CN1233416C - Compound pepsin powder for treating child dyspepsia and its preparation method - Google Patents
Compound pepsin powder for treating child dyspepsia and its preparation method Download PDFInfo
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- CN1233416C CN1233416C CN 03146129 CN03146129A CN1233416C CN 1233416 C CN1233416 C CN 1233416C CN 03146129 CN03146129 CN 03146129 CN 03146129 A CN03146129 A CN 03146129A CN 1233416 C CN1233416 C CN 1233416C
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Abstract
The present invention discloses a new compound pepsin powder for treating child dyspepsia. The raw preparation materials of the active ingredient of the compound pepsin powder comprise pepsin, white atractylodes rhizome, hawthorn fruit, Chinese yam and Chicken's Gizzard-membrane. The active ingredient can be prepared into various dosage forms together with pharmacally accepted carriers or excipients. The compound pepsin powder has the advantages of obvious therapeutic effect and no toxic or side effect.
Description
(1) technical field
Invention relates to a kind of Pharmaceutical composition, specifically, is a kind of compound recipe pepsin powder, and this compound recipe pepsin powder has the purposes of treatment infantile dyspepsia, and the preparation method of this compound recipe pepsin powder.
(2) background technology
Dyspepsia, infantile malnutrition is one of commonly encountered diseases, and decoction is generally adopted in treatment by Chinese herbs, and pill is made oral medicine, but general medicine is after digestive tract, the part effective ingredient is difficult to absorb, and drug effect only can be kept several hours in the digestive tract, must take repeatedly in 1st, and take medicine for a long time, and in the infusion pharmacy procedure, the part effective ingredient is destroyed, and medicine effect can not be given full play to.Especially children's takes medicine very difficultly, and goes to hospital, takes medicine to decoct medicinal herbs all very trouble.
CN1104514A discloses a kind of Chinese patent medicine that the intestines and stomach digests the disease infantile osteomalacia for the treatment of, and this Chinese patent medicine comprises following Chinese crude drug composition and each composition weight in grams number thereof: east ginseng 20-55g, Squama Manis 13-40g, Rhizoma Atractylodis Macrocephalae 31-63g, Fructus Aurantii 30-65g, Endothelium Corneum Gigeriae Galli 13-45g, Omphalia 30-65g, Semen Arecae 40-70g, Cinnabaris 18-45g, Fructus Quisqualis 70-140g, Semen Pharbitidis 10-70g and Rhizoma Zingiberis 5-25g.These Chinese crude drug composition weight in grams numbers need be looked the different and an amount of plus-minuss different with the state of an illness of patient's difference, disease of treatment.
(3) summary of the invention
[problem that will solve]
One of purpose of the present invention just provides a kind of compound recipe pepsin powder for the treatment of infantile dyspepsia, and this compound recipe pepsin powder can effectively be treated diseases such as infantile dyspepsia, and has no side effect.
Another object of the present invention provides the preparation method of this compound recipe pepsin powder.
[technical scheme]
This compound recipe pepsin powder comprises following materials of weight proportions:
Pepsin 20-40 part Rhizoma Atractylodis Macrocephalae 380-420 part Fructus Crataegi 550-630 part
Rhizoma Dioscoreae 550-630 part Endothelium Corneum Gigeriae Galli 370-420 part sucrose 950-1000 part.
Described component optimum ratio is:
600 parts of 400 portions of Fructus Crataegis of 31.6 parts of Rhizoma Atractylodis Macrocephalaes of pepsin
970 parts of 400 portions of sucrose of 600 parts of Endothelium Corneum Gigeriae Galli of Rhizoma Dioscoreae.
The source of the Chinese crude drug that above-mentioned embodiment is mentioned is as follows:
Pepsin: the pepsin that extracts in the gastric mucosa for pig, cattle, sheep, peptic effect.
