CN100455306C - Traditional Chinese medicine preparation for treating stomach and intestinal disease and its preparation - Google Patents

Abstract

The invention relates to a traditional Chinese medicinal composition for treating intestinal tract diseases, wherein the raw materials include red ginseng 131 weight parts, scented tea 2500 weight parts, bitter orange 250 weight parts. The invention also discloses the process for preparing the medicament.

Description

A kind of Chinese medicine preparation for the treatment of stomach and intestinal tract disease and preparation method thereof

Technical field

The present invention relates to a kind of Chinese medicine preparation and preparation method thereof, particularly a kind of Chinese medicine preparation for the treatment of stomach and intestinal tract disease and preparation method thereof.

Background technology

Disease of stomach is a kind of commonly encountered diseases, and it is having a strong impact on the healthy of people.Stomach and intestinal tract disease all belong to and are difficult to eradicate, easily the disease of showing effect repeatedly.The medicine of existing treatment disease of stomach is a lot, but the side effect of the tangible chemical medicine of most of curative effects is very important, is not suitable for taking for a long time, and the curative effect of the unconspicuous Chinese patent medicine of most of side effect is not satisfactory again.And, in the research that continues, find because the defective of extract drugs technology that make bioavailability of medicament, medicine stability undesirable, the dosage form kind is also abundant inadequately, is suitable for crowd's narrow range.Chinese medicine preparation can be tablet, capsule, granule, pill, powder, soft capsule, unguentum, drop pill, syrup, mixture, pharmaceutical dosage form is the application form of Drug therapy disease, under the prerequisite that guarantees curative effect, the multiformity of dosage form has greatly satisfied the different medication demand of vast sufferer.

WEIFUCHUN PIAN is that the applicant goes through a kind of Chinese medicine preparation for the treatment of stomach and intestinal tract disease that year develops surplus in the of 20, and product is listed national Chinese medicine protection kind in, and its compositing formula is maintained secrecy by the applicant always.Patent application 200510076815.9 discloses the pharmaceutical preparation of a kind of prophylactic treatment stomach and digestive tract disease, this application is formed according to the disclosed raw material of Chinese medicine of the WEIFUCHUN Chinese medicinal tablet description of product, having carried out patent by the conventional amount used of raw material of Chinese medicine simultaneously declares, though but the curative effect catalog of the description of this patent application has adopted the disclosed therapeutic effect of WEIFUCHUN tablet, but its description there is no specific embodiment, unexposed raw material compositing formula with obvious curative effects.

Summary of the invention

The invention provides a kind of reasonable recipe, treatment stomach and intestinal tract disease and have good Chinese medicine preparation of obvious curative effects and preparation method thereof.

Radix Ginseng Radix Ginseng is the dry root of Araliaceae (Araliaceae) plant Radix Ginseng Panax ginsengC.A.Mey..The grower is " Park Ginseng ", and wild product are practised and claimed " wild ginseng ".The Radix Ginseng calls Korean Ginseng, and its former plant is identical with homemade Radix Ginseng.Radix Ginseng Rubra is the dry root and rhizome of cultivation product after steaming of Radix Ginseng, and excavate autumn, clean, and after steaming, drying.Its medical material standard is pressed the 105th page of Radix Ginseng Rubra item of Pharmacopoeia of the People's Republic of China version in 2005 and is checked.The total amount that Radix Ginseng Rubra contains ginsenoside Rg l (C42H72O14) and ginsenoside Re (C48H82O18) must not be less than 0.20%.Radix Ginseng Rubra has that strongly invigorating primordial QI, multiple arteries and veins take off admittedly, invigorating the spleen to benefit the lung, effect such as promote the production of body fluid, calm the nerves.

Radix Ginseng Rubra is warm in nature, and other Radix Ginsengs are flat.Radix Ginseng Rubra has the effect of nourishing qi to stop, especially to because of long-term digestive system disease patient weak, QI failing to control blood good effect being arranged.

The medical material standard of Herba Rabdosiae glaucocalycis is checked down by Herba Rabdosiae glaucocalycis item in " Zhejiang Province's Chinese crude drug standard " of Zhejiang Province food and medicine Surveillance Authority issue in 2000.Herba Rabdosiae glaucocalycis is labiate Herba Rabdosiae glaucocalycis Rabdosia amethystoides (Benth.) Hara, largesepal rabdosia leaf Rabdosia macrocalyx (Dunn.) Hara and dry aerial parts or the rhizome that belongs to several plants together thereof.Its energy heat-clearing and toxic substances removing, eliminating stasis to stop pain.Can be used for gastralgia, sore swollen toxin, tumor.

