CN102698189B - Chinese medicinal composition and preparation with function of treating helicobacter pylori in stomach and preparation method thereof - Google Patents

Abstract

A traditional Chinese medicine composition with the effect of treating gastric Helicobacter pylori. The traditional Chinese medicine composition is made of the following raw materials in parts by weight: 10-30 parts by weight of Atractylodes Rhizoma Atractylodes Rhizome, 9-20 parts by weight of Chenpi, and 10-30 parts by weight of Poria cocos. Parts by weight, pinellia 9-20 parts by weight, amomum 4-10 parts by weight, and turmeric 9-30 parts by weight. It is confirmed by clinical tests that the powder prepared from the traditional Chinese medicine composition of the invention has good efficacy in treating gastric Helicobacter pylori, has quick onset, no toxic and side effects, and the total effective rate can reach 100%. It has a good application prospect and market prospect.

Description

Traditional Chinese medicine composition, preparation and preparation method thereof with efficacy in treating gastric Helicobacter pylori

technical field

The invention relates to a traditional Chinese medicine composition, in particular to a traditional Chinese medicine composition, a preparation and a preparation method thereof, which have the effect of treating gastric Helicobacter pylori.

Background technique

Helicobacter pylori is a spiral-shaped, micro-anaerobic bacteria that requires very harsh growth conditions. In 1983, it was successfully isolated from the gastric mucosal biopsy tissue of patients with chronic active gastritis for the first time. It is the only microbial species known to be able to survive in the human stomach. Helicobacter pylori disease includes gastritis, peptic ulcer, and lymphoproliferative gastric lymphoma caused by Helicobacter pylori infection. The poor prognosis of Helicobacter pylori disease is gastric cancer.

The general treatment principle for Helicobacter pylori infection is mainly antibiotics, supplemented by acid suppressants, commonly used antibiotics such as amoxicillin, gentamicin, clarithromycin and amoxicillin. However, long-term use or excessive use of antibiotics will cause hidden harm to the human body. Such as damage to human organs, induce bacterial resistance and so on. Especially for children, the injury is particularly serious. Therefore, there is an urgent need for a drug that has a good curative effect and can replace antibiotics for the treatment of gastric Helicobacter pylori.

Contents of the invention

The purpose of the present invention is to propose a Chinese medicine composition with the effect of treating gastric Helicobacter pylori.

The second object of the present invention is to propose the preparation method and optimal dosage form of the above-mentioned traditional Chinese medicine composition.

The present invention selects a combination of fifteen herbs including Atractylodes macrocephala, tangerine peel, poria cocos, pinellia, amomum seed, cypress seed, perilla leaf, windproof, corrugated seed, sea octopus, berberine, turmeric, hawthorn, divine comedy and roasted licorice, and is prepared into an oral preparation. Can play the effect of treating gastric Helicobacter pylori.

The effect of described each flavor medicine is as follows:

Atractylodes macrocephala: Stir-fried Atractylodes macrocephala is suitable for tonifying deficiency. Its effects are to invigorate qi and invigorate the spleen, dry dampness and diuresis, stop sweating and relieve miscarriage. This product is sweet and bitter and warm in nature. It mainly belongs to the Spleen and Stomach Meridian. Its main function is to invigorate the spleen and dry dampness. Endogenous water-dampness causes symptoms such as lack of appetite, loose stool or diarrhea, phlegm retention, edema, and leukorrhea. This product is not only good at invigorating qi to restore spleen movement, but also can dry dampness and diuresis to eliminate dampness.

Tangerine peel: Qi regulating medicine, regulating Qi and invigorating the spleen, drying dampness and resolving phlegm. For spleen and stomach qi stagnation syndrome, this product is pungent and warm, has the functions of promoting qi and relieving pain, invigorating the spleen and harmonizing the middle. Because of its bitterness and temperature, it is dry, so it is most suitable for stagnation of qi in the middle of cold and damp resistance. Treat cold and dampness in the middle burner, spleen and stomach qi stagnation, abdominal pain, nausea and vomiting, diarrhea, etc. It is used for vomiting, hiccups, pungent orange peel, good at sorting out the movement of qi, regulating the middle burner and making it rise and fall in an orderly manner.

