CN105663079B - A method of it prepares and subtracts taste antiphlogistic bezoar capsule - Google Patents
A method of it prepares and subtracts taste antiphlogistic bezoar capsule Download PDFInfo
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- CN105663079B CN105663079B CN201610119434.2A CN201610119434A CN105663079B CN 105663079 B CN105663079 B CN 105663079B CN 201610119434 A CN201610119434 A CN 201610119434A CN 105663079 B CN105663079 B CN 105663079B
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- 239000002775 capsule Substances 0.000 title claims abstract description 54
- 206010004542 Bezoar Diseases 0.000 title claims abstract description 49
- 238000000034 method Methods 0.000 title claims abstract description 39
- 235000019640 taste Nutrition 0.000 title claims abstract description 32
- 239000002260 anti-inflammatory agent Substances 0.000 title claims abstract description 28
- 230000001741 anti-phlogistic effect Effects 0.000 title claims abstract description 28
- 239000000843 powder Substances 0.000 claims abstract description 46
- 239000006071 cream Substances 0.000 claims abstract description 38
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims abstract description 31
- 229910052602 gypsum Inorganic materials 0.000 claims abstract description 24
- 239000010440 gypsum Substances 0.000 claims abstract description 24
- DTGKSKDOIYIVQL-WEDXCCLWSA-N (+)-borneol Chemical compound C1C[C@@]2(C)[C@@H](O)C[C@@H]1C2(C)C DTGKSKDOIYIVQL-WEDXCCLWSA-N 0.000 claims abstract description 23
- REPVLJRCJUVQFA-UHFFFAOYSA-N (-)-isopinocampheol Natural products C1C(O)C(C)C2C(C)(C)C1C2 REPVLJRCJUVQFA-UHFFFAOYSA-N 0.000 claims abstract description 23
- 241000208671 Campanulaceae Species 0.000 claims abstract description 23
- 229940116229 borneol Drugs 0.000 claims abstract description 23
- CKDOCTFBFTVPSN-UHFFFAOYSA-N borneol Natural products C1CC2(C)C(C)CC1C2(C)C CKDOCTFBFTVPSN-UHFFFAOYSA-N 0.000 claims abstract description 23
- DTGKSKDOIYIVQL-UHFFFAOYSA-N dl-isoborneol Natural products C1CC2(C)C(O)CC1C2(C)C DTGKSKDOIYIVQL-UHFFFAOYSA-N 0.000 claims abstract description 23
- 239000000706 filtrate Substances 0.000 claims abstract description 21
- 238000002360 preparation method Methods 0.000 claims abstract description 18
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- 235000008081 Rheum officinale Nutrition 0.000 claims abstract description 14
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- 235000019425 dextrin Nutrition 0.000 claims abstract description 9
- 238000001291 vacuum drying Methods 0.000 claims abstract description 9
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- 239000000463 material Substances 0.000 claims description 34
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Classifications
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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
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/4841—Filling excipients; Inactive ingredients
- A61K9/4866—Organic macromolecular compounds
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/045—Hydroxy compounds, e.g. alcohols; Salts thereof, e.g. alcoholates
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K33/00—Medicinal preparations containing inorganic active ingredients
- A61K33/06—Aluminium, calcium or magnesium; Compounds thereof, e.g. clay
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- 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
- A61K35/12—Materials from mammals; Compositions comprising non-specified tissues or cells; Compositions comprising non-embryonic stem cells; Genetically modified cells
- A61K35/37—Digestive system
- A61K35/413—Gall bladder; Bile
-
- 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)
- A61K36/34—Campanulaceae (Bellflower family)
- A61K36/346—Platycodon
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- A—HUMAN NECESSITIES
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- 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)
- A61K36/48—Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
- A61K36/484—Glycyrrhiza (licorice)
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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)
- A61K36/53—Lamiaceae or Labiatae (Mint family), e.g. thyme, rosemary or lavender
- A61K36/539—Scutellaria (skullcap)
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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)
- A61K36/70—Polygonaceae (Buckwheat family), e.g. spineflower or dock
- A61K36/708—Rheum (rhubarb)
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- 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
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- Health & Medical Sciences (AREA)
- Natural Medicines & Medicinal Plants (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
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- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
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- Alternative & Traditional Medicine (AREA)
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Abstract
The present invention relates to field of pharmaceutical preparations, and in particular to a method of it prepares and subtracts taste antiphlogistic bezoar capsule.It is of the present invention to prepare the method raw material progress pre-treatment each first for subtracting taste antiphlogistic bezoar capsule; then filtrate is collected after taking gypsum, campanulaceae, Radix Glycyrrhizae, the radix scutellariae of the net system of recipe quantity to add water to cook; vacuum-concentrcted is mixed at smashed rheum officinale, artificial bezoar powder and the dextrin that vacuum drying after medicinal extract is ground into dried cream powder and recipe quantity; wet granulation, it is dry；Then it is mixed with the smashed borneol of recipe quantity, fills capsule.Using preparation method provided by the invention in the case where amplifying working condition, every batch of yield may be up to 320,000, be easy to industrialized production.And obtained subtract that taste antiphlogistic bezoar capsule is met the quality standard, active constituent content is high, stability is good, disintegration is easy to absorb fastly, release is excellent.
