CN106309894A - Radix asparagi and radix ophiopogonis drop pill preparation method - Google Patents
Radix asparagi and radix ophiopogonis drop pill preparation method Download PDFInfo
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- CN106309894A CN106309894A CN201610682555.8A CN201610682555A CN106309894A CN 106309894 A CN106309894 A CN 106309894A CN 201610682555 A CN201610682555 A CN 201610682555A CN 106309894 A CN106309894 A CN 106309894A
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- radix ophiopogonis
- drop pill
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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
- A61K36/8965—Asparagus, e.g. garden asparagus or asparagus fern
-
- 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
- A61K36/8968—Ophiopogon (Lilyturf)
-
- 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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/2031—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyethylene oxide, poloxamers
-
- F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
- F26—DRYING
- F26B—DRYING SOLID MATERIALS OR OBJECTS BY REMOVING LIQUID THEREFROM
- F26B5/00—Drying solid materials or objects by processes not involving the application of heat
- F26B5/04—Drying solid materials or objects by processes not involving the application of heat by evaporation or sublimation of moisture under reduced pressure, e.g. in a vacuum
- F26B5/06—Drying solid materials or objects by processes not involving the application of heat by evaporation or sublimation of moisture under reduced pressure, e.g. in a vacuum the process involving freezing
-
- 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, 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
- A61K2236/39—Complex extraction schemes, e.g. fractionation or repeated extraction steps
-
- 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
Abstract
The invention relates to a radix asparagi and radix ophiopogonis drop pill preparation method. The method includes the steps of preparing radix asparagi extracts and radix ophiopogonis extracts, mixing radix asparagi and radix ophiopogonis, conducting dropping and the like. A radix asparagi and radix ophiopogonis drop pill can remarkably reduce the cough frequency of rats in a cough inducing and asthma inducing instrument, the cough frequency reduced by the radix asparagi and radix ophiopogonis drop pill is higher than that reduced by radix asparagi and radix ophiopogonis paste, and the drop pill has a better effect on treating lung heat yin deficiency type coughing rats.
Description
[technical field]
The invention belongs to technical field of traditional Chinese medicine pharmacy.The present invention relates to the preparation method of a kind of Radix Asparagi and Radix Ophiopogonis drop pill.
[background technology]
Erdong gao records in version " Chinese Pharmacopoeia " in 2015, and prescription is 500 grams of Radix Asparagis and 500 grams of Radix Ophiopogonis.It is prepared
Method is that decocting time is 3h for the first time by two taste Chinese medicine boiling 3 times, and second time is respectively 2h with third time, collecting decoction,
Filtering, filtrate is condensed into the clear paste that relative density is 1.21～1.25 (80 DEG C).Every 100g clear paste adds 50g refined honey, is uniformly mixed so as to obtain
Described erdong gao.It has effect of nourishing YIN and moistening the lung, few for the cough caused by dryness expectorant caused by lack of lung-YIN, sputum mixed with blood, dryness in the nasal cavity
Pharyngalgia.This dosage form is yellowish-brown stiff semifluid, and ampoule is 9～15 grams, 2 times on the one.
Radix Asparagi is the dried root of liliaceous plant Radix Asparagi Asparagus cochinchinensis (Lour.) Merr.,
Original name Radix Asparagi, begins to be loaded in Shennong's Herbal, has nourishing YIN and moistening the lung, effect that lung heat clearing is promoted the production of body fluid.Radix Asparagi medical material mainly contains many
Carbohydrate content and saponin component, polysaccharide composition includes Polysaccharide A, tetra-kinds of polysaccharide of B, C, D, saponins include Chinaroot Greenbier Rhizome sapogenin,
Diosgenin, refined nurse sapogenin etc..
Radix Ophiopogonis is the dried root of Liliaceae many plants Ophiopogon Radix Ophiopogonis japonicus (L.f) Ker-Gawl..It
There is YIN nourishing and the production of body fluid promoting, effect that lung moistening clears away heart-fire.Radix Ophiopogonis, main chemical compositions was polysaccharide, steroidal saponin, homoisoflavone class, amino
Acid, cupreol, stigmasterol, glycocide compound, CYCLIC DIPEPTIDES compounds, amides compound, polyhydrony fatty acid and phenol
Acid compounds etc., wherein Radix Ophiopogonis polysaccharide is one of principle active component of Radix Ophiopogonis.The composition of polysaccharide in the Radix Ophiopogonis of different sources
And content there is also difference.
The defect of erdong gao is that dose is big, reduce relative to solid preparation poor stability, easy mouldy corruption, drug effect and
Carry inconvenience etc..In order to overcome these defects, intend it is carried out improving dosage form, be prepared as drop pill.
Gao Jianping et al. is at erdong gao and the pharmacological research of polysaccharide component thereof, and China's pharmacology communication, in 2003,20 (1): 18
Point out, erdong gao Clinical pharmacological efficiency with its contained by polysaccharide composition relevant, erdong gao adds refined honey and to be not added with refined honey (clear
Cream) pharmacological action no significant difference, therefore do not consider the effect of refined honey when improving dosage form.
Drop pill is the novel form utilizing solid dispersion technology principle to prepare, and after drop pill medicine is melted with substrate, reduces
With the contact area of air so that the stability of medicine improves.Equipment required for drop pill production is relatively easy, automatically
Change degree is high, and the cycle is short, cost-effective.Drop pill disintegrate simultaneously is rapid, dissolution rate is fast, rapid-action, it is simple to carry and take.
