CN107334927A - A kind of preparation method for the medicine and its chewable tablets for treating children's indigestion and apositia - Google Patents
A kind of preparation method for the medicine and its chewable tablets for treating children's indigestion and apositia Download PDFInfo
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- CN107334927A CN107334927A CN201710475144.6A CN201710475144A CN107334927A CN 107334927 A CN107334927 A CN 107334927A CN 201710475144 A CN201710475144 A CN 201710475144A CN 107334927 A CN107334927 A CN 107334927A
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/61—Myrtaceae (Myrtle family), e.g. teatree or eucalyptus
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/48—Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
- A61K36/484—Glycyrrhiza (licorice)
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/75—Rutaceae (Rue family)
- A61K36/752—Citrus, e.g. lime, orange or lemon
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- A—HUMAN NECESSITIES
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/88—Liliopsida (monocotyledons)
- A61K36/896—Liliaceae (Lily family), e.g. daylily, plantain lily, Hyacinth or narcissus
- A61K36/8968—Ophiopogon (Lilyturf)
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
- A61K9/0056—Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
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- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
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- A61K2236/50—Methods involving additional extraction steps
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Abstract
The invention discloses a kind of indigestion for treating children caused by weakness of the spleen and the stomach, function are uncomfortable and the pharmaceutical composition of apositia and its preparation method of chewable tablets.The pharmaceutical composition is prepared by the bulk drug of following parts by weight：356 534 parts of cloves, 1777.6 2666.4 parts of dried orange peel (going white), 888.8 1333.2 parts of the tuber of dwarf lilyturf, 888.8 1333.2 parts of radix glycyrrhizae (processing), 888.8 1333.2 parts of myrobalan's (big gun, stoning), 888.8 1333.2 parts of rascal (going white).For treating indigestion and apositia of the children caused by weakness of the spleen and the stomach, function are uncomfortable.
Description
Technical field
It is used to treat indigestion and apositia of the children caused by weakness of the spleen and the stomach, function are uncomfortable the present invention relates to a kind of
Pharmaceutical composition and its chewable tablets preparation method, belong to pharmaceutical technology field.
Background technology
China is the first in the world children big country, and the absolute number of domestic children's population is still huge.2008 years 0-14 year
Population is 251,660,000 people.Late, dilute, few family planning policy is but come into effect from China from the seventies, Chinese population
Fertility-rate declines at an unprecedented rate.Although the growth to some products ＆ services demands can slow down even under
Drop, but requirement to its quality and price endurance can substantially rise.
Children below China 14 years old account for the 22.4% of total population, and the illness rate of children is 12.33%, account for total ill population
19.35%, but in the thousands of kinds of medicines commercially to circulate, medicine variety but only has kind more than 60 at present, dedicated for children
Treatment less than 2%.Such case occur was grown because of children's medicine construction cycle, and children's feature of different age group is not
Together, dosage is also different, causes research and development and production cost height to be looked forward to, enterprise's enthusiasm for production is not high.The children in China at present
The people of population 2.5 hundred million, the first in the world children big country.From the total amount of ill population, there is larger blank in pediatric drugs market,
Urgent clinical needs aim at the medicine that child patient group is developed, there are about at present 85% children's illnesses for respiratory disease and
Disease of digestive system.0-4 year room Children respiratory system disease and disease of digestive system, which add up to, accounts for the age group number of patients
89.95%.5-14 year children's respiratory system and the class patient's proportion of disease of digestive system two are slightly below 0-4 year children's group, but
Being that both are total is still up to 83.05%.Children's common frdquently encountered disease such as flu, fever, dyspepsia, diarrhoea, night sweat promotes consultation rate one
Directly maintain a high position.
Domestic pediatric drugs are started late, and pediatric drugs particularity determine product relatively be grown up medication cycle to grow,
Research and development are difficult, therefore the paediatrics medicine in domestic market import and joint pharmaceutical factory occupies most important part, place leading market status.Disappear
It is also one of main medication field of paediatrics to change Systemic administration, at present in this kind of medication in the market mainly with children's diarrhae medication and
Based on stomach strengthening and digestion promoting medicine.Fastest-rising treatment classification is gastrointestinal agents in pediatric drugs market, and annual growth reaches 19%.
In recent years, increasing proton pump inhibitor develops children's formulation, but poison caused by chemosynthesis medicine is secondary to be made
With also increasingly apparent, thus as Chinese patent drug toxic side effect it is small, can long-term prescription advantage have in children's medicine market it is huge
Advantage, while the drug safety of clinical child patient group can be largely improved, and can solve the present situation in short supply of clinical children's medicine.
Children anorexia (chiidren anorexia) is using long-term anorexia, sees and eat not greedy, even food refusal as performance
A kind of illness, it is the common the spleen-stomach diseases of paediatrics.Foreign Epidemic disease learns investigation display, baby and preschool child's apocleisis, food refusal etc.
