CN108355041A - A kind of preparation process of Gualou Xiebai Banxia Tang solid pharmaceutical preparation - Google Patents
A kind of preparation process of Gualou Xiebai Banxia Tang solid pharmaceutical preparation Download PDFInfo
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- CN108355041A CN108355041A CN201810481136.7A CN201810481136A CN108355041A CN 108355041 A CN108355041 A CN 108355041A CN 201810481136 A CN201810481136 A CN 201810481136A CN 108355041 A CN108355041 A CN 108355041A
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- 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)
- A61K36/42—Cucurbitaceae (Cucumber family)
- A61K36/428—Trichosanthes
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- 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)
- A61K36/88—Liliopsida (monocotyledons)
- A61K36/888—Araceae (Arum family), e.g. caladium, calla lily or skunk cabbage
- A61K36/8888—Pinellia
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- 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)
- A61K36/88—Liliopsida (monocotyledons)
- A61K36/896—Liliaceae (Lily family), e.g. daylily, plantain lily, Hyacinth or narcissus
- A61K36/8962—Allium, e.g. garden onion, leek, garlic or chives
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P11/00—Drugs for disorders of the respiratory system
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P11/00—Drugs for disorders of the respiratory system
- A61P11/06—Antiasthmatics
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N30/00—Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation
- G01N30/02—Column chromatography
-
- 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
- A61K2236/50—Methods involving additional extraction steps
- A61K2236/51—Concentration or drying of the extract, e.g. Lyophilisation, freeze-drying or spray-drying
-
- 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
- A61K2236/50—Methods involving additional extraction steps
- A61K2236/53—Liquid-solid separation, e.g. centrifugation, sedimentation or crystallization
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N30/00—Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation
- G01N30/02—Column chromatography
- G01N2030/022—Column chromatography characterised by the kind of separation mechanism
- G01N2030/027—Liquid chromatography
Abstract
The invention discloses a kind of preparation processes of Gualou Xiebai Banxia Tang solid pharmaceutical preparation, include the following steps：(1) it chooses and examines qualified Snakegourd Fruit, Longstamen Onion Bulb, pinellia pharmaceutical decocting piece and yellow rice wine by national standard；(2) medicinal material of step (1) and yellow rice wine are mixed in prescription ratio, heating is boiled, and keeps slightly boiling 1~1.5 hour；(3) after slightly boiling extraction, with 100~300 mesh screens, filtrate removes impurity and macromolecular substances by high speed centrifugation, obtains clear extracting solution；(4) spare by extracting solution by depressurizing low temperature concentration；(5) a certain proportion of auxiliary material is added in concentrate or is not added with auxiliary material, mixing, by being spray-dried rapid draing into powder；(6) powder for obtaining step (5), granule is prepared by wet granulation, dry granulation or boiling granulating.It is convenient that Gualou Xiebai Banxia Tang solid pharmaceutical preparation prepared by the present invention carries, convenient to take, convenient for storage, is conducive to the marketization.
Description
Technical field
The present invention relates to a kind of preparation processes of Chinese medicine preparation, and in particular to a kind of Gualou Xiebai Banxia Tang solid pharmaceutical preparation
Industrialization preparation process.
Background technology
Gualou Xiebai Banxia Tang comes from Zhang Zhongjing《Synopsis Golden Chamber chest impediment and cardialgia is losed heart a disease piece》, stop up for treating sputum
It contains, chest sun numbness hinders its " unable to tie down due to obstruction of QI in the chest, the person of chesting pain radiating to the back ", is the treatment obstruction of qi in the chest, pained most classic prescriptions.The party is in Chinese medicine
Bed is widely used in coronary heart diseases and angina pectoris, myocardial infarction, heart failure, vital myocarditis, chronic cor pulmonale, the heart
A variety of treatments for feeling concerned about disease such as not normal are restrained, in addition to this, it can also be used to the lung pattern diseases such as chronic bronchitis, bronchial asthma
Treatment.
The medicine group of Gualou Xiebai Banxia Tang becomes：Chinese juniper beach wormwood real one piece (smashing), three liang of Longstamen Onion Bulb, half liter of the tuber of pinellia, white wine are a pipeful of,
Preparation method is：Upper four taste takes four liters with decocting.