CN 101239150 A discloses a kind of Radix Asparagi and Radix Ophiopogonis oral formulations and preparation method thereof, relates to the 8 taste Chinese medicines such as Radix Asparagi
Preparation method, prescription is inconsistent with the present invention, is also not directed to the preparation method of drop pill；CN 102772382 B relates to a kind of Radix Ophiopogonis
Saponin D drop pill and preparation method thereof, different from the medicine of the present invention；Literature search, also find no pass Radix Asparagi and Radix Ophiopogonis drop pill and
The report of preparation method.
Use the Radix Asparagi for preparing of a conventional oven drying means and Radix Ophiopogonis extract, owing to becoming with saponin containing polysaccharide
Point, have and draw moist, and be difficult to be dried, the extract thickness obtained, be difficult to pulverize, use extraction prepared by Freeze Drying Technique
Loosening, it is easy to pulverize, can prevent moisture absorption after being prepared into drop pill material, have dissolution rate fast, bioavailability is high, surely
Qualitative high feature.
[summary of the invention]
[solving the technical problem that]
It is an object of the invention to provide the preparation method of a kind of Radix Asparagi and Radix Ophiopogonis drop pill.
[technical scheme]
The present invention is achieved through the following technical solutions.
The present invention relates to the preparation method of a kind of Radix Asparagi and Radix Ophiopogonis drop pill.
The step of this preparation method is as follows:
A, prepare Radix Asparagi and Radix Ophiopogonis extract
According to the ratio 1:5～10 of raw material in gram with water in terms of ml, Radix Asparagi or raw material Radix Ophiopogonis are added in water soak 0.5～
1.0h, then extracts 55～65min under micro-boiling, filters, and filtering residue continues repetitive operation by this way 2～4 times, the filter of collection
Liquid merges；
Then allow merging filtrate be concentrated into 1/10th of its original volume on a rotary evaporator, add by volume
95% ethanol solution, makes the concentration of alcohol of described merging filtrate reach by volume 80%, places 12～24h, at rotating speed 3000
～under conditions of 6000r/min centrifugal 15～25min, the precipitation obtained is dissolved in temperature 45～60 DEG C of water, be then placed in temperature-
5～-40 DEG C at carry out precooling, then be vacuum dried under vacuum 1.3～80 handkerchief, then obtain Radix Asparagi or Radix Ophiopogonis extracts
Thing；
B, preparation Radix Asparagi and Radix Ophiopogonis
The Radix Asparagi that step A obtains is mixed homogeneously according to weight ratio 1:0.8～1.2 with Radix Ophiopogonis extract；Polyethylene Glycol simultaneously
6000 substrate heat in adding heat container under agitation, extract with Radix Ophiopogonis once the melted Radix Asparagi that just adds of described substrate
Thing mixture, obtains Radix Asparagi and Radix Ophiopogonis drop pill material；
Radix Asparagi is 1:3～5 with the weight ratio of Radix Ophiopogonis extract mixture with polyethylene glycol 6000 substrate；
C, dripping
Pill dripping machine fluid reservoir is heated to temperature 75～85 DEG C, and the Radix Asparagi and Radix Ophiopogonis drop pill material that step B is obtained joins liquid storage
In room, drip in the condensed fluid that temperature is 6～8 DEG C by water dropper, collect molding drop pill in pill dripping machine outlet, wipe surface cooling away
Liquid, is dried, obtains described Radix Asparagi and Radix Ophiopogonis drop pill.
According to the another kind of preferred implementation of the present invention, in step, merging filtrate is at temperature 60～80 DEG C and pressure
30～120min are concentrated under conditions of 0.08～0.1MPa.
According to the another kind of preferred implementation of the present invention, in step, the granularity of Radix Asparagi or Radix Ophiopogonis extract be 80～
150 mesh.
According to the another kind of preferred implementation of the present invention, in stepb, the described poly-second of polyethylene glycol 6000 substrate
Glycol 4000 substrate replaces.
According to the another kind of preferred implementation of the present invention, in step C, Radix Asparagi and Radix Ophiopogonis drop pill material is with 8～12 per minute
Speed carry out dripping.
According to the another kind of preferred implementation of the present invention, in step C, described condensed fluid is dimethicone, liquid
Paraffin body or edible vegetable oil.
According to the another kind of preferred implementation of the present invention, in step C, between described water dropper and condensed fluid liquid level away from
From being 12.5～17.5cm.
According to the another kind of preferred implementation of the present invention, in step C, described edible vegetable oil is Oleum Arachidis hypogaeae semen, sesame
Oleum Sesami, soybean oil or olive oil.
According to the another kind of preferred implementation of the present invention, in step C, wipe the drop pill of surface coolant away in temperature 30
～60 DEG C be dried under conditions of pressure 1～0.1MPa.
According to the another kind of preferred implementation of the present invention, in step C, described Radix Asparagi and Radix Ophiopogonis drop pill diameter is 2～4mm.
The present invention is described in more detail below.
The present invention relates to the preparation method of a kind of Radix Asparagi and Radix Ophiopogonis drop pill.
The stability of Radix Asparagi and Radix Ophiopogonis soft extract is poorer than solid preparation at present, and dose is big, carries also inconvenient.Erdong gao main
Composition polysaccharide and saponins have and draw moist, and when preparing drop pill, needs are dried simultaneously, by Radix Asparagi and Radix Ophiopogonis extract at temperature 60 C
Baking oven in dry, owing in extracting solution, sugar content is higher, required drying time is long, is dried also incomplete, by dried material
When grinding to form fine powder, long with the air contact time, powder easily absorbs moisture in air caking so that it is be not uniformly dispersed in base
In matter, affect the preparation of drop pill.Therefore, the present invention uses freeze-drying to be dried.Freeze-drying is under low temperature, low pressure
Carrying out, moisture directly distils, and the material dewatering ratio obtained is more thoroughly, it is simple to long time stored.Owing to being dried in the frozen state
Completing, there is not case-hardened problem in material, and it is internally formed the spongy of porous, the loosest, it is easy to dispersed
In melted substrate so as to get drop pill color even.Therefore, in the present invention, described Radix Asparagi or raw material Radix Ophiopogonis are all answered
This understanding is the Radix Asparagi through freeze-drying process or raw material Radix Ophiopogonis.