Poria cocos: This product is diuresis and swelling medicine, and its effect is diuretic diuresis, invigorating the spleen, calming the mind. Applied to diarrhea due to spleen deficiency, this product can invigorate the spleen and expel dampness to stop diarrhea, especially suitable for diarrhea due to excessive dampness due to spleen deficiency.

Pinellia: a medicine for resolving phlegm, relieving cough and relieving asthma. Its effects are to dry dampness and resolve phlegm, reduce adverse flow and stop vomiting, eliminate lumps and dissipate stagnation; externally used for reducing swelling and relieving pain. Pinellia is bitter in taste, calms the stomach, and is an essential medicine for stopping vomiting. For vomiting due to various reasons, it can be used in combination with the syndrome, and it is especially suitable for vomiting caused by phlegm retention or stomach cold.

Amomum: medicine for removing dampness, promoting qi circulation by removing dampness, warming middle-Jiao and stopping diarrhea, antiabortive. It is mainly used for dampness resistance in the middle burner and spleen-stomach qi stagnation syndrome, vomiting and diarrhea due to spleen-stomach deficiency and cold. This product is pungent, dissipating and warming, with a fragrant smell. It can remove dampness and wake up the spleen. Various syndromes are commonly used, especially those with stagnation of Qi due to cold and dampness are the most suitable. This product can warm the middle and warm the stomach to stop vomiting and diarrhea, but its focus is on warming the spleen.

Curcuma turmeric: blood-activating and stasis-removing medicine, promoting blood circulation and relieving pain, promoting qi circulation and relieving stagnation, clearing away heart-fire and cooling blood, invigorating the gallbladder and reducing jaundice. This taste is pungent, can act and disperse, and can not only promote blood circulation but also promote qi, so it can treat pain caused by stagnation of qi and blood.

Coptidis: heat-clearing medicine. Clearing away heat and dampness, purging fire and detoxification. It is mainly used for fullness due to damp-heat, vomiting and acid regurgitation. This product is bitter and severe cold. Its heat-clearing and damp-drying power is greater than Scutellaria baicalensis, especially better than clearing middle-jiao damp-heat.

Hawthorn: It is advisable to use fried hawthorn, a digestive medicine. Dispelling indigestion and stagnation, promoting qi and dispelling stasis. This product is sour and sweet, slightly warm but not hot, good for digestion and digestion, and can cure various dietary stagnation, especially the key medicine for digesting greasy meat stagnation. It can be used for those who suffer from abdominal fullness, belching and acid regurgitation, abdominal pain and loose stools due to meat-eating stagnation.

Divine Comedy: Stir-fried Divine Comedy and digestive medicine should be used. The effect of digestion and stomach. This product is pungent to dissipate and eliminate food, sweet, warm and invigorating the spleen, appetizing, and stopping diarrhea.

Bai Kou Ren: medicine for removing dampness. It has the effects of dispelling dampness and promoting qi, warming the middle and stopping vomiting. Applied to damp-resisting middle energizer and spleen-stomach qi stagnation syndrome, it can promote qi expansion, warm stomach and stop vomiting, especially suitable for stomach-cold damp-restricted qi stagnation and vomiting.

Su Ye: anti-surgical medicine. It has the effects of relieving the exterior and dispelling cold, promoting qi circulation and widening the middle. It is used for stagnation of spleen and stomach, chest tightness and vomiting. This taste is pungent and effective. It can promote qi to relieve swelling, harmonize the stomach and stop vomiting. It also has the function of regulating qi and preventing miscarriage. ,feel sick and vomit.

