CN1231255C - Capsule formula for treating astriction prepared using pumpkin as main raw material and its preparation method - Google Patents

Capsule formula for treating astriction prepared using pumpkin as main raw material and its preparation method Download PDF

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CN1231255C
CN1231255C CN 200410013663 CN200410013663A CN1231255C CN 1231255 C CN1231255 C CN 1231255C CN 200410013663 CN200410013663 CN 200410013663 CN 200410013663 A CN200410013663 A CN 200410013663A CN 1231255 C CN1231255 C CN 1231255C
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cucurbitae moschatae
fructus cucurbitae
raw material
capsule
preparation
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CN1533805A (en
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金建文
于春林
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Hebei Yuzhilin Biotechnology Co ltd
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Abstract

The present invention relates to a formula of a capsule prepared from pumpkin as a main raw material for treating constipation and a preparation method of the capsule. The ubiquitous problems of traditionally cathartic products are mainly solved that drastic purgative components as main bodies can cause stomachache, diarrhea, humoral imbalance, enteric plexus nerve damage, etc. after taken, and dependence phenomena can occur easily; in addition, materials processed by a traditional technology have the disadvantages of insufficient grain fineness, low biological availability and unfavorable clinic effect. The present invention has the technical scheme that the capsule is made from 7 raw materials of pumpkin peel, pumpkin stalk, pumpkin collateral, Poria, tremella, xylo oligosaccharide and aloe. The preparation method comprises the following steps: impurity removing, extracting, decocting, low temperature drying and superfine grinding processing. The capsule of the present invention is suitable for treating intractable constipation caused by various reasons for old and frail persons, puerpera, children, postoperative patients, etc., and has the advantages of low dosage, rapid effect taking, comfortable defecation and no stomachache and diarrhea. The normally physiological defecation of most patients with intractable constipation can be realized after the capsule is consecutively taken for nearly 1 month.

Description

With the Fructus Cucurbitae moschatae is the capsule and the preparation method of the treatment constipation of primary raw material preparation
One, technical field
The present invention relates to a kind of is the capsule and the production technology thereof of the treatment obstipation of primary raw material preparation with the Fructus Cucurbitae moschatae.
Two, background technology
The rhythm of current work, study, life is obviously accelerated, and social pressure increases, and causes the incidence rate of obstipation more and more higher, and health is threatened greatly.And the ubiquitous maximum drawback of product of state's internal therapy constipation has two to select at present: (1) raw material is many based on cathartic or even drastic purgative composition, takes medicine back stomachache and diarrhoea obviously.Because moisture is unbalance in the body, take for a long time in addition the enteric plexus nerve is caused damage, so in case drug withdrawal, constipation is but more serious, phenomenon appears relying on especially easily; (2) the material particles fineness of traditional handicraft processing only about the 100-140 order, absorbs slowly so enter in the body, and bioavailability is lower, so drug dose is big, medicining times is many, and clinical effectiveness is undesirable.
Employing as primary raw material, is resolved safely the method for constipation with Fructus Cucurbitae moschatae, yet there are no report.
Three, summary of the invention
The present invention is intended to overcome the above-mentioned disadvantage and the shortcoming of relieving constipation preparation in the past, proposes a kind of new capsule formula and production method thereof.Viewpoint according to motherland's medical science " equilibrium between yin and yang ", both considered clearing away heat-fire and YIN nourishing invigorating middle warmer complementary relationship, again in conjunction with scientific and reasonable adjustment prescriptions of characteristics such as the whole intestinal theories of modern medicine intestinal microecology, adopt advanced air-flow ultra-fine grinding technology simultaneously, the fineness of the particles of main and auxiliary material is not being damaged under the bioactive prerequisite, reached more than 500 orders.The capsule that has guaranteed preparation enters disintegrate absorption rapidly in the body, and bioavailability is stable to be improved.And little based on safety, no pain, consumption, take that number of times is few, instant effect, nothing rely on, do not rebound etc., reaches the purpose of the therapeutic effect that significantly improves obstipation.
Technology contents of the present invention is: the capsule that with the Fructus Cucurbitae moschatae is the treatment constipation of primary raw material preparation, seven flavor raw materials according to following weight proportion are formed Fructus Cucurbitae moschatae clothing 20-40%, Pedicellus Cucurbitae 10-30%, Fructus Cucurbitae moschatae network 5-15%, Poria 5-10%, Tremella 5-12%, Aloe 8-12%, oligomeric xylose 10-20%.
