
The pharmaceutical composition of the present invention can significantly improve tumor control rate, be made up of Radix Angelicae Sinensis and toad skin relative to existing
Antike capsule there is the antitumor activity that significantly improves.The pharmaceutical composition of the present invention is applied to patient with advanced cancer, uses
Make antineoplastic adjuvant drug, clinical symptoms can be improved, improve life quality.
The method of the present invention extracts the dried venom of toads by the sodium chloride solution using low concentration, has imitated fluid environment, more favorably
In the dissolving and dispersion of dried venom of toads breast, so as to improve the extract yield of the dried venom of toads.In addition, in dried venom of toads extraction process, being aided with ultrasound
Operation, can further reduce particle aggregation, be conducive to the dissolution of effective ingredient.
Description of the drawings
Hereinafter, with reference to accompanying drawing describing embodiment of the present invention in detail, wherein：
Fig. 1 is the process chart of an embodiment of preparation method of the present invention.
Specific embodiment
Embodiment 1
The preparation of angelica extract
Radix Angelicae Sinensis medicinal material cutting, crushing are obtained into angelica powder.By the angelica powder concentration of 3 times of quality based on angelica powder quality
For the ethanol water refluxing extraction 1 time of 90% (v/v), backflow 2.5 hours, filter, obtain Radix Angelicae Sinensis ethanol aqueous extract every time
With the Radix Angelicae Sinensis dregs of a decoction；The water of 6 times of quality based on Radix Angelicae Sinensis dregs of a decoction quality is added to the Radix Angelicae Sinensis dregs of a decoction, is decocted and is extracted 2 times, decoct 0.5 every time
Hour, obtain Radix Angelicae Sinensis aqueous extract.
The preparation of dried venom of toads extract
The dried venom of toads is ground into into dried venom of toads powder, dried venom of toads powder is taken, the concentration for adding 10 times based on dried venom of toads powder quality amounts is 0.5% (g/
Ml sodium-chloride water solution), grinds to form dried venom of toads breast, is subsequently adding by 100 times of quality of dried venom of toads breast matter gauge, the second that concentration is 45%
Alcohol solution, extracts 5 times at 80 DEG C, 2 hours every time, obtains dried venom of toads extract.
Radix Angelicae Sinensis ethanol aqueous extract is well mixed with dried venom of toads extract, medicinal extract is condensed into.Then, by Radix Angelicae Sinensis aqueous extract
With above the step of the medicinal extract that obtains mix, concentration is obtained final product for treating the pharmaceutical composition of tumour.
Embodiment 2
The preparation of angelica extract
Radix Angelicae Sinensis medicinal material cutting, crushing are obtained into angelica powder.By the angelica powder for obtaining with 3 times based on angelica powder quality quality,
Concentration is 45% ethanol water refluxing extraction 5 times, every time backflow 0.5 hour, is filtered, obtain Radix Angelicae Sinensis ethanol aqueous extract and
The Radix Angelicae Sinensis dregs of a decoction；The water of 1 times of quality based on Radix Angelicae Sinensis dregs of a decoction quality is added to the Radix Angelicae Sinensis dregs of a decoction, is decocted and is extracted 4 times, 0.5 hour every time,
Obtain Radix Angelicae Sinensis aqueous extract.
The preparation of dried venom of toads extract
The dried venom of toads is ground into into dried venom of toads powder, dried venom of toads powder is taken, adds 45 times of quality based on dried venom of toads powder quality, concentration to be 4.5%
(m/v) sodium-chloride water solution, grinds to form dried venom of toads breast, and it is 75% (v/ to be subsequently adding by 55 times of quality of dried venom of toads breast matter gauge, concentration
V) ethanol water, extracts 2 times at 30 DEG C, 8 hours every time, obtains dried venom of toads extract.
Radix Angelicae Sinensis ethanol aqueous extract is well mixed with dried venom of toads extract, medicinal extract is condensed into.Then, by Radix Angelicae Sinensis aqueous extract
With above the step of the medicinal extract that obtains mix, concentration is obtained final product for treating the pharmaceutical composition of tumour.
Embodiment 3
Dried venom of toads extracting method is contrasted
Existing method
Dried venom of toads powder is taken, 80% ethanol water of 10 times of quality based on dried venom of toads powder quality, each refluxing extraction 1.5 is added
Hour, extract 3 times, merge extract, concentrate in a water bath, calculate extract yield, extract result as shown in table 1 below.