Fangfeng: Antidiarrheal medicine. Its effect is expelling wind and relieving exterior syndrome, eliminating dampness and relieving pain, relieving spasm. With its property of promoting clearing, drying and dampness, it can be used for diarrhea caused by deficiency of the spleen due to excessive dampness and excess of clearing yang.

Corrugated seed: a medicine for resolving phlegm, relieving cough and asthma. It has the effects of eliminating phlegm and softening hard mass, suppressing acid and relieving pain. This product can not only eliminate phlegm but also remove blood stasis. It has the function of resolving stasis and dispelling stagnation. It is also used for liver and stomach disharmony, stomach pain and acid regurgitation.

Sea Cuttlefish: Astringent. It has the effects of astringent and hemostasis, antacid and pain relief, dampness and sores. It is used for stomachache and acid regurgitation. This taste is salty and astringent. It can suppress acid and relieve pain. It is a good product for treating hyperacidity in epigastric pain.

Licorice: Radix Glycyrrhizae should be used as a tonic. It has the effects of invigorating the spleen and replenishing qi, eliminating phlegm and relieving cough, relieving spasm and relieving pain, clearing heat and detoxifying, and harmonizing various medicines. It is often used in spleen-qi deficiency syndrome, epigastric cavity, and acute pain of extremities. This product can play a role in reconciling medicinal properties in many prescriptions.

In order to realize the purpose of the present invention, the present invention adopts following concrete technical scheme:

A traditional Chinese medicine composition with the effect of treating gastric Helicobacter pylori, said traditional Chinese medicine composition is made of the following crude drugs in proportions by weight:

10-30 parts by weight of Atractylodes Rhizome, 9-20 parts by weight of dried tangerine peel, 10-30 parts by weight of Poria cocos, 9-20 parts by weight of pinellia pinellia, 4-10 parts by weight of amomum, and 9-30 parts by weight of turmeric.

A Chinese medicine composition based on the above formula with the effect of treating gastric Helicobacter pylori, said Chinese medicine composition is made of the following raw materials in proportions by weight:

10-30 parts by weight of Atractylodes macrocephala, 9-20 parts by weight of tangerine peel, 10-30 parts by weight of poria cocos, 9-20 parts by weight of pinellia, 4-10 parts by weight of amomum, 9-30 parts by weight of turmeric, 9-20 parts by weight of white cocos 9-20 parts by weight of Perilla leaves, 8-20 parts by weight of Fangfeng, 10-30 parts by weight of corrugated seeds, 10-20 parts by weight of sea octopus, 5-15 parts by weight of Coptidis Rhizoma, 8-20 parts by weight of Hawthorn, 8 parts by weight of Divine Comedy ～20 parts by weight, 6～15 parts by weight of licorice.

The preferred proportioning by weight of the Chinese medicine composition is as follows:

15 parts by weight of Atractylodes macrocephala, 12 parts by weight of tangerine peel, 12 parts by weight of poria cocos, 12 parts by weight of pinellia, 6 parts by weight of amomum, 10 parts by weight of turmeric, 10 parts by weight of white coriander, 10 parts by weight of perilla leaves, 10 parts by weight of windproof, corrugated 10 parts by weight of seedlings, 10 parts by weight of squid octopus, 6 parts by weight of Coptis chinensis, 10 parts by weight of hawthorn, 10 parts by weight of Divine Comedy, 10 parts by weight of licorice.

It is recommended to use fried Atractylodes macrocephala, fried hawthorn is recommended for hawthorn, fried divine song is recommended for Shenqu, and roasted licorice is recommended for licorice.

A traditional Chinese medicine extract with the effect of treating gastric Helicobacter pylori, said extract is prepared from the above-mentioned traditional Chinese medicine composition through a conventional traditional Chinese medicine extraction method.

The use of the traditional Chinese medicine extract in the preparation of a traditional Chinese medicine preparation with the effect of treating gastric Helicobacter pylori.

A traditional Chinese medicine preparation with the effect of treating gastric Helicobacter pylori, said traditional Chinese medicine preparation is made of the above-mentioned traditional Chinese medicine composition and pharmaceutically acceptable auxiliary materials.