Currently, there is no the related preparations of Gualou Xiebai Banxia Tang to list on domestic market, relevant big production is also had no
Technique is reported.Currently, alcohol precipitation, high temperature drying, powder after the water extraction or alcohol extracting, concentration that are generally used in the big production of Chinese patent drug
The technological processes such as broken, molding, this conventional production technology has the advantages such as simple, the at low cost and technology maturation of equipment, in reality
Well received in the industrialization of border, regrettably there are two obvious shortcomings for this production technology at present, first, alcohol precipitation process may
Generate certain chemical reactions；Second is that high-temperature drying procedures can destroy certain thermally labile components, two above main problem can make
The Chinese medicine preparation of acquisition material base in large-scale production process changes, and leads to the difference on clinical efficacy.Therefore, it continues to use
Current Chinese patent drug extraction process can not ensure big there may be patent medicine defectives in classics recipe progress industrialization process
Consistency of the product that production is obtained with traditional handicraft in inherent quality.
Therefore, problem above is solved, it is necessary to respect traditional medication custom and decocting process, be extracted with sophisticated equipment
The preparation of acquisition should keep should also having carrying side with consistency of the decoction on whole material composition, novel formulation obtained by former technique
Just the advantages that, stability is good and convenient to take.
Invention content
The purpose of the present invention is in view of the above shortcomings of the prior art, provide a kind of Gualou Xiebai Banxia Tang solid pharmaceutical preparation
Preparation process determines that decocting time, filtering and concentration of lab scale craft etc. are specifically joined by groping traditional decoction technique
Lab scale craft parameter is transformed into big production by number, reconciles the technique ginseng of decoction, technique, drying, granulation in big production etc.
It is consistent to monitor the chemical constituent in large-scale production process before and after each step using HPLC multicomponent fingerprint atlas detection methods for number
Property, it is ensured that the decoction substance that the Gualou Xiebai Banxia Tang new formulation that modern extraction process obtains is obtained with traditional decoction extraction
It forms almost the same.
Recipe quantity and decocting process in the preparation process of Gualou Xiebai Banxia Tang solid pharmaceutical preparation provided by the invention use
Following scheme is realized：
(1) conversion of recipe quantity：
Recipe quantity metering conversion, be according to the measurement unit of Han dynasty since the measurement unit of Han dynasty is different from the modern times
It is converted with modern measurement unit, the recipe quantity of Gualou Xiebai Banxia Tang original side is as follows：
Chinese juniper beach wormwood real one piece (smashing), three liang of Longstamen Onion Bulb, half liter of the tuber of pinellia, white wine are a pipeful of.
Since Snakegourd Fruit is not of uniform size, the weight of one piece of Snakegourd Fruit is simultaneously not fixed, and the present invention randomly selects in medicinal material market
100 pieces of Snakegourd Fruits, average weight 62g.
Suggestion of the present invention through Literature Consult and clinical classical prescription doctor, chooses pinellia and is used as the tuber of pinellia in original side,
The yellow rice wine that selection meets 13662 standards of GB/T is used as the white wine in original side.
The present invention is equal to modern 15.6g by Han dynasty one or two and converts, three liang of Longstamen Onion Bulb i.e. 47g；The a pipeful of of Han dynasty be
Decaliter, one is upgraded to modern 200ml；Half liter of pinellia, that is, 100ml pinellias, weigh to obtain 47g；The a pipeful of i.e. 2000ml yellow rice wine of white wine.
I.e. the dosage of each taste medicine is in we：
Snakegourd Fruit 62g, Longstamen Onion Bulb, pinellia each 47g, yellow rice wine 2000ml.
(2) optimal extraction technology：
According to the related requirement of country, production technology and the traditional handicraft of classics recipe are answered almost the same therefore of the invention
The determination of the parameters such as middle Extraction solvent and dosage, extraction time is compared with traditional technique (lab scale craft)
On the basis of determine, Gualou Xiebai Banxia Tang exists《Synopsis Golden Chamber》Described in preparation method it is as follows：
Upper four taste takes four liters with decocting.
For decocting time depending on the variation of decoction liquor, the one of Han dynasty is upgraded to modern 200ml, decocts 2000ml liquids extremely
The time of 800ml liquids, that is, decocting time is to get lab scale soup.