The incidence of feeding problem is about 12%-34%, and in China, this sick incidence of disease gradually rises.According to statistics, have in China city and detest
The child of food tendency has accounted for 25%-50%, and illness rate is up to 15%, and rural area infant is also in being continuously increased.As domestic and international at present
By the illness of most attention, traditional Chinese and western medicine educational circles all is making great efforts to explore its effective treatment method paediatrics.Western medicine is using more
Have a psychotherapy, promote digestive tract power reinforcing medicine, the replacement therapy of vitamin, enzyme and trace element.Wherein, psychotherapy is only applicable
In anorexia nervosa；The application for promoting digestive tract power reinforcing medicine is to weaken caused apocleisis for peristole, in recent years it has been proposed that can
Children anorexia is treated with prepulsid (Cisapride), but finds that Cisapride there are many side effects, is forbidden by U.S. FDA
Use；Zinc supplementation therapy be only to because zinc insufficiency of intake person is effective, it is poor to the absorption because of zinc and Use barriers person's effect, to not being
Due to zinc-deficiency, causer is invalid；Replenishing vitamins, enzyme are same only effective to such nutriment deficient patients, but can not release
Form the cause of disease of these nutriments shortage.From this, with Chinese traditional treatment children anorexia into the traditional Chinese medical science, combination of Chinese tradiational and Western medicine doctor
Must be by the Exploring Road.
In recent years, the domestic Chinese traditional treatment technique study about children anorexia is many, including traditional method treatment and medicine
Treatment.It has been proposed that good curative effect can be obtained by pinching ridge treatment Anorexia Children with acupuncture, acupuncture Fpir Crevices cave or massage, but children are to it
Fear is produced, is not easy to receive.And drug therapy a portion function is partial to strengthening spleen and nourishing stomach, such as youngster's treasured cream；Another part work(
Relieving dyspepsia, such as infantile appetite piece can be partial to.Therefore current still shortage is specially strong for the incoordination between the spleen and the stomach spleen mistake of children anorexia card category
Transport the active drug of infant.
Pharmaceutical composition used in the present invention derives from《The formulary of peaceful benevolent dispensary》With《Key to therapeutic of children's disease》In
Beneficial Huang is dissipated, and the medicinal material tuber of dwarf lilyturf for treating stomach-Yin deficiency is added according to modern environment and child development feature：
《The formulary of peaceful benevolent dispensary》
【Prescription】The money of cloves four (loseing fire), two liang of dried orange peel (going white), radix glycyrrhizae, myrobalan's (big gun stonings), rascal (going white),
Each one or two.
【Process】Upper is smalls.
【Major function】The spleen and stomach in children weakness is controlled, stomachache lets out dysentery, do not think newborn food, keep vomiting, and tired god is lazy, and the heart side of body is swollen
Swollen, color bluish yellow is weak and weary through illness not wake up.
【Usage and dosage】An a lot of money is often taken, water seven divides small cup, decocts to five, six points, and food advances, amount size plus-minus and clothes.This medicine
There is the magical effect pole, can not describe.
《Key to therapeutic of children's disease》
【Alias】Tonifying spleen dissipates.
【Prescription】Dried orange peel (goes white one or two), cloves (two money, side's banksia rose), myrobalan's (big gun stoning), rascal (is gone white), sweet
Careless (processing each five money).
【Major function】Middle benefit gas qi-regulating, invigorating the spleen to arrest diarrhea.Control weakness of the spleen and the stomach, stomachache lets out dysentery, does not think newborn food, and the tired face of god is yellow, infantile malnutrition due to digestive disturbances or intestinalparasites
Product abdomen bodice is thin.
【Usage and dosage】Upper is end.The three years old money of youngster one half, half, water, decocts three points, is taken before eating.
Dried orange peel, rascal regulating qi-flowing for strengthening spleen, cloves warming spleen and stomach for dispelling cold, myrobalan's relieving diarrhea with astringents, honey-fried licorice root are invigorated the spleen and benefited qi in side.All medicines are matched somebody with somebody
5, there are middle benefit gas qi-regulating, the work(of invigorating the spleen to arrest diarrhea.We are so that weakness of the spleen and the stomach, stomachache lets out dysentery, vomiting gastral cavity is swollen, do not think breast food, the tired face of god is yellow
For dialectical main points.Modern times are usually used in treating infantile diarrhea, children's indigestion etc..Modern society environment pollutes getting worse,
Crowd's rhythm of life is fast, and children's taste problem is more because stomach-Yin deficiency causes, and the tuber of dwarf lilyturf is sweet, slight bitter, is slightly cold.Moistening lung clears away heart-fire, purge heat and promote the production of body fluid,
Stomach can be entered with nourishing the stomach liquid, stimulating appetite, can more enter spleen to help spleen to dissipate and be skillful in lung, Dingchuan relieving coughing.Therefore the tuber of dwarf lilyturf is added in side, be used for
Treat stomach-Yin deficiency.