Table 1
| Sequence number | Dried venom of toads powder sampling amount | Extract weight | Yield |
| 1 | 0.21g | 0.071g | 33.8% |
| 2 | 0.22g | 0.073g | 33.2% |
| 3 | 0.20g | 0.069g | 34.5% |
| 4 | 0.19g | 0.065g | 34.2% |
| 5 | 0.23g | 0.078g | 33.9% |
The method of the present invention：
Dried venom of toads powder is taken, the sodium-chloride water solution that 30 times of mass concentrations based on dried venom of toads powder quality are 0.9% (g/ml) is added,
Dried venom of toads breast is ground to form under normal temperature, 40 DEG C of grinding 30min is then heated to, is subsequently adding 70 times of quality by dried venom of toads breast matter gauge
95% ethanol water, the ultrasound 30min at a temperature of 40 DEG C.Ultrasound terminate after at 40 DEG C insulated and stirred extract 4 hours, from
The heart, collects supernatant, adds 95% ethanol water of 70 times of quality for pressing dried venom of toads breast matter gauge, in 40 DEG C of temperature in precipitation
After spending ultrasound 30min, ultrasound to terminate, at 40 DEG C, insulated and stirred is extracted 4 hours, and supernatant is collected in centrifugation；Merging is carried twice
Liquid is taken, is sealed, is incubated under the conditions of 40 DEG C standby.It is as shown in table 2 below that the dried venom of toads extracts result.
Table 2
| Sequence number | Dried venom of toads powder sampling amount | Extract weight | Yield |
| 1 | 0.2095g | 0.1094g | 52.22% |
| 2 | 0.2137g | 0.1112g | 52.04% |
| 3 | 0.2012g | 0.1051g | 52.24% |
| 4 | 0.2077g | 0.1078g | 51.90% |
| 5 | 0.2111g | 0.1107g | 52.44% |
| 6 | 0.2200g | 0.1145g | 52.05% |
Embodiment 4
With the contrast extracted after water and the 0.5% sodium-chloride water solution grinding dried venom of toads
Extracted with water
Dried venom of toads powder is taken, the water of 45 times of quality based on dried venom of toads powder quality is added, dried venom of toads breast is ground to form under normal temperature, is then heated to
40 DEG C, 40min is ground, 95% ethanol water of 100 times be subsequently adding based on dried venom of toads breast weight surpasses at a temperature of 40 DEG C
Sound 60min, then insulated and stirred is extracted 2 hours at a temperature of 40 DEG C, centrifugation, is collected supernatant, is added above-mentioned in precipitation
The ethanol water of same amount in step, the ultrasound 60min at a temperature of 40 DEG C, then insulated and stirred is extracted at a temperature of 40 DEG C
2 hours, supernatant was collected in centrifugation；Merge extract twice, sealing is incubated under the conditions of 40 DEG C standby.Extraction the results are shown in Table 3.
Table 3
Extracted with 0.5% sodium-chloride water solution
Dried venom of toads powder is taken, 0.5% sodium-chloride water solution of 10 times of quality is added, dried venom of toads breast is ground to form under normal temperature, is then heated
To 40 DEG C, 30min is ground, 95% ethanol water by dried venom of toads breast matter 70 times of quality of gauge is subsequently adding, in 40 DEG C of temperature
Lower ultrasonic 30min, then at 40 DEG C, insulated and stirred is extracted 8 hours, centrifugation, collects supernatant, above-mentioned step is added in precipitation
The ethanol water of same amount in rapid, the ultrasound 30min at a temperature of 40 DEG C, then insulated and stirred extraction 8 hours at 40 DEG C, from
The heart, collects supernatant；Merge extract twice, sealing is incubated under the conditions of 40 DEG C standby.Extraction the results are shown in Table 4.
Table 4
| Sequence number | Dried venom of toads sampling amount | Extract weight | Yield |
| 1 | 0.1989g | 0.1032g | 51.89% |
| 2 | 0.2066g | 0.1069g | 51.74% |
| 3 | 0.1997g | 0.1039g | 52.03% |
| 4 | 0.2003g | 0.1028g | 51.32% |
| 5 | 0.2012g | 0.1048g | 52.09% |
| 6 | 0.2001g | 0.1052g | 52.57% |
From the present embodiment, compared with extraction is carried out with water, when being extracted with 0.5% sodium-chloride water solution, even if
Parameter when some parameters are not as being extracted with water, but final yield ratio water extracts taller.