The medical material standard of Fructus Aurantii (parched) is pressed under the 171st page of Fructus Aurantii item of Pharmacopoeia of the People's Republic of China version in 2005 and is checked.Fructus Aurantii (parched) is the dry immature fruit of rutaceae Citrus aurantium Linn. Citrus aurantium L. and variety thereof.Gather when peel is still green July, is two halves from the middle part crosscut, dries or cold drying.Get the Fructus Aurantii sheet, fry to complexion changed dark according to Pharmacopoeia of the People's Republic of China parched with bran method.Fructus Aurantii (parched) can relax its high strong property, the invigorating the stomach and promoting digestion of relatively regulating the flow of vital energy.Be used for dyspepsia and stagnate vomiting belch, rubella pruritus.Studies show that Fructus Aurantii and Fructus Aurantii (parched) decocting liquid to the rabbit intestine in vitro rabbit isolated uterine and white mice gastrointestinal motility all influential, but Fructus Aurantii (parched) decocting liquid action intensity is lower than the product of giving birth to, thereby has slowed down the stimulation of Fructus Aurantii to the intestinal smooth muscle.

A kind of Chinese medicine preparation for the treatment of stomach and intestinal tract disease is by the water of following main materials and/or alcohol extract is made active component and pharmaceutically acceptable additives are formed: Radix Ginseng Rubra 131 weight portions, Herba Rabdosiae glaucocalycis 2500 weight portions, Fructus Aurantii (parched) 250 weight portions.

Its preparation method comprises the following steps:

(1) takes by weighing the following traditional Chinese medicines material as raw material: Radix Ginseng Rubra 131, Herba Rabdosiae glaucocalycis 2500 weight portions, Fructus Aurantii 250 weight portions;

(2) red ginseng powder is broken into fine powder;

(3) smash after Herba Rabdosiae glaucocalycis cleans and add 5-15 times of water gaging normal pressure or decompression decoction secondary, each 1-3 hour, merge extractive liquid,, precipitation, filtration, filtrate for later use;

(4) cut into pieces after the Fructus Aurantii cleaning, get wheat bran and place the heat pot, be heated to when smoldering, add the Fructus Aurantii sheet, stir fast, fry to medical material surface displaing yellow or complexion changed and take out when dark, sieve removes wheat bran, cools, and per 100 kilograms of clean medical materials carry out parch with 10 kilograms of wheat brans;

(5) Fructus Aurantii (parched) adds 5-15 times of water gaging normal pressure or decompression decoction secondary, each 1-3 hour, merge extractive liquid,, precipitation, filtration, filtrate for later use;

(6) above-mentioned two kinds of filtrates merging is condensed into paste, adds Radix Ginseng Rubra fine powder and adjuvant, and drying is made preparation promptly.

Radix Ginseng Rubra: sweet, little hardship, temperature, effect is obvious.Herba Rabdosiae glaucocalycis: hardship, little suffering, cold, it is less relatively that plant contains effective composition.Fructus Aurantii: hardship, suffering, acid, wet, use history for a long time.Proportioning Radix Ginseng Rubra of the present invention is minimum, and Fructus Aurantii takes second place, and Herba Rabdosiae glaucocalycis amount maximum meets traditional Chinese medical science traditional theory, also meets the different reality of each raw material functional component content.On pharmacology, Radix Ginseng Rubra in the compatibility of the present invention carries according to " Japan hanako materia medica ": can " control gas in the accent; digesting and appetizing ", " medicine origin " claim can " control the taste YANG QI deficiency ...; during invigorating middle warmer is slow ", modern " Chinese medicine voluminous dictionary " reports that also Radix Ginseng Rubra can make chronic gastritis patient gastropathy disappear, appetite strengthens, stool is normal, and total acidity gastric juice increases.The Herba Rabdosiae glaucocalycis pharmacological testing shows: staphylococcus aureus extremely sensitive (flat board burrow method); The Song Shi dysentery bacterium, escherichia coli, bacillus pyocyaneus, Bacillus typhi medium sensitivity.The modern study of Fructus Aurantii (parched) shows, water decoction 3.33 * 10-3g/ml is inhibitory action to the stripped duodenum of rabbit, when concentration is 9.99 * 10-3g/ml, the rabbit that the remarkable antagonism acetylcholine of energy is caused shrinks from carrying ileum, irritate stomach 100% Fructus Aurantii (parched) decocting liquid 0.1ml, can obviously promote the mice gastrointestinal peristalsis.

The present invention is three kinds of raw material reasonable compatibilities, Synergistic mutually, and its active ingredient easily is absorbed by the body, and treatment stomach and intestinal tract disease curative effect show Millefolium, side effect is little.

