CN109925440A - A kind of Chinese-medicine oral cavity mucosal absorption preparation and preparation method thereof - Google Patents
A kind of Chinese-medicine oral cavity mucosal absorption preparation and preparation method thereof Download PDFInfo
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Abstract
The invention discloses a kind of Chinese-medicine oral cavity mucosal absorption preparations and preparation method thereof, belong to field of traditional Chinese medicine preparation.To overcome existing formulation of ' Sheng Mai ' effective component, pharmacological property, effect and major function variation in extraction, subtractive process, bioavilability is low, the deficiency for carrying, taking inconvenience etc. uses full micro mist technology of preparing to formulation of ' Sheng Mai ' of the present invention, and buccal absorption preparation is made.Formulation of ' Sheng Mai ' of the present invention is used as medicine with full micro mist, it is more in line with classics recipe Shengmai San original dosage form pharmacological property and the legislation rules for the treatment of, and it can avoid loss of the effective component in extraction, concentration process, pass through buccal absorption simultaneously, avoid first pass effect, bioavilability is improved, the clinical efficacy of product is improved.
Description
Technical field
The present invention relates to a kind of Chinese-medicine oral cavity mucosal absorption preparation and preparation method thereof more particularly to a kind of raw arteries and veins of full micro mist
Buccal absorption preparation and preparation method thereof, belongs to field of traditional Chinese medicine pharmacy.
Background technique
Shengmai San also known as Shengmai Yin are the famous ancient prescriptions of Chinese medicine supplementing qi and nourishing yin.Shengmai San comes from Jin and Yuan dynasty Zhang Yuan earliest
Plain written " medicine origin " (1186) have more than 800 years history so far.Shengmai San is by ginseng, Radix Ophiopogonis, three taste of Schisandra chinensis
Chinese medicinal composition has effects that nourishing generate fluid, astringing YIN to stop sweating, and treatment hot summer weather sweat is more, and gas consumption hurts liquid, puts forth effort on tonifying lung, enriching yin, supports
The heart is more gentle Qi-tonifying prescription to have the effect of nourishing generate fluid, and existing clinic is widely used in all diseases of cardiovascular and cerebrovascular.With
Further investigation to formulation of ' Sheng Mai ' opens this prescription in the frontier of other each section's disease treatments.
Shengmai San early stage dosage form is powder, and the formula prepared slices of Chinese crude drugs are directly crushed and taken without decoction, prepared slices of Chinese crude drugs pharmacological property
It can completely be passed in vivo, thus the effect of playing it and major function.But it clinically applies at present predominantly existing
For dosage form, such as oral solution, capsule, injection, it is above modern times formulation of ' Sheng Mai ' production preparation process in, can through extraction,
The processing such as alcohol precipitation and water are heavy, by this process, many ingredients all can decompose and convert.For example, some researches show that pass through
Heating decocts, and a variety of ginsenosides in ginseng medicine materical crude slice can occur conversion, decompose, the type and ratio of ginsenoside and protoplast
Ginseng medicine materical crude slice is compared and can be changed a lot.In addition to ginseng, Radix Ophiopogonis and Schisandra chinensis in raw arteries and veins formula extract, after purification its at
Dividing can also occur to change accordingly.According to Chinese medicine property theory, the variation of this material base certainly will cause the change of pharmacological property, body
Can be varied widely in now to formulation of ' Sheng Mai ' the effect of and major function, thus the clinical efficacy of formulation of ' Sheng Mai ' is caused it is unfavorable
It influences.
In addition to this, formulation of ' Sheng Mai ' on sale is mainly SHENGMAI YIN KOUFUYE, SHENGMAI JIAONANG and shengmai injection etc. in the market
Dosage form.Since traditional Chinese medicine injection complicated component can generate allergic reaction and heat source response, therefore clinically using less.Shengmai Yin mouth
Though it is convenient to take to take liquid patient, liquid preparation is carried, transport, storage is inconvenient and drug dispersion is big, Yi Yinqi drug
Chemical degradation and influence product physical stability etc..
In view of the above-mentioned deficiency of existing formulation of ' Sheng Mai ', it is necessary to find a kind of new formulation of ' Sheng Mai ' and preparation method thereof, make
The pharmacological property that can retain Shengmai San early stage dosage form, curative effect and major function and absorbed without gastrointestinal tract, avoid liver
Influence of the first pass effect to preparation bioavilability, while performance general action can also be taken orally, safely and effectively, patient is easy to connect
By, and production link can be reduced, production efficiency is improved, production cost, easy to carry, transport and storage are reduced.
Summary of the invention
The purpose of the present invention is on the basis of existing formulation of ' Sheng Mai ', provide one kind to be more in line with classics recipe Shengmai San original
The life arteries and veins oral mucosal absorbent preparation and preparation method thereof of dosage form Medicinal Trait and the legislation rules for the treatment of, to provide one for clinical application
Kind simplicity, safe and efficient therapeutic choice.
Compared with existing formulation of ' Sheng Mai ', the present invention is directly used as medicine with the full micro mist of Chinese medicine, be can promote the dissolution of effective substance, is released
It puts and absorbs, improve effective substance in the intracorporal bioavilability of people, saved the prepared slices of Chinese crude drugs, improved the medicine of formulation of ' Sheng Mai '
Effect, also more meets the theory calls that traditional Chinese medicine emphasizes that medicinal material full constituent is used as medicine used in prescription, and is glutinous with modern oral cavity
The form of film absorbable preparation is presented, it then follows traditional Chinese medicine carries out the principle of innovation and development on the basis of succession.It is complete with the prepared slices of Chinese crude drugs
Micro mist is used as medicine, and can avoid loss of effective components, and drugloading rate is big, maximum up to 75%, reduces dose, improves patient medication
Compliance.