With the Fructus Cucurbitae moschatae is the capsular preparation method of the treatment constipation of primary raw material preparation, and step is as follows:
(1) chooses by weight ratio that Fructus Cucurbitae moschatae clothing, Pedicellus Cucurbitae, Fructus Cucurbitae moschatae network, Poria, 5 kinds of raw materials of Tremella are selected, after the roguing, soaks;
(2) decoct 3 times;
(3) collecting decoction, filtration;
(4) simmer down to thick paste;
(5) choosing Aloe by weight ratio pulverizes, sieves;
(6) with concentrated thick paste and Aloe fine powder mix homogeneously such as above-mentioned Fructus Cucurbitae moschatae clothing;
(7) cold drying;
(8) with the airflow milling ultra-fine grinding of above-mentioned material;
(9) above-mentioned micropowder fully is mixed into final material with oligomeric xylose;
(10) branch is encapsulated.
The present invention since in the side by the function of the gentleness detoxifcation of Fructus Cucurbitae moschatae, relieving constipation and " walking crosswise meridians ", play safety and gentle basic defecating feces excretion; By the effect of aloetic heat clearing away diarrhea inducing, strengthen the relieving constipation effect simultaneously; And the YIN nourishing of promoting the production of body fluid of Tremella, the spleen invigorating invigorating middle warmer function of Poria, then can further play stable large intestine moisture, the promotion relieving constipation effect of keeping on the one hand, on the other hand, can also prevent to a certain extent that Aloe is in the clearing away heat and loosing the bowels process, the body fluid that may cause is unbalance, after avoiding causing realizing normal relieving constipation, occurs " bounce-back " phenomenon again and takes place; In addition, utilize oligomeric xylose can strengthen the propagation of bacillus bifidus in the intestinal, reduce the intestinal pH value, environment in improving, thus remove metabolite, increase stool moisture, further promote enterokinesia, guarantee the stable intestinal motive force of safeguarding lastingly.All medicines share, and promote mutually, condition each other, and are collaborative with aforementioned all medicines, receive the effect of comparatively equilibrated safe loosening bowel to relieve constipation altogether.Diseases such as therefore, the present invention's capsule is applicable to cureless obstipation, and, constipation smooth to long-term bitter taste in the mouth and dry throat, anorexia, abdominal part overflow, aerofluxus, feces volume are few and difficult have remarkable, safe curative effect.
The capsule of process that employing the present invention relates to preparation, adjuvants such as major ingredient such as Fructus Cucurbitae moschatae clothing, Pedicellus Cucurbitae, Fructus Cucurbitae moschatae network and Poria, Tremella, Aloe have obtained superfine grinding, reach more than 500 orders.The fineness of the particles of main and auxiliary material is not being damaged under the bioactive prerequisite, obtained sufficient mixing, divide encapsulated with the superfine mixed powder.
Sample capsules with the preparation of the method that the present invention relates to is not limited by age, sex, physiological condition, is suitable for the obstipation that a variety of causes causes (comprise old, puerpera, child, operation after patient etc.) crowd and takes; Particularly can also prevent the usefulness of the special project health care that cordis and cerebral accident takes place as the patient that obstipation suffers from serious hypertension, cardiovascular and cerebrovascular disease simultaneously; In addition, product of the present invention also has good result to removing enterotoxin and blood toxicity and skin care.And consumption is little, take number of times few (every day only 1 time is about average 0.4 gram), instant effect (rapid constipation relieving of the same day or next day), and it is very light that defecation is felt, do not have stomachache and diarrhoea.The patient of most obstipations takes about 1 month continuously, just can realize the normal physiological defecation.
For showing safety of the present invention and to the therapeutic effect of obstipation, the following test that the present invention has finished:
(1) safety toxicological evaluation.
Testing result: belong to actual nontoxic level material; Salmonella reversion test, mouse bone marrow cells micronucleus test and the test of mouse sperm distortion analysis detect negative; 30 days feeding trials do not see that it has any toxicity damage effect to animal subject.