Drop pill reduces with the contact area of air, so that medicine stability improves.Setting required for drop pill production
Standby relatively easy, automaticity is high, and the cycle is short, cost-effective.Drop pill disintegrate simultaneously is rapid, rapid-action, it is simple to carry and
Take.
The step of this preparation method is as follows:
A, prepare Radix Asparagi and Radix Ophiopogonis extract
According to the ratio 1:5～10 of raw material in gram with water in terms of ml, Radix Asparagi or raw material Radix Ophiopogonis are added to by volume in water
Soaking 0.5～1.0h, then extract 55～65min under micro-boiling, filter, filtering residue continues repetitive operation by this way 2～4
Secondary, the filtrate of collection merges；
Then allow merging filtrate be concentrated into 1/10th of its original volume on a rotary evaporator, add by volume
95% ethanol solution, makes the concentration of alcohol of described merging filtrate reach by volume 80%, places 12～24h, at rotating speed 3000
～under conditions of 6000r/min centrifugal 15～25min, the precipitation obtained is dissolved in temperature 45～60 DEG C of water, be then placed in temperature-
5～-40 DEG C at carry out precooling, then be vacuum dried under vacuum 1.3～80 handkerchief, then obtain Radix Asparagi or Radix Ophiopogonis extracts
Thing；
Radix Asparagi or raw material Radix Ophiopogonis that the present invention uses are all product solds on market.
Merging filtrate concentrates 30 temperature 60～80 DEG C on a rotary evaporator under conditions of pressure 0.08～0.1MPa
～120min.The Rotary Evaporators that the present invention uses is product sold in the market, such as by EYELA company with trade name
N-1100 product sold.
In the present invention, the Main Function making merging filtrate concentration of alcohol reach 80% is to remove impurity, improves extract
The content of middle effective ingredient.
The precipitation obtained after concentration is soluble in water, then precooling, then the main purpose that vacuum drying so processes is
Making extract dehydration completely, quality is loose, it is simple to the mixing of substrate.
In the present invention, use in current processing technique of Chinese herbs field normally used disintegrating apparatus to described Radix Asparagi
Or Radix Ophiopogonis extract carries out pulverization process, collect Radix Asparagi that granularity is 80～150 mesh or Radix Ophiopogonis extract carries out the preparation of drop pill.
B, preparation Radix Asparagi and Radix Ophiopogonis
The Radix Asparagi that step A obtains is mixed homogeneously according to weight ratio 1:0.8～1.2 with Radix Ophiopogonis extract；Polyethylene Glycol simultaneously
6000 substrate heat in adding heat container under agitation, extract with Radix Ophiopogonis once the melted Radix Asparagi that just adds of described substrate
Thing mixture, obtains Radix Asparagi and Radix Ophiopogonis drop pill material；
Use the DWJ-sold by Yantai hundred Yao Tai Chinese medicine Science and Technology Ltd. with trade name Multifunctional drop pills production experimental machine
2000S5 type pill dripping machine, selection water-soluble polyethylene glycol 6000 is as substrate, by Radix Asparagi and the (letter below of Radix Ophiopogonis extract mixture
Claim medicine) it is blended in condensed fluid 8 DEG C, droplet preparation droplet under conditions of 15cm with fluid reservoir temperature 80 DEG C in varing proportions with substrate
Ball, using roundness, leaches the time limit as evaluation index, and it the results are shown in Table 1.
Table 1: the medication amount impact on drop pill
As shown in Table 1, along with drug loading changes, leach the time limit without significant change, when drug loading is 25%, drip
Ball roundness is slightly worse, drug loading 20% and following time, roundness and leach time limit zero difference.Therefore, this extract mixtures
With the weight ratio of polyethylene glycol 6000 substrate be 1:3～19 be rational, preferably 1:3～9；More preferably 1:3～5.
According to the present invention, described polyethylene glycol 6000 substrate can replace by Macrogol 4000 substrate, and they have
Same effect and effect.
C, dripping
Pill dripping machine fluid reservoir is heated to temperature 75～85 DEG C, and the Radix Asparagi and Radix Ophiopogonis drop pill material that step B is obtained joins liquid storage
In room, drip in the condensed fluid that temperature is 6～8 DEG C by water dropper, collect molding drop pill in pill dripping machine outlet, wipe surface cooling away
Liquid, is dried, obtains described Radix Asparagi and Radix Ophiopogonis drop pill.
In the present invention, described condensed fluid is dimethicone, liquid paraffin or edible vegetable oil.Dimethicone without
Taste is nontoxic, has physiological inertia, good chemical stability, range of viscosities extensively, and freezing point is low, and flash-point is high, and hydrophobic performance is good, and
There is the highest shear resistance, can in 50～180 DEG C of temperature life-time service.The dimethicone that the present invention uses is current city
Product sold on field, such as by Shenzhen Jin Bosheng Science and Technology Ltd. with trade name dimethicone product sold.
Liquid paraffin is semi-transparent clear oily liquids, odorless time cold, tasteless, slightly oil sample gas taste during heating, insoluble
Yu Shui, ethanol, be dissolved in volatile oil, stable to light, heat, acid etc., can be used as the substrate of ointment, liniment and cosmetics.The present invention makes
Liquid paraffin be product sold in the market, such as led to Chemical Co., Ltd. with trade name liquid stone by Shenzhen Zhong Run
Wax product sold.