Using above-mentioned lab scale soup as standard decoction, with the finger-print of foundation, method of quality control, guidance are touched as a whole
The big processing parameter of rope establishes the preparation production technique route of Gualou Xiebai Banxia Tang, the big production technology that the present invention obtains
Parameter ensure that the product quality consistency obtained with lab scale craft, the i.e. consistency of clinical efficacy.
It is discussed based on above-mentioned scheme, a kind of preparation process of Gualou Xiebai Banxia Tang solid pharmaceutical preparation provided by the invention is logical
Following technical scheme is crossed to be achieved：
(1) choose examines qualified Snakegourd Fruit, Longstamen Onion Bulb, pinellia pharmaceutical decocting piece and yellow rice wine, medicinal material mainly to select by national standard
Fetch the high-quality tcm and herbal slice derived from Genuine producing area；
(2) medicinal material of step (1) and yellow rice wine are mixed in prescription ratio, heating is boiled, and keeps slightly boiling 1~1.5 hour；
(3) after slightly boiling extraction, with 100~300 mesh screens, filtrate removes impurity and macromolecular by high speed centrifugation
Substance obtains clear extracting solution；
(4) extracting solution of step (3) is concentrated by depressurizing low temperature, is concentrated to certain relative density, it is spare；
(5) a certain proportion of auxiliary material is added in the concentrate that step (4) obtains or is not added with auxiliary material, mixing is dry by spraying
Dry rapid draing is at powder；
(6) powder for obtaining step (5), granule is prepared by wet granulation, dry granulation or boiling granulating；
(7) global quality control is carried out to the granule of acquisition, is according to the finger-print for establishing feature with standard decoction
Control method carries out overall monitor, to ensure that the material base of lilii and Rehmanniae Decoction in big production process does not have to product quality
There is significant change.
Preferably, prescription ratio is from each taste survival dose in Gualou Xiebai Banxia Tang in the step (2), by certain folding
The modern measurement unit that is converted to of coefficient is calculated, as 1 liang of Han dynasty based on 15.6g；1 liter of Han dynasty is based on 200ml etc..
Preferably, the high speed centrifugation in the step (3) is that disk centrifuges or tubular type centrifugation, wherein disk centrifugal rotational speed are
7000~12000 revs/min；Tubular type centrifugal rotational speed is 9000~25000 revs/min.
Preferably, the relative density of concentrate is 1.01~1.20 in the step (4).
Preferably, the auxiliary material in the step (5) is the one or more of soluble starch, maltodextrin, sucrose.
Preferably, the intake air temperature being spray-dried in the step (5) is 160~190 DEG C, air outlet temperature 65~85
DEG C, feed liquid 5~200kg/h for the treatment of capacity, wherein pneumatic spray drying throughput are 0.4~3.0m3/min；Atomizer is dry
8000~25000 revs/min of dry centrifugation rate, a diameter of 50~350mm of spray disk.
Preferably, boiling granulating feeding temperature is 20~50 DEG C in the step (6), and intake air temperature is 60~150 DEG C,
30~75 DEG C of air outlet temperature, 10~100kg/h of feed liquid treating capacity.
Preferably, the detection method of finger-print chromatography is high performance liquid chromatography in the step (7).
Preferably, finger-print requires sample finger-print compared with reference fingerprint in the step (7), similar
Degree is 0.90 or more.
Compared with traditional handicraft, the present invention has the following advantages：
1, Gualou Xiebai Banxia Tang solid pharmaceutical preparation prepared by the present invention carries convenient, convenient to take, convenient for storage, is conducive to
The marketization；
2, decocting process parameter from traditional decoction technological parameter and has equivalent extraction effect；
3, concentrating and impurity removing process uses physics mode to remove impurity under cryogenic, will not cause to be thermally decomposed, chemistry
The change of the material bases such as composition transfer；
4, drying process uses wink-dry technology, and material composition will not be made unstable because of high temperature；
5, it after the completion of prepared by standard decoction, establishes using standard decoction as the global quality control pattern of reference, using referring to
Whole chemical compositions composition, the multicomponent Con trolling index of foundation is used in line graphical spectrum technology overall monitor standard decoction
The product stability produced greatly is investigated to establish the term of validity of patent medicine preparation.