The specific embodiment

Embodiment 1:

Take by weighing the following traditional Chinese medicines material as raw material: Radix Ginseng Rubra 131 grams, Herba Rabdosiae glaucocalycis 2500 grams, Fructus Aurantii 250 grams; Red ginseng powder is broken into fine powder; Smash after Herba Rabdosiae glaucocalycis cleans and add 5 times of water gaging normal pressures or decompression decoction secondary, each 1-3 hour, merge extractive liquid,, precipitation, filtration, filtrate for later use; Cut into pieces after the Fructus Aurantii cleaning, get wheat bran and place the heat pot, be heated to when smoldering, add the Fructus Aurantii sheet, stir fast, fry to medical material surface displaing yellow or complexion changed and take out when dark, sieve removes wheat bran, cools, and per 100 kilograms of clean medical materials carry out parch with 10 kilograms of wheat brans; Fructus Aurantii (parched) adds 5 times of water gaging normal pressures or decompression decocts secondary, and each 1-3 hour, merge extractive liquid,, precipitation, filtration, filtrate for later use; The merging of above-mentioned two kinds of filtrates is condensed into paste, adds Radix Ginseng Rubra fine powder and adjuvant, and drying is pulverized the system granule with dry product, and makes tablet after an amount of magnesium stearate is mixed.

Embodiment 2:

Take by weighing the following traditional Chinese medicines material as raw material: Radix Ginseng Rubra 131 grams, Herba Rabdosiae glaucocalycis 2500 grams, Fructus Aurantii 250 grams; Red ginseng powder is broken into fine powder; Smash after Herba Rabdosiae glaucocalycis cleans and add 10 times of water gaging normal pressures or decompression decoction secondary, each 1-3 hour, merge extractive liquid,, precipitation, filtration, filtrate for later use; Cut into pieces after the Fructus Aurantii cleaning, get wheat bran and place the heat pot, be heated to when smoldering, add the Fructus Aurantii sheet, stir fast, fry to medical material surface displaing yellow or complexion changed and take out when dark, sieve removes wheat bran, cools, and per 100 kilograms of clean medical materials carry out parch with 10 kilograms of wheat brans; Fructus Aurantii (parched) adds 10 times of water gaging normal pressures or decompression decocts secondary, and each 1-3 hour, merge extractive liquid,, precipitation, filtration, filtrate for later use; Above-mentioned two kinds of filtrates merging is condensed into paste, adds Radix Ginseng Rubra fine powder and adjuvant, and drying will be sterilized behind dry product pulverizing, the sieving to obtain fine powder, and the soybean oil that adds about one times of amount is made soft capsule.

The Chinese medicine preparation that embodiment 1 is made carries out every index test, and the result is as follows:

One, toxicity check:

Acute toxicity, long term toxicity: the acute toxinology experiment that is undertaken by the Inst. of Traditional Chinese Medicine, Zhejiang Prov shows, mice maximum tolerated dose＞50g/kg is equivalent to 672 times of human dosage, and this product safety range is bigger.Rat is pressed 6.72～50 times of continuous raisings 180 days of human dosage, does not see that the toxicity variation of the unusual and main organs tissue of outward appearance, body weight, routine blood test, hepatic and renal function appears in rat.

Two, function test result:

1. prevent and treat gastric precancerous lesion and suppress gastric cancer

Bring out the rat stomach precancerosis with N-methyl-N '-nitro-N-nitrosoguanidine (MNNG)

Become with morning, late gastric cancer and take place.Feeding medicine group and MNNG modeling group are relatively as a result:

● to the control of gastric precancerous lesion:

● to the influence of gastric cancer

2. to test gastric mucosa of rat CA _72-4Influence:

CA _72-4Be tumor-associated glycoprotein antigen, be considered to a kind of tumor markers relevant with gastroenteric tumor.

3. treatment Rats with Spleen-deficiency helicobacter pylori (HP) infects the research of gastritis:

4. medicine can obviously improve symptoms such as upper abdomen dull pain, distension clinical, to mice emptying test result:

Grouping	N	Dosage (g/kg)	Methyl orange residual rate % (mean ± SD)
					The blank group	9	The equivalent normal saline	38.39±7.52
The medicine low dose group	8	0.3	20.88±10.30	P＜0.01
					Dosage group in the medicine	8	0.6	22.50±3.91	P＜0.01
The medicine high dose group	10	1.2	28.35±8.71	P＜0.01

5. the clinical verification of Drug therapy chronic atrophic gastritis or companion intestinal epithelial metaplasia, dysplasia (Chinese medical discrimination belong to weakness of the spleen and stomach hold concurrently syndrome of stagnation of QI), case 440 examples, 120 people are organized in treatment, matched group 120 people, open group 200 people.Use the contrast of dimension enzyme sheet.