Drug effect molecule is the material base of herbal nature, and the full micropowder technology of the present invention is not changing Shengmai San pharmacological property substance base
It is more more uniform than Ordinary pulverization granularity under the premise of plinth, traditional Shengmai San medicinal powder particle diameter distribution can be overcome uneven, particle size differences are big
The drawbacks of, the tablet appearance difference of preparation is small, and face shaping more meets the requirement of Modern preparations, and can completely retain tradition
Pharmacological property, effect and the major function of Shengmai San.
In addition, buccal absorption preparation of the present invention is absorbed by mucous membrane of mouth approach, liver first-pass effect can avoid, it is raw
Object availability is high；Buccal absorption preparation can pass through the oral purpose for realizing performance general action, safely and effectively, Huan Zherong
It is easily accepted by, is provided convenience for the bad patient's medication of some function of deglutition；Suitable for the patient of children, old man and dysphagia,
Exploitation is also suitable into mouth containing health food, is had a vast market foreground.
The invention discloses a kind of Chinese-medicine oral cavity mucosal absorption preparations and preparation method thereof, and prescription is by as follows at grouping
At:
A, Radix Ophiopogonis, the full micro mist of Schisandra chinensis；
B, one of ginseng, Radix Codonopsis or the full micro mist of red ginseng；
C, filler, adhesive, lubricant, disintegrating agent and corrigent；
Wherein, full micropowder weight proportion are as follows: one of ginseng, Radix Codonopsis or red ginseng 1-3 parts by weight, Radix Ophiopogonis 2-5 parts by weight, the five tastes
Sub- 1-2 parts by weight.
The full micro mist is the most fine powder or impalpable powder of one note on the use defined of " Chinese Pharmacopoeia " version in 2015.Most fine powder
Referring to all to be sieved by No. six, and containing the powder that can be no less than 95% by No. seven sieves；Impalpable powder, which refers to, all to be sieved by No. eight,
And containing the powder that can be no less than 95% by No. nine sieves.
Preferably, the parts by weight of the Radix Ophiopogonis are as follows: 2-3；It is highly preferred that full micropowder weight proportion are as follows: ginseng, Radix Codonopsis or red
2 parts by weight of one of ginseng, 2 parts by weight of Radix Ophiopogonis, 1 parts by weight of Schisandra chinensis；Or 1 parts by weight of one of ginseng, Radix Codonopsis or red ginseng, 2 weight of Radix Ophiopogonis
Measure part, 1 parts by weight of Schisandra chinensis；Or 3 parts by weight of one of ginseng, Radix Codonopsis or red ginseng, 3 parts by weight of Radix Ophiopogonis, 2 parts by weight of Schisandra chinensis.
Preferably, Chinese-medicine oral cavity mucosal absorption preparation of the present invention is in lozenge, sublingual tablet, chewable tablets or oral disintegrating tablet
It is a kind of.
Preferably, filler of the present invention is mannitol, Icing Sugar, pregelatinized starch, glucose, lactose, sorbierite, wood
One or more of sugar alcohol, sucrose；Described adhesive is one or more of hydroxypropyl methylcellulose, povidone, starch slurry；
The lubricant is one or more of superfine silica gel powder, talcum powder, polyethylene glycol, lauryl sodium sulfate, magnesium stearate；Institute
Stating disintegrating agent is PVPP (crosslinked polyvinylpyrrolidone), CCNa (croscarmellose sodium), low substituted hydroxy-propyl fiber
One or more of element；The corrigent is one of peppermint oil, lemon oil, orange oil, flavoring pineapple essence, flavoring banana essence.
Preferably, auxiliary material accounts for weight of formulation percentage in the lozenge are as follows: filler 10.0%-16.0%, adhesive
6.0%-12.0%, lubricant 0.2%-3.0%, corrigent 0.5%-2.5%；Auxiliary material accounts for weight of formulation hundred in the chewable tablets
Divide ratio are as follows: filler 9.0%-15.0%, adhesive 5.0%-14.0%, lubricant 0.2%-3.0%, corrigent 0.5%-
2.5%；Auxiliary material accounts for weight of formulation percentage in the sublingual tablet are as follows: filler 8.0%-15.0%, adhesive 4.0%-
10.0%, lubricant 0.2%-3.0%, disintegrating agent 4.0%-7.0%, corrigent 0.5%-2.5%；Auxiliary material in the oral disintegrating tablet
Account for weight of formulation percentage are as follows: filler 7.0%-14.0%, adhesive 4.0%-10.0%, lubricant 0.2%-3.0%, collapse
Solve agent 6.0%-9.0%, corrigent 0.5%-2.5%.