Description of the drawings
Fig. 1 is the selection of one gained chromatogram of selection method and wavelength；
Fig. 2 is two gained chromatogram of selection method；
Fig. 3 is three gained chromatogram of selection method；
Fig. 4 is four gained chromatogram of selection method；
Fig. 5 is Gualou Xiebai Banxia Tang reference fingerprint；
Fig. 6 is Gualou Xiebai Banxia Tang solid pharmaceutical preparation production link quality control chart.
Specific implementation mode
With reference to embodiment, the technical solution further illustrated the present invention, but the embodiment is merely to illustrate this hair
The bright rather than limitation present invention.
Embodiment 1：The preparation of Gualou Xiebai Banxia Tang particle；
Snakegourd Fruit 4.6kg, Longstamen Onion Bulb 3.5kg, pinellia 3.5kg, yellow rice wine 150L.
The above medicinal material is put into extractor, yellow rice wine is added, heating boils, and after keeping slightly boiling 1 hour, stops heating.
The above extracting solution is filtered with the sieve of 150 mesh.After letting cool, with (7000~9000 revs/min of disk plate centrifuge
Clock) centrifugation, extracting solution must be clarified as sample detection 1.
Extracting solution depressurizes (≤65 DEG C) concentrations of (≤0.08MPa) low temperature, and it is 1.03~1.08g/ml to be concentrated into relative density,
Stop heating concentration and is used as sample detection 2.
The above liquid is spray-dried, spray drying parameters are：185 DEG C of intake air temperature, 65 DEG C of air outlet temperature,
Into medicine speed 10kg/h, throughput 1.6m3/ min obtains dried powder, spare, as sample detection 3.
It by the above powder, is pelletized with fluid bed granulator, feeding temperature is 37 DEG C, and intake air temperature is 110 DEG C, air outlet temperature
60 DEG C of degree, feed liquid treating capacity 10kg/h.Granule after granulation is Gualou Xiebai Banxia Tang particle, as sample detection 4.
Embodiment 2：The foundation of Gualou Xiebai Banxia Tang finger-print；
1) preparation of Chinese medicine standard decoction：
15 batches or more representative Snakegourd Fruits, Longstamen Onion Bulb, pinellia pharmaceutical decocting piece and yellow rice wine, every batch of prescription are bought on the market
Amount is：Snakegourd Fruit 62g, Longstamen Onion Bulb 47g, pinellia 47g, yellow rice wine 2000ml.The above medicinal material and yellow rice wine are placed in medicine pot, heating is boiled
Boiling, keeps slightly boiling 70 minutes；After slightly boiling is extracted, filter to get 15 batches of Gualou Xiebai Banxia Tang standard decoctions.
2) foundation of finger-print：
A. the preparation of test solution：
The standard decoction for taking this product, with the test solution of 0.45 μm of water phase membrane filtration, that is, standard decoction, (1ml contains medicinal material
0.195g)；Concentrate, intermediate, powder in production process are respectively settled to the solution of 1ml 0.195g containing medicinal material with water,
With 0.45 μm of water phase membrane filtration up to the test solution of the above sample.
B. the selection of chromatographic condition：
Method one：Phenomenon C18 chromatographic columns (250mm × 4.6mm, 5 μm), column temperature are 20 DEG C, flow velocity 1ml/
Min, Detection wavelength：215,254,315nm, mobile phase and degree elution requirement are as shown in the table：
| Time (min) | Methanol (%) | 0.1% phosphoric acid (%) |
| 0 | 5 | 95 |
| 90 | 95 | 5 |
Obtained chromatogram is shown in attached drawing 1.
As a result：Chromatographic peak is concentrated mainly within 40min, and separating degree is bad, and the Chromatographic information under 215nm is relatively abundant.
Method two：Phenomenon C18 chromatographic columns (250mm × 4.6mm, 5 μm), column temperature are 20 DEG C, flow velocity 1ml/
Min, Detection wavelength：215nm, mobile phase and degree elution requirement are as shown in the table：
| Time (min) | Methanol (%) | 0.1% phosphoric acid (%) |
| 0 | 5 | 95 |
| 20 | 5 | 95 |
| 80 | 45 | 55 |
Obtained chromatogram is shown in attached drawing 2.
As a result：Chromatographic peak separating effect before 10min is bad.