The Rhizoma Atractylodis Macrocephalae (stir-fry): the dry rhizome of the feverfew Rhizoma Atractylodis Macrocephalae.Invigorating the spleen and benefiting QI is arranged, the dampness diuretic, hidroschesis, antiabortive effect is used for insufficiency of the spleen lack of appetite, and abdominal distention is had loose bowels.
Rhizoma Dioscoreae: be the dry rhizome of plant Rhizoma Dioscoreae.The spleen reinforcing nourishing the stomach is arranged, the lung benefiting that promotes the production of body fluid, the effect of the kidney invigorating arresting seminal emission.
Fructus Crataegi: the dry mature fruit of rosaceous plant Cortex cinnamomi japonici (Ramulus Cinnamomi).Promoting digestion and invigorating the stomach is arranged, the effect of circulation of qi promoting dissipating blood stasis.
Endothelium Corneum Gigeriae Galli: be the dry inner wall of sandbag of Phasianidae animal man chicken.Invigorating the stomach and promoting digestion is arranged, and the effect of arresting seminal emission is used for food stagnation and does not disappear.
Above-mentioned prescription of the present invention can directly be pulverized or be refining as the active component for the treatment of the infantile dyspepsia medicine through the extraction of the conventional extractive technique in this area such as decoction and alcohol sedimentation technique or ethanol extract from water precipitation.Described active component can be made various pharmaceutical formulations such as powder, tablet, oral liquid, granule, injection, capsule or the like with pharmaceutically acceptable carrier or excipient composition.Wherein said pharmaceutically acceptable carrier or excipient are selected according to different dosage forms.These used carriers or excipient can determine for the those of ordinary skill of pharmaceutical field.
Active ingredient in pharmaceutical of the present invention can prepare according to following three kinds of methods:
First method, it contains the following step: take by weighing raw materials of traditional Chinese medicinal materials according to above-mentioned consumption; Except that pepsin, all the other are dried and crushed into fine powder with above-mentioned medical material, other add cane sugar powder in proportion with the pepsin facing-up, sieve, mixing, packing is made.
Second method, it contains the following step: take by weighing raw materials of traditional Chinese medicinal materials according to above-mentioned consumption; With above-mentioned medical material except that pepsin, all the other are dried and crushed into coarse powder, with the ethanol of 50-60% be solvent 60-70 ℃ of reflux, extract,, extracting solution is after reclaiming ethanol, cryoconcentration becomes thick extractum, dry, be ground into fine powder, other add cane sugar powder in proportion with the pepsin facing-up, sieve, mixing, packing is made.
The third method, it contains the following step: take by weighing raw materials of traditional Chinese medicinal materials according to above-mentioned consumption; Except that pepsin, all the other decoct with water twice with above-mentioned medical material, 2-3 hour for the first time, 1-2 hour for the second time, filter, merging filtrate leaves standstill clarification, and low-temperature evaporation is concentrated into the thick paste shape, and drying is ground into fine powder, other add cane sugar powder in proportion with the pepsin facing-up, sieve, mixing, packing is made.
[beneficial effect]
Pharmaceutical composition of the present invention has diseases such as treatment children's food stagnation, abdominal distention after meal, stool are rare clearly, dyspepsia.The total effects of diseases such as the medicament of making as active component with said composition powder or its extract is rare clearly to treatment children's food stagnation, abdominal distention after meal, stool, dyspepsia is 95-100%.Through acute and long term toxicity test, be increased to usual amounts and show for 200 times and have no side effect.
(4) specific embodiment
Further describe the present invention with the test example by the following examples.
Embodiment 1: the preparation of powder
Take by weighing these raw materials of traditional Chinese medicinal materials according to following consumption:
600 parts of 400 portions of Fructus Crataegis of 31.6 parts of Rhizoma Atractylodis Macrocephalaes of pepsin
970 parts of 400 portions of sucrose of 600 parts of Endothelium Corneum Gigeriae Galli of Rhizoma Dioscoreae
Except that pepsin, all the other are dried and crushed into fine powder with above-mentioned medical material, other add cane sugar powder in proportion with the pepsin facing-up, sieve mixing; Make.