● the symptom Comparison of therapeutic

Grouping	The example number	Clinical recovery	Produce effects	Effectively	Invalid	Obvious effective rate %	Total effective rate %
								The treatment group	120	19	49	42	10	56.67	91.76
Open group	200	27	65	92	16	46	92
								Treatment adds open group	320	46	114	134	26	50	91.88
Matched group	120	4	19	57	40	19.17	66.67

Through Ridit check, treatment group, open group, treatment add open group relatively to be had with matched group and shows the property annotated difference (U=6.22,5.91,6.80) P＜0.01.

● each organizes gastroscope, pathology Comparison of therapeutic

Grouping	The example number	Clinical recovery	Produce effects	Effectively	Invalid	Obvious effective rate %	Total effective rate %
								The treatment group	120	10	34	38	38	36.67	68.33
Open group	178	6	29	61	82	19.67	53.93
								Treatment adds open group	298	16	63	99	120	26.51	59.73
Matched group	120	1	10	36	73	9.17	39.17

Through Ridit check, treatment group, open group, treatment add open group relatively to be had with matched group and shows the property annotated difference (U=5.06,2.59,4.12), P＜0.01.

● treatment adds the contrast of open group treatment front and back gastric tissue pathologic finding

Check through Ridit, body of gland atrophy, minimizing and intestinal epithelial metaplasia and dysplasia that treatment adds behind the open group patient treatment show the property annotated difference (U=5.58,5.96,2.87), P＜0.01 than having before treating.

In clinical research: the 32nd page of " journal of shanghai Chinese medicine " 1997 the 5th phase, Li Xiaoming is reported in " WEIFUCHUN PIAN treatment chronic gastritis 60 routine observation of curative effect " literary composition: WEIFUCHUN PIAN treatment chronic gastritis 60 examples, superficial gastritis 40 examples wherein, atrophic gastritis 20 examples were treated clinical efficacy obvious effective rate 22% 3 months, total effective rate 86.67%, gastroscope obvious effective rate 18%, total effective rate 83.33%, pathology obvious effective rate 15% total effective rate 71.67%.

" Guiyang College of Traditional Chinese Medicine's journal " the 3rd phase in 1998, Huang Tao reports in " observation of curative effect of Chinese medicine WEIFUCHUN PIAN treatment chronic gastritis " literary composition: Chinese medicine WEIFUCHUN PIAN treatment chronic gastritis 140 examples, 70 examples are organized in treatment, and matched group 70 examples were observed 2 months, treatment group doing well,improving total effective rate 90%, matched group is 64%, and gastroscope treatment group total effective rate reaches 86%, and matched group is 63%, handle by statistics, two groups of p values are all less than 0.01.

Claims (2)

1. Chinese medicine preparation for the treatment of stomach and intestinal tract disease is by the water of following main materials and/or alcohol extract is made active component and pharmaceutically acceptable additives are formed: Radix Ginseng Rubra 131 weight portions, Herba Rabdosiae glaucocalycis 2500 weight portions, Fructus Aurantii 250 weight portions.

2. the preparation method of the Chinese medicine preparation of treatment stomach according to claim 1 and intestinal tract disease is characterized in that: comprise the following steps:

(1) takes by weighing the following traditional Chinese medicines material as raw material: Radix Ginseng Rubra 131 weight portions, Herba Rabdosiae glaucocalycis 2500 weight portions, Fructus Aurantii 250 weight portions;

(2) red ginseng powder is broken into fine powder;

(3) smash after Herba Rabdosiae glaucocalycis cleans and add 5-15 times of water gaging normal pressure or decompression decoction secondary, each 1-3 hour, merge extractive liquid,, precipitation, filtration, filtrate for later use;

(4) cut into pieces after the Fructus Aurantii cleaning, get wheat bran and place the heat pot, be heated to when smoldering, add the Fructus Aurantii sheet, stir fast, fry to medical material surface displaing yellow or complexion changed and take out when dark, sieve removes wheat bran, cools, and per 100 kilograms of clean medical materials carry out parch with 10 kilograms of wheat brans;

(5) Fructus Aurantii (parched) adds 5-15 times of water gaging normal pressure or decompression decoction secondary, each 1-3 hour, merge extractive liquid,, precipitation, filtration, filtrate for later use;

(6) merging of above-mentioned filtrate is condensed into paste, adds Radix Ginseng Rubra fine powder and adjuvant, and drying is made preparation, promptly.