Embodiment 5
The preparation of capsule
Chinese medicine and consumption are shown in Table 5.
Table 5
Formulation：Capsule, specification：Per dress 0.1g.
Technological process is as shown in figure 1, concrete technology is as described below.
1. pretreatment of raw material
1.1 select：Radix Angelicae Sinensis is placed on and is selected on medicine platform, well-chosen removes impurity and non-medicinal effects.Medicine is weighed respectively
The weight of material, impurity and non-medicinal effects；Medicinal material after selection fills Turnover Box (bag) respectively, sealing, labels, Zhuan Xia roads wash
Operation.
1.2 wash：Radix Angelicae Sinensis is rinsed well repeatedly with medicine-washing machine, discharged, drip is swum to the greatest extent.
1.3 cutting：Radix Angelicae Sinensis is cut into the medicinal material section of 2～4cm with reciprocal medicine cutter.
It 1.4 is dried：Radix Angelicae Sinensis medicinal material section is laid on basin, thickness about 2cm, is dried 1～2.5 hour in putting baking oven,
Baking temperature is 60～80 DEG C.Taking-up dries in the air cool, weighs, standby.
1.5 Radix Angelicae Sinensis are crushed：Dried Radix Angelicae Sinensis is ground into into angelica powder, it is standby.
1.6 dried venoms of toads are crushed：The dried venom of toads is ground into into dried venom of toads powder, it is standby.
2. extract
2.1 Radix Angelicae Sinensis are extracted
Take angelica powder, add 70% ethanol water refluxing extraction of 5 times of quality based on angelica powder quality twice, every time
Backflow 1.5 hours, filters, and merges Radix Angelicae Sinensis ethanol aqueous extract, standby.The Radix Angelicae Sinensis dregs of a decoction add 3 times of quality water every time, decoct twice,
1 hour every time, filter, merge Radix Angelicae Sinensis aqueous extract, it is standby.
2.2 dried venoms of toads are extracted
Dried venom of toads powder is taken, 0.9% (g/ml) physiological saline of 30 times of quality based on dried venom of toads powder quality is added, is fully ground into toad
Crisp breast, adds 95% ethanol water to extract, is sufficiently stirred for, and insulated and stirred is extracted 4 hours at a temperature of 50～60 DEG C, is carried altogether
Take twice, every time using 95% ethanol water for pressing dried venom of toads breast matter 70 times of quality of gauge；Filter, merge dried venom of toads extract, it is standby
With.
2.3 concentration
Radix Angelicae Sinensis alcohol extract and dried venom of toads extract are well mixed, economic benefits and social benefits concentration are squeezed into and is received in cream tank, reclaim ethanol, it is standby
With.Concentration technology parameter is as shown in table 6 below.
Table 6
| Evaporimeter liquid level | Vapour pressure (Mpa) | Vacuum (Mpa) | Temperature (DEG C) |
| Visor 1/3 | 0.05-0.15 | ≥0.07 | ≤60 |
Radix Angelicae Sinensis aqueous extract is mixed with the concentrated extract of Radix Angelicae Sinensis alcohol extract and dried venom of toads extract, is concentrated, it is standby.
3. it is spray-dried
The medicinal extract that 2.3 are finally concentrated to give continuously is spray dried to be dried medicinal powder.EAT sets 110～130 DEG C,
And load the medicinal powder after spraying in clean transfer container.
4. preparation
4.1 granulation
It is dried medicinal powder and makes particle, after particle drying, loads in clean container.
4.2 whole grain
By dry particle pelletizing machine (30 mesh sieve) whole grain, mixing chamber is transferred to.
4.3 mixing
Dry particle is put in vacuum quick three-dimensional entry mixers, closes charging aperture, start mixing, 25 points of incorporation time
Clock.It is discharged to add a cover in clean container and seals, weighs.
4.4 capsules are filled
Mixed processes are obtained medicinal powder to load in the hopper of capsule filling machine, Capsules, adjustment loading amount and the method for double differences is added,
Start filling capsule after qualified；Per theoretical loading：0.10g/ grains, adjustment are suitably filled with speed；Populated capsule is used
Capsule polisher is polished.
4.5 it is aluminum-plastic packaged
Capsule is loaded in the drug bucket of Aluminium-coating Packer, start carries out aluminum-plastic packaged, compressing aluminium-plastic panel detection and closes
Lattice product.