It is a further object to provide the preparation methods of the Chinese-medicine oral cavity mucosal absorption preparation:
A, prepared slices of Chinese crude drugs disintegrating process:
One of ginseng, Radix Codonopsis or red ginseng and Radix Ophiopogonis and Schisandra chinensis are weighed by weight, and net system is dried, and is placed in 45 ± 2 DEG C
Baking oven in heated-air drying handle 1-2 hours, one of ginseng, Radix Codonopsis or red ginseng are cut into the piece with a thickness of 5-12mm, it is standby
With；
One of dried ginseng, Radix Codonopsis or red ginseng and Radix Ophiopogonis are subjected to Ordinary pulverization respectively, obtain coarse powder, crosses 24 mesh
Sieve；
One of ginseng, Radix Codonopsis or red ginseng coarse powder, Radix Ophiopogonis coarse powder and the net medicinal material of Schisandra chinensis are taken, most fine powder or pole are individually ground into
Fine powder, then be uniformly mixed by weight ratio, full micro mist must be mixed, it is spare；
Or one of ginseng, Radix Codonopsis or red ginseng coarse powder, Radix Ophiopogonis coarse powder and the net medicinal material of Schisandra chinensis are taken, mixing by weight ratio is equal
It is even, it is ground into most fine powder or full fine powder, full micro mist must be mixed, it is spare；
B, preparation process:
It takes step A to mix full micro mist, filler, adhesive, lubricant and the corrigent of recipe quantity is added, by pharmaceutically normal
Rule method is prepared into lozenge or chewable tablets；
Or step A is taken to mix full micro mist, filler, adhesive, lubricant, disintegrating agent and the corrigent of recipe quantity is added,
Oral disintegrating tablet or sublingual tablet are prepared by pharmaceutically conventional method.
Compared with prior art, the raw arteries and veins buccal absorption preparation of the full micro mist of the present invention and its preparation process have following excellent
Point and significant progress:
1, it overcomes modern formulation of ' Sheng Mai ' to extract, the loss of subtractive process prepared slices of Chinese crude drugs effective component, convert, pharmacological property changes greatly
Deng drawback, remain the pharmacological property, curative effect and major function of Shengmai San early stage powder, clinical effectiveness is better than existing market life on sale
Arteries and veins product.
2, directly it is used as medicine with the full micro mist of Chinese medicine, under the premise of not changing Shengmai San pharmacological property, effect and major function, than general
Logical grinding particle size is more uniform, overcome can traditional Shengmai San medicinal powder particle diameter distribution it is uneven, the big drawback of particle size differences, the piece of preparation
Agent difference in appearance is small, and face shaping more meets the requirement of Modern preparations.Also, the full micro mist drugloading rate that is used as medicine is big, main ingredient institute accounting
Example maximum can reduce dose, improve the compliance that patient takes up to 75%.
3, buccal absorption preparation of the present invention can be achieved to play general action with the absorption of mucous membrane of mouth approach by oral
Purpose, and be avoided that liver first-pass effect, bioavilability is high, and safely and effectively, patient is acceptant, to swallow to be some
The bad patient's medication of function provides convenience, the patient suitable for children, old man and dysphagia.
4, present invention improves preparation process, shortening the production cycle (such as saves the extraction in Shengmai Yin preparation process, seeps
The links such as filter, steam distillation), the prepared slices of Chinese crude drugs are saved, production cost is reduced.
Preparation process, the clinic of preparation of a kind of Chinese-medicine oral cavity mucosal absorption preparation of the present invention and preparation method thereof from drug
Effect and patient breach the limitation and deficiency of conventional formulation of ' Sheng Mai ' in terms of taking compliance and applicability, be suitble to scale
Mass production has a vast market foreground.
Specific embodiment
Below by way of specific embodiment, the invention will be further described, but this is not a limitation of the present invention, this
Field technical staff basic thought according to the present invention, can make various modifications or improvements, but as long as not departing from of the invention
Basic thought is all within the scope of the present invention.
The preparation of the raw arteries and veins buccal tablet of the full micro mist of embodiment 1
A, prepared slices of Chinese crude drugs disintegrating process: 1 parts by weight ginseng, 2 parts by weight Radix Ophiopogonis and 2 parts by weight Schisandra chinensis, net system are weighed and is dried in the air
It is dry, it is placed in 45 ± 2 DEG C of baking oven and is handled 2 hours with heated-air drying, ginseng is cut into the piece with a thickness of 10mm, it is spare；It will
Dried ginseng, Radix Ophiopogonis carry out Ordinary pulverization respectively, obtain coarse powder, cross 24 meshes；Take by weight ratio ginseng, Radix Ophiopogonis coarse powder and
The net medicinal material of Schisandra chinensis is uniformly mixed, is ground into most fine powder, must mix full micro mist, spare；
B, preparation process: taking step A to mix full micro mist, be separately added into total formulation weight 12.0% glucose, 10.0%
Hydroxypropyl methylcellulose and 2.0% orange oil, mixed with equivalent gradually-increased, particle be made, dry, whole grain, then to add agent total
The magnesium stearate total mix of weight 1.0%, tabletting is to get theoretical slice weight 0.6g.
The preparation of the raw arteries and veins buccal tablet of the full micro mist of embodiment 2
A, prepared slices of Chinese crude drugs disintegrating process: 2 parts by weight red ginsengs, 2 parts by weight Radix Ophiopogonis and 1 parts by weight Schisandra chinensis, net system are weighed and is dried in the air
It is dry, it is placed in 45 ± 2 DEG C of baking oven and is handled 1 hour with heated-air drying, red ginseng is cut into the piece with a thickness of 5mm, it is spare；It will do
Dry good red ginseng, Radix Ophiopogonis carry out Ordinary pulverization respectively, obtain coarse powder, cross 24 meshes；Red ginseng, Radix Ophiopogonis coarse powder and five are taken by weight ratio
The net medicinal material of taste, is respectively crushed into impalpable powder, is uniformly mixed, must mix full micro mist, spare；
B, preparation process: taking step A to mix full micro mist, be separately added into total formulation weight 10.0% lactose, 12.0%
Starch slurry and 1.0% flavoring banana essence, mixed with equivalent gradually-increased, particle be made, dry, whole grain, then plus total formulation weight
2.0% talcum powder total mix, tabletting is to get theoretical slice weight 0.6g.