The traditional Chinese medicine preparation is powder, tablet, oral liquid, capsule or decoction.

A method for preparing the Chinese medicine composition, the method steps are as follows:

(1) Weigh each raw material according to the above weight ratio, and set aside;

(2) Dry the raw materials, mix and grind them into powder, and pass through a 100-200 mesh sieve;

(3) Just pack it separately.

Pass through a 100-mesh sieve in the step (2). What the method prepares is an oral powder.

The best preparation of the present invention is a powder, and its recommended method of use is: take after mixing with boiling water, 3 times a day, 1 bag each time, and take 10 g in each bag orally.

Beneficial effects of the present invention:

It is confirmed by clinical tests that the powder prepared from the traditional Chinese medicine composition of the present invention has good efficacy in treating gastric Helicobacter pylori, has quick effect, has no toxic and side effects, and has a total effective rate of up to 100%. It has a good application prospect and market prospect.

Detailed ways

The medicinal materials used in this example can all be purchased from China Medicinal Materials Company, and conform to the first standard of the Pharmacopoeia of the People's Republic of China, 2005 edition.

The preparation of embodiment 1 powder of the present invention

(1) Weigh each API according to the following proportions, and set aside;

Atractylodes macrocephala 15g, Chenpi 12g, Poria 12g, Pinellia 12g, Amomum 6g, Curcuma 10g.

(2) Dry each raw material medicine, mix and grind it into powder, and pass through a 100-mesh sieve;

(3) Just pack it separately.

The preparation of embodiment 2 powders of the present invention

(1) Weigh each API according to the following proportions, and set aside;

Atractylodes macrocephala 10g, Chenpi 20g, Poria 30g, Pinellia 9g, Amomum 4g, Curcuma 30g.

(2) Dry each raw material, mix and grind them into powder, and pass through a 200-mesh sieve;

(3) Just pack it separately.

The preparation of embodiment 3 powders of the present invention

(1) Weigh each API according to the following proportions, and set aside;

Stir-fried Atractylodes macrocephala 30g, orange peel 9g, Poria cocos 10g, pinellia 20g, amomum 10g, turmeric 9g.

(2) Dry each raw material medicine, mix and grind it into powder, and pass through a 100-mesh sieve;

(3) Just pack it separately.

The preparation of embodiment 4 powders of the present invention

(1) Weigh each API according to the following proportions, and set aside;

15g Atractylodes macrocephala, 12g tangerine peel, 12g poria cocos, 12g pinellia, 6g amomum, 10g turmeric, 10g white coriander, 10g perilla leaf, 10g windproof, 10g corrugated seed, 10g sea octopus, 6g berberine, 10g hawthorn, 10g divine comedy, licorice 10g.

(2) Dry each raw material medicine, mix and grind it into powder, and pass through a 100-mesh sieve;

(3) Just pack it separately.

The preparation of embodiment 5 powders of the present invention

(1) Weigh each API according to the following proportions, and set aside;

Atractylodes macrocephala 10g, tangerine peel 20g, Poria cocos 30g, pinellia 9g, amomum 10g, turmeric 9g, white coriander 20g, perilla leaves 9g, windproof 20g, corrugated seeds 30g, sea octopus 15g, coptis 5g, hawthorn 8g, divine comedy 20g, licorice 15g.

(2) Dry each raw material, mix and grind them into powder, and pass through a 200-mesh sieve;

(3) Just pack it separately.

The preparation of embodiment 6 powder of the present invention

(1) Weigh each API according to the following proportions, and set aside;

Atractylodes macrocephala 30g, tangerine peel 9g, Poria cocos 10g, pinellia 20g, amomum 4g, turmeric 30g, white coriander 9g, perilla leaves 20g, windproof 8g, corrugated seeds 10g, sea octopus 20g, coptis 15g, hawthorn 20g, divine comedy 8g, licorice 6g.