Described edible vegetable oil is Oleum Arachidis hypogaeae semen, Oleum sesami, soybean oil or olive oil, and they are all to sell in the market
Product.
The several factors that affect drop pill quality are discussed below.
The evaluation methodology of drop pill quality is as follows:
1. leach the time limit: take test sample 6 ball, select in the art normally used 0.42,1.0 or 2.0mm aperture
The hanging basket of screen cloth, wherein pill diameter is at below the 2.5mm screen cloth of aperture 0.42mm, and pill diameter is used between 2.5～3.5
The screen cloth of aperture 1.0mm, pill diameter, at more than the 3.5mm screen cloth of aperture 2.0mm, uses and is sent out science and technology by huge sky, Tianjin
The method that the disintegration tester that company limited sells with trade name intelligence disintegration test device describes according to its description is measured.
2. pill weight variation: take test sample 20 ball, accurately weighed gross weight, then the weight of the most weighed every ball, the weight of every ball
Compare with indicating ball heavy phase, calculate the coefficient of variation.
3. roundness: by visual examination, by roundness quality, non-round be designated as 1～5 point respectively to rounding.
Drip away from impact:
Dripping away from the roundness mainly affecting drop pill, drip away from excessive, it is longer that medicine drips the time in atmosphere, has little time to enter cooling
Liquid is the most cooled, ball type not rounding；And medicine drips suffered action of gravity and easily falls and dissipate into granule, and pill weight variation is bigger.According to above
Medication amount affects experimental condition and carries out drop pill, select three levels 10,15,20cm, with roundness as evaluation index, test knot
Fruit is listed in table 2.
Table 2: drip away from the impact on drop pill
As shown in Table 2, during distance 15cm between water dropper and condensed fluid liquid level, the roundness of drop pill is optimal, drips
Away from when 10～20cm, the roundness of drop pill is all preferable, therefore, drips away from being rational 10～20cm, preferably 15cm.
The impact of condensate temperature:
Select polyethylene glycol 6000 as substrate, medicine is mixed according to above-mentioned preferred proportion with substrate, dripping away from 15cm
With prepare drop pill under conditions of fluid reservoir temperature 80 DEG C, select coolant temperature 6 DEG C, 8 DEG C, 10 DEG C of three levels, with drop pill circle
Whole degree, being limited to index when leaching, investigate temperature and change the impact on drop pill molding, its result of the test is listed in table 3.
Table 3: the condensate temperature impact on drop pill
As shown in Table 3, when condensate temperature is 6～8 DEG C, drop pill roundness, leach the time limit all preferable, 6～8 DEG C
Time, the two zero difference, when condensate temperature is 10 DEG C, roundness is slightly worse, and therefore, condensate temperature is rational at 6～8 DEG C,
Preferably 8 DEG C.
Drip speed impact:
Dripping speed and mainly affect drop pill molding, drip fast too fast, drop is easily sticked together；Dripping speed the slowest, drop becomes big, drop pill
Becoming weight, ball mass discrepancy is big, and production efficiency is low simultaneously.Herb liquid of the present invention relatively thickness, Radix Asparagi and Radix Ophiopogonis drop pill material can be with per minute 8
～the speed of 12 carries out dripping.Optimal speed of dripping is 10/min.Changing and drip speed, drop pill outward appearance, without significant difference, is dragged without adhesion
Tail phenomenon, pill shaped circle is whole, it is contemplated that production efficiency problem, and selecting maximum speed of dripping is 10/min.
The orthogonal experiment of drop pill preparation technology
On the basis of above-mentioned single factor exploration, choose three the factor medicines bigger on the impact of drop pill quality and substrate weight
Measure than (A), drip away from (B), condensate temperature (C), use orthogonal experiment drop pill moulding process to be optimized, to leach the time limit
(Y1), weight differential (Y2), roundness (Y3) as evaluation index, use following comprehensive scoring method to evaluate drop pill quality, carry out work
Skill conditional filtering:
Comprehensive grading=100 × Y1min/Y1i×0.6+100×Y2min/Y2i×0.2+100×Y3i/Y3max×0.2。
In formula:
Min represents value minimum in respective evaluation index；
I represents experiment sequence number；
Max represents value maximum in respective evaluation index.
Factor is shown in Table 4 with level, and Orthogonal experiment results is listed in Table 5 below, and the results of analysis of variance is shown in Table 6.
Table 4: factor and level
Table 5: drop pill moulding process Orthogonal experiment results
Table 6: analysis of variance table
From Orthogonal experiment results and table 6 the results of analysis of variance of table 5, medicine and matrix weight ratio are to affect Radix Asparagi and Radix Ophiopogonis to drip
The principal element of ball molding, has a significant impact the quality of drop pill.Each factor on drop pill quality affect size be medicine with
Matrix weight than > condensate temperature > and drip away from, optimised process is A2B2C1, being medicine and matrix ratios is 1:4, drip away from for
15cm, condensate temperature is 7 DEG C.
Confirmatory experiment:
Repeat to prepare 3 batches of drop pill by above-mentioned optimum process condition, and it is leached the time limit, pill weight variation, roundness are carried out
Evaluation and test, the results are shown in Table 7 for it.These results show every all to meet regulation, illustrate that this technique repeatability is good.
Table 7: Radix Asparagi and Radix Ophiopogonis drop pill preparation technology confirmatory experiment
The drop pill of preparation leached the time limit less than 4 minutes, fater disintegration, dissolution onset.
In this step, the drop pill of the surface coolant condition at temperature 30～60 DEG C with pressure 1～0.1MPa is wiped away
Under be dried.The drying equipment used the step for of the present invention is product sold in the market, such as by Wujiang Hua Fei
Company of heating equipment company limited is with trade name hot air circulation drying oven product sold.