The preparation of the raw arteries and veins buccal tablet of the full micro mist of embodiment 3
A, prepared slices of Chinese crude drugs disintegrating process: 3 parts by weight Radix Codonopsis, 4 parts by weight Radix Ophiopogonis and 2 parts by weight Schisandra chinensis, net system are weighed and is dried in the air
It is dry, it is placed in 45 ± 2 DEG C of baking oven and is handled 1.5 hours with heated-air drying, Radix Codonopsis is cut into the piece with a thickness of 12mm, it is spare；
Dried Radix Codonopsis, Radix Ophiopogonis are subjected to Ordinary pulverization respectively, obtain coarse powder, crosses 24 meshes；Radix Codonopsis, Radix Ophiopogonis coarse powder are taken by weight ratio
With the net medicinal material of Schisandra chinensis, it is respectively crushed into impalpable powder, is uniformly mixed, full micro mist must be mixed, it is spare；
B, preparation process: taking step A to mix full micro mist, is separately added into Icing Sugar, 4.0% cream of total formulation weight 14.5%
Sugar, 6.0% povidone and 2.5% peppermint oil, are mixed with equivalent gradually-increased, particle are made, dry, whole grain, then add agent
The superfine silica gel powder total mix of total weight 2.0%, tabletting is to get theoretical slice weight 0.6g.
The preparation of the raw arteries and veins chewable tablets of the full micro mist of embodiment 4
A, prepared slices of Chinese crude drugs disintegrating process: 3 parts by weight ginsengs, 3 parts by weight Radix Ophiopogonis and 2 parts by weight Schisandra chinensis, net system are weighed and is dried in the air
It is dry, it is placed in 45 ± 2 DEG C of baking oven and is handled 2 hours with heated-air drying, ginseng is cut into the piece with a thickness of 12mm, it is spare；It will
Dried ginseng, Radix Ophiopogonis carry out Ordinary pulverization respectively, obtain coarse powder, cross 24 meshes；Take by weight ratio ginseng, Radix Ophiopogonis coarse powder and
The net medicinal material of Schisandra chinensis, is respectively crushed into most fine powder, is uniformly mixed, must mix full micro mist, spare；
B, preparation process: taking step A to mix full micro mist, be separately added into total formulation weight 12.5% mannitol, 8.0%
Hydroxypropyl methylcellulose and 1.5% peppermint oil, mixed with equivalent gradually-increased, particle be made, dry, whole grain, then plus total formulation weight
The polyethylene glycol total mix of amount 3.0%, tabletting is to get theoretical slice weight 0.6g.
The preparation of the raw arteries and veins chewable tablets of the full micro mist of embodiment 5
A, prepared slices of Chinese crude drugs disintegrating process: 2 parts by weight Radix Codonopsis, 5 parts by weight Radix Ophiopogonis and 2 parts by weight Schisandra chinensis, net system are weighed and is dried in the air
It is dry, it is placed in 45 ± 2 DEG C of baking oven and is handled 2 hours with heated-air drying, Radix Codonopsis is cut into the piece with a thickness of 8mm, it is spare；It will do
Dry good Radix Codonopsis, Radix Ophiopogonis carry out Ordinary pulverization respectively, obtain coarse powder, cross 24 meshes；Radix Codonopsis, Radix Ophiopogonis coarse powder and five are taken by weight ratio
The net medicinal material of taste is uniformly mixed, is ground into most fine powder, must mix full micro mist, spare；
B, preparation process: taking step A to mix full micro mist, be separately added into total formulation weight 9.0% sorbierite, 10.0%
Povidone, 2.0% starch slurry and 1.5% orange oil, are mixed with equivalent gradually-increased, and particle is made, dry, whole grain, then plus
The lauryl sodium sulfate total mix of total formulation weight 1.5%, tabletting is to get theoretical slice weight 0.6g.
The preparation of the raw arteries and veins chewable tablets of the full micro mist of embodiment 6
A, prepared slices of Chinese crude drugs disintegrating process: 1 parts by weight red ginseng, 4 parts by weight Radix Ophiopogonis and 1 parts by weight Schisandra chinensis, net system are weighed and is dried in the air
It is dry, it is placed in 45 ± 2 DEG C of baking oven and is handled 1 hour with heated-air drying, red ginseng is cut into the piece with a thickness of 6mm, it is spare；It will do
Dry good red ginseng, Radix Ophiopogonis carry out Ordinary pulverization respectively, obtain coarse powder, cross 24 meshes；Red ginseng, Radix Ophiopogonis coarse powder and five are taken by weight ratio
The net medicinal material of taste is uniformly mixed, is ground into impalpable powder, must mix full micro mist, spare；
B, preparation process: taking step A to mix full micro mist, be separately added into total formulation weight 14.0% sucrose, 10.0%
Starch slurry and 0.5% flavoring banana essence, mixed with equivalent gradually-increased, particle be made, dry, whole grain, then plus total formulation weight
0.5% magnesium stearate total mix, tabletting is to get theoretical slice weight 0.6g.