Test item:
1. acute toxicity test (detailed process slightly)
2. genetic toxicity test (detailed process slightly)
3. 30 days feeding trials (detailed process slightly)
Detect conclusion:
1. acute toxicity test: test with the large and small Mus per os acute toxicity (LD of sample to two kinds of sexes 50) all greater than 10.00g/kgBW, according to the acute toxicity classification, true border is nontoxic.
2. genetic toxicity test: the result shows the hereditary-less toxicity effect.
(1) Salmonella reversion test: the result is negative.
(2) PCEMNR micronucleus test: the result is negative.
(3) mouse sperm deformity test: the result is negative.
3. 30 days feeding trials of rat: experimental group that Clinical Laboratory, blood biochemical are learned and checked, the internal organs weighing result shows each inspection item and matched group comparison, difference is not remarkable.The result of histopathologic examination shows that liver,spleen,kidney, stomach, intestinal, the testis (ovary) of matched group and high dose group hero, female rats there is no the histopathology relevant with empirical factor and change.
(2) bowel relaxing functions animal experiment.
Testing result: according to " health food check and technical specification " (2003 editions) criterion that health ministry is worked out, the present invention has good bowel relaxing functions, and animal is had no adverse effects.
Detection method:
1. intestinal motility experiment
2. the mensuration of mice defecation time, fecal grains and stool weight
Detect content:
1. sample is to the influence of mice body weight
2. sample is to the influence of prepared Chinese ink propelling rate
3. sample is to the influence of defecation time
4. sample is to the influence of defecation grain number
5. sample is to the influence of defecation weight
Check conclusion:
Per os gives the sample 12 days of mice various dose, and between model control group (0g/kgBW) relatively, 0.1g/kgBW organizes every index does not all have significant difference P>0.05; 0.2g/kg organizing every index, BW all do not have significant difference P>0.05; 0.6g/kg the BW group can shorten mice defecation time P<0.05, increases mice row melena grain and counts P<0.01, increases mice defecation weight P<0.05, weight of mice has no adverse effects.According to " health food check with assessment technique standard) " (2003 editions) to the criterion of bowel relaxing functions health food as can be known, sample has bowel relaxing functions.
(3) clinical bowel relaxing functions viewing test.
Test item: bowel relaxing functions human feeding trial
Test basis: " the health food function assessment assessment process and the method for inspection "
Result and judgement: 100 satisfactory constipation experimenters, the test-meal group is taken sample capsules, and 3 every night, every day 1 time, matched group is taken positive reference substance old man constipation-relieving tea, and each 2 bags, are and take 15 days continuously every day 1 time.The defecation frequency of test-meal group as a result obviously increases by 2.92 ± 2.26 times, feces character deliquescing 1.20 ± 0.67 degree, defecation condition is improved 1.26 ± 0.80 grades, the matched group defecation frequency obviously increases by 2.34 ± 1.59 times, feces character deliquescing 1.18 ± 0.75 degree, and defecation condition is improved 1.10 ± 0.71 grades, routine blood test, routine urinalysis and blood biochemistry index are all in normal range before and after two groups of test-meals, can think that sample has bowel relaxing functions, and the healthy nothing of examination trencherman is obviously influenced.
1. object and method
1.1 tried thing: sample capsules is provided by the inventor.Positive reference substance: old man's constipation-relieving tea, Nanning city five power HANYAO institutes are produced.Lot number: No. the 558th, hygienic food and health number (1998).Date of manufacture: 20020202.
1.2 study subject: press the principle of voluntariness and select 18-65 year, constipation experimenter 100 examples.
1.2.1 diagnostic criteria: infrequent defecation time lengthening, the big dry and hard or involved and abstruse not smooth functional constipation person of potbellied matter.
1.2.2 the person's of including in standard:
1.2.2.1 defecation frequency reduces and feces hardness enhancer.
Be less than 3 times the person week 1.2.2.2 defecate.
1.2.2.3 there is not organic constipation person.
1.2.2.4 habitual constipation person.
1.2.3 eliminator's standard:
1.2.3.1 the age, gestation or women breast-feeding their children were to these health product allergy sufferers under-18s or over-65s person.
1.2.3.2 be associated with serious primary disease such as conscience kidney and hemopoietic system, or other accompanying diseases arranged just in therapist, the psychotic.