(2) Dry each raw material medicine, mix and grind it into powder, and pass through a 100-mesh sieve;

(3) Just pack it separately.

The preparation of embodiment 7 capsules of the present invention

Raw material and dosage:

Stir-fried Atractylodes macrocephala 15g, tangerine peel 12g, Poria cocos 12g, Pinellia 12g, Amomum 6g, Baikouren 10g, perilla leaves 10g, Fangfeng 10g, corrugated seeds 10g, squid octopus 10g, Coptidis 6g, turmeric 10g, fried hawthorn 10g, fried Divine Comedy 10g, roasted licorice 10g.

Preparation:

Weigh the crude drug according to the above dosage for later use, add 10 times of 75% ethanol for reflux extraction, reclaim the extract, and filter through a 120-mesh stainless steel sieve; add anhydrous sodium sulfate and let it stand overnight, filter to obtain fatty oil medicinal residue for subsequent use; Add 10 times the amount of water to extract twice, the first time is 1 hour, the second time is 2 hours, the two extracts are mixed and spray-dried to obtain a dry powder for later use. The fatty oil is mixed with dry powder and packed into capsules.

Clinical trials and results of the present invention

1 clinical data

1.1 The diagnostic criteria refer to the diagnostic criteria for chronic gastritis, fullness syndrome, and peptic ulcer in "Consensus Opinions on Some Clinical Aspects of Helicobacter Pylori (2003. Tongcheng, Anhui)" and "Guiding Principles for Clinical Research of New Chinese Medicines (Trial)". All were positive for Hp in the 14-C urea breath test, and endoscopy showed gastric ulcer or duodenal ulcer, excluding atrophic gastritis, precancerous lesions and cancerous changes suggested by pathology.

1.2 General information The observed cases were all inpatients in the Chinese People's Liberation Army General Hospital from June 2009 to June 2010. A total of 640 cases were randomly divided into 8 groups. The treatment group consisted of 560 cases, including 328 males and 232 females; aged 15 to 76 years, with an average of 39.2 years. The control group consisted of 80 cases, including 46 males and 34 females; aged 14 to 65 years, with an average of 34.5 years. There was no significant difference between the two groups in general information such as gender and age (P>0.05), and they were comparable.

2 treatment methods

2.1 The treatment group was treated with the powder prepared in Examples 1, 2, 3, 4, 5, 6 and the capsules prepared in Example 7, respectively treatment group 1, treatment group 2, treatment group 3, treatment group 4, treatment group 5. Treatment group 6 and treatment group 7, powder usage method: boiled water, 3 times a day, 1 bag each time, 10g per bag orally; capsule usage method: 3 capsules at a time, 3 times a day, 0.4g per capsule oral. 6 weeks of treatment is a course of treatment, and the curative effect is observed after a course of treatment.

2.2 The control group received triple therapy, omeprazole capsules 20 mg each time, twice a day, orally on an empty stomach; clarithromycin 500 mg each time, twice a day, orally on an empty stomach. Amoxicillin 100mg each time, 2 times a day, orally after meals. Except for the above-mentioned medicines, omeprazole was used for 4 weeks for patients with gastric ulcer and 6 weeks for patients with duodenum, all other medicines were withdrawn after 7 days of treatment. Withdrawal of the drug in January review Hp.

3 Efficacy criteria and treatment results

3.1 The curative effect standard refers to "Digestive Tract Endoscopy". Cure: all symptoms and signs disappeared, gastroscopic examination of gastric mucosa was basically normal, and pathological tissue biopsy was basically normal. Significant effect: symptoms and signs basically disappeared or alleviated, gastric mucosal erosion and hemorrhage disappeared in gastroscopic examination, congestion was relieved, lesion range was reduced by more than 1/2, and pathological biopsy improved significantly. Improvement: Symptoms and signs were relieved, the extent of lesion was reduced by no more than 1/2 in gastroscopic examination, and pathological tissue biopsy improved. Invalid: no change or aggravation of symptoms and signs, no change or aggravation of gastroscopy. Hp reexamination turned negative to be cleared.