Description
Technical field
The present invention relates to field of pharmaceutical preparations, and in particular to a method of it prepares and subtracts taste antiphlogistic bezoar capsule.
Background technique
Detoxicating tablet of cow-bezoar is heat-clearing and detoxifying drug standing in family and traditional Chinese patent drug, by cow-bezoar, realgar, gypsum, big
Huang, radix scutellariae, campanulaceae, borneol and Radix Glycyrrhizae composition, play the role of it is clearing heat and detoxicating, for Sheng in burning hot, abscess of throat, swelling and aching of gum,
The diseases such as aphthae, red eye, swell pain.Recently the study found that taking detoxicating tablet of cow-bezoar for a long time, to nervous system, digestive system, secrete
The toxic side effects such as urinary system, blood, breathing, skin.Main noxious material is realgar in detoxicating tablet of cow-bezoar, and content is endured
Greatly, main component is orpiment, that is, the arsenic being commonly called as.Arsenic is in addition to liver, kidney, hematological system, nerveous system
System and the toxic effect of reproductive system, can also act on protein and cause anaphylaxis lesion.In addition to the above symptom, antiphlogistic bezoar
Piece also will cause some additive, and clinical manifestation is to occur serious withrawal symptom after being discontinued, and abscess of throat aggravates etc., is taken medicine again
Above-mentioned symptom is alleviated rapidly afterwards.
Subtract the secondary development that taste antiphlogistic bezoar capsule is famous-brand and high-quality Chinese patent drug detoxicating tablet of cow-bezoar, is on the basis of detoxicating tablet of cow-bezoar
It goes up " side's of repairing remodeling " and is developed into.Subtract the prescription that taste antiphlogistic bezoar capsule is detoxicating tablet of cow-bezoar on prescription to subtract realgar and form,
As cow-bezoar, rheum officinale, gypsum, radix scutellariae, campanulaceae, borneol, seven taste Chinese traditional medicine composition of Radix Glycyrrhizae form, function be it is clearing heat and detoxicating, cure mainly fire
Re Neisheng, abscess of throat, swelling and aching of gum, aphthae, red eye, swell pain.Solves cow-bezoar solution on the basis of keeping original curative effect
The safety issue for the arsenic poisoning that realgar causes in malicious piece.Subtract taste antiphlogistic bezoar capsule in dosage form using disintegration and release ratio
Tablet more preferably capsule dosage form, improves bioavilability.
Subtract in taste antiphlogistic bezoar capsule prescription, cow-bezoar, rheum officinale are monarch drug in a prescription.Cow-bezoar bitter is cold and cool, is clearing heat and detoxicating key medicine, energy
Waking up the patient from unconsciousness by clearing away heart fire, slit phlegm arresting convulsion, for treating abscess of throat, noma aphtha, oral administration and externally all has good effect." meeting medicine cures mirror " meaning is originally
Product: " erysipelas is treated, noma, larynx is swollen, all real examples danger person again." rheum officinale bitter is cold and cool, property sedimentation, can drastic purgation real heat, cleanse intestines
Stomach is walked without keeping, and is clearing heat-fire, the common product of removing pattogenic heat from the blood and toxic material from the body.Shennong's Herbal calls this product: " cleansing stomach, weeding through the old to new." with
Upper two taste is directed to primary symptom and plays leading role.Gypsum, radix scutellariae, borneol are ministerial drug.Gypsum be it is pungent, sweet, property Great Cold is apt to clear purging the lung of pathogenic fire
The fire of stomach, and the heat of fleshy exterior can be solved, to the swelling and aching of gum of exuberance of stomach fire, aphthae is rather effective, and " A View of Epidemic Febrile Diseases with Rashes " calls this product:
" cold in nature, big clearing away the stomach-heat；Property light gas, can expelling pathogenic factors from muscles and skin heat；Property of body sinking drops, and can rush down real heat." radix scutellariae be common clearing heat-fire antidote,
Especially it is apt to clear purging the lung of pathogenic fire and the fire of large intestine, rushes down part of the body cavity above the diaphragm housing the heart and lungs real heat clearly." pearl sac " call this product: " the cool heart, control it is damp and hot in lung, on purte the white
It is inverse." the pungent scattered hardship of borneol rushes down, fragrance is walked to alter, and can dissipate hot and suffocating, external application energy clearing away heat to and alleviating pain myogenic, common by ophthalmology, larynx section." book on Chinese herbal medicine
Detailed outline " meaning this product: it " treats sore throat ... toothache ... and leads to all keys, dissipate stagnated fire." more than three tastes can assist monarch drug in a prescription for primary symptom very well.Tangerine
Stalk and Radix Glycyrrhizae are adjuvant.The pungent scattered hardship of campanulaceae is rushed down, and light liter is floating, is longer than clearing throat, and " book on Chinese herbal medicine is looked for the truth " meaning: " campanulaceae system, which opens, to be mentioned
The medicine of lung qi can be all medicine ships, and the floating of load can draw hardship and rush down drastic purgation agent, be divided into function as supreme ...." Radix Glycyrrhizae is raw with rushing down
Fire removing toxic substances, especially kind coordinating the drug actions of a prescription, above two taste are our adjuvant.