1.2.3.3 do not meet the standard of including in, do not take in accordance with regulations and tried thing, there are not the effect of judgement or data not umbra sound effect or safety judgement person.
1.3 contrast form: adopt two kinds of EXPERIMENTAL DESIGN of contrast between self and group; Positive controls is taken old man's constipation-relieving tea of defecating feces excretion.
1.4 taking dose and time: the test-meal group is taken 3 of capsules every night, and every day 1 time, matched group is taken old man's constipation-relieving tea, and each 2 bags, every day 1 time, continuous 15 days, the experimenter cut out medicine or other health product of relevant loosening bowel to relieve constipation at experimental session.
1.5 instrument and reagent: ten analysers of MEK-6318K type blood counting instrument (Japan produces) NIDIRON urine (Germany produces), automatic clinical chemistry analyzer (U.S.'s product) model RA1000, the biochemical reagents box is all provided by middle living company.
2. observation index:
Each is checked once before and after the experiment.
2.1 ordinary circumstance: detailed medical history-taking, understand experimenter's spirit, sleep, diet, observation main clinic symptoms: feeling of fullness, abdominal distention, dry stool knot, involved and abstruse not smooth situation.By the mild symptoms multiple integral, calculate the doing well,improving rate.
2.2 effect observation:
2.2.1 every day defecation frequency:
2.2.2 defecation condition: be divided into the I-IV level according to difficult defecation, the statistics integrated value.
I level (0 minute): defecation is normal.
II level (1 minute): bearing down, sense of discomfort are only arranged.
III level (2 minutes): bearing down, sense of discomfort are obvious, or have just frequently but difficult defecation and measure few, less appearance stomachache or anus burn feeling.
IV level (3 minutes): stomachache or anus burn feeling often occur, influence defecation.
2.2.3 feces character: the feces character is divided into I-III level according to Bristol feces character classification method.
I level (0 minute):, level and smooth and soft as sausage or Serpentis; The picture sausage, but slight crack is arranged on its surface; Soft agglomerate has tangible edge (easily discharging).
II level (1 minute): the sausage character, but agglomerate is arranged: the bulk of pine, edge roughness is as slimy feces.
III level (2 minutes): isolating hard group, as pit (being difficult for discharging).
2.3 safety is observed:
2.3.1 blood and hematuria routine examination:
Red blood cell count(RBC), hemoglobin, numeration of leukocyte is urinated ten detections.
2.3.2 biochemical indicator is measured:
Serum albumin ALB, total protein TP, darling renal function (glutamic oxaloacetic transaminase, GOT AST, glutamate pyruvate transaminase ALT, uremic UREA, inosine CRE), blood glucose GLu, blood fat (T-CHOL TC, triglyceride TG).
2.3.3 Abdominal B type ultrasonography, electrocardiogram, the fluoroscopy of chest of x line.
3. the defecation effect is judged:
Effectively: defecation frequency obviously increases, and an index integration obviously descends in the defecation condition feces character binomial index, and difference has significance.
Invalid: defecation frequency does not have obvious increase, and defecation condition and feces character do not have significant change.
4. experimental result:
4.1 general situation:
Observe constipation experimenter 100 examples altogether, be divided into two groups at random.