Embodiment 2: the preparation of powder
Take by weighing these raw materials of traditional Chinese medicinal materials according to following consumption
600 parts of 400 portions of Fructus Crataegis of 31.6 parts of Rhizoma Atractylodis Macrocephalaes of pepsin
970 parts of 400 portions of sucrose of 600 parts of Endothelium Corneum Gigeriae Galli of Rhizoma Dioscoreae
With above-mentioned medical material except that pepsin, all the other are dried and crushed into coarse powder, with the ethanol of 50-60% be solvent 60-70 ℃ of reflux, extract,, extracting solution is after reclaiming ethanol, cryoconcentration becomes thick extractum, dry, be ground into fine powder, other add cane sugar powder in proportion with the pepsin facing-up, sieve, mixing is made.
Embodiment 3: the preparation of powder
Take by weighing these raw materials of traditional Chinese medicinal materials according to following consumption
600 parts of 400 portions of Fructus Crataegis of 31.6 parts of Rhizoma Atractylodis Macrocephalaes of pepsin
970 parts of 400 portions of sucrose of 600 parts of Endothelium Corneum Gigeriae Galli of Rhizoma Dioscoreae
Except that pepsin, all the other decoct with water twice with above-mentioned medical material, 2-3 hour for the first time, 1-2 hour for the second time, filter, merging filtrate leaves standstill clarification, and low-temperature evaporation is concentrated into the thick paste shape, and drying is ground into fine powder, other add cane sugar powder in proportion with the pepsin facing-up, sieve, mixing is made.
Test example 1: thing of the present invention is to the clinical efficacy of treatment infantile dyspepsia
Method:
Materials and methods:
(1) object of study: the age is one full year of life child in 40 days-10 puerperal, masculinity and femininity child; Differential diagnosis in tcm is:
The deficiency of spleen-QI breast food internal injury of holding concurrently: see (1) pale tongue, corpulent tongue or tooth seal, white and thin fur are arranged; (2) thready and weak pulse, fingerprint is stagnant; (3) fatigue and lack of strength; (4) spiritlessness and sparing of words.
Person with Spleen Deficiency: primary symptom sees 1, stomach is received lack of appetite or appetite is poor; 2, stool undesired (half congealed mashed, earlier hard back half congealed, the time hard when half congealed) 3, abdominal distention after meal or afternoon abdominal distention, inferior disease is seen: tastelessness and no thirst, desire for hot drinks, watery saliva flowing from the mouth, continuous and dull pain in the abdomen, happiness peace happiness temperature, nausea and vomiting, gastral cavity are vexed, borborygmus, become thin, shallow complexion etc.
The temper degree is held wet disease under the arm: disease sees that let out temper deficient syndrome increasing loose stool, white and greasy fur.
Spleen deficiency syndrome: disease sees that the temper deficient syndrome adds the cold syndrome of the stomach cold extremities, eats promptly and rushes down, and it is rare clearly, die-hard to defecate, and the complexion Guang is white, sunken fontanel.
(2) Therapeutic Method:
The treatment group gives embodiment of the invention powder, and is oral, a 0.75g, and 2 times on the one, 6 months courses of treatment, matched group gives the Chinese patent drugs for treatment 6 months of CN1104514A.
(3) observational technique:
Before and after the treatment to the clinical common sympton of patient, observe, before the treatment and treatment does just routine test of hematuria, the heart, liver, renal function index in back 1 month respectively and detects, measure with conventional method.
(4) curative effect index:
1, the powder of the embodiment of the invention 1 is 100% to the treatment total effective rate of infantile spleen deficiency disease, and wherein: the clinical recovery rate is 68.9%, and its curative effect is better than matched group, and wherein total effective rate is 84.6%, and apparent recovery from illness is 17.30%, the results are shown in Table 1.