Subtract taste antiphlogistic bezoar capsule and country 3 is approved as by State Food and Drug Administration on September 23rd, 2003
Kind new medicine, New Drug Certificate number are as follows: national drug standard Z20030107, New Drug Certificate holder are as follows: the grand limited public affairs of letter pharmacy in Guangdong
Department.Subtracting taste antiphlogistic bezoar capsule is exclusive product, and China has at present and only Long Xin pharmaceutical Co. Ltd in Guangdong is approved production originally
Product.
Summary of the invention
The purpose of the present invention is to provide a kind of prepare to subtract the method for taste antiphlogistic bezoar capsule.The method of the invention can be compared with
Bigization retains the effective component of each raw material in prescription, and is easy to industrialized production.Product active constituent content obtained is high, steady
It is qualitative it is good, release is excellent.
To achieve the purpose of the present invention, the present invention adopts the following technical scheme:
A method of it prepares and subtracts taste antiphlogistic bezoar capsule, comprising the following steps:
1) pre-treatment: rheum officinale, borneol crush, gypsum, campanulaceae, Radix Glycyrrhizae and radix scutellariae net system；
2) preparation of dried cream powder: gypsum, campanulaceae, Radix Glycyrrhizae, radix scutellariae after weighing net system by recipe quantity are collected after adding water to cook
Filtrate, vacuum-concentrcted are crushed into powder at vacuum drying after medicinal extract；
3) it pelletizes: weighing smashed rheum officinale, the artificial bezoar powder of recipe quantity, it is mixed with dried cream powder obtained by step 2) and dextrin
Even, wet granulation is dry；
4) total mix and filling: weighing the smashed borneol of recipe quantity, mixes filling capsule with particle made from step 3).
Wherein, of the present invention to subtract taste antiphlogistic bezoar capsule, main active is in parts by mass, comprising: cow-bezoar 1
Part, 40 parts of gypsum, 40 parts of rheum officinale, 30 parts of radix scutellariae, 20 parts of campanulaceae, 5 parts of borneol, 10 parts of Radix Glycyrrhizae.
The method of the invention, step 1) is described to be crushed to smash it through 80 meshes.
According to the present invention, the method step 2) is described add water to cook it is secondary to add water to cook, every time respectively plus raw material 8-12
The water of amount again decocts 2-3 hours, and decocting liquid filtering merges.It will be understood by those skilled in the art that described decoct is 100 DEG C slightly boiled
It decocts.In certain embodiments, add the water of 8 times of raw material amounts for the first time, decoct 3 hours, second plus 10 times of amount water of raw material,
It decocts 2 hours.In certain embodiments, add the water of 10 times of raw material amounts for the first time, decoct 2 hours, second plus raw material 10
Amount water again decocts 3 hours.In other specific embodiments, add the water of 10 times of raw material amounts for the first time, decocts 2 hours, second
Add 8 times of amount water of raw material, decocts 2 hours.
Further, it needs to be filtered decocting liquid after decoction in step 2).Preferably, the decocting liquid be filtered into it is pan-fried
200 mesh screen of liquid.
According to the present invention, first filter vacuum is concentrated under reduced pressure into medicinal extract after collecting filtrate for step 2), is then dried in vacuo powder
It is broken into powder.
Wherein, the step 2) vacuum-concentrcted is preferably in vacuum degree -0.02~-0.10Mpa, temperature≤80 DEG C item
Filtrate is concentrated under part.
In some embodiments, relative density is when the step 2) vacuum-concentrcted is preferably concentrated into 80 DEG C
1.03~1.20 medicinal extract.
In certain embodiments, at vacuum degree -0.09Mpa, 80 DEG C of temperature, concentrating the filtrate to relative density is
Cream is received when 1.03.In certain embodiments, it under vacuum degree -0.03Mpa, temperature 70 C, concentrates the filtrate to relatively close
Degree receives cream when being 1.20.In other specific embodiments, at vacuum degree -0.07Mpa, 80 DEG C of temperature, concentrate the filtrate to
Relative density receives cream when being 1.10.
Further, the step 2) vacuum drying is preferably in vacuum degree -0.02~-0.10Mpa, temperature≤80 DEG C item
It is dry under part.
In some embodiments, the step 2) drying is lower than 6% dry cream to moisture content.