According to the present invention, described Radix Asparagi and Radix Ophiopogonis drop pill diameter is 2～4mm.
[beneficial effect]
The invention has the beneficial effects as follows: compared with prior art, the drop pill dose that the present invention provides reduces than erdong gao,
Stability increases.Radix Asparagi and Radix Ophiopogonis drop pill of the present invention can significantly reduce rat and draw the cough number of times breathed heavily in instrument luring to cough, and Radix Asparagi and Radix Ophiopogonis drop pill drops
Low cough number of times is more more than erdong gao, shows that the effect of its treatment lung-heat yin-deficiency type cough rat is more preferable.
[detailed description of the invention]
The present invention is will be better understood that by following embodiment.
Embodiment 1: the preparation of Radix Asparagi and Radix Ophiopogonis drop pill
The enforcement step of this embodiment is as follows:
A, prepare Radix Asparagi and Radix Ophiopogonis extract
According to the ratio 1:6 of raw material in gram with water in terms of ml, Radix Asparagi or raw material Radix Ophiopogonis are added in water soak 1.0h, then
Extracting 55min under micro-boiling, filter, filtering residue continues repetitive operation by this way 2 times, and the filtrate of collection merges；
Then allow merging filtrate on the Rotary Evaporators sold with trade name N-1100 by EYELA company, be concentrated into it
/ 10th of original volume, add 95% ethanol solution by volume, make the concentration of alcohol of described merging filtrate reach with body
Long-pending meter 80%, places 12h, centrifugal 21min under conditions of rotating speed 5000r/min, and the precipitation obtained is dissolved in temperature 45 C water,
Then it is placed at temperature-5～-40 DEG C and carries out precooling, then be vacuum dried under vacuum 1.3～80 handkerchief, then obtain sky
Winter or Radix Ophiopogonis extract, pulverize extract to granularity 100 mesh；
B, preparation Radix Asparagi and Radix Ophiopogonis
The Radix Asparagi that step A obtains is mixed homogeneously according to weight ratio 1:0.8 with Radix Ophiopogonis extract；Polyethylene glycol 6000 base simultaneously
Matter heats in adding heat container under agitation, mixes with Radix Ophiopogonis extract once the melted Radix Asparagi that just adds of described substrate
Thing, obtains Radix Asparagi and Radix Ophiopogonis drop pill material；
Radix Asparagi is 1:3 with the weight ratio of Radix Ophiopogonis extract mixture with polyethylene glycol 6000 substrate；
C, dripping
The DWJ-that will be sold with trade name Multifunctional drop pills production experimental machine by Yantai hundred Yao Tai Chinese medicine Science and Technology Ltd.
The fluid reservoir of 2000S5 type pill dripping machine is heated to temperature 78 DEG C, and the Radix Asparagi and Radix Ophiopogonis drop pill material that step B is obtained joins in fluid reservoir,
Under conditions of distance between water dropper and condensed fluid liquid level is 15cm, drip to temperature by water dropper with the speed of 8 per minute
Be in the liquid paraffin condensed fluid of 8 DEG C, pill dripping machine outlet collect molding drop pill, wipe surface coolant away, temperature 40 DEG C with
It is dried under conditions of pressure 0.8MPa, obtains the Radix Asparagi and Radix Ophiopogonis drop pill of a diameter of 4mm.
Embodiment 2: the preparation of Radix Asparagi and Radix Ophiopogonis drop pill
The enforcement step of this embodiment is as follows:
A, prepare Radix Asparagi and Radix Ophiopogonis extract
According to the ratio 1:5 of raw material in gram with water in terms of ml, Radix Asparagi or raw material Radix Ophiopogonis are added in water soak 0.5h, then
Extracting 65min under micro-boiling, filter, filtering residue continues repetitive operation by this way 3 times, and the filtrate of collection merges；
Then allow merging filtrate on the Rotary Evaporators sold with trade name N-1100 by EYELA company, be concentrated into it
/ 10th of original volume, add 95% ethanol solution by volume, make the concentration of alcohol of described merging filtrate reach with body
Long-pending meter 80%, places 24h, centrifugal 15min under conditions of rotating speed 6000r/min, and the precipitation obtained is dissolved in temperature 50 C water,
Then it is placed at temperature-5～-40 DEG C and carries out precooling, then be vacuum dried under vacuum 1.3～80 handkerchief, then obtain sky
Winter or Radix Ophiopogonis extract；Pulverize extract to granularity 80 mesh；
B, preparation Radix Asparagi and Radix Ophiopogonis
The Radix Asparagi that step A obtains is mixed homogeneously according to weight ratio 1:1.0 with Radix Ophiopogonis extract；Macrogol 4000 base simultaneously
Matter heats in adding heat container under agitation, mixes with Radix Ophiopogonis extract once the melted Radix Asparagi that just adds of described substrate
Thing, obtains Radix Asparagi and Radix Ophiopogonis drop pill material；
Radix Asparagi is 1:4 with the weight ratio of Radix Ophiopogonis extract mixture with Macrogol 4000 substrate；
C, dripping
The DWJ-that will be sold with trade name Multifunctional drop pills production experimental machine by Yantai hundred Yao Tai Chinese medicine Science and Technology Ltd.
The fluid reservoir of 2000S5 type pill dripping machine is heated to temperature 75 DEG C, and the Radix Asparagi and Radix Ophiopogonis drop pill material that step B is obtained joins in fluid reservoir,
Under conditions of distance between water dropper and condensed fluid liquid level is 12.5cm, drip to temperature by water dropper with the speed of 10 per minute
Degree is in the dimethicone condensed fluid of 6 DEG C, collects molding drop pill in pill dripping machine outlet, wipes surface coolant away, in temperature 30
DEG C with pressure 1.0MPa under conditions of be dried, obtain the Radix Asparagi and Radix Ophiopogonis drop pill of a diameter of 3mm.