Table 1 powder of the present invention is to infantile spleen deficiency patient's clinical observation
| Group | Clinical scale | Case load | Recovery from illness | Produce effects | Effectively | Invalid | Total effective rate (%) |
| Thing of the present invention | Gently | 45 | 32 | 11 | 2 | 100 | |
| In | 58 | 39 | 14 | 5 | 100 | ||
| Heavy | 16 | 11 | 3 | 2 | 100 | ||
| Matched group | Gently | 18 | 3 | 6 | 5 | 4 | 77.8 |
| In | 21 | 4 | 11 | 3 | 3 | 85.7 | |
| Heavy | 13 | 2 | 7 | 3 | 1 | 92.3 |
2. the powder of the embodiment of the invention 1 treatment total effective rate that children's's deficiency of spleen-QI is held under the arm wet disease is 94.8%, and wherein the clinical recovery rate is 56.5%, and its curative effect is better than matched group, and its total effective rate is 75%, and the clinical recovery rate is 18.8%, and its overall result sees Table 2.
Table 2 powder of the present invention is held wet disease patient's clinical observation under the arm to children's's deficiency of spleen-QI
| Group | Clinical scale | Case load | Recovery from illness | Produce effects | Effectively | Invalid | Total effective rate (%) |
| Thing of the present invention | Gently | 52 | 31 | 17 | 2 | 2 | 96.1 |
| In | 36 | 21 | 8 | 6 | 1 | 97.2 | |
| Heavy | 27 | 13 | 5 | 6 | 3 | 88.9 | |
| Matched group | Gently | 22 | 3 | 11 | 3 | 5 | 77.3 |
| In | 14 | 4 | 5 | 2 | 3 | 78.6 | |
| Heavy | 12 | 2 | 4 | 2 | 4 | 66.7 |
3, the powder of the embodiment of the invention 1 is to children's's deficiency of spleen-YANG patient's clinical observation, and its total effective rate is 94.6%, and wherein recovery from illness is 64%, and matched group, its total effective rate is 75.4%, cure rate is 19.7%, is better than matched group, the results are shown in Table 3.
Table 3 thing of the present invention is to children's's deficiency of spleen-YANG patient's clinical observation
| Group | Clinical scale | Case load | Recovery from illness | Produce effects | Effectively | Invalid | Total effective rate (%) |
| Thing of the present invention | Gently | 52 | 34 | 18 | 2 | 2 | 96.4 |
| In | 42 | 29 | 10 | 1 | 2 | 95.2 | |
| Heavy | 13 | 8 | 1 | 2 | 2 | 84.6 | |
| Matched group | Gently | 23 | 4 | 8 | 5 | 6 | 73.9 |
| In | 21 | 5 | 7 | 5 | 4 | 81 | |
| Heavy | 17 | 3 | 5 | 4 | 5 | 70.6 |
4, this product clinical observation is the shortest is one month, the longest is 2 months, during treating, do not see any toxic and side effects and untoward reaction, we find that also this product is especially just green to infantile diarrhea in therapeutic process, die-hard, more than person that has loose bowels has medicine to arrive upright effect of ending, and also is one of distinguishing feature of this product.
Test example 2: thing of the present invention is to the long term toxicity test of rat
Method:
Materials and methods:
(1) test material: animal: age in Wistar rat 6-8 week is available from Beijing animal center
Reagent: be commercially available
(2) test method: get 60 of rats, be divided into 3 groups at random, 20 every group, male female 20, male female all usefulness, 1 group is the blank group, gives normal saline 20ml/kg, gives thing of the present invention heavy suspension respectively for 2 groups, 3 groups, dosage is 24g/kg, 12g/kg.8 weeks of successive administration.Per 4 weeks weigh once, observe the activities in rats situation at any time, and after the last administration 2 hours, measure every group of rat hemogram blood parameters from the eye socket blood sampling, all animals is put to death in the back, and postmortem is also cutd open and is got main organs and do histological examination.