In certain embodiments, at 80 DEG C of temperature, vacuum degree -0.09Mpa, drying to medicinal extract moisture content is lower than
Dry cream is received when 6%.In certain embodiments, dry to medicinal extract moisture content at temperature 70 C, vacuum degree -0.03Mpa
Dry cream is received when lower than 6%.It is dry to medicinal extract water at 80 DEG C of temperature, vacuum degree -0.07Mpa in other specific embodiments
Point content receives dry cream when being lower than 6%.
The method of the invention, step 2) are further crushed into powder the powder that gets dry extract after extract dry.Preferably, the powder
It is broken to cross 80 meshes after crushed for dry cream.
According to the present invention, step 3) weighs the smashed rheum officinale of recipe quantity, artificial bezoar powder, mixed with dried cream powder and dextrin
Even, wet granulation is dry.Preferably, the step 3) wet granulation is to be added in granulator, is made with 70-85% ethyl alcohol
Grain.
It will be understood by those skilled in the art that of the present invention prepare in the method for subtracting taste antiphlogistic bezoar capsule, according to glue
The loading amount that capsule is 0.4g/ calculates required dextrin quality, and weighs required dextrin according to quantity.
Further, the method for the invention, step 3) include the steps that dry.
In some embodiments, the drying is that wet granular is dried under conditions of≤80 DEG C to pellet moisture≤6%.
In certain embodiments, the step 3) drying is specially that inlet air temperature≤80 DEG C are arranged, and opens air-introduced machine
And blender, it opens steam heating and operation is dried, pellet moisture should be controlled≤6%, carry out receipts particle after qualified.
It further, in some embodiments, further include that dried particle is added in crushing and pelletizing machine, with 40 mesh
Sieve carry out whole grain.
The method of the invention, step 4), which mixes particle made from step 3) with the borneol of crushing, to be placed on hard capsule and fills
The machine of filling out is filled capsule, and final obtained loading amount is 0.4g/ and subtracts taste antiphlogistic bezoar capsule.Wherein, those skilled in the art
It can be filled according to the conventional capsule model for understanding that selection is suitable.
As shown from the above technical solution, the present invention provides a kind of prepare to subtract the method for taste antiphlogistic bezoar capsule.The present invention
It is described to prepare the method raw material progress pre-treatment first for subtracting taste antiphlogistic bezoar capsule, then take gypsum, the tangerine of the net system of recipe quantity
Stalk, Radix Glycyrrhizae, radix scutellariae collect filtrate after adding water to cook, vacuum-concentrcted is ground into dried cream powder and prescription at vacuum drying after medicinal extract
Smashed rheum officinale, artificial bezoar powder and the dextrin of amount mix, and wet granulation is dry；Then with the smashed ice of recipe quantity
Piece mixes, and fills capsule.It is of the present invention prepare subtract taste antiphlogistic bezoar capsule method be respectively adopted vacuum-concentrcted method and
Vacuum decompression seasoning is concentrated and is dried to decocting liquid, concentration boiling point is reduced using vacuum, to reduce high temperature to decocting liquid
The destruction of middle effective component has been effectively maintained a part component content.It is produced using preparation method provided by the invention in amplification
Under the conditions of, every batch of yield may be up to 320,000, be easy to industrialized production.And the taste antiphlogistic bezoar capsule obtained that subtracts meets quality
Standard, active constituent content are high, stability is good, disintegration is easy to absorb fastly, release is excellent.
Detailed description of the invention
In order to more clearly explain the embodiment of the invention or the technical proposal in the existing technology, to embodiment or will show below
There is attached drawing needed in technical description to be briefly described.
Fig. 1 shows the process flow chart of the method for the invention.
Specific embodiment
Below in conjunction with the embodiment of the present invention, technical scheme in the embodiment of the invention is clearly and completely described,
Obviously, described embodiments are only a part of the embodiments of the present invention, instead of all the embodiments.Based in the present invention
Embodiment, every other embodiment obtained by those of ordinary skill in the art without making creative efforts, all
Belong to the scope of protection of the invention.
For a further understanding of the present invention, the present invention will be described in detail combined with specific embodiments below.Wherein, except spy
It does not mentionlet alone outside bright, raw material described in preparation method of the present invention is well known to those skilled in the art, and can pass through commercial sources
It is commercially available or is prepared by the cultivation of method disclosed in the prior art, harvesting from a medical store, specification meets country
Or professional standard.
Embodiment 1: vacuum concentration process test
By gypsum, campanulaceae, Radix Glycyrrhizae, radix scutellariae medicinal materials raw material net system.It is accurate respectively to weigh the gypsum after net system according to prescription ratio
160g, campanulaceae 80g, Radix Glycyrrhizae 40g, radix scutellariae 120g, are placed in round-bottomed flask, and in the ratio of solid-liquid ratio 1:10, purified water 4L is added,
After 100 DEG C of constant temperature slightly boiled water-baths decoct 2 hours, filtrate is collected in filtering.Purified water is added in the ratio of solid-liquid ratio 1:10 in filter residue
4L, after 100 DEG C of constant temperature slightly boiled water-baths decoct 2 hours again, filtering merges the filtrate after extracting twice, obtains mixed extract.Ginseng
According to yellow in the method detection said extracted object of assay under radix scutellariae item in 2015 editions " Chinese Pharmacopoeia " first medicinal materials and medicine materical crude slice
The content of a kind of reed mentioned in ancient books glycosides is 1.112mg/mL.