Embodiment 6
In the present embodiment, composition and toad skin and the combination of angelica extract of the inventor with regard to the dried venom of toads and angelica extract
Thing affects to be studied on S180 tumor-bearing mices.
Research flow process is as follows.
Sample 1：Capsule 's content made by toad cake extract and angelica extract
Sample 2：Capsule 's content made by toad skin extract and angelica extract
Experimental technique：Well-grown S180 mouse tumor cells are taken, with physiological saline with 1:4 dilution (cell concentrations about 1
×107Individual/ml), the right armpit subcutaneous vaccination 0.2ml of every mouse；After animal packet sets up S180 lotus knurl ICR mouse models,
Postvaccinal mouse is randomly divided into into 8 groups, per group each 12, i.e. model control group, 1 high dose group of sample (0.342g/kg), sample
1 middle dose group of product (0.171g/kg), 1 low dose group of sample (0.086g/kg), 2 high dose group of sample (0.342g/kg), sample
2 middle dose groups (0.171g/kg), 2 low dose group of sample (0.086g/kg), endoxan group (30mg/kg)；Mouse S180 lotuses
Administration from 3rd day after knurl, sample 1 and 2 high dose group dosage of sample are 0.342g/kg, middle dose group dosage is
0.171g/kg, low dose group dosage be 0.086g/kg, endoxan dosage be 30mg/kg, daily gastric infusion
Once, model control group gives same volume physiological saline gavage, successive administration 10 days all mouse to be taken off at vertebra on 11st daily
Extremely, solution takes tumor mass and claims knurl weight, takes thymus gland and spleen and weighs.
Tumour tumour inhibiting rate=(the average knurl weight of the average knurl weight/model control group of 1- medication groups) × 100%.
Statistical analysis：All data using statistical package SPSS17.0 process, data withTable
Show, multigroup is compared using one-way analysis of variance (One way-ANOVA), and comparing between two groups is carried out with non-paired t test.
Experimental result
Impact of the table 7 to the thymus index and index and spleen index of S180 tumor-bearing mices
Compare with model group, * * P<0.05, * P<0.05；Compare with 2 corresponding dosage group of sample,▲▲P<0.01。
Impact of the table 8 to the knurl weight and tumour inhibiting rate of S180 tumor-bearing mices
Compare with model group, * * P<0.05, * P<0.05；Compare with 2 corresponding dosage group of sample,▲▲P<0.01。
Test result indicate that, comparing with model comparison, the height of sample 1 and sample 2, middle dose group are to S180 tumour cell lotuses
The knurl weight of knurl mouse has significant inhibitory action, and (0.05) P ＜ 0.01, P ＜, is remarkably improved tumor control rate；Sample 1 is high
Dosage is compared with 2 high dose of sample, is substantially reduced the knurl weight (P ＜ 0.01) of tumor-bearing mice, is dramatically increased and tumor-bearing mice is swollen
Knurl inhibiting rate；Compare with model comparison, 2 height of sample 1 and sample, middle dose group can dramatically increase thymus index and index and spleen index,
Compare with 2 high dose of sample, 1 high dose group of sample can dramatically increase thymus gland and index and spleen index, and (P ＜ 0.01, P ＜ is 0.05).
Claims (13)
1. a kind of pharmaceutical composition for treating tumour, described pharmaceutical composition are made up of Radix Angelicae Sinensis and the dried venom of toads.
2. pharmaceutical composition according to claim 1, it is characterised in that the mass ratio of Radix Angelicae Sinensis and the dried venom of toads is 1680: 1～
1200: 1, preferably 1400: 1.
3. pharmaceutical composition according to claim 1, it is characterised in that described pharmaceutical composition is capsule；Preferably,
The content of the capsule is medicament composition granule.
4. a kind of method for preparing pharmaceutical composition as claimed any one in claims 1 to 3, methods described include following step
Suddenly：
(1) by Radix Angelicae Sinensis cutting, crush, by the angelica powder for obtaining ethanol water refluxing extraction, filter, obtain Radix Angelicae Sinensis ethanol water
Extract and the Radix Angelicae Sinensis dregs of a decoction；By Radix Angelicae Sinensis dregs of a decoction water boiling and extraction, Radix Angelicae Sinensis aqueous extract is obtained；
(2) dried venom of toads is ground into into powder, the sodium-chloride water solution for adding concentration to be 0.5～4.5% (g/ml) grinds to form dried venom of toads breast,
Ethanol water extraction is subsequently adding, dried venom of toads extract is obtained；
(3) Radix Angelicae Sinensis ethanol aqueous extract is well mixed with dried venom of toads extract, is condensed into medicinal extract；
(4) medicinal extract that Radix Angelicae Sinensis aqueous extract is obtained with step (3) is mixed, concentration is obtained final product.