4.2 situation was relatively as two groups of observations were last:
Situation comparison as table l observation is last (X ± SD)
Grouping Example number (example) Age (year) The man The woman The course of disease (year) Constipation (inferior/week)
The examination trencherman 50 42.12±10.68 15 35 6.54±4.75 2.30±0.65
Matched group 50 45.46±8.34 25 25 5.59±4.82 2.58±0.54
Two groups have P between the comparability group>0.05
4.3 defecation frequency changes:
Table 2 defecation frequency changes (inferior/week)
The example number Before the test-meal After the test-meal Difference
The examination trencherman 50 2.30±0.65 5.22±2.46 2.92±2.26
Matched group 50 2.58±0.54 4.92±1.78 2.34±1.59
*#P>0.05 between P<0.01 group
4.4 defecation condition changes:
Table 3 integral of defecation condition changes (level)
The example number Before the test-meal After the test-meal Difference
The examination trencherman 50 2.02±0.59 0.76±0.77 -1.26±0.80 **
Matched group 50 1.96±0.49 0.86±0.70 -1.10±0.71 **
*#P>0.05 between P<0.0l group
4.5 the feces character changes:
Table 4 feces character integration changes (degree)
The example number Before the test-meal After the test-meal Difference
The examination trencherman 50 1.82±0.39 0.62±0.60 -1.20±0.67 **
Matched group 50 1.94±0.24 0.76±0.74 -1.18±0.75 **
*#P>0.05 between P<0.01 group
4.6 the variation of clinical symptoms before and after the test-meal:
The variation of clinical symptoms before and after table 5 test-meal
Symptom Produce effects (example) Effectively (example) Invalid (example) Improvement rate %
Matched group Observation group Matched group Observation group Matched group Observation group Matched group Observation group
Feeling of fullness 4 8 26 25 3 10 81.82 76.74
The dry stool knot 12 16 22 25 8 8 80.95 83.67
Involved and abstruse not smooth 18 20 22 22 10 7 80.00 80.56
4.7 symptom integral changes:
Table 6 symptom integral changes
The example number Before the test-meal After the test-meal Difference
The examination trencherman 50 13.00±6.15 5.86±4.89 7.14±4.15 **
Matched group 50 12.86±3.98 6.00±2.57 -6.86±3.87 **
*#P>0.05 between P<0.0l group
4.8 safety indexes detects: (detailed process slightly)
4.9 Abdominal B type ultrasonography, electrocardiogram, the fluoroscopy of chest of X line is all in normal range
5. conclusion:
5.1 100 routine constipation experimenters took sample capsules and old man's constipation-relieving tea 15 days on request, test-meal group as a result defecation frequency weekly increases by 2.92 ± 2.26 times, feces character deliquescing 1.20 ± 0.67 degree, defecation condition is improved 1.26 ± 0.80 grades, matched group defecation frequency weekly increases by 2.34 ± 1.59 times, feces character deliquescing 1.18 ± 0.75 degree, defecation condition is improved 1.10 ± 0.71 grades, and interpret sample capsule and old man's constipation-relieving tea all have bowel relaxing functions.
5.2 sample capsules has the improvement effect to feeling of fullness, dry stool, involved and abstruse symptom such as not smooth.
5.3 before and after the sample capsules test-meal, hemoglobin, erythrocyte, leukocyte, total serum protein, albumin, glutamate pyruvate transaminase, glutamic oxaloacetic transaminase, GOT, inosine, carbamide, blood glucose, blood fat and routine urinalysis etc. detect index all in normal range, illustrate that this product has no adverse effects to the experimenter is healthy.
5.4 after the sample capsules test-meal, do not meet quick and other untoward reaction.
Four, the specific embodiment
The present invention will further be illustrated by following examples.
With the Fructus Cucurbitae moschatae is the capsule formula of the treatment constipation of primary raw material preparation, and the weight proportion of each raw material is: Fructus Cucurbitae moschatae clothing 30%, Pedicellus Cucurbitae 18.5%, Fructus Cucurbitae moschatae network 11.5%, Poria 7%, Tremella 8%, Aloe 11%, oligomeric xylose 14%.
With the Fructus Cucurbitae moschatae is the capsular preparation method of the treatment constipation of primary raw material preparation, and step is as follows:
(1) chooses by weight ratio that Fructus Cucurbitae moschatae clothing, Pedicellus Cucurbitae, Fructus Cucurbitae moschatae network, Poria, 5 kinds of raw materials of Tremella are selected, after the roguing, soaks;
(2) decoct 3 times;
(3) collecting decoction, filtration;
(4) simmer down to thick paste;
(5) choosing Aloe by weight ratio pulverizes, sieves;
(6) with concentrated thick paste and Aloe powder mix homogeneously such as above-mentioned Fructus Cucurbitae moschatae clothing;
(7) cold drying;
(8) with the airflow milling ultra-fine grinding of above-mentioned material;
(9) above-mentioned micropowder fully is mixed into final material with oligomeric xylose;
(10) branch is encapsulated.
According to a kind of be the capsular preparation method of primary raw material preparation treatment obstipation with the Fructus Cucurbitae moschatae, described step (1) is removed impurity, that step (2-6) is extracted, boiled is concentrated, add the Aloe powder premix, and step (7) cold drying makes moisture≤8%, ash≤5% in the raw material.