(3) result of the test:
One, to the influence of animal ordinary circumstance and body weight gain:
Administration group rat is compared with the blank group, and ordinary circumstance of rat such as behavior, activity, hair, appetite, feces etc. are Non Apparent Abnormality all, and administration group rat body weight and matched group be no significant difference relatively.The results are shown in Table 1.
Table 1 thing of the present invention is to the influence of rat body weight net added value (X, g)
| Group | Number of rats | Starting weight | 4 weeks | 8 weeks |
| Contrast | 20 | 168±22 | 222±40 | 269±36 |
| Low dosage | 20 | 164±24 | 230±37 | 274±34 |
| High dose | 20 | 165±32 | 236±30 | 280±41 |
Annotate: compare P＞0.05 with matched group.
Two, hematological examination result
By the eye socket venous blood collection, measure periphery RBC number, platelet count, total white blood cells and classification respectively at administration 8 all backs, content of hemoglobin, 8 all every indexs of administration as a result and blank group be no significant difference relatively.The results are shown in Table 2.
Table 2 thing of the present invention is to the influence of rat hemogram
| Number of rats (only) | Erythrocyte 10 12/L | Hemoglobin g/L | Platelet 108/L | Leukocyte | |||
| Sum 10 8/L | Lymph % | Neutral % | |||||
| Contrast | 20 | 9.5±1.4 | 110±5 | 234±38 | 9.6±2.1 | 75±4.6 | 24.7±5.2 |
| Low dosage | 20 | 9.5±2.0 | 107±7 | 253±52 | 10.2±2.8 | 75.3±3.7 | 24.8±5.4 |
| High dose | 20 | 9.4±1.8 | 112±8 | 247±48 | 10.6±2.7 | 74.8±4.4 | 25.4±5.0 |
Three, blood parameters
Respectively organize serum alanine aminotransferase (ALT), Aspartic Acid aminotransferase (AST), blood urea nitrogen (BUN) and creatinine (Cr) respectively at 8 week of administration back blood sampling mensuration, the result shows, 8 weeks of administration and the relatively more equal no significant difference of blank group.
The results are shown in Table 3.
Table 3 thing of the present invention is to the influence of blood parameters
| Group | Number of rats (only) | ALP (albumin) (U/L) | ALP (albumin) (U/L) | ALP (albumin) (U/L) | Gr (creatinine) (umol/L) |
| Contrast | 20 | 38±3 | 84±9 | 10.3±2.5 | 70.8±11.9 |
| Low dosage | 20 | 39±2 | 86±10 | 10.6±2.7 | 72.3±11.7 |
| High dose | 20 | 37±3 | 88±12 | 10.8±3.1 | 70.6±12.1 |
Annotate: each dosage group and matched group compare the P value all greater than 0.05.
Four, histological examination
1, organ coefficient: measure the heart of rat after 8 weeks of administration respectively, the organ coefficient of liver, spleen, lung, kidney.The result shows that all organ coefficients of two administration group rats are compared with blank group rat does not all have significant difference.The results are shown in Table 4.
Table 4 thing of the present invention is to organ weights (internal organs weight/body weight, * 10
-8) influence
| Group | Number of rats | The heart | Liver | Kidney | Lung | Spleen |
| Matched group | 20 | 2.80±0.34 | 17.83±1.87 | 3.48±0.72 | 4.04±0.52 | 2.16±0.24 |
| Low dosage | 20 | 3.10±0.36 | 18.14±1.72 | 3.49±0.68 | 3.98±0.46 | 2.17±0.26 |
| High dose | 20 | 3.18±0.35 | 17.54±1.43 | 3.57±0.77 | 4.02±0.58 | 2.20±0.26 |
Annotate: each dosage group matched group compares the P value all greater than 0.05.