(1) normal pressure concentration and vacuum-concentrcted compare
Measure 6 parts of above-mentioned mixed extract, every part of each 500mL.Wherein two parts of extracting solutions are normal at 90 DEG C, 100 DEG C respectively
Press water-bath concentration.Other three parts of extracting solutions vacuum-concentrcted at 60 DEG C, 70 DEG C, 80 DEG C, 90 DEG C respectively, adjustment pressure is about
For -0.09MPa.After extracting solution is concentrated into the medicinal extract that relative density is about 1.08 under the conditions of each, scutelloside in each medicinal extract is detected
Content, test result see the table below 1.
Table 1: the testing result of content of baicalin in medicinal extract obtained by different temperatures, different method for concentration
According to data in table 1 it is found that when vacuum-concentrcted the loss of scutelloside small, therefore vacuum decompression is concentrated compared with normal pressure
Concentration is concentrated better than normal pressure.And vacuum-concentrcted is the results show that radix scutellariae after vacuum-concentrcted at 60-90 DEG C under different temperatures
Glycosides loss is respectively less than 5%, and content fall is smaller, therefore thickening temperature≤90 DEG C are than convenient.
(2) vacuum degree test is concentrated under reduced pressure
3 parts of above-mentioned mixed extract is measured, every part of each 500mL, in Rotary Evaporators, set temperature is 80 DEG C, adjustment
Pressure is that scutelloside in each medicinal extract is detected after being concentrated into the medicinal extract that relative density is about 1.08 in -0.03, -0.06, -0.09MPa
Content, test result see the table below 2.
Table 2: content of baicalin testing result in medicinal extract obtained by vacuum-concentrcted under different vacuum degrees
By 2 result of table as it can be seen that scutelloside concentration front and back content decline difference is little under each pressure, therefore the optional model of pressure is concentrated
It encloses for -0.03~-0.09MPa.
(3) medicinal extract concentration densities are tested
3 parts of above-mentioned mixed extract is measured, every part of each 500mL, in Rotary Evaporators, set temperature is 80 DEG C, adjustment
Pressure is -0.08MPa, and after being concentrated into 50mL, 40mL, 30mL respectively, relative density and observation state, test are measured at 80 DEG C
As a result 3 be see the table below.
Table 3: content of baicalin testing result in medicinal extract obtained by vacuum-concentrcted under different vacuum degrees
| Concentration volume (mL) | Relative density (g/mL) after concentration | Enrichment stage |
| 50 | 1.03 | Diluter, easily collecting, loss are smaller |
| 40 | 1.11 | More sticky, easily collecting, loss are small |
| 30 | 1.20 | It is sticky, smaller compared with easily collecting, loss |
As seen from the results in Table 3, when concentration relative density reaches between 1.03-1.20, medical fluid is sticky and compared with easily collecting, extension
Wall phenomenon is relatively light, loss is smaller.
Embodiment 2: vacuum drying process test
By gypsum, campanulaceae, Radix Glycyrrhizae, radix scutellariae medicinal materials raw material net system.It is accurate respectively to weigh the gypsum after net system according to prescription ratio
160g, campanulaceae 80g, Radix Glycyrrhizae 40g, radix scutellariae 120g, are placed in round-bottomed flask, and in the ratio of solid-liquid ratio 1:10, purified water 4L is added,
After 100 DEG C of constant temperature slightly boiled water-baths decoct 2 hours, filtrate is collected in filtering.Purified water is added in the ratio of solid-liquid ratio 1:10 in filter residue
4L, after 100 DEG C of constant temperature slightly boiled water-baths decoct 2 hours again, filtering merges the filtrate after extracting twice.Filtrate is through vacuum decompression
Concentration, setting thickening temperature is 80 DEG C, vacuum degree is -0.07MPa, is concentrated into the medicinal extract that relative density is about 1.08.It weighs
The medicinal extract weight for stating acquisition is 726.5g, contains measurement under radix scutellariae item in 2015 editions " Chinese Pharmacopoeia " first medicinal materials of reference and medicine materical crude slice
The content that fixed method detects scutelloside in above-mentioned medicinal extract is 12.25mg/g.
(1) constant pressure and dry and the dry investigation of vacuum decompression and humid test
Weigh 5 parts of above-mentioned medicinal extract, every part of each 50g.Wherein two parts of medicinal extract normal pressure forced air drying at 90 DEG C, 100 DEG C respectively.
