DE102021122431A1 - Composition of traditional Chinese medicine - Google Patents

Abstract

The invention relates to the technical field of medicine and discloses a composition of traditional Chinese medicine for treating allergic purpura. The composition of traditional Chinese medicine is made up of the following ingredients: Red peony root, Morning glory (Codonopsis pilosula), Woad leaf (Isatidis folium), Indigo naturalis, Cord tree (Sophora flavescens), Tree peony root bark (Moutan cortex), Pseudoginseng (Panax notoginseng) , and Astragalus (Astragalus). The composition of traditional Chinese medicine according to the present invention exhibits significant effects of heat quenching and detoxification, cooling blood and removing rash, dissolving blood stasis and relieving pain, and is an effective medicine for treating allergic purpura, particularly allergic purpura of the wind-heat type.

Description

technical field

The invention relates to the technical field of traditional Chinese medicine, in particular a traditional Chinese medicinal composition for the treatment of allergic purpura, also known as Schoenlein-Henoch purpura or IgA vasculitis, and manufacturing processes for the various dosage forms of the same.

background

Allergic purpura or Schoenlein-Henoch purpura represents a relatively common form of systemic vasculitis of small blood vessels as the main pathology. The permeability of the patient's capillaries is increased, as a result of which lymph and blood penetrate into the intercellular spaces of the body, causing hematoma or exudative bleeding in internal ones organs and skin as well as mucous membranes. The clinical symptoms of the disease mainly include skin purpura, abdominal pain, joint pain, gastrointestinal irritation, etc., and most patients show renal damage of varying degrees.

In Western medicine, hormones and immunosuppressants are mainly used for the clinical treatment of Henoch-Schoenlein purpura. While these play some role, they only provide limited control over the disease. There is a susceptibility to relapse and numerous complications arise. Long-term medication is obviously associated with side effects and the clinical effectiveness is far from ideal.

According to its clinical manifestation, the disease belongs to the category of diseases such as "petechiae" and "blood syndrome" according to traditional Chinese medicine. In traditional Chinese medicine, it is believed that its cause can be divided mainly into two parts: externally arising feelings and internal injuries. External feelings are mostly caused by yang evils such as wind-heat and dry fire, and some are yin evils or epidemic poison in the form of damp heat enters the inside and the heat is reduced; internal injuries are due to inadequate constitution, eating and drinking, and chronic fever. The mechanism consists mainly of heat stasis blood sites, internal injury sites, heat stasis blood pressure, and occlusion with congestion. Children are the body of immature yin and yang. They are weak in righteousness and prone to evil. When they are feeling down, they are often affected by heat or other hot things. Evil wind-heat poison fights with the camp blood, burns the vascular system, blood does not flow through the meridian, overflows, out of the pulse, and radiates as purpura.

The treatment of allergic purpura is mainly based on two types of symptoms: the wind-heat type and the damp poison type. It uses heat quenching, blood cooling, blood congestion removal, rash removal, dampness removal and detoxification and other treatment methods. The local blood circulation is improved and the capillary connection is reduced. Therefore, there is a need to develop a traditional Chinese medicine composition for treating allergic purpura with a more precise curative effect.

Summary

The present invention provides a traditional Chinese medicine composition for treating allergic purpura, particularly wind-heat type allergic purpura, which includes components with strict requirements, is consistent with science, shows significant curative effects, the curative effects of the drug can maximize, is easy to manufacture, exhibits good patient compliance, and has no toxic effects or side effects.

), 13 - 15 Teile Glockenwinde (Codonopsis pilosula) (

), 15 - 17 Teile Färberwaidblätter (Isatidis folium)(

), 6 - 8 Teile Indigo Naturalis (

), 4 - 6 Teile Schnurbaum (Sophora flavescens) (

), 10 - 12 Teile Strauchpaeonien-Wurzelrinde (Moutan cortex) (

), 16 - 18 Teile Pseudoginseng (Panax notoginseng) (

), 13 - 15 Teile Tragant (Astragalus) (

).In order to achieve the above objects, the technical solution according to the present invention is a traditional Chinese medicine composition for the treatment of allergic purpura, characterized in that the drug is composed of the following medicinal substances, in parts by weight: 12-14 Parts peony root red (

), 13 - 15 parts of morning glory (Codonopsis pilosula) (

), 15 - 17 parts woad leaves (Isatidis folium)(

), 6 - 8 parts Indigo Naturalis (

), 4 - 6 parts cord tree (Sophora flavescens) (

), 10 - 12 parts of tree peony root bark (Moutan cortex) (

), 16 - 18 parts Pseudoginseng (Panax notoginseng) (

), 13 - 15 parts Astragalus (Astragalus) (

).