The preparation of the raw arteries and veins sublingual lozenge of the full micro mist of embodiment 7
A, prepared slices of Chinese crude drugs disintegrating process: 3 parts by weight ginsengs, 5 parts by weight Radix Ophiopogonis and 1 parts by weight Schisandra chinensis, net system are weighed and is dried in the air
It is dry, it is placed in 45 ± 2 DEG C of baking oven and is handled 1 hour with heated-air drying, ginseng is cut into the piece with a thickness of 10mm, it is spare；It will
Dried ginseng, Radix Ophiopogonis carry out Ordinary pulverization respectively, obtain coarse powder, cross 24 meshes；Take by weight ratio ginseng, Radix Ophiopogonis coarse powder and
The net medicinal material of Schisandra chinensis, is respectively crushed into most fine powder, is uniformly mixed, must mix full micro mist, spare；
B, preparation process: taking step A to mix full micro mist, be separately added into total formulation weight 8.0% xylitol, 8.0%
Starch slurry, 2.25% PVPP and 2.0% Oleum Citri Reticulatae, mixed with equivalent gradually-increased, particle be made, dry, whole grain, then add
The magnesium stearate of agent total weight 0.5%, 1.5% superfine silica gel powder and 2.25% CCNa total mix, tabletting is to get theoretical slice weight
0.6g。
The preparation of the raw arteries and veins sublingual lozenge of the full micro mist of embodiment 8
A, prepared slices of Chinese crude drugs disintegrating process: 3 parts by weight red ginsengs, 3 parts by weight Radix Ophiopogonis and 1 parts by weight Schisandra chinensis, net system are weighed and is dried in the air
It is dry, it is placed in 45 ± 2 DEG C of baking oven and is handled 1.5 hours with heated-air drying, red ginseng is cut into the piece with a thickness of 7mm, it is spare；It will
Dried red ginseng, Radix Ophiopogonis carry out Ordinary pulverization respectively, obtain coarse powder, cross 24 meshes；Take by weight ratio red ginseng, Radix Ophiopogonis coarse powder and
The net medicinal material of Schisandra chinensis, is respectively crushed into impalpable powder, is uniformly mixed, must mix full micro mist, spare；
B, it preparation process: takes step A to mix full micro mist, is separately added into the lactose of total formulation weight 6.0%, 5.0% sugarcane
The flavoring pineapple essence of sugar, 2.0% mannitol, 5.0% povidone, 2.0% CCNa and 0.5%, is mixed with equivalent gradually-increased, system
It is dry at particle, whole grain, then plus total formulation weight 2.5% superfine silica gel powder and 1.0% CCNa, 1.0% low-substituted hydroxypropyl
Base cellulose total mix, tabletting is to get theoretical slice weight 0.6g.
The preparation of the raw arteries and veins sublingual tablet of the full micro mist of embodiment 9
A, prepared slices of Chinese crude drugs disintegrating process: 1 parts by weight Radix Codonopsis, 2 parts by weight Radix Ophiopogonis and 1 parts by weight Schisandra chinensis, net system are weighed and is dried in the air
It is dry, it is placed in 45 ± 2 DEG C of baking oven and is handled 2 hours with heated-air drying, Radix Codonopsis is cut into the piece with a thickness of 11mm, it is spare；It will
Dried Radix Codonopsis, Radix Ophiopogonis carry out Ordinary pulverization respectively, obtain coarse powder, cross 24 meshes；Take by weight ratio Radix Codonopsis, Radix Ophiopogonis coarse powder and
The net medicinal material of Schisandra chinensis is uniformly mixed, is ground into most fine powder, must mix full micro mist, spare；
B, it preparation process: takes step A to mix up micro mist, is separately added into the mannitol of total formulation weight 10.0%, 8.0% hydroxyl
Third methylcellulose, 2.5% low-substituted hydroxypropyl cellulose and 1.0% flavoring banana essence, are mixed with equivalent gradually-increased, are made
Grain, dry, whole grain, then plus total formulation weight 1.0% talcum powder and 2.5% low-substituted hydroxypropyl cellulose total mix, tabletting,
To obtain the final product, theoretical slice weight 0.6g.
The preparation of the raw arteries and veins oral disintegrating tablet of the full micro mist of embodiment 10
A, prepared slices of Chinese crude drugs disintegrating process: 1 parts by weight ginseng, 2 parts by weight Radix Ophiopogonis and 1 parts by weight Schisandra chinensis, net system are weighed and is dried in the air
It is dry, it is placed in 45 ± 2 DEG C of baking oven and is handled 2 hours with heated-air drying, ginseng is cut into the piece with a thickness of 9mm, it is spare；It will do
Dry good ginseng, Radix Ophiopogonis carry out Ordinary pulverization respectively, obtain coarse powder, cross 24 meshes；Ginseng, Radix Ophiopogonis coarse powder and five are taken by weight ratio
The net medicinal material of taste is uniformly mixed, is ground into impalpable powder, must mix full micro mist, spare；
B, it preparation process: takes step A to mix full micro mist, is separately added into the pregelatinized starch 8.0% of total formulation weight 8.0%
Starch slurry, 2.0% povidone, 2.5% PVPP and 1.5% lemon oil, mixed with equivalent gradually-increased, particle be made,
It is dry, whole grain, then plus total formulation weight 0.5% magnesium stearate and 2.5% PVPP total mix, tabletting is to get theoretical slice weight
0.6g。
The preparation of the raw arteries and veins oral disintegrating tablet of the full micro mist of embodiment 11
A, prepared slices of Chinese crude drugs disintegrating process: 3 parts by weight ginsengs, 5 parts by weight Radix Ophiopogonis and 2 parts by weight Schisandra chinensis, net system are weighed and is dried in the air
It is dry, it is placed in 45 ± 2 DEG C of baking oven and is handled 1 hour with heated-air drying, ginseng is cut into the piece with a thickness of 9mm, it is spare；It will do
Dry good ginseng, Radix Ophiopogonis carry out Ordinary pulverization respectively, obtain coarse powder, cross 24 meshes；Ginseng, Radix Ophiopogonis coarse powder and five are taken by weight ratio
The net medicinal material of taste, is respectively crushed into impalpable powder, is uniformly mixed, must mix full micro mist, spare；
B, preparation process: taking step A to mix full micro mist, be separately added into total formulation weight 14.0% sorbierite, 4.0%
Povidone, 3.0% CCNa and 0.5% flavoring pineapple essence, mixed with equivalent gradually-increased, particle be made, dry, whole grain, then plus
The lauryl sodium sulfate of total formulation weight 0.5% and 2.0% CCNa, 1.0% PVPP total mix, tabletting is to get theoretical piece
Weight 0.6g.