Because the variant while used preparation method of drug prescription amount contained in the different times classic of TCM is more simple
It is plain coarse, Clinical practice can not be accurately instructed, while children are in the period that human body constantly grows, hepatic and renal function, maincenter
Nervous system and internal system develop still unsound, the metabolism to medicine, excretion and poor resistance.Therefore children should be combined to give birth to
Reason feature, the rational use of medicines, reduce the generation of adverse drug reaction.Infant there is no sense of independence, easily struggle during medication；It is older
Children dependence during one's sickness is strong, emotional lability, anxiety are frightened, be also easy to produce conflict, cause drug compliance to decline, therefore
Select suitable formulation extremely important.
Current pharmaceutical formulation on the market, mainly based on formulation of being grown up, children's formulation ratio is smaller.Clinical application exist into
People's medicine is used for the phenomenon of children, have impact on drug compliance to a certain extent.Children use adult medication, during divided dose simultaneously
It can not accomplish that dosage is accurate, and slow-release tablet, once destroying its structure easily occurs adverse reaction.Herbal toxic effect compared with
Small, as the father and mother of only-child, it has been a kind of trend to select Chinese patent drug to be cured the disease for love youngster.The agent of TCM Pediatrics medication in recent years
Type design also develops towards scientific and practicality direction, effervescent tablet, chewable tablets, suppository, aerosol etc. formulation occurs.Mouthful
Clothes administration is a kind of the most convenient, economic and most widely used method of administration of child patient treatment.But infant taking is consolidated
Body medicine acquires a certain degree of difficulty, from the point of view of rice Intranet Chinese patent drug hospital general layout data, oral liquid and chewable tablet in clinical practice
The medicinal application of type is most.
The present inventor refers to the document of contemporaneity different authors by consulting the evolution of ancient Chinese measuring weighing instrument,
The approximate range from the pharmaceutical composition proportion of composing described in two different ancient books and records is determined, it is determined that pharmaceutical composition group
While proportional, the present inventor is also studied the processing mode of pharmaceutical composition, to more letter contained in ancient books and records
Plain coarse medicine processing method carried out creativeness improvement, according to contained by different medicinal materials the characteristics of active component it is targeted
The improvement and optimization that have carried out extracting method, farthest remain the active ingredient in each medicinal material, and pass through animal drugs
Different proportion combination of the Neo-Confucianism experiment to pharmaceutical composition is verified, drug composition effective proportion of composing is finally determined
Scope, and therefrom preferably go out optimal pharmaceutical composition prescription.
The content of the invention
The present inventor refers to the document of contemporaneity different authors by consulting the evolution of ancient Chinese measuring weighing instrument,
The pharmaceutical composition proportion of composing described in from two different ancient books and records is determined, it is 37.3 grams that the Song Dynasty one or two, which closes modern,《It is peaceful
The Bureau of People's Welfare Pharmacies side》It is cloves 14.92g (loseing fire) that contained prescription, which is scaled modern unit, and dried orange peel (removes white) 74.6g, radix glycyrrhizae,
Myrobalan's (big gun stoning), rascal (going white), each 37.3g.It is cloves each taking dosage each taking an a lot of money equivalent to modern 5.6g
0.41g (loses fire), and dried orange peel (removes white) 2.07g, radix glycyrrhizae, myrobalan's (big gun stoning), rascal (going white), each 1.04g.《Children's medicine is demonstrate,proved
Straight rhymed formula》It is dried orange peel (removing white 37.3g) that contained prescription, which is scaled modern unit, and cloves (7.46g, side's banksia rose), (big gun is gone myrobalan
Core), rascal (is gone white), radix glycyrrhizae (processing) each 18.65g.Three years old youngsters each taking a money half equivalent to modern 5.6g, each taking dosage
For dried orange peel (removing white 2.07g), cloves (0.41g, side's banksia rose), myrobalan's (big gun stoning), rascal (is gone white), and radix glycyrrhizae (processing) is each
1.04g.2 classics of TCM determine that the yellow scattered every 1000 parts prescription of the contained benefit of ancient prescription is more than：
410 parts of cloves, 2070 parts of dried orange peel (going white), 1040 parts of radix glycyrrhizae (processing), 1040 parts of myrobalan's (big gun, stoning), rascal (is gone
1040 parts in vain)
From Song dynasty's change of more than 900 years natural environment so far and the influence of the wild change man kind of Chinese medicine, the medicine of modern times plantation
Material has certain gap with Song Dynasty medicinal material in drug effect, therefore uses modern medicinal material progress side by the contained prescription recipe quantity of Song Dynasty ancient books and records
Prepared by agent can not realize the optimum efficiency of ancient prescription, the present inventor according to contained by different medicinal materials the characteristics of active component targetedly
The improvement and optimization of extracting method have been carried out, has farthest remained the active ingredient in each medicinal material, and pass through animal pharmacology
Learn different proportion combination of the experiment to pharmaceutical composition to verify, finally determine and prepare effective medicine using modern medicinal material
The medicinal material proportion of composing scope of composition, and therefrom preferably go out optimal pharmaceutical composition prescription.The present inventor is also to medicine simultaneously
The processing mode of compositions is studied, and more simple and crude coarse medicine processing method contained in ancient books and records is created
The improvement for the property made, the method for decoction is changed to pharmaceutical composition being prepared into clinical suitable after the contained crude drug of ancient book and records is crushed
Answering property is good, is easy to storage with carrying modern medicines preparation formulation.
The invention discloses a kind of pharmaceutical composition and its preparation method of chewable tablets, it is characterised in that the pharmaceutical composition and its
Chewable tablets can be used for indigestion and apositia of the treatment children caused by weakness of the spleen and the stomach, function are uncomfortable.
Technical scheme disclosed in this invention is as follows：
Pharmaceutical composition disclosed by the invention is prepared by the bulk drug of following parts by weight：Cloves 356-534 parts, dried orange peel
(going white) 1777.6-2666.4 parts, tuber of dwarf lilyturf 888.8-1333.2 part, radix glycyrrhizae (process) 888.8-1333.2 parts, myrobalan's (big gun, stoning)
888.8-1333.2 parts, rascal (go white) 888.8-1333.2 parts.It is preferably made 1000 parts.
Pharmaceutical composition disclosed by the invention is preferably prepared by the bulk drug of following parts by weight：Cloves 400.5-
489.5 parts, dried orange peel (goes white) 1999.8-2444.2 parts, tuber of dwarf lilyturf 999.9-1222.1 part, and radix glycyrrhizae (processs) 999.9-1222.1 parts,
Myrobalan (big gun, stoning) 999.9-1222.1 parts, rascal (go white) 999.9-1222.1 parts.It is preferably made 1000 parts.
Pharmaceutical composition optimum proportioning disclosed by the invention is prepared by the bulk drug of following parts by weight：445 parts of cloves,
2222 parts of dried orange peel (going white), 1111 parts of the tuber of dwarf lilyturf, 1111 parts of radix glycyrrhizae (processing), 1111 parts of myrobalan's (big gun, stoning), rascal (going white) 1111
Part.It is preferably made 1000 parts.
The method for preparing raw material of pharmaceutical composition disclosed by the invention, comprises the following steps：
The cloves of recipe quantity, dried orange peel, myrobalan, rascal are taken, the water that above-mentioned 8-10 times of medicinal material weight is measured is added, is heated to boiling
Rise, keep slight boiling condition, volatile oil is extracted with steam distillation, when no longer being distillated to volatile oil, the another device of volatile oil is collected,
0-10 DEG C of refrigeration of the aqueous solution after distillation is standby.
The dregs of a decoction after volatile oil are extracted, all 8-10 times of medicinal material weight in the tuber of dwarf lilyturf, radix glycyrrhizae and the prescription of recipe quantity is added and measures
Decocting boil three times, each 1-2 hours, collecting decoction, filtration, filtrate merges with the above-mentioned aqueous solution, puts in vacuum concentration pot, in
Vacuum-0.02-- 0.08MPa, 40-80 DEG C of temperature is concentrated into the clear cream of relative density about 1.11 (50 DEG C), stand-by.
Qinghuo reagent is put and processing is dried in air dry oven or vacuum drying chamber or microwave drying oven, and moisture control exists
Less than 3%.
Dry cream is crushed, and extraction gained volatile oil is added and mixed, loads fine aluminium bag, seals and produce.
The yield that crude drug is converted into dry cream is about 13-20%, totally 1000 parts.
The chewing piece preparation method of pharmaceutical composition disclosed by the invention, comprises the following steps：
Composition dried cream powder is taken, addition excipients are appropriate, appropriate flavouring, are well mixed, and add adhesive and prepare in right amount
Into softwood, the particle of appropriate particle size is prepared into by facility for granulating, adds lubricant, carried out tabletting using tablet press machine, be made altogether,
Produce.It is preferred that taking 1000 parts of composition dried cream powder, 2000 are made.
Further, excipients used in the chewing piece preparation method of pharmaceutical composition disclosed by the invention can be sugarcane
The chewable tablets such as sugar, dextrin, lactose, mannitol, sorbierite, xylitol, pregelatinized starch, starch, microcrystalline cellulose often use excipient
One or more in agent.
Further, flavouring used in the chewing piece preparation method of pharmaceutical composition disclosed by the invention can be sweet tea
Taste agent (such as sucrose, Stevioside, acesulfame potassium, aspartame, glycyrrhizin, Sucralose), acid (such as citric acid, apple
Acid, tartaric acid etc.), the one or more in flavouring agent (natural essence, synthetic fragrance).
Further, adhesive used in the chewing piece preparation method of pharmaceutical composition disclosed by the invention can be
One kind in the chewable tablets typical binders such as water, ethanol, starch slurry, carboxymethyl cellulose, PVP, hydroxypropyl methyl cellulose
It is or several.
Further, lubricant used in the chewing piece preparation method of pharmaceutical composition disclosed by the invention can be micro-
The one or more divided in the conventional lubricant of the chewable tablets such as silica gel, magnesium stearate, talcum powder.
Further, facility for granulating used in the chewing piece preparation method of pharmaceutical composition disclosed by the invention can be
The conventional facility for granulating of the preparations such as oscillating granulator, bulk drug of pretreatment adds with interior granulator, dry granulating machine, fluid bed.
Pharmaceutical composition disclosed by the invention and its chewable tablets, it is characterised in that the pharmaceutical composition and its chewable tablets can use
In indigestion and apositia of the treatment children caused by weakness of the spleen and the stomach, function are uncomfortable.
The instructions of taking of medicine composition chewable tablet disclosed by the invention is takes 3 times daily, and less than 3 years old children every time 1
Piece, 2 tablets once by more than 3 years old children, chews clothes before meals.
Embodiment
Embodiment one：
Prescription：
Cloves 445g, dried orange peel (remove white) 2222g, tuber of dwarf lilyturf 1111g, and radix glycyrrhizae (processs) 1111g, myrobalan (big gun, stoning) 1111g,
Rascal (removes white) 1111g
Raw material process：
The cloves of recipe quantity, dried orange peel, myrobalan, rascal are taken, the drinking water of 10 times of amounts of medicinal material weight is added, is heated to seething with excitement,
Slight boiling condition is kept, volatile oil is extracted with steam distillation, when no longer being distillated to volatile oil, the another device of volatile oil is collected, steamed
0-10 DEG C of refrigeration of the aqueous solution after evaporating is standby.
The dregs of a decoction after volatile oil are extracted, add the water of all 8 times of amounts of medicinal material weight in the tuber of dwarf lilyturf, radix glycyrrhizae and the prescription of recipe quantity
Decoct three times, 1.5 hours every time, collecting decoction, filtration, filtrate merges with the above-mentioned aqueous solution, put in vacuum concentration pot, in vacuum
Degree -0.06MPa, temperature 50 C is concentrated into the clear cream of relative density about 1.11 (50 DEG C), stand-by.
Qinghuo reagent is put and processing is dried in microwave drying oven, and moisture is controlled below 3%.
Dry cream is crushed, and extraction gained volatile oil is added and mixed, loads fine aluminium bag, seals and produce.
Chewable tablets preparation technology：
The raw material prepared by above step is taken, is weighed, adds the sucrosedextrin mixture (1 of 2 times of amounts：3), it is well mixed,
Purified Water q. s are added, prepare softwood, using oscillating granulator, 14-30 eye mesh screens prepare particle, and obtained particle puts baking
In case, particle after drying is crossed 12-24 mesh sieve whole grains by 40 DEG C of dryings 2 hours, control moisture below 3%, puts stainless steel turnover
Bucket is contained, and dried particle is weighed, and is added in three-dimensional mixer, adds gross weight 0.2-0.5% magnesium stearate, mixing
Uniformly, 2000 are pressed into using tablet press machine, quality inspection, packaging, produced.
Embodiment two：
Prescription：
Cloves 400g, dried orange peel (remove white) 2000g, tuber of dwarf lilyturf 1000g, and radix glycyrrhizae (processs) 1000g, myrobalan (big gun, stoning) 1000g,
Rascal (removes white) 1000g
Raw material process：
The cloves of recipe quantity, dried orange peel, myrobalan, rascal are taken, the drinking water of 8 times of amounts of medicinal material weight is added, is heated to seething with excitement, is protected
Slight boiling condition is held, volatile oil is extracted with steam distillation, when no longer being distillated to volatile oil, the another device of volatile oil is collected, distillation
0-10 DEG C of refrigeration of the aqueous solution afterwards is standby.
The dregs of a decoction after volatile oil are extracted, add all 10 times of amounts of medicinal material weight in the tuber of dwarf lilyturf, radix glycyrrhizae and the prescription of recipe quantity
Decocting is boiled three times, 1 hour every time, collecting decoction, and filtration, filtrate merges with the above-mentioned aqueous solution, put in vacuum concentration pot, in vacuum
Degree -0.04MPa, temperature 60 C is concentrated into the clear cream of relative density about 1.11 (50 DEG C), stand-by.
Qinghuo reagent is put and processing is dried in vacuum drying chamber, and moisture is controlled below 3%.
Dry cream is crushed, and extraction gained volatile oil is added and mixed, loads fine aluminium bag, seals and produce.
Chewable tablets preparation technology：
The raw material prepared by above step is taken, is weighed, adds the xylitol of 1.5 times of amounts, appropriate Stevioside, citric acid are fitted
Amount, it is well mixed, adds in top-jet-type fluid bed, using purified water as adhesive, set temperature of charge as 35-50 DEG C, wait to preheat
When temperature rises to 35 DEG C, open peristaltic pump and start to spray, it is 10-50 revs/min and mist to spray speed according to granulating situation regulating liquid medicine
Change pressure is 0.08-0.30MPa.The motion conditions of particle are observed at any time, and air inducing air quantity is constantly increased in the range of 30-50Hz
Greatly, to make powder suspend make a certain degree of flowing in the gas flow.Repeated spray is dried, until particle granulating is uniformly, well, color
It is damp consistent, stop spraying after meeting the requirements.In whole process, Timing vibration bag hose make the powder of collection shake fall on fluid bed with
Drop and particle contact granulating.After spraying terminates, material continued in 30-35 DEG C of dry 1-2 hour, controlled moisture below 3%,
Heating is closed, when temperature is down to room temperature naturally, trembles the clear powder discharging of bag.Particle after drying is crossed into 18-30 mesh sieve whole grains, put stainless
Steel turnover barrel is contained, and dried particle is weighed, and is added in three-dimensional mixer, adds gross weight 0.2-0.5% differential silicon
Glue talc mixture (1：1), it is well mixed, is pressed into 2000 using tablet press machine, quality inspection, packaging, produces.
Embodiment three：
Prescription：
Cloves 500g, dried orange peel (remove white) 2500g, tuber of dwarf lilyturf 1250g, and radix glycyrrhizae (processs) 1250g, myrobalan (big gun, stoning) 1250g,
Rascal (removes white) 1250g
Raw material process：
The cloves of recipe quantity, dried orange peel, myrobalan, rascal are taken, the drinking water of 8 times of amounts of medicinal material weight is added, is heated to seething with excitement, is protected
Slight boiling condition is held, volatile oil is extracted with steam distillation, when no longer being distillated to volatile oil, the another device of volatile oil is collected, distillation
0-10 DEG C of refrigeration of the aqueous solution afterwards is standby.
The dregs of a decoction after volatile oil are extracted, add all 10 times of amounts of medicinal material weight in the tuber of dwarf lilyturf, radix glycyrrhizae and the prescription of recipe quantity
Decocting is boiled three times, 2 hours every time, collecting decoction, and filtration, filtrate merges with the above-mentioned aqueous solution, put in vacuum concentration pot, in vacuum
Degree -0.05MPa, 40 DEG C of temperature is concentrated into the clear cream of relative density about 1.11 (50 DEG C), stand-by.
Qinghuo reagent is put and processing is dried in air dry oven, and moisture is controlled below 3%.
Dry cream is crushed, and extraction gained volatile oil is added and mixed, loads fine aluminium bag, seals and produce.
Chewable tablets preparation technology：
The raw material prepared by above step is taken, is weighed, adds the mannitol milk-sugar mixture (1 of 1.5 times of amounts：1), acesulfame potassium
In right amount, appropriate malic acid, it is well mixed, adds in dry granulating machine, using 14-30 mesh whole grain screen clothes, prepare particle, put stainless
Steel turnover barrel is contained, and obtained particle is weighed, and is added in three-dimensional mixer, adds gross weight 0.2-0.5% magnesium stearate,
It is well mixed, 2000 are pressed into using tablet press machine, quality inspection, packaging, is produced.
Example IV：
The pharmacological testing of functional dyspepsia FD
1 material
1.1 trial drug
Former side's decocting liquid of the contained recipe quantity of beneficial yellow scattered ancient books, conventional to decoct 2 times, aqueous is condensed into 200%, puts 4 DEG C of ice
It is standby in case, distilled water diluting is used as needed with preceding, medicinal material is purchased from attached peaceful hospital of The Medical College of Changzhi, Shanxi, through The Medical College of Changzhi, Shanxi
Crude drug teaching and research room of department of pharmacy identifies；Drug regimen raw material in embodiments of the invention one, the dosage needed for preceding basis, adds steaming
Distilled water dissolved dilution forms；Prepared chewable tablets in the embodiment of the present invention one, the dosage needed for preceding basis, grinds and adds distilled water
Dissolved dilution forms；Motilium, Xian-Janssen Pharmaceutical Ltd. produce, the dosage needed for preceding basis, grind plus distillation is water-soluble
Solution dilution forms；Bolus for reinforcing middle-jiao and replenishing qi, development in science and technology Co., Ltd of Beijing Tongrentang produce, and the dosage needed for preceding basis, add distillation
Water grinding dilution forms.1.2 animal
SD systems rat, NIH systems mouse, provided by department of pharmacy of The Medical College of Changzhi, Shanxi pharmacological evaluation room.
1.3 instrument
722 type spectrophotometers, the analytical instrument factory of Shanghai the 3rd；Centrifuge, Beijing Medical Centrifugal Machine Factory；PYX-DHS-
3540 type water isolation type electrothermostats, the factory of Shanghai advance medicine equipment one.
1.4 reagent
Alcian blue, it is phenol red, provided by department of pharmacy of The Medical College of Changzhi, Shanxi pharmacological evaluation room.
2 methods and result
2.1 pairs of normal Mouse Stomach emptyings and the influence of Intestinal pushing
Taking mouse 50, male and female dual-purpose, body weight 18-20g is randomly divided into 5 groups, and packet and administration are shown in Table 1, gastric infusion,
Volume is 25mL/kg, one time a day, continuous 3d, fasting 12h before last dose, the phenol red solution of 2h gavages 0.04% after administration
(aqueous 1.5% carboxymethyl cellulose is disorderly) 0.25mL, 20min puts to death animal, while takes out stomach and small intestine, and small intestine is laid in into blank sheet of paper
On.Stomach is placed in 30mL 0.5mol/L NaOH solution, is cut off stomach along greater curvature, is fully washed lower gastric content, take 5mL to centrifuge
(3000r/min, 10min) takes supernatant to survey its absorbance in 560nm colorimetrics with 722 spectrophotometers, and it is phenol red then to calculate stomach
Residual rate, using the phenol red residual rate of stomach as metrics evaluation gastric emptying speed, Intestinal propulsive rate then with it is phenol red in small intestine divide a word with a hyphen at the end of a line away from
Evaluated from the percentage for accounting for small intestine total length.It the results are shown in Table 1.
The pharmaceutical composition of the present invention of table 1 and normal Mouse Stomach is emptied chewable tablets and the influence of Intestinal pushing (N=10)
Note：Compared with blank group, * P<0.05
Bulk drug group of the present invention is obviously promoted effect with chewable tablets group to the emptying of normal Mouse Stomach as can be seen from Table 1,
Compared with the yellow scattered group of blank group and benefit, there is significant difference (P<0.05), illustrate that bulk drug group of the present invention aligns with chewable tablets group
The facilitation of normal mouse gastric emptying is substantially better than beneficial yellow scattered group；But each group experiment on mouse Intestinal pushing there are no significant influence (P
>0.05)。
The influence of 2.2 pairs of rat hydrochloric acid in gastric juice, pepsinia
180~220g of body weight rats 50 are taken, are randomly divided into 5 groups, gastric infusion, volume is 1mL/, one time a day,
Continuous 3d, single cage fasting 36h before last dose, free water, 2h after administration, with ether light anesthesia animal, cuts off belly
Hair, routine disinfection skin, opens 1 about long 2.5cm otch along hunter's line under xiphoid-process, carefully lifts stomach, refers in pylorus and 12
Intestines joint portion suture ligature, carefully avoids blood vessel, injects each medicine or distilled water 5mL/kg in duodenum immediately.Sent after suture
Is fasting for solids and liquids in the withdrawal of currency from circulation, and cervical vertebra is taken off after 5min and puts to death animal, takes out stomach, collects gastric juice in graduated centrifuge tube, while along greater curvature
Stomach is cut off, filter paper gently wipes the debris on coat of the stomach, in the alcian blue solution that magenblase people is prepared, will collect in centrifuge tube
Gastric juice 15min is centrifuged with 3000r/min, Aspirate supernatant, discharged with 0.02mmol/L NaOH to determine free acid and total acid
Amount, pepsin activity is determined, the results are shown in Table 2.
Influence of the pharmaceutical composition and chewable tablets of the present invention of table 2 to rat hydrochloric acid in gastric juice and pepsinia
Note：Compared with blank group, * P<0.05, * * P<0.01.
As seen from Table 2, benefit it is yellow dissipate group and bulk drug of the present invention and chewable tablets group can reduce free acid, total acidity and
Pepsin activity, the yellow scattered group of benefit have significant difference (P compared with blank group in terms of free acid and total acidity is reduced<
0.05), bulk drug and chewable tablets group of the present invention has extremely conspicuousness compared with blank group in terms of free acid and total acidity is reduced
Difference (P<0.01)；Beneficial yellow scattered group there was no significant difference (P in terms of pepsin activity is reduced compared with blank group>0.05),
Bulk drug and chewable tablets group of the present invention has compared with blank group in terms of pepsin activity is reduced and its significant difference (P<
0.01)；It is in Inhibitory Effect to rat hydrochloric acid in gastric juice, pepsin to illustrate bulk drug and chewable tablets group of the present invention, and inhibition is bright
Aobvious scattered group yellow better than benefit.
Gastric emptying is that gastric content is discharged into duodenal process through pylorus.The stomach of about 40~50% indigestion patient
Emptying substantially slows down than normal healthy controls person, shows as gastric liquid and solid or mixes the gastric emptying of food, and motor activation regulator
Symptom can be improved, promote gastric emptying, it is the main pathophysiological reaction of indigestion patient to illustrate gastric hypokinesia.Test above
The pharmaceutical composition and chewable tablets for proving the present invention can substantially accelerate gastric emptying, and its positive effect is yellow better than ancient prescription benefit to be dissipated.
Research in recent years shows that the gastric acid secretion of most indigestion cases is not increased, therefore is presumably due to patient
To caused by hydrochloric acid in gastric juice sensitiveness increase, treating indigestion with acid-suppressing medicine, about 50% research, particularly multiple cross design are ground
Study carefully and show there is the effect of obvious.This is test result indicates that the pharmaceutical composition and chewable tablets of the present invention have to hydrochloric acid in gastric juice, pepsin
There is obvious inhibitory action, it is yellow scattered that its Acidinhibitor is substantially better than ancient prescription benefit.
Claims (9)
- A kind of 1. drug regimen for being used to treat indigestion and apositia of the children caused by weakness of the spleen and the stomach, function are uncomfortable Thing, it is characterised in that：Composition for treatment is prepared by the bulk drug of following parts by weight, and the bulk drug is：Cloves 356-534 parts, dried orange peel (go white) 1777.6-2666.4 parts, tuber of dwarf lilyturf 888.8-1333.2 part, and radix glycyrrhizae (processs) 888.8- 1333.2 parts, myrobalan (big gun, stoning) 888.8-1333.2 parts, rascal (goes white) 888.8-1333.2 parts.