Embodiment 3: prepared by Radix Asparagi and Radix Ophiopogonis drop pill
The enforcement step of this embodiment is as follows:
A, prepare Radix Asparagi and Radix Ophiopogonis extract
According to the ratio 1:10 of raw material in gram with water in terms of ml, Radix Asparagi or raw material Radix Ophiopogonis are added in water soak 0.7h, so
After under micro-boiling, extract 60min, filter, filtering residue continues repetitive operation by this way 4 times, and the filtrate of collection merges；
Then allow merging filtrate on the Rotary Evaporators sold with trade name N-1100 by EYELA company, be concentrated into it
/ 10th of original volume, add 95% ethanol solution by volume, make the concentration of alcohol of described merging filtrate reach with body
Long-pending meter 80%, places 16h, centrifugal 25min under conditions of rotating speed 3000r/min, and the precipitation obtained is dissolved in 55 DEG C of water of temperature,
Then it is placed at temperature-5～-40 DEG C and carries out precooling, then be vacuum dried under vacuum 1.3～80 handkerchief, then obtain sky
Winter or Radix Ophiopogonis extract, pulverize extract to granularity 150 mesh；
B, preparation Radix Asparagi and Radix Ophiopogonis
The Radix Asparagi that step A obtains is mixed homogeneously according to weight ratio 1:1.2 with Radix Ophiopogonis extract；Polyethylene glycol 6000 base simultaneously
Matter heats in adding heat container under agitation, mixes with Radix Ophiopogonis extract once the melted Radix Asparagi that just adds of described substrate
Thing, obtains Radix Asparagi and Radix Ophiopogonis drop pill material；
Radix Asparagi is 1:5 with the weight ratio of Radix Ophiopogonis extract mixture with polyethylene glycol 6000 substrate；
C, dripping
The DWJ-that will be sold with trade name Multifunctional drop pills production experimental machine by Yantai hundred Yao Tai Chinese medicine Science and Technology Ltd.
The fluid reservoir of 2000S5 type pill dripping machine is heated to temperature 82 DEG C, and the Radix Asparagi and Radix Ophiopogonis drop pill material that step B is obtained joins in fluid reservoir,
Under conditions of distance between water dropper and condensed fluid liquid level is 17.5cm, drip to temperature by water dropper with the speed of 12 per minute
Degree is in the Oleum Arachidis hypogaeae semen edible vegetable oil condensed fluid of 7 DEG C, collects molding drop pill in pill dripping machine outlet, wipes surface coolant away,
It is dried under conditions of temperature 60 C and pressure 0.4MPa, obtains the Radix Asparagi and Radix Ophiopogonis drop pill of a diameter of 2mm.
Embodiment 4: prepared by Radix Asparagi and Radix Ophiopogonis drop pill
The enforcement step of this embodiment is as follows:
A, prepare Radix Asparagi and Radix Ophiopogonis extract
According to the ratio 1:8 of raw material in gram with water in terms of ml, Radix Asparagi or raw material Radix Ophiopogonis are added in water soak 0.9h, then
Extracting 58min under micro-boiling, filter, filtering residue continues repetitive operation by this way 3 times, and the filtrate of collection merges；
Then allow merging filtrate on the Rotary Evaporators sold with trade name N-1100 by EYELA company, be concentrated into it
/ 10th of original volume, add 95% ethanol solution by volume, make the concentration of alcohol of described merging filtrate reach with body
Long-pending meter 80%, places 20h, centrifugal 20min under conditions of rotating speed 6000r/min, and the precipitation obtained is dissolved in temperature 60 C water,
Then it is placed at temperature-5～-40 DEG C and carries out precooling, then be vacuum dried under vacuum 1.3～80 handkerchief, then obtain sky
Winter or Radix Ophiopogonis extract, pulverize extract to granularity 120 mesh；
B, preparation Radix Asparagi and Radix Ophiopogonis
The Radix Asparagi that step A obtains is mixed homogeneously according to weight ratio 1:1.0 with Radix Ophiopogonis extract；Polyethylene glycol 6000 base simultaneously
Matter heats in adding heat container under agitation, mixes with Radix Ophiopogonis extract once the melted Radix Asparagi that just adds of described substrate
Thing, obtains Radix Asparagi and Radix Ophiopogonis drop pill material；
Radix Asparagi is 1:4 with the weight ratio of Radix Ophiopogonis extract mixture with polyethylene glycol 6000 substrate；
C, dripping
The DWJ-that will be sold with trade name Multifunctional drop pills production experimental machine by Yantai hundred Yao Tai Chinese medicine Science and Technology Ltd.
The fluid reservoir of 2000S5 type pill dripping machine is heated to temperature 85 DEG C, and the Radix Asparagi and Radix Ophiopogonis drop pill material that step B is obtained joins in fluid reservoir,
Under conditions of distance between water dropper and condensed fluid liquid level is 15cm, drip to temperature by water dropper with the speed of 10 per minute
It is in the olive oil edible vegetable oil condensed fluid of 7 DEG C, collects molding drop pill in pill dripping machine outlet, wipe surface coolant away, in temperature
Spend 50 DEG C to be dried under conditions of pressure 0.1MPa, obtain the Radix Asparagi and Radix Ophiopogonis drop pill of a diameter of 4mm.