Method three：Phenomenon C18 chromatographic columns (250mm × 4.6mm, 5 μm), column temperature are 20 DEG C, flow velocity 1ml/
Min, Detection wavelength：215nm, mobile phase and degree elution requirement are as shown in the table：
| Time (min) | Methanol (%) | 0.1% phosphoric acid (%) |
| 0 | 3 | 97 |
| 20 | 3 | 97 |
| 80 | 45 | 55 |
Obtained chromatogram is shown in attached drawing 3.
As a result：The chromatographic peak separating effect of 10min or so is still bad.
Method four：Phenomenon C18 chromatographic columns (250mm × 4.6mm, 5 μm), column temperature are 20 DEG C, flow velocity 1ml/
Min, Detection wavelength：215nm, mobile phase and degree elution requirement are as shown in the table：
| Time (min) | Methanol (%) | 0.1% phosphoric acid (%) |
| 0 | 1 | 99 |
| 20 | 3 | 97 |
| 80 | 45 | 55 |
Obtained chromatogram is shown in attached drawing 4.
As a result：Chromatographic peak separating degree is preferable, and Chromatographic information is relatively abundant.
C. finger-print chromatographic condition determines：
By above-mentioned experiment, confirmation fingerprint spectrum method is method four, i.e.,：Phenomenon C18 chromatographic columns (250mm ×
4.6mm, 5 μm), column temperature is 20 DEG C, flow velocity 1ml/min, Detection wavelength：215nm, mobile phase and degree elution requirement such as following table institute
Show：
| Time (min) | Methanol (%) | 0.1% phosphoric acid (%) |
| 0 | 1 | 99 |
| 20 | 3 | 97 |
| 80 | 45 | 55 |
D. the foundation of finger-print：
15 batch Gualou Xiebai Banxia Tang standard decoctions are taken, high performance liquid chromatography inspection is carried out by finger-print chromatographic condition
It surveys, obtained collection of illustrative plates is analyzed by similarity evaluation, obtains Gualou Xiebai Banxia Tang
Reference fingerprint is shown in attached drawing 5.
Embodiment 3：Gualou Xiebai Banxia Tang particulate production global quality control；
According to Gualou Xiebai Banxia Tang fingerprint spectrum method, to (sampling and examining in embodiment 1 after being centrifuged in product preparation process
It surveys 1), after concentration (sample detection 2 in embodiment 1), after drying (sample detection 3 in embodiment 1), (is taken in embodiment 1 after granulation
4) sample that sample detection obtains carries out efficient liquid phase chromatographic analysis, and obtained chromatogram is shown in attached drawing 6；With Gualou Xiebai Banxia Tang pair
Similarity analysis is carried out according to finger-print, similarity illustrates that each production link can guarantee Snakegourd Fruit Longstamen Onion Bulb half 0.90 or more
The inherent quality of summer soup does not change substantially, and the Gualou Xiebai Banxia Tang solid pharmaceutical preparation of preparation does not change the substance of decoction substantially
Basis.
Claims (6)
1. a kind of preparation process of Gualou Xiebai Banxia Tang solid pharmaceutical preparation, which is characterized in that include the following steps：
(1) it chooses and examines qualified Snakegourd Fruit, Longstamen Onion Bulb, pinellia pharmaceutical decocting piece and yellow rice wine by national standard, medicinal material, which is mainly chosen, to be come
High-quality tcm and herbal slice derived from Genuine producing area；
(2) medicinal material of step (1) and yellow rice wine are mixed in prescription ratio, heating is boiled, and keeps slightly boiling 1~1.5 hour；
(3) after slightly boiling extraction, with 100~300 mesh screens, filtrate removes impurity and macromolecular complex by high speed centrifugation
Matter obtains clear extracting solution；
(4) by the extracting solution of step (3) by depressurizing low temperature concentration, the relative density for being concentrated to concentrate is 1.01~1.20,
It is spare；
(5) a certain proportion of auxiliary material is added in the concentrate that step (4) obtains or is not added with auxiliary material, mixing is fast by being spray-dried
Speed is dried to powder, and the auxiliary material is the one or more of soluble starch, maltodextrin, sucrose, the spray drying into
Draught temperature is 160~190 DEG C, 65~85 DEG C of air outlet temperature, and feed liquid 5~200kg/h for the treatment of capacity, wherein air-flowing type spraying are dry
Pathogenic dryness flow is 0.4~3.0m3/min；Atomizer dries 8000~25000 revs/min of centrifugation rate, disk diameter of spraying
For 50~350mm；
(6) powder for obtaining step (5), granule is prepared by wet granulation, dry granulation or boiling granulating；
(7) global quality control is carried out to the granule of acquisition, is to be controlled according to the finger-print for establishing feature with standard decoction
Method carries out overall monitor to product quality, and the material base to ensure lilii and Rehmanniae Decoction in big production process is not bright
Aobvious variation.