Vacuum decompression is dry at 70 DEG C, 80 DEG C, 90 DEG C respectively for other three parts of medicinal extract, and adjustment pressure is about -0.09MPa.Under the conditions of each
Medicinal extract is dried to constant weight, and dry extract is obtained.The content of scutelloside in each dry extract is detected, test result see the table below 4.
Table 4: content of baicalin testing result in medicinal extract obtained by different temperatures, different drying means
As seen from the results in Table 4, it is larger that the loss amount compared with before drying is dried in normal pressure forced air drying, at 100 DEG C of scutelloside.
At a temperature of same dried, the loss of scutelloside is small compared with constant pressure and dry when vacuum decompression is dry, therefore vacuum decompression drying is better than
Normal pressure forced air drying.And vacuum decompression is dry the results show that scutelloside damages after vacuum-concentrcted at 70-90 DEG C under different temperatures
It loses and is respectively less than 5%, content fall is smaller, therefore drying temperature≤90 DEG C are than convenient.
(2) it is dried under reduced pressure vacuum degree test
3 parts of above-mentioned medicinal extract is weighed, every part of each 50g carries out vacuum decompression drying, sets drying temperature as 80 DEG C, adjustment is dry
Dry vacuum degree is -0.03, -0.06, -0.09MPa, after drying to constant weight, detects the content of scutelloside in each dry extract, test knot
Fruit see the table below 5.
Table 5: content of baicalin testing result in medicinal extract obtained by vacuum-concentrcted under different vacuum degrees
By 5 result of table as it can be seen that the dry front and back content decline difference of scutelloside is little under each vacuum degree, therefore it is optional that pressure is concentrated
Range is -0.03~-0.09MPa.
Embodiment 3: subtract the preparation of taste antiphlogistic bezoar capsule
Composition is as follows: (1000)
Capsule preparation method thereof is as follows:
(1) preparation of rheum officinale, borneol medicinal material powder:
Rhubarb medicinal material is cleaned up, is dry after cutting.80 meshes are crossed after pulverizing medicinal materials after drying to get rhubarb medicinal material
Powder, it is spare.Take broken rear 80 meshes of crossing of borneol to get borneol medicinal material powder, it is spare.
(2) preparation of dried cream powder:
By gypsum, campanulaceae, Radix Glycyrrhizae, radix scutellariae medicinal materials raw material net system.Precision weigh the gypsum 200g after net system, campanulaceae 100g,
After Radix Glycyrrhizae 50g, radix scutellariae 150g, put into extractor.Add water to extract twice: adding 8 times of water for the first time, 100 DEG C of constant temperature slightly boiled
After decocting 3 hours, medical fluid carries out filtration with 200 mesh and is stored in medicine liquid tank.Second plus 10 times of water, 100 DEG C of constant temperature slightly boiled pan-fried
After boiling 2 hours, drain is carried out with 200 mesh.Merge filtrate, vacuum concentrator twice, and controlling concentration parameter is vacuum degree-
80 DEG C of 0.09Mpa, temperature concentrate the filtrate to when relative density is 1.03 (80 DEG C of surveys) and receive cream.Then by the extraction after concentration
Medicinal extract vacuum drying, controls 80 DEG C of temperature, vacuum degree -0.09Mpa, receives dry cream when medicinal extract moisture content is lower than 6%.Dry cream warp
80 meshes are smashed it through to get gypsum, campanulaceae, Radix Glycyrrhizae, radix scutellariae dried cream powder, accurately weighed dried cream powder weight is 138.6g.
(3) granulation, dry, whole grain and total mix process:
Accurately weigh rhubarb medicinal material powder 200g, artificial bezoar powder 5g, whole dried cream powder 138.6g obtained above and dextrin
31.4g is added in wet mixing pelletizer.Unlatching is stirred at low speed and is cut, and premixing is stirred after five minutes. while stirring
By 80% ethyl alcohol of 40mL from add slurry window be slowly added into wet granulator, be stirred granulation, up to by material stirring at
It is granular.The wet granular that will be made, is poured into boiling drier, and inlet air temperature≤80 DEG C are arranged, and is opened air-introduced machine and blender, is beaten
It opens steam heating and operation is dried, pellet moisture should be controlled≤6%, carry out receipts particle after qualified.By dried particle
It is added in crushing and pelletizing machine, carries out whole grain with the sieve of 40 mesh.In qualified whole Squaretaperblender, the borneol of batch has been weighed
25g is all added in total mix machine.Feed opening is closed, total mix after twenty minutes, discharges.
(4) capsule is filled:
Material, which is placed in automatic hard capsule filler, after above-mentioned whole grain is filled capsule, and qualified capsule is put into throwing
Polishing operation is carried out in ray machine, the capsule surface for polishing out answers smooth clean and tidy, the obtained capsule 1000 of theory, and specification is
0.4g/.
Embodiment 4: subtract the preparation of taste antiphlogistic bezoar capsule
Composition is as follows: (1000)
Capsule preparation method thereof is as follows:
(1) preparation of rheum officinale, borneol medicinal material powder:
Rhubarb medicinal material is cleaned up, is dry after cutting.80 meshes are crossed after pulverizing medicinal materials after drying to get rhubarb medicinal material
Powder, it is spare.Take broken rear 80 meshes of crossing of borneol to get borneol medicinal material powder, it is spare.