The preparation of the raw arteries and veins oral disintegrating tablet of the full micro mist of embodiment 12
A, prepared slices of Chinese crude drugs disintegrating process: 2 parts by weight Radix Codonopsis, 4 parts by weight Radix Ophiopogonis and 1 parts by weight Schisandra chinensis, net system are weighed and is dried in the air
It is dry, it is placed in 45 ± 2 DEG C of baking oven and is handled 1.5 hours with heated-air drying, Radix Codonopsis is cut into the piece with a thickness of 10mm, it is spare；
Dried Radix Codonopsis, Radix Ophiopogonis are subjected to Ordinary pulverization respectively, obtain coarse powder, crosses 24 meshes；Radix Codonopsis, Radix Ophiopogonis coarse powder are taken by weight ratio
With the net medicinal material of Schisandra chinensis, it is respectively crushed into impalpable powder, is uniformly mixed, full micro mist must be mixed, it is spare；
B, preparation process: taking step A to mix full micro mist, be separately added into total formulation weight 10.0% xylitol, 8.0%
Hydroxypropyl methylcellulose, 3.0% low-substituted hydroxypropyl cellulose and 1.0% flavoring banana essence, are mixed with equivalent gradually-increased, are made
Particle, dry, whole grain, then plus the magnesium stearate of total formulation weight 1.0%, 0.5% talcum powder, 0.5% polyethylene glycol and
1.0% PVPP total mix, tabletting is to get theoretical slice weight 0.6g.
The measurement of the raw arteries and veins mucous membrane of mouth preparation disintegration time limited of embodiment 13
Using four disintegration time limit test (general rule 0921) measurements of " Chinese Pharmacopoeia " version in 2015, indigo plant will be hung and hang on branch
On frame, immerse in 1000ml beaker, and when the position for adjusting hanging basket makes it drop to low spot sieve away from beaker bottom 25mm, beaker
37 ± 1 DEG C of temperature of water is inside filled, adjusting height of water level, sieve is at the 15mm of underwater when hanging basket being made to rise lofty perch, hanging basket top
Portion can not be immersed in solution.Each 6 of difference Example 1,2,3,7,8,9,10,11 and 12 obtained tablets, are placed in lifting
In the glass tube of formula disintegration tester hanging basket, starting disintegration tester is checked.Disintegration time limited regulation is not met if any 1, should separately take 6
Retrial should all meet regulation.
Raw arteries and veins buccal absorption preparation disintegration time mensuration result obtained by the different embodiments of table 1
| Sampling | 1(s) | 2(s) | 3(s) | 4(s) | 5(s) | 6(s) | Average disintegration time/s |
| Embodiment 1 | 1002 | 1009 | 1017 | 1023 | 1035 | 1044 | 1021.67 |
| Embodiment 2 | 762 | 776 | 781 | 785 | 790 | 794 | 781.33 |
| Embodiment 3 | 1129 | 1136 | 1144 | 1152 | 1157 | 1165 | 1147.17 |
| Embodiment 7 | 81 | 86 | 92 | 97 | 105 | 110 | 95.17 |
| Embodiment 8 | 144 | 158 | 163 | 166 | 172 | 185 | 164.67 |
| Embodiment 9 | 227 | 233 | 246 | 252 | 261 | 275 | 249.00 |
| Embodiment 10 | 19 | 24 | 25 | 29 | 31 | 34 | 27.00 |
| Embodiment 11 | 26 | 29 | 31 | 36 | 38 | 42 | 33.67 |
| Embodiment 12 | 33 | 39 | 45 | 47 | 51 | 56 | 45.17 |
By experimental result it can be concluded that, the raw arteries and veins lozenge of the full micro mist of the present invention 10 minutes with up to 30 minutes hereinafter, tongue
Bottom sheet is all disintegrated and dissolves in 5 minutes, and oral disintegrating tablet is all disintegrated in 60 seconds and by shining net.The above tablet collapses
The solution time meets the relevant regulations of four disintegration time limit tests of " Chinese Pharmacopoeia " version in 2015.
Embodiment 14 gives birth to arteries and veins mucous membrane of mouth preparation for treating coronary heart diseases and angina pectoris (type of deficiency of both QI and YIN) clinical observation on the therapeutic effect
Coronary heart diseases and angina pectoris is the common disease of cardiovascular system, this experiment is to 150 Treating Patients of Angina Pectoris (gas
Yin bivacuity type) it is treated using SHENGMAI KELI and the raw arteries and veins buccal absorption preparation of the present invention, compare the clinical efficacy of the two.