3.2 Treatment Outcomes

Table 1 Comparison of clinical curative effect after treatment

Compared the cure rate between the treatment group and the control group, the difference has very significant significance (P<0.01), and the treatment group is obviously better than the control group.

Claims (10)

1. the Chinese medicine composition with treatment stomach Helicobacter pylori effect, is characterized in that, described Chinese medicine composition is made by the crude drug of following weight parts proportioning:

The Rhizoma Atractylodis Macrocephalae 10～30 weight portions, Pericarpium Citri Reticulatae 9～20 weight portions, Poria 10～30 weight portions, the Rhizoma Pinelliae 9～20 weight portions, Fructus Amomi 4～10 weight portions, Radix Curcumae 9～30 weight portions.

2. the Chinese medicine composition with treatment stomach Helicobacter pylori effect, is characterized in that, described Chinese medicine composition is made by the crude drug of following weight parts proportioning:

The Rhizoma Atractylodis Macrocephalae 10～30 weight portions, Pericarpium Citri Reticulatae 9～20 weight portions, Poria 10～30 weight portions, the Rhizoma Pinelliae 9～20 weight portions, Fructus Amomi 4～10 weight portions, Radix Curcumae 9～30 weight portions, roud cardamon seed 9～20 weight portions, Folium Perillae 9～20 weight portions, Radix Saposhnikoviae 8～20 weight portions, Concha Arcae 10～30 weight portions, Endoconcha Sepiae 10-20 weight portion, Rhizoma Coptidis 5～15 weight portions, Fructus Crataegi 8～20 weight portions, Massa Medicata Fermentata 8～20 weight portions, Radix Glycyrrhizae 6～15 weight portions.

3. Chinese medicine composition according to claim 2, is characterized in that, described Chinese medicine composition is made by the crude drug of following weight parts proportioning:

The Rhizoma Atractylodis Macrocephalae 15 weight portions, Pericarpium Citri Reticulatae 12 weight portions, Poria 12 weight portions, the Rhizoma Pinelliae 12 weight portions, Fructus Amomi 6 weight portions, Radix Curcumae 10 weight portions, roud cardamon seed 10 weight portions, Folium Perillae 10 weight portions, Radix Saposhnikoviae 10 weight portions, Concha Arcae 10 weight portions, Endoconcha Sepiae 10 weight portions, Rhizoma Coptidis 6 weight portions, Fructus Crataegi 10 weight portions, Massa Medicata Fermentata 10 weight portions, Radix Glycyrrhizae 10 weight portions.

4. the Chinese medicine extract with treatment stomach Helicobacter pylori effect, is characterized in that, described extract is prepared through conventional Traditional Chinese medicine extraction method by claim 1,2 or 3 described Chinese medicine compositions.

5. Chinese medicine extract claimed in claim 4 has purposes in the Chinese medicine preparation for the treatment of stomach Helicobacter pylori effect in preparation.

6. the Chinese medicine preparation with treatment stomach Helicobacter pylori effect, is characterized in that, described Chinese medicine preparation is made by acceptable adjuvant on claim 1,2 or 3 described Chinese medicine compositions and pharmaceutics.

7. Chinese medicine preparation according to claim 6, is characterized in that, described Chinese medicine preparation is powder, tablet, oral liquid, capsule or soft extract.

8. a method for preparing claim 1,2 or 3 described Chinese medicine compositions, is characterized in that, described method step is as follows:

(1) take each crude drug according to claim 1,2 or 3 described weight portion proportionings, standby;

(2) each crude drug is dried, mixed grinding, to Powdered, is crossed 100～200 mesh sieves;

(3) packing gets final product.

9. method according to claim 8, is characterized in that, crosses 100 mesh sieves in described step (2).

10. method according to claim 9, is characterized in that, what described method prepared is oral powder.