(2) preparation of dried cream powder:
By gypsum, campanulaceae, Radix Glycyrrhizae, radix scutellariae medicinal materials raw material net system.Precision weigh the gypsum 200g after net system, campanulaceae 100g,
After Radix Glycyrrhizae 50g, radix scutellariae 150g, put into extractor.Add water to extract twice: adding 10 times of water for the first time, 100 DEG C of constant temperature slightly boiled
After decocting 2 hours, medical fluid carries out filtration with 200 mesh and is stored in medicine liquid tank.Second plus 10 times of water, 100 DEG C of constant temperature slightly boiled pan-fried
After boiling 3 hours, drain is carried out with 200 mesh.Merge filtrate, vacuum concentrator twice, and controlling concentration parameter is vacuum degree-
0.03Mpa, temperature 70 C are concentrated the filtrate to when relative density is 1.20 (80 DEG C of surveys) and are received cream.Then by the extraction after concentration
Medicinal extract vacuum drying, controls temperature 70 C, vacuum degree -0.03Mpa, receives dry cream when medicinal extract moisture content is lower than 6%.Dry cream warp
80 meshes are smashed it through to get gypsum, campanulaceae, Radix Glycyrrhizae, radix scutellariae dried cream powder, accurately weighed dried cream powder weight is 130.1g.
(3) granulation, dry, whole grain and total mix process:
Accurately weigh rhubarb medicinal material powder 200g, artificial bezoar powder 5g, whole dried cream powder 130.1g obtained above and dextrin
39.9g is added in wet mixing pelletizer.Unlatching is stirred at low speed and is cut, and premixing is stirred after five minutes. while stirring
By 80% ethyl alcohol of 40mL from add slurry window be slowly added into wet granulator, be stirred granulation, up to by material stirring at
It is granular.The wet granular that will be made, is poured into boiling drier, and inlet air temperature≤80 DEG C are arranged, and is opened air-introduced machine and blender, is beaten
It opens steam heating and operation is dried, pellet moisture should be controlled≤6%, carry out receipts particle after qualified.By dried particle
It is added in crushing and pelletizing machine, carries out whole grain with the sieve of 40 mesh.In qualified whole Squaretaperblender, the borneol of batch has been weighed
25g is all added in total mix machine.Feed opening is closed, total mix after twenty minutes, discharges.
(4) capsule is filled:
Material, which is placed in automatic hard capsule filler, after above-mentioned whole grain is filled capsule, and qualified capsule is put into throwing
Polishing operation is carried out in ray machine, the capsule surface for polishing out answers smooth clean and tidy, the obtained capsule 1000 of theory, and specification is
0.4g/.
Embodiment 5: subtract the preparation of taste antiphlogistic bezoar capsule
Composition is as follows: (320,000)
Capsule preparation method thereof is as follows:
(1) preparation of rheum officinale, borneol medicinal material powder:
Rhubarb medicinal material is cleaned up, is dry after cutting.80 meshes are crossed after pulverizing medicinal materials after drying to get rhubarb medicinal material
Powder, it is spare.Take broken rear 80 meshes of crossing of borneol to get borneol medicinal material powder, it is spare.
(2) preparation of dried cream powder:
By gypsum, campanulaceae, Radix Glycyrrhizae, radix scutellariae medicinal materials raw material net system.Precision weigh the gypsum 64kg after net system, campanulaceae 32kg,
After Radix Glycyrrhizae 16kg, radix scutellariae 48kg, put into extractor.Add water to extract twice: adding 10 times of water for the first time, 100 DEG C of constant temperature micro-
After boiling decocts 2 hours, medical fluid carries out filtration with 200 mesh and is stored in medicine liquid tank.Second plus 8 times of water, 100 DEG C of constant temperature slightly boiled pan-fried
After boiling 2 hours, drain is carried out with 200 mesh.Merge filtrate, vacuum concentrator twice, and controlling concentration parameter is vacuum degree-
80 DEG C of 0.07Mpa, temperature concentrate the filtrate to when relative density is 1.10 (80 DEG C of surveys) and receive cream.Then by the extraction after concentration
Medicinal extract vacuum drying, controls 80 DEG C of temperature, vacuum degree -0.07Mpa, receives dry cream when medicinal extract moisture content is lower than 6%.Dry cream warp
80 meshes are smashed it through to get gypsum, campanulaceae, Radix Glycyrrhizae, radix scutellariae dried cream powder, accurately weighed dried cream powder weight is 44.5kg.