1, clinical data
The Treating Patients of Angina Pectoris 150 that selection Linyi institute of traditional Chinese medicine accepts for medical treatment in January, 2017 in July, 2017
Example, is randomly divided into 4 treatment groups, and every group 30, control group 30.All cases meet the diagnosis mark of coronary disease and angina pectoris
Standard, Chinese medical discrimination are syndrome of deficiency of both qi and yin.Two groups of patients are distributed upper no significant difference (P > 0.05) in gender, age, the course of disease, have
Comparativity.
2, treatment method
Control group patient take SHENGMAI KELI (sample is provided by Lunan Pharmaceutical Co., Ltd. laboratory, 10 grams/bag,
Lot number: 20161119；Formula: ginseng, Radix Ophiopogonis, Schisandra chinensis, auxiliary material are sucrose), 3 times a day, one bag (6g), boiled water rush every time
Clothes, two weeks for a course for the treatment of.
1 to 4 group patient for the treatment of takes Chinese-medicine oral cavity mucosal absorption system prepared by the embodiment of the present invention 2,4,9 and 10 respectively
Agent 30 (0.6g/ piece) on the one, divides 3-5 oral cavity buccal, two weeks for a course for the treatment of.
Observation item: the daily forward and backward detailed inquiry angina pectoris attacks situation of medication, and it is primary to trace tranquillization lead ECG,
Forward and backward promoting circulation of blood, urine, feces routine test respectively is treated, adverse reaction is observed in Liver and kidney function inspection.
Statistical procedures: two groups of effective percentage are analyzed with 16.0 statistical software of SPSS-, using χ2It examines.
3, curative effect determinate standard and result
3.1 angina pectoris symptom criterions of therapeutical effect are referring to " clinical test of new Chinese medicine treatment thoracic obstruction (coronary disease and angina pectoris) refers to
Lead principle " it formulates, effective symptom disappear or mostly disappear, III grade is relieved to I grade of standard；It is effective: panic attacks number, degree
And the duration has substantially reduced, II grade is relieved to I grade, and III grade is relieved to II grade；In vain；Symptom is substantially identical as before treatment.
3.2 Angina Pectoris from Coronary Artery Disease with Therapy of Combination of TCM with Western Medicine of ECG curative effect evaluation criteria 1979 and arrhythmia cordis forum
" coronary disease and angina pectoris and ECG curative effect evaluation criteria " is formulated.Effective: electrocardiogram restores to " substantially normal " (i.e. normal model
Enclose) or reach " normal ECG "；Effective: the reduction of S-T segment with rise 0.05mV or more after treatment, but does not reach normal level,
It shoals in main lead negative T wave (up to 25% or more person) or T wave is from flat becomes upright, chamber or indoor conduction resistance
Stagnant improver；Invalid: electrocardiogram is substantially identical as before treatment；Aggravate: S-T segment reduces 0.05mV or more before relatively treating, main
Lead negative T wave deepens (up to 25% or more), or upright T wave flattens smooth, and flat T wave, which becomes, to be inverted, and ectopic cardiac rhythm, room occurs
Room block or intraventricular block.
3.3 result
Angina pectoris symptom curative effect, is shown in Table 1:
1 angina pectoris symptom curative effect of table compares
Note: treatment group compared with the control group, P < 0.05；3 groups are treated compared with 1,2,4 group for the treatment of, P < 0.05.
ECG curative effect is shown in Table 2:
2 ECG curative effect of table compares
Note: treatment group compared with the control group, P < 0.01；3 groups are treated compared with 1,2,4 group for the treatment of, P < 0.05.
3.4 adverse reaction
Adverse reaction is not found in therapeutic process.Treat forward and backward progress blood, routine urianlysis and hepatic and renal function inspection, nothing
Obvious abnormal change.
The experimental results showed that Chinese-medicine oral cavity mucosal absorption preparation of the present invention and common SHENGMAI KELI are in treatment type of deficiency of both QI and YIN
Comparing in the curative effect of coronary disease and angina pectoris has significant difference (P < 0.05), illustrates Chinese-medicine oral cavity mucosal absorption preparation of the present invention
Curative effect be better than without full Crushing of Ultrafine processing, with existing preparation process production and conventional oral approach life arteries and veins product.
Claims (9)
1. a kind of Chinese-medicine oral cavity mucosal absorption preparation, which is characterized in that prescription is made of following ingredients:
A, Radix Ophiopogonis, the full micro mist of Schisandra chinensis；
B, one of ginseng, Radix Codonopsis or the full micro mist of red ginseng；
C, filler, adhesive, lubricant, disintegrating agent and corrigent；
Wherein, full micropowder weight proportion are as follows: one of ginseng, Radix Codonopsis or red ginseng 1-3 parts by weight, Radix Ophiopogonis 2-5 parts by weight, Schisandra chinensis 1-
2 parts by weight；
The full micro mist is most fine powder as defined in " Chinese Pharmacopoeia " or impalpable powder.
2. preparation as described in claim 1, which is characterized in that the parts by weight of the Radix Ophiopogonis are as follows: 2-3；Preferably, described complete
The weight proportion of micro mist are as follows: 2 parts by weight of one of ginseng, Radix Codonopsis or red ginseng, 2 parts by weight of Radix Ophiopogonis, 1 parts by weight of Schisandra chinensis；Preferably
It is the weight proportion of the full micro mist are as follows: 1 parts by weight of one of ginseng, Radix Codonopsis or red ginseng, 2 parts by weight of Radix Ophiopogonis, 1 weight of Schisandra chinensis
Part；Preferably, the weight proportion of the full micro mist are as follows: 3 parts by weight of one of ginseng, Radix Codonopsis or red ginseng, 3 parts by weight of Radix Ophiopogonis, five
2 parts by weight of taste.