The most preferred technical solution of the present invention is that the medicinal product of the present invention is prepared from the following raw materials, in parts by weight: 13 parts of red peony root, 14 parts of morning glory (Codonopsis pilosula), 16 woad leaves (Isatidis folium), 7 Parts Indigo Naturalis, 5 parts Cord Tree (Sophora flavescens), 11 parts Tree Peony root bark (Moutan cortex), 17 parts Pseudoginseng (Panax notoginseng), 14 parts Astragalus (Astragalus).

The dosage form of said drug consists of an oral preparation.

Said oral preparations include granules, capsules or tablets.

The manufacturing process for the above preparations in the form of granules comprises: weighing the above traditional Chinese medicine ingredients according to the above proportions and crushing into coarse powder; Wrap with gauze and boil twice, for the first boil add 8 times the amount of water and steep for 4 hours; 2 h boil, filter; for the second boil, add 4 times the amount of water, boil for 2 hours, mix the brew and filter; Concentrate to a clear ointment with a specific gravity of 1.10-1.15 at 65°C, add an appropriate amount of soft material of dextrin and sucrose, prepare a wet granulate, pass through an 80 mesh screen, dry, size , re-sifting, bagging and packaging.

The manufacturing process for the above preparations in the form of capsules comprises: weighing the above traditional Chinese medicine ingredients according to the above proportions and crushing into coarse powder; Wrap with gauze and boil twice, for the first boil add 8 times the amount of water and steep for 4 hours; 2 h boil, filter; for the second boil, add 4 times the amount of water, boil for 2 hours, mix the brew and filter; Concentrating into a clear ointment with a specific gravity of 1.10-1.15 at 65°C, drying at a low temperature of 50°C, crushing into a medium-fine powder, adding an appropriate amount of excipients, mixing uniformly, and filling into capsules .

The manufacturing process for the above preparations in the form of tablets comprises: weighing the above traditional Chinese medicine ingredients according to the above proportions and crushing into a coarse powder; Wrap with gauze and boil twice, for the first boil add 8 times the amount of water and steep for 4 hours; 2 h boil, filter; for the second boil, add 4 times the amount of water, boil for 2 hours, mix the brew and filter; Concentrating into a clear ointment with a specific gravity of 1.10-1.15 at 65°C, drying at a low temperature of 50°C, crushing into a medium-fine powder, adding an appropriate amount of excipients, pressing and coating.

Traditional Chinese medicine believes that this disease is characterized by yang arising in the body and heat cloaked in moisture. It is caused by humidity and heat. It burns the veins and spreads to the skin, producing purpura; when it collects in the colon, it causes abdominal pain and blood in the stool, joint swelling, and pain. The formulation of the present invention is strict, the medication is simplified, and the combination is reasonable. The overall effect of the formula is to quench the heat and detoxify, cool the blood and clear the rash, clear blood congestion and relieve pain. It is dialectically administered for allergic purpura, especially Wind-Heat type allergic purpura, and has a strong targeted effect. According to the evidence in clinical use, the curative effect is unequivocal, the properties of the drug are mild, there are no toxic side effects or undesirable reactions, and the safety factor is high.

The invention also relates to the use of the above-mentioned medicament in the manufacture of medicaments for the treatment of allergic purpura of the wind-heat type. During the clinical observation process, the treatment effect in 90 patients was significantly better in the treatment group than in the control group, and from comparing the treatment group with the control group a, it can be seen that the traditional Chinese medicine composition of the present invention is strictly indicated. A change in the formulation has a major impact on the therapeutic effect. In addition, the vital signs of the treatment group were stable and it occurred no serious side effects such as allergies during treatment. After the treatment, the blood counts, urine counts and electrocardiogram of the patients in the treatment group were statistically processed, and no obvious abnormalities occurred. The results indicate that the clinical use of the present formulation is safe and effective and deserves further research and dissemination.

Detailed description

The present invention is described in more detail below based on specific embodiments, but the present invention is not limited to the following specific embodiments. Changes, combinations or substitutions made to the present invention within the scope of the present invention, or made without departing from the spirit, inventive idea and scope of the present invention, will be apparent to those skilled in the art and are within the scope of the present invention includes.

EXAMPLE 1: Granules

The raw materials according to the present invention are weighed according to the following proportions by weight: 13 parts red peony root, 14 parts morning glory (Codonopsis pilosula), 16 parts woad leaves (Isatidis folium), 7 parts indigo naturalis, 5 parts cord tree (Sophora flavescens), 11 parts shrub peony Root bark (Moutan cortex), 17 parts pseudoginseng (Panax notoginseng), 14 parts tragacanth (Astragalus).

• Abwiegen der vorstehend genannten Bestandteile der traditionellen chinesischen Medizin gemäß den oben genannten Anteilen und Zerkleinern zu einem grobem Pulver; Umwickeln mit Gaze und zweimaliges Abkochen, für das erste Abkochen Zugeben der 8-fachen Menge an Wasser und Weichen lassen für 4 Stunden; 2 h Abkochen, Filtrieren; