Background technology
Apositia is the name of disease of modern medicine, and loss of appetite, appetite that clinical main manifestations is the long period reduce.How weakness of the spleen and stomach, incoordination between the spleen and stomach can cause apositia, and loss of appetite, appetite that clinical main manifestations is the long period reduce.According to apositia, clinical manifestation is divided into six types to the people such as Sang Li: 1. dysfunction of the spleen in transportation type, control and should spleen invigorating help fortune, whetting appetite, 2. qi-deficiency of spleen and stomach, control suitable replenishing QI to invigorate the spleen, eliminating dampness by diuresis stomach function regulating, 3. liver qi stagnation type, controls suitable depressed liver-energy dispersing and QI regulating, activating the spleen appetizing, 4. resistance type in dyspepsia, controls suitable dyspepsia and intestinal stasis relieving, and spleen invigorating helps fortune, 5. type of deficiency of stomach yin, should nourishing the stomach to promote the production of body fluid, nourishing YIN to relieve dryness syndrome, 6. malnutrition due to parasitic infestation impairment of the spleen type, control should anthelmintic go to amass, invigorating the spleen and stomach, the main cause of primary disease, at taste, adopts respectively the principles such as activating the spleen, stomach invigorating, warming middle-JIAO, dampness in treatment.
At present, the conventional prescription for the treatment of for apositia of children has comprised Ramulus Uncariae Cum Uncis and Periostracum Cicadae two herbal medicines more, these two kinds of medicines all have sedation, for height, hot infantile convulsion person is suitable, moreover Periostracum Cicadae taken medicine after the side effect of abdominal distention, borborygmus and stomachache, this is also unfavorable for the safety that pediatric patient is taken medicine.And the dosage forms such as oral liquid, syrup that adopt in prior art, dosage form is more single, is unfavorable for the external development of Chinese medicine preparation more.
Microcapsule be for medicine compared with new technology, the fast development of pharmacy science, only use original preparation technique, sometimes can not meet clinical demand, the field of Chinese medicines is all the more so, need to carry out novel form and increase Chinese medicine added value, medicine can be covered bad smell and the taste of Chinese medicine after microencapsulation, and improves the stability of medicine.The present invention, through the screening to a large amount of adjuvants, except prescription is improved, also provides a kind of trial to this prescription novel form.
Summary of the invention
The invention provides a kind of microcapsule formulation of stomach function regulating spleen invigorating, be prepared from Cortex Magnoliae Officinalis 600g-700g by following composition, Flos Chrysanthemi 600g-700g, Fructus Aurantii 800g-900g, Semen Coicis 800g-900g, Fructus Oryzae Germinatus 800g-900g, Fructus Crataegi 400g-500g, Herba Lophatheri 600g-700g, Radix Glycyrrhizae 1000g-1100g, cane sugar powder 800g-900g, wall material is made up of monoglyceride, sucrose ester, maltodextrin and soybean protein, wherein monoglyceride 2g-4g, sucrose ester 0.5g-0.7g, maltodextrin 30g-60g, soybean protein 30g-60g.
Microcapsule formulation of the present invention obtains by being prepared as follows step: 1) take by weight Cortex Magnoliae Officinalis, Flos Chrysanthemi, Fructus Aurantii, Semen Coicis, Fructus Crataegi, Fructus Oryzae Germinatus, Herba Lophatheri, Radix Glycyrrhizae and pulverize, soak, add 4-5 times of water to decoct 3 times, each 45-60min, merges decoction liquor, concentrated, adding 70% ethanol leaves standstill, filter, rotary evaporation is removed ethanol, the dry powder that obtains; 2) taking by weight cane sugar powder, with 1) powder that obtains mixes; 3) get in 70% ethanol that powder that 10g is mixed to get is added to 50ml for subsequent use as capsule-core; 4) taking by weight monoglyceride, sucrose ester, maltodextrin, soybean protein is dissolved in 700ml water for subsequent use; 5) by 3) the capsule-core liquid that obtains is slowly added to 4) aqueous solution in, cross colloid mill 3 times, spraying is dry, obtains microcapsule.
Cortex Magnoliae Officinalis, Fructus Aurantii enter stomach, spleen channel, all have the effect that promotes stomach function, removing food stagnancy food, and " fire " are made in food stagnation, have pathogenic fire reducing effect with Flos Chrysanthemi, and it share and also produces certain synergism, then with other composition use, anorexia is had to suitable curative effect.Be prepared into microcapsule and covered the bad smell of Chinese medicine, improved the stability of medicine, and also promoted the added value of Chinese medicine preparation.Conventional capsule material and carrier material comprise that natural polymer is as gelatin, arabic gum, alginate, starch, albumen etc., and semi-synthetic and synthesized polymer material, and the present invention has filtered out and is most appropriate to Chinese medicine composition of the present invention and seals the good adjuvant of effect through great many of experiments, finally complete dosage form.