Test example 1: the comparison of dose
The implementation of this test example is as follows:
According to erdong gao and the preparation method of Radix Asparagi and Radix Ophiopogonis drop pill, prepare erdong gao and Radix Asparagi and Radix Ophiopogonis drop pill respectively.
The preparation method of erdong gao is that boiling 3 times, when decocting for the first time by 500 grams of Radix Asparagis and 500 grams of mixing Radix Ophiopogonis
Between be 3h, second time with third time be respectively 2h, collecting decoction, filtration, it is 1.21～1.25 (80 that filtrate is condensed into relative density
DEG C) clear paste, obtain clear paste about 670 grams.Every 100g clear paste adds 50g refined honey, is uniformly mixed so as to obtain described erdong gao, about 1000 grams.Press
According to 2015 version " Chinese Pharmacopoeia " dose be one time 9～15 grams.
According to method preparation method in embodiment, prepare Radix Asparagi and Radix Ophiopogonis drop pill, at the steps such as 1000 grams of medical materials pass through and extract, concentration
After reason, prepare 660g drop pill, according to medical material ratio be converted to dose be one time 6～10 grams.The result of the test row of the two
In table 8.
Table 8: the amount ratio of different dosage form is relatively
By the result of table 8 it can be seen that after being prepared as drop pill, the dose of Radix Asparagi and Radix Ophiopogonis drop pill reduces 33% than erdong gao.
Experimental 2: the impact of chronic cough rat antitussive effect after lung-heat yin-deficiency type is infected
(1) animal packet
Take 40 male SD rats, body weight 160～180g, be randomly divided into 4 groups, respectively erdong gao group, Radix Asparagi and Radix Ophiopogonis drop pill group,
Model group and blank group.
(2) after lung-heat yin-deficiency type infects prepared by chronic cough rat model
Erdong gao group, Radix Asparagi and Radix Ophiopogonis drop pill group, model group rats prepare chronic cough rat model after lung-heat yin-deficiency type infects, empty
10 SD rats of white group do not make any process, feed of freely drinking water.3 groups of rats are exposed in cigarette smog and set up air flue height instead
Ying Xing: every morning 9 point, at 4 o'clock in afternoon 3 groups of rats are put in the semiclosed animal raising box that top is open, the chest upper right corner
Place an ashtray, after+48 cigarette lighters of 10g saw dust, put into ashtray simultaneously, close the lid, use wet towel the most again
Cover, prevent smog from overflowing, take out rat after 30 minutes, 2 times/day, continue 10 days.The 11st, 14, sootiness in the morning in 17 day terminates
After, the endotoxin nasal drop collunarium with concentration as 0.4mg/mL, collunarium dosage is 10 μ L/10g body weight；At the 11st～19 day, often
Afternoon day gives 30mg/mL thyroxine suspension oral gavage respectively, and volume 3mL/ is only.
3 groups of rats respectively at the 12nd, 13,15,16,18, draw with capsaicin atomization and cough 19 day evening, capsaicin concentration is 1
×10-4Mol/L, 3 minutes/time, every day 1 time.The preparation of this model is that (Zhou Ting et al., after lung-heat yin-deficiency type infects reference literature
The foundation of chronic cough rat model and evaluation, Chinese medicine Leader, 2016,22 (5): 16-20.) carry out.
(3) it is administered
Difference gastric infusion erdong gao and Radix Asparagi and Radix Ophiopogonis drop pill after the preparation of above-mentioned model, dosage erdong gao is 1.6g kg-1, Radix Asparagi and Radix Ophiopogonis drop pill is 0.8g kg-1(during gavage, being ground into the granule of suitable gavage), the normal saline of blank group gavage same volume,
Every day 2 times, continuous 7 days, observed behavior changed, and after within the 8th day, being administered, 1h measures cough number of times.Data represent with (x ± s), adopt
By SPSS 19.0 statistics software processes experimental data, P < 0.05 is that difference is statistically significant.
(4) observation index
1. animal behavioral study: the rat mental status, the bodily form, hair in observation experiment process (including modeling and administration process)
Send out, take food, the ethological change such as stool.
2. cough the mensuration of number of times: take 1 × 10-4The capsaicin solution of mol/L coughs liquid as drawing, and joins to lure to cough to draw and breathes heavily
In the nebulizer of instrument, it is atomized 3min, after atomization stops, observing 2min again, record the cough number of times in each group of rat 5min.
(5) result
1. behavioristics's change:
Blank group is before and after modeling, and Hair of Rat is glossy, and personality is docile, is quick on the draw, breathes gentle, and nose moistens, and enters
Food is actively.
Model group rats hair is matt, comes off more serious, and dysphoria reacts too drastic, tachypnea, and dryness in the nasal cavity is rubescent,
Feed reduces, thirst and liking drink, constipation with dry stool etc..
Upon administration, hair gradually becomes from tarnish certain gloss, dysphoria to erdong gao group, reacts too drastic, breathes
Shallow the symptoms such as dryness in the nasal cavity is rubescent take a turn for the better soon, but more blank group still has certain difference.
After Radix Asparagi and Radix Ophiopogonis drop pill group is administered, hair gradually becomes glossy from tarnish, dysphoria, reacts too drastic, tachypnea,
The symptoms such as dryness in the nasal cavity is rubescent are clearly better, and more blank group of difference is inconspicuous.Show that Radix Asparagi and Radix Ophiopogonis drop pill is improving rat behavior change feelings
Condition is strong compared with erdong gao.
Respectively group rat coughs number of times in 5min, the results are shown in Table 9.