According to a kind of be the capsular preparation method of primary raw material preparation treatment obstipation with the Fructus Cucurbitae moschatae, described step (8-9) ultra-fine grinding is handled, and is to be 500 orders with extract such as Fructus Cucurbitae moschatae clothing, Pedicellus Cucurbitae, Fructus Cucurbitae moschatae network, Poria, Tremella and final pulverizing of Aloe; Oligomeric xylose is original powdery.

Claims (4)

1. one kind is the capsule of the treatment obstipation of primary raw material preparation with the Fructus Cucurbitae moschatae, it is characterized in that making Fructus Cucurbitae moschatae clothing 20-40%, Pedicellus Cucurbitae 10-30%, Fructus Cucurbitae moschatae network 5-15%, Poria 5-10%, Tremella 5-12%, Aloe 8-12%, oligomeric xylose 10-20% according to seven flavor raw materials of following weight proportion.
According to claim 1 described a kind of be the capsule of the treatment obstipation of primary raw material preparation with the Fructus Cucurbitae moschatae, it is characterized in that the weight proportion of described each raw material is: Fructus Cucurbitae moschatae clothing 30%, Pedicellus Cucurbitae 18.5%, Fructus Cucurbitae moschatae network 11.5%, Poria 7%, Tremella 8%, Aloe 11%, oligomeric xylose 14%.
Claim 1 described a kind of be the capsular preparation method of the treatment obstipation of primary raw material preparation with the Fructus Cucurbitae moschatae, it is characterized in that may further comprise the steps:
(1) chooses by weight ratio that Fructus Cucurbitae moschatae clothing, Pedicellus Cucurbitae, Fructus Cucurbitae moschatae network, Poria, 5 kinds of raw materials of Tremella are selected, after the roguing, soaks;
(2) decoct 3 times;
(3) collecting decoction, filtration;
(4) simmer down to thick paste;
(5) choosing Aloe by weight ratio pulverizes, sieves;
(6) with concentrated thick paste and Aloe fine powder mix homogeneously such as above-mentioned Fructus Cucurbitae moschatae clothing;
(7) cold drying;
(8) with the airflow milling ultra-fine grinding of above-mentioned material;
(9) above-mentioned micropowder fully is mixed into final material with oligomeric xylose;
(10) branch is encapsulated.
According to claim 3 described a kind of be the capsular preparation method of the treatment obstipation of primary raw material preparation with the Fructus Cucurbitae moschatae, it is characterized in that described step (7) cold drying, make moisture≤8%, ash≤5% in the raw material; Step (8) ultra-fine grinding is handled, and is to be 500 orders with extract such as Fructus Cucurbitae moschatae clothing, Pedicellus Cucurbitae, Fructus Cucurbitae moschatae network, Poria, Tremella and final pulverizing of Aloe; Oligomeric xylose is original powdery.
CN 200410013663 2004-04-07 2004-04-07 Capsule formula for treating astriction prepared using pumpkin as main raw material and its preparation method Expired - Lifetime CN1231255C (en)

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN105412204B (en) * 2015-12-03 2020-06-26 青岛市中心医院 Pharmaceutical composition for treating senile constipation and application thereof
CN111202797A (en) * 2019-11-14 2020-05-29 河北御芝林药业有限公司 New application of laxative formula with five fruits and vegetables as raw materials for increasing gastrointestinal motility and promoting gastrointestinal emptying
CN111202796A (en) * 2019-11-14 2020-05-29 河北御芝林药业有限公司 New application of cathartic composition prepared from five fruits and vegetables in enhancing gastrointestinal motility and promoting digestion
CN111202789A (en) * 2019-11-14 2020-05-29 河北御芝林药业有限公司 New application of bowel relaxing formula with five fruits and vegetables as raw materials for increasing intestinal moisture and lubricating intestinal tract
CN111202798A (en) * 2019-11-14 2020-05-29 河北御芝林药业有限公司 New application of bowel relaxing formula with five fruits and vegetables as raw materials for increasing intestinal mucus layer and protecting intestinal tract
CN111202800A (en) * 2020-03-09 2020-05-29 河北御芝林药业有限公司 New application of bowel relaxing formula with five fruits and vegetables as raw materials for enhancing immunity

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