3. such as the described in any item preparations of claim 1-2, which is characterized in that the preparation be lozenge, chewable tablets, sublingual tablet or
One of oral disintegrating tablet.
4. preparation as claimed in claim 3, which is characterized in that auxiliary material accounts for weight of formulation percentage in the lozenge are as follows: filling
Agent 10.0%-16.0%, adhesive 6.0%-12.0%, lubricant 0.2%-3.0%, corrigent 0.5%-2.5%.
5. preparation as claimed in claim 4, which is characterized in that auxiliary material accounts for weight of formulation percentage in the chewable tablets are as follows: fills out
Fill agent 9.0%-15.0%, adhesive 5.0%-14.0%, lubricant 0.2%-3.0%, corrigent 0.5%-2.5%.
6. preparation as claimed in claim 4, which is characterized in that auxiliary material accounts for weight of formulation percentage in the sublingual tablet are as follows: fills out
Fill agent 8.0%-15.0%, adhesive 4.0%-10.0%, lubricant 0.2%-3.0%, disintegrating agent 4.0%-7.0%, flavoring
Agent 0.5%-2.5%.
7. preparation as claimed in claim 4, which is characterized in that auxiliary material accounts for weight of formulation percentage in the oral disintegrating tablet are as follows: fills out
Fill agent 7.0%-14.0%, adhesive 4.0%-10.0%, lubricant 0.2%-3.0%, disintegrating agent 6.0%-9.0%, flavoring
Agent 0.5%-2.5%.
8. the preparation as described in any one of claim 3-7, which is characterized in that the filler is mannitol, Icing Sugar, pre- glue
Change one or more of starch, glucose, lactose, sorbierite, xylitol, sucrose；Described adhesive be hydroxypropyl methylcellulose,
One or more of povidone, starch slurry；The lubricant is superfine silica gel powder, talcum powder, polyethylene glycol, dodecyl sulphate
One or more of sodium, magnesium stearate；The disintegrating agent be one of PVPP, CCNa, low-substituted hydroxypropyl cellulose or
It is several；The corrigent is one of peppermint oil, lemon oil, orange oil, flavoring pineapple essence, flavoring banana essence.
9. such as the preparation method of Chinese-medicine oral cavity mucosal absorption preparation of any of claims 1-8, which is characterized in that packet
Include the following steps:
A, prepared slices of Chinese crude drugs disintegrating process:
One of ginseng, Radix Codonopsis or red ginseng and Radix Ophiopogonis and Schisandra chinensis are weighed by weight, and net system is dried, and 45 ± 2 DEG C of baking is placed in
It is handled 1-2 hours in case with heated-air drying, one of ginseng, Radix Codonopsis or red ginseng is cut into the piece with a thickness of 5-12mm, it is spare；
One of dried ginseng, Radix Codonopsis or red ginseng and Radix Ophiopogonis are subjected to Ordinary pulverization respectively, obtain coarse powder, crosses 24 meshes；
One of ginseng, Radix Codonopsis or red ginseng coarse powder, Radix Ophiopogonis coarse powder and the net medicinal material of Schisandra chinensis are taken, most fine powder or superfine is individually ground into
Powder, then be uniformly mixed by weight ratio, full micro mist must be mixed, it is spare；
Or one of ginseng, Radix Codonopsis or red ginseng coarse powder, Radix Ophiopogonis coarse powder and the net medicinal material of Schisandra chinensis are taken, it is uniformly mixed by weight ratio, powder
It is broken into most fine powder or full fine powder, full micro mist must be mixed, it is spare；
B, preparation process:
It takes step A to mix full micro mist, filler, adhesive, lubricant and the corrigent of recipe quantity is added, by pharmaceutically routine side
Method is prepared into lozenge or chewable tablets；
Or step A is taken to mix full micro mist, filler, adhesive, lubricant, disintegrating agent and the corrigent of recipe quantity is added, by medicine
Conventional method is prepared into oral disintegrating tablet or sublingual tablet on.
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Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1593621A (en) * | 2004-06-22 | 2005-03-16 | 张晴龙 | Orally disintegrating tablet of 'Shengmai' and its preparation |
| CN1616024A (en) * | 2003-09-15 | 2005-05-18 | 南京大学 | Shengmai powder injection and shengmai chewing tablet and its producing process |
| CN1899507A (en) * | 2005-07-22 | 2007-01-24 | 张晴龙 | Oral disintegration tablet for supplementing qi and recovering pulse and its preparing method |
| CN102961582A (en) * | 2012-12-07 | 2013-03-13 | 鲁南制药集团股份有限公司 | Compound traditional Chinese medicine superfine powder dispersion preparation and preparation method thereof |
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2017
- 2017-12-19 CN CN201711370352.6A patent/CN109925440A/en active Pending
Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1616024A (en) * | 2003-09-15 | 2005-05-18 | 南京大学 | Shengmai powder injection and shengmai chewing tablet and its producing process |
| CN1593621A (en) * | 2004-06-22 | 2005-03-16 | 张晴龙 | Orally disintegrating tablet of 'Shengmai' and its preparation |
| CN1899507A (en) * | 2005-07-22 | 2007-01-24 | 张晴龙 | Oral disintegration tablet for supplementing qi and recovering pulse and its preparing method |
| CN102961582A (en) * | 2012-12-07 | 2013-03-13 | 鲁南制药集团股份有限公司 | Compound traditional Chinese medicine superfine powder dispersion preparation and preparation method thereof |
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