Table 9: each group rat cough number of times measures (x ± s, secondary)
Compare with model group: * P ＜ 0.05
As shown in Table 10, erdong gao and Radix Asparagi and Radix Ophiopogonis drop pill all can significantly reduce rat and draw the cough time breathing heavily in instrument luring to cough
Number, compares with model group, and difference is statistically significant, and it is more more than erdong gao that Radix Asparagi and Radix Ophiopogonis drop pill reduces cough number of times, shows that it is treated
The effect of lung-heat yin-deficiency type cough rat is more preferable.
In sum, Radix Asparagi and Radix Ophiopogonis drop pill dose reduces, preferable in treatment lung-heat yin-deficiency type cough rat drug effect, is prepared as solid
After body preparation easy to carry.
Claims (10)
1. the preparation method of a Radix Asparagi and Radix Ophiopogonis drop pill, it is characterised in that the step of the method is as follows:
A, prepare Radix Asparagi and Radix Ophiopogonis extract
According to the ratio 1:5～10 of raw material in gram with water in terms of ml, Radix Asparagi or raw material Radix Ophiopogonis are added in water soak 0.5～
1.0h, then extracts 55～65min under micro-boiling, filters, and filtering residue continues repetitive operation by this way 2～4 times, the filter of collection
Liquid merges；
Then allow merging filtrate be concentrated into 1/10th of its original volume on a rotary evaporator, add 95% second by volume
Alcoholic solution, makes the concentration of alcohol of described merging filtrate reach by volume 80%, places 12～24h, at rotating speed 3000～
Being centrifuged 15～25min under conditions of 6000r/min, the precipitation obtained is dissolved in temperature 45～60 DEG C of water, is then placed in temperature-5
～at-40 DEG C, carry out precooling, then be vacuum dried under vacuum 1.3～80 handkerchief, then obtain Radix Asparagi or Radix Ophiopogonis extract.
B, preparation Radix Asparagi and Radix Ophiopogonis
The Radix Asparagi that step A obtains is mixed homogeneously according to weight ratio 1:0.8～1.2 with Radix Ophiopogonis extract；Polyethylene glycol 6000 simultaneously
Substrate heats in adding heat container under agitation, mixes with Radix Ophiopogonis extract once the melted Radix Asparagi that just adds of described substrate
Compound, obtains Radix Asparagi and Radix Ophiopogonis drop pill material；
Radix Asparagi is 1:3～5 with the weight ratio of Radix Ophiopogonis extract mixture with polyethylene glycol 6000 substrate；
C, dripping
Pill dripping machine fluid reservoir is heated to temperature 75～85 DEG C, and the Radix Asparagi and Radix Ophiopogonis drop pill material that step B is obtained joins in fluid reservoir,
Drip in the condensed fluid that temperature is 6～8 DEG C by water dropper, collect molding drop pill in pill dripping machine outlet, wipe surface coolant away, dry
Dry, obtain described Radix Asparagi and Radix Ophiopogonis drop pill.
Preparation method the most according to claim 1, it is characterised in that in step, merging filtrate is temperature 60～80 DEG C
With concentration 30～120min under conditions of pressure 0.08～0.1MPa.
The granularity of preparation method the most according to claim 1, it is characterised in that in step, Radix Asparagi or Radix Ophiopogonis extract
It is 80～150 mesh.
Preparation method the most according to claim 1, it is characterised in that in step, described polyethylene glycol 6000 substrate
Replace by Macrogol 4000 substrate.
Preparation method the most according to claim 1, it is characterised in that in step C, Radix Asparagi and Radix Ophiopogonis drop pill material with per minute 8～
The speed of 12 carries out dripping.
Preparation method the most according to claim 1, it is characterised in that in step C, described condensed fluid is dimethyl-silicon
Oil, liquid paraffin or edible vegetable oil.
Preparation method the most according to claim 1, it is characterised in that in step C, described water dropper and condensed fluid liquid level it
Between distance be 12.5～17.5cm.
Preparation method the most according to claim 6, it is characterised in that in step C, described edible vegetable oil is Semen arachidis hypogaeae
Oil, Oleum sesami, soybean oil or olive oil.
Preparation method the most according to claim 1, it is characterised in that in step C, the drop pill wiping surface coolant away exists
Temperature 30～60 DEG C are dried under conditions of pressure 1～0.1MPa.
Preparation method the most according to claim 1, it is characterised in that in step C, described Radix Asparagi and Radix Ophiopogonis drop pill diameter is 2
～4mm.
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN107569464A (en) * | 2017-09-28 | 2018-01-12 | 承德医学院 | One kind is relieved inflammation or internal heat dripping pill and preparation method thereof |
| CN114689764A (en) * | 2020-12-29 | 2022-07-01 | 四川新绿色药业科技发展有限公司 | Multi-component quality detection method for Erdong decoction extract |
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| CN1365719A (en) * | 2001-01-15 | 2002-08-28 | 杨孟君 | Nano medicine 'Erdong' and its preparing process |
| CN105663690A (en) * | 2016-03-11 | 2016-06-15 | 孙彪 | Health-aiding compound dropping pills and preparing method thereof |
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2016
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| CN1365719A (en) * | 2001-01-15 | 2002-08-28 | 杨孟君 | Nano medicine 'Erdong' and its preparing process |
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN107569464A (en) * | 2017-09-28 | 2018-01-12 | 承德医学院 | One kind is relieved inflammation or internal heat dripping pill and preparation method thereof |
| CN107569464B (en) * | 2017-09-28 | 2021-10-15 | 承德医学院 | Fire-clearing dropping pill and preparation method thereof |
| CN114689764A (en) * | 2020-12-29 | 2022-07-01 | 四川新绿色药业科技发展有限公司 | Multi-component quality detection method for Erdong decoction extract |
| CN114689764B (en) * | 2020-12-29 | 2023-06-27 | 四川新绿色药业科技发展有限公司 | Multi-component quality detection method for Erdong decoction extract |
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