2, histological examination: 8 weeks of administration are put to death each treated animal of zootomy, its main organs is carried out the inspection of cardinal principle specimen there is no unusual pathological change.Get this product high dose group and the blank group rat heart, liver, spleen, lung, kidney stomach function regulating specimen fixedly is drawn materials, and does conventional organization section, HE dyeing, light microscopy checking, the visible this product high dose group of result compare organizational structure with blank group and cellular morphology all basic identical.
Claims (5)
1, a kind of compound recipe pepsin powder for the treatment of infantile dyspepsia is characterized in that comprising following materials of weight proportions:
Pepsin 20-40 part Rhizoma Atractylodis Macrocephalae 380-420 part Fructus Crataegi 550-630 part
Rhizoma Dioscoreae 550-630 part Endothelium Corneum Gigeriae Galli 370-420 part sucrose 950-1000 part.
2, compound recipe pepsin powder according to claim 1 is characterized in that the consumption proportion (by weight) of described raw material is:
600 parts of 400 portions of Fructus Crataegis of 31.6 parts of Rhizoma Atractylodis Macrocephalaes of pepsin
970 parts of 400 portions of sucrose of 600 parts of Endothelium Corneum Gigeriae Galli of Rhizoma Dioscoreae.
3, the preparation method of claim 1 or 2 described compound recipe pepsin powders comprises the steps:
A) take by weighing raw materials of traditional Chinese medicinal materials according to above-mentioned consumption;
B) with above-mentioned medical material except that pepsin, all the other are dried and crushed into fine powder, other add cane sugar powder in proportion with the pepsin facing-up, sieve, mixing, packing is made.
4, the preparation method of claim 1 or 2 described compound recipe pepsin powders comprises the steps:
A) take by weighing raw materials of traditional Chinese medicinal materials according to above-mentioned consumption;
B) with above-mentioned medical material except that pepsin, all the other are dried and crushed into coarse powder, with the ethanol of 50-60% be solvent 60-70 ℃ of reflux, extract,, extracting solution is after reclaiming ethanol, cryoconcentration becomes thick extractum, dry, be ground into fine powder, other add cane sugar powder in proportion with the pepsin facing-up, sieve, mixing, packing is made.
5, the preparation method of claim 1 or 2 described compound recipe pepsin powders comprises the steps:
A) take by weighing raw materials of traditional Chinese medicinal materials according to above-mentioned consumption;
B) with above-mentioned medical material except that pepsin, all the other decoct with water twice, 2-3 hour for the first time, 1-2 hour for the second time, filter merging filtrate, leave standstill clarification, low-temperature evaporation is concentrated into the thick paste shape, and drying is ground into fine powder, other add cane sugar powder in proportion with the pepsin facing-up, sieve, mixing, packing is made.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 03146129 CN1233416C (en) | 2003-07-24 | 2003-07-24 | Compound pepsin powder for treating child dyspepsia and its preparation method |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 03146129 CN1233416C (en) | 2003-07-24 | 2003-07-24 | Compound pepsin powder for treating child dyspepsia and its preparation method |
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| Publication Number | Publication Date |
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| CN1478548A CN1478548A (en) | 2004-03-03 |
| CN1233416C true CN1233416C (en) | 2005-12-28 |
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| Application Number | Title | Priority Date | Filing Date |
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| CN 03146129 Expired - Lifetime CN1233416C (en) | 2003-07-24 | 2003-07-24 | Compound pepsin powder for treating child dyspepsia and its preparation method |
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Families Citing this family (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104644963A (en) * | 2013-11-21 | 2015-05-27 | 青岛润鑫伟业科贸有限公司 | Spleen-fortifying stomach-nourishing composition |
| CN104998004A (en) * | 2015-07-14 | 2015-10-28 | 张永霞 | Tea soup for treating infantile malnutrition and preparation method thereof |
| CN106975076A (en) * | 2017-04-14 | 2017-07-25 | 青岛市第三人民医院 | A kind of pepsin coating tablet containing Chinese medical extract |
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