(3) granulation, dry, whole grain and total mix process:
Accurately weigh rhubarb medicinal material powder 65kg, artificial bezoar powder 1.6kg, whole dried cream powder 44.5kg obtained above and paste
Smart 8.9kg is added in wet mixing pelletizer.Unlatching is stirred at low speed and is cut, and premixing stirring after five minutes, stirs one on one side
While 80% ethyl alcohol of 12.8kg is stirred granulation, until by material stirring from adding slurry window to be slowly added into wet granulator
At graininess.The wet granular that will be made, is poured into boiling drier, and inlet air temperature≤80 DEG C are arranged, and opens air-introduced machine and stirring
Device opens steam heating and operation is dried, and pellet moisture should be controlled≤6%, carry out receipts particle after qualified.It will be dried
Particle is added in crushing and pelletizing machine, carries out whole grain with the sieve of 40 mesh.In qualified whole Squaretaperblender, batch has been weighed
Borneol 8kg is all added in total mix machine.Feed opening is closed, total mix after twenty minutes, discharges.
(4) capsule is filled:
Material, which is placed in automatic hard capsule filler, after above-mentioned whole grain is filled capsule, and qualified capsule is put into throwing
Polishing operation is carried out in ray machine, the capsule surface for polishing out answers smooth clean and tidy, the obtained capsule 320,000 of theory, and specification is
0.4g/.
Embodiment 6: study on the stability
Subtract taste antiphlogistic bezoar capsule according to the production of embodiment 3-5 the method respectively, with aluminum-plastic packaged, 12/plate.It will
It is 75% ± 5% that sample, which is put into relative humidity, in the climatic chamber that 40 ± 2 DEG C of temperature, carries out accelerated test.According to national medicine
Product standard (YBZ02582003-2009Z), respectively at 0,1,2,3, sampling in June, respectively to sample property, identification, inspection, content
Measurement, microorganism etc. are multinomial to be detected, and the steadiness of each batch sample is investigated.Test result see the table below 6.
Table 6: accelerated test investigates result
Note: --- to be not detected.
Subtract taste antiphlogistic bezoar capsule in accelerated test item made from the method for the invention as known to each accelerated test result
Each test rating in 6 months is placed under part to meet the requirements of the standard, and shows to subtract taste cow-bezoar made from preparation method of the present invention
Detoxicating capsule it is with good stability.
Claims (7)
1. a kind of prepare the method for subtracting taste antiphlogistic bezoar capsule, which comprises the following steps:
1) medicinal material pre-treatment: rheum officinale, borneol crush, gypsum, campanulaceae, Radix Glycyrrhizae, radix scutellariae net system；
2) preparation of dried cream powder: gypsum, campanulaceae, Radix Glycyrrhizae, radix scutellariae after weighing net system by recipe quantity collect filtrate after adding water to cook,
Vacuum-concentrcted is crushed into powder at vacuum drying after medicinal extract；The vacuum-concentrcted be vacuum degree -0.02~-
Under the conditions of 0.10Mpa, temperature≤80 DEG C, when filtrate is concentrated into 80 DEG C relative density be 1.03~1.20 medicinal extract；The vacuum
Dry is the dry dry cream to moisture content lower than 6% under the conditions of vacuum degree -0.02~-0.10Mpa, temperature≤80 DEG C；
3) it pelletizes: weighing smashed rheum officinale, the artificial bezoar powder of recipe quantity, mixed with dried cream powder obtained by step 2) and dextrin,
Wet granulation, it is dry；
4) total mix and filling: weighing the smashed borneol of recipe quantity, mixes filling capsule with particle made from step 3).
2. crushing the method according to claim 1, wherein step 1) is described to smash it through 80 meshes.
3. method according to claim 1 or 2, which is characterized in that step 2) is described add water to cook it is secondary to add water to cook,
Respectively add 8-12 times of the raw material water measured every time, decoct 2-3 hours, decocting liquid filtering merges.
4. according to the method described in claim 3, it is characterized in that, the decocting liquid is filtered into 200 mesh screen of decocting liquid.
5. method according to claim 1 or 2, which is characterized in that described crush of step 2) is that dry cream crosses 80 after crushed
Mesh.
6. method according to claim 1 or 2, which is characterized in that the step 3) wet granulation is to be added in granulator,
Particle is made with 70-85% ethyl alcohol.
7. method according to claim 1 or 2, which is characterized in that the drying is wet granular under conditions of≤80 DEG C
It dries to pellet moisture≤6%.
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN102091135A (en) * | 2009-12-14 | 2011-06-15 | 汤明昌 | Bezoar antidotal pills (tables and capsules) containing bezoar cultured in vitro and preparation method thereof |
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| CN102091135A (en) * | 2009-12-14 | 2011-06-15 | 汤明昌 | Bezoar antidotal pills (tables and capsules) containing bezoar cultured in vitro and preparation method thereof |
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| Title |
|---|
| 中药材黄芩的研究进展;战渤玉等;《中医药信息》;20081231;第25卷(第6期);第16-20页 |
| 牛黄解毒片中黄芩苷的含量测定;袁国秀;《中国社区医师 医学专业》;20111231;第13卷(第23期);第3页 |
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