5. method according to claim 4, it is characterised in that in step (1), the ethanol water refluxing extraction
For：The volume fraction that 3～8 times of quality based on angelica powder quality are added in angelica powder is 45～90% ethanol water, is returned
Stream is extracted 1～5 time, is extracted 0.5～3.5 hour every time.
6. method according to claim 5, it is characterised in that in step (1), the ethanol water refluxing extraction
For：The volume fraction that 5 times of quality based on angelica powder quality are added in angelica powder is 70% ethanol water, refluxing extraction 2
It is secondary, extract 1.5 hours every time.
7. method according to claim 4, it is characterised in that in step (1), the water boiling and extraction is：To Radix Angelicae Sinensis
The dregs of a decoction add the water of 1～8 times of quality based on Radix Angelicae Sinensis dregs of a decoction quality, decoct 2～5 times, decoct 0.5～4.5 hour every time；More preferably
, the water boiling and extraction is：The water of 3 times of quality based on Radix Angelicae Sinensis dregs of a decoction quality is added to the Radix Angelicae Sinensis dregs of a decoction, is decocted 2 times, decocted every time
Boil 1 hour.
8. the dried venom of toads is ground into powder by method according to claim 4, it is characterised in that in step (2), and toad is pressed in addition
The physiological saline of crisp powder quality 10～45 times of quality of meter, grinds to form dried venom of toads breast, is subsequently adding by 55～100 times of dried venom of toads breast matter gauge
The volume fraction of quality is 45～95% ethanol water, stirs and extracts 2～5 times, carry at a temperature of 30～80 DEG C every time
Take 2～8 hours, filter, obtain dried venom of toads extract；Preferably, the concentration of the sodium chloride of the physiological saline is 0.65～0.9%
(g/ml)。
9. the dried venom of toads is ground into powder by method according to claim 4, it is characterised in that in step (2), and toad is pressed in addition
The physiological saline of 30 times of quality of crisp powder quality meter, grinds to form dried venom of toads breast, is subsequently adding by dried venom of toads breast matter 70 times of quality of gauge
Volume fraction is 95% ethanol water, stirs and extracts 2 times, extract 4 hours every time, filter at a temperature of 50～60 DEG C,
Obtain dried venom of toads extract.
10. method according to claim 4, it is characterised in that in step (2), the dried venom of toads is ground into dried venom of toads powder, adds
Based on dried venom of toads powder quality, the concentration of 10～45 times of quality is the sodium chloride solution of 0.5%～4.5% (g/ml), grinds to form the dried venom of toads
Breast；The dried venom of toads breast that grinding is obtained is heated to into 25～45 DEG C, 40 DEG C are preferably heated to, 20～30min is ground, it is preferred to grind
30min, is subsequently adding by the ethanol water that the volume fraction of 55～100 times of quality of dried venom of toads breast matter gauge is 45～95%,
At 25～45 DEG C, 20～40min of ultrasound preferably at 40 DEG C, preferably ultrasound 30min；Then insulated and stirred is extracted 2～8 hours,
It is preferred that 4 hours, supernatant is collected in centrifugation, and according to above-mentioned steps, in precipitation, same addition presses the 55～100 of dried venom of toads breast matter gauge
The volume fraction of times quality is 45～95% ethanol water, at 25～45 DEG C, ultrasound 20 at a temperature of preferably 40 DEG C～
40min, preferably ultrasound 30min, then insulated and stirred extraction 2～8 hours, preferably 4 hours, supernatant was collected in centrifugation；Merge two
Secondary extract.
11. methods according to claim 4, it is characterised in that methods described also includes：The concentration that step (4) is obtained
Product is spray-dried to make medicinal powder, is then prepared into capsule.
Pharmaceutical composition prepared by 12. methods according to any one of claim 4 to 11.
13. pharmaceutical compositions according to any one of claims 1 to 3,12 or according to any one of claim 4 to 11
Pharmaceutical composition prepared by described method is preparing treatment tumour, the preferably use in the medicine of the cancer of the esophagus, cancer of the stomach or liver cancer
On the way.
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