Detailed description of the invention
Following examples are to further illustrate of the present invention, but never limit the scope of the present invention.Further elaborate the present invention below with reference to embodiment, but it will be appreciated by those skilled in the art that the present invention is not limited to the preparation method of these embodiment and use.And those skilled in the art can be equal to replacement, combination, improvement or modify the present invention according to description of the invention, but these all will comprise within the scope of the invention.
embodiment 1
Cortex Magnoliae Officinalis 600g, Flos Chrysanthemi 600g, Fructus Aurantii 800g, Semen Coicis 800g, Fructus Oryzae Germinatus 800g, Fructus Crataegi 400g, Herba Lophatheri 600g, Radix Glycyrrhizae 1000g, cane sugar powder 800g, monoglyceride 2g, sucrose ester 0.5g, maltodextrin 30g, soybean protein 60g.
Preparation method is: 1) take by weight Cortex Magnoliae Officinalis, Flos Chrysanthemi, Fructus Aurantii, Semen Coicis, Fructus Crataegi, Fructus Oryzae Germinatus, Herba Lophatheri, Radix Glycyrrhizae and pulverize, soak, add 4 times of water to decoct 3 times, each 45min, merges decoction liquor, concentrated, adding 70% ethanol leaves standstill, filter, rotary evaporation is removed ethanol, the dry powder that obtains; 2) taking by weight cane sugar powder, with 1) powder that obtains mixes; 3) get in 70% ethanol that powder that 10g is mixed to get is added to 50ml for subsequent use as capsule-core; 4) taking by weight monoglyceride, sucrose ester, maltodextrin, soybean protein is dissolved in 700ml water for subsequent use; 5) by 3) the capsule-core liquid that obtains is slowly added to 4) aqueous solution in, cross colloid mill 3 times, spraying is dry, obtains microcapsule.
embodiment 2
Cortex Magnoliae Officinalis 700g, Flos Chrysanthemi 700g, Fructus Aurantii 900g, Semen Coicis 900g, Fructus Oryzae Germinatus 900g, Fructus Crataegi 500g, Herba Lophatheri 700g, Radix Glycyrrhizae 1100g, cane sugar powder 900g, monoglyceride 4g, sucrose ester 0.7g, maltodextrin 45g, soybean protein 60g.
Preparation method is: 1) take by weight Cortex Magnoliae Officinalis, Flos Chrysanthemi, Fructus Aurantii, Semen Coicis, Fructus Crataegi, Fructus Oryzae Germinatus, Herba Lophatheri, Radix Glycyrrhizae and pulverize, soak, add 5 times of water to decoct 3 times, each 45min, merges decoction liquor, concentrated, adding 70% ethanol leaves standstill, filter, rotary evaporation is removed ethanol, the dry powder that obtains; 2) taking by weight cane sugar powder, with 1) powder that obtains mixes; 3) get in 70% ethanol that powder that 10g is mixed to get is added to 50ml for subsequent use as capsule-core; 4) taking by weight monoglyceride, sucrose ester, maltodextrin, soybean protein is dissolved in 700ml water for subsequent use; 5) by 3) the capsule-core liquid that obtains is slowly added to 4) aqueous solution in, cross colloid mill 3 times, spraying is dry, obtains microcapsule.
embodiment 3
Cortex Magnoliae Officinalis 650g, Flos Chrysanthemi 650g, Fructus Aurantii 850g, Semen Coicis 850g, Fructus Oryzae Germinatus 850g, Fructus Crataegi 450g, Herba Lophatheri 650g, Radix Glycyrrhizae 1050g, cane sugar powder 850g, monoglyceride 3g, sucrose ester 0.6g, maltodextrin 30g, soybean protein 45g.
Preparation method is: 1) take by weight Cortex Magnoliae Officinalis, Flos Chrysanthemi, Fructus Aurantii, Semen Coicis, Fructus Crataegi, Fructus Oryzae Germinatus, Herba Lophatheri, Radix Glycyrrhizae and pulverize, soak, add 5 times of water to decoct 3 times, each 45min, merges decoction liquor, concentrated, adding 70% ethanol leaves standstill, filter, rotary evaporation is removed ethanol, the dry powder that obtains; 2) taking by weight cane sugar powder, with 1) powder that obtains mixes; 3) get in 70% ethanol that powder that 10g is mixed to get is added to 50ml for subsequent use as capsule-core; 4) taking by weight monoglyceride, sucrose ester, maltodextrin, soybean protein is dissolved in 700ml water for subsequent use; 5) by 3) the capsule-core liquid that obtains is slowly added to 4) aqueous solution in, cross colloid mill 3 times, spraying is dry, obtains microcapsule.
clinical research
The present invention observes the 60 routine apositia patients that meet inclusive criteria altogether, and the course of disease does not finish and occurs anaphylaxis or serious adverse reaction person, should stop research, but exceeded 1/2 the course for the treatment of person should add up effective.
Curative effect determinate standard:
Clinical recovery: appetite and appetite all return to normal level;
Effective: appetite is obviously recovered, appetite returns to 3/4 of former level;
Effective: appetite makes moderate progress, appetite is recovered to some extent, but does not reach 3/4 of former level;
Invalid: appetite and appetite are without improvement.
Patient is divided into treatment group and matched group at random, treatment group gives microcapsule formulation prepared by embodiment 1, matched group gives the Xiao ' erqixingcha syrup that commercially available Guang Yao group produces, three times on the one, administration three days, result shows that treatment group total effective rate is 92%, matched group is 78%, illustrate that treatment group is obviously better than commercially available syrup group, show that the application's microcapsule bioavailability is high.