- 2. the pharmaceutical composition described in claim 1, it is characterised in that：It is prepared by the bulk drug of following parts by weight：Cloves 400.5-489.5 parts, dried orange peel (go white) 1999.8-2444.2 parts, tuber of dwarf lilyturf 999.9-1222.1 part, and radix glycyrrhizae (is processed) 999.9-1222.1 parts, myrobalan (big gun, stoning) 999.9-1222.1 parts, rascal (go white) 999.9-1222.1 parts.
- 3. the pharmaceutical composition described in claim 1 or 2, it is characterised in that：It is prepared by the bulk drug of following parts by weight：445 parts of cloves, 2222 parts of dried orange peel (going white), 1111 parts of the tuber of dwarf lilyturf, 1111 parts of radix glycyrrhizae (processing), 1111 parts of myrobalan's (big gun, stoning), 1111 parts of rascal (going white).
- 4. the pharmaceutical composition described in claim any one of 1-3, wherein dried orange peel use white processed product or its activity Extract, radix glycyrrhizae use honey-fried licorice root processed product or its activity extract, and myrobalan uses processed product or its work of stoning Property extract, rascal use white processed product or its activity extract.
- 5. the pharmaceutical composition described in claim any one of 1-4, its preparation method comprise the following steps：A. the cloves of recipe quantity, dried orange peel, myrobalan, rascal are taken, medicinal material 8-10 times of water measured of weight is added, is heated to seething with excitement, is kept Slight boiling condition, volatile oil is extracted with steam distillation, when no longer being distillated to volatile oil, the another device of volatile oil is collected, after distillation 0-10 DEG C of refrigeration of the aqueous solution it is standby；B. the dregs of a decoction after volatile oil are extracted, add what all 8-10 times of medicinal material weight in the tuber of dwarf lilyturf, radix glycyrrhizae and the prescription of recipe quantity were measured Decocting is boiled three times, each 1-2 hours, collecting decoction, and filtration, filtrate merges with the above-mentioned aqueous solution, put in vacuum concentration pot, Yu Zhen Reciprocal of duty cycle -0.02~-0.08MPa, 40-80 DEG C of temperature is concentrated into the clear cream of relative density about 1.11 (50 DEG C), stand-by；C. qinghuo reagent is put and processing is dried in air dry oven or vacuum drying chamber or microwave drying oven, and moisture is controlled 3% Below；D. dry cream is crushed, and extraction gained volatile oil is added and mixed, loads fine aluminium bag, seals and produce.
- 6. the pharmaceutical composition described in claim any one of 1-5, it is characterised in that the pharmaceutical composition be used for treat children because Weakness of the spleen and the stomach, function uncomfortable caused indigestion and apositia.
- 7. the pharmaceutical composition described in claim any one of 1-6, described pharmaceutical composition formulation is chewable tablets, preparation method bag Include following steps：Composition dried cream powder is taken, addition excipients are appropriate, appropriate flavouring, are well mixed, and addition adhesive is prepared into soft in right amount Material, the particle of appropriate particle size is prepared into by facility for granulating, adds lubricant, carried out tabletting using tablet press machine, produce.
- 8. the pharmaceutical composition described in claim 7, the excipients used in it be sucrose, dextrin, lactose, mannitol, sorbierite, One or more in xylitol, pregelatinized starch, starch, microcrystalline cellulose；Flavouring used in it is sweetener (such as sugarcane Sugar, Stevioside, acesulfame potassium, aspartame, glycyrrhizin, Sucralose etc.), acid (such as citric acid, malic acid, tartaric acid Deng), the one or more in flavouring agent (natural essence, synthetic fragrance)；Adhesive used in it is water, ethanol, starch One or more in slurry, carboxymethyl cellulose, PVP, hydroxypropyl methyl cellulose；Lubricant used be differential silica gel, The one or more of magnesium stearate, talcum powder；Facility for granulating used in it be oscillating granulator, bulk drug of pretreatment adds with interior granulator, Dry granulating machine, fluid bed.
- 9. the pharmaceutical composition described in claim 7 or 8, it is characterised in that the chewable tablets every is equivalent to bulk drug cloves 0.23g, dried orange peel (remove white) 1.11g, tuber of dwarf lilyturf 0.56g, and radix glycyrrhizae (processs) 0.56g, myrobalan (big gun, stoning) 0.56g, and rascal (is gone white) 0.56g。
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| CN109157621A (en) * | 2018-08-31 | 2019-01-08 | 阜阳健诺生物科技有限公司 | A kind of aid digestion chewing sugar and preparation method thereof |
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| CN105343511A (en) * | 2015-12-15 | 2016-02-24 | 李国深 | Pediatric diet adjustment composition |
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| CN105343511A (en) * | 2015-12-15 | 2016-02-24 | 李国深 | Pediatric diet adjustment composition |
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Application publication date: 20171110 |