2. the preparation process of Gualou Xiebai Banxia Tang solid pharmaceutical preparation according to claim 1, it is characterised in that：The step
(2) prescription ratio is from each taste survival dose in Gualou Xiebai Banxia Tang in, the modern metering being converted to by certain conversion factor
Unit, as 1 liang of Han dynasty based on 15.6g；1 liter of Han dynasty is based on 200ml etc..
3. the preparation process of Gualou Xiebai Banxia Tang solid pharmaceutical preparation according to claim 1, it is characterised in that：The step
(3) high speed centrifugation in is that disk centrifuges or tubular type centrifuges, and wherein disk centrifugal rotational speed is 7000~12000 revs/min；Tubular type
Centrifugal rotational speed is 9000~25000 revs/min.
4. the preparation process of Gualou Xiebai Banxia Tang solid pharmaceutical preparation according to claim 1, it is characterised in that：The step
(6) boiling granulating feeding temperature is 20~50 DEG C in, and intake air temperature is 60~150 DEG C, 30~75 DEG C of air outlet temperature, feed liquid
10~100kg/h for the treatment of capacity.
5. the preparation process of Gualou Xiebai Banxia Tang solid pharmaceutical preparation according to claim 1, it is characterised in that：The step
(7) detection method of finger-print chromatography is high performance liquid chromatography in.
6. the preparation process of Gualou Xiebai Banxia Tang solid pharmaceutical preparation according to claim 1, it is characterised in that：The step
(7) finger-print requires sample finger-print compared with reference fingerprint in, and similarity is 0.90 or more.
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|---|---|---|---|
| CN201810481136.7A CN108355041B (en) | 2018-05-18 | 2018-05-18 | Preparation process of snakegourd fruit, allium macrostemon and pinellia ternata decoction solid preparation |
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|---|---|---|---|
| CN201810481136.7A CN108355041B (en) | 2018-05-18 | 2018-05-18 | Preparation process of snakegourd fruit, allium macrostemon and pinellia ternata decoction solid preparation |
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Cited By (4)
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|---|---|---|---|---|
| CN108888748A (en) * | 2018-09-22 | 2018-11-27 | 广州志道经方科技有限公司 | A kind of preparation process of banxia xiexin decoction solid pharmaceutical preparation |
| CN110376294A (en) * | 2019-05-28 | 2019-10-25 | 神威药业集团有限公司 | A kind of construction method of Snakegourd Fruit granule finger-print |
| CN111214607A (en) * | 2020-03-20 | 2020-06-02 | 鲁南制药集团股份有限公司 | Preparation method of trichosanthes kirilowii, allium macrostemon and pinellia ternate particles |
| CN113607855A (en) * | 2021-08-23 | 2021-11-05 | 神威药业集团有限公司 | Fingerprint spectrum of medicinal preparation of snakegourd fruit, allium macrostemon and pinellia ternata decoction, and establishing method and application thereof |
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Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN108888748A (en) * | 2018-09-22 | 2018-11-27 | 广州志道经方科技有限公司 | A kind of preparation process of banxia xiexin decoction solid pharmaceutical preparation |
| CN110376294A (en) * | 2019-05-28 | 2019-10-25 | 神威药业集团有限公司 | A kind of construction method of Snakegourd Fruit granule finger-print |
| CN110376294B (en) * | 2019-05-28 | 2021-07-23 | 神威药业集团有限公司 | Method for constructing fingerprint spectrum of snakegourd fruit formula particles |
| CN111214607A (en) * | 2020-03-20 | 2020-06-02 | 鲁南制药集团股份有限公司 | Preparation method of trichosanthes kirilowii, allium macrostemon and pinellia ternate particles |
| CN113607855A (en) * | 2021-08-23 | 2021-11-05 | 神威药业集团有限公司 | Fingerprint spectrum of medicinal preparation of snakegourd fruit, allium macrostemon and pinellia ternata decoction, and establishing method and application thereof |
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| CN108355041B (en) | 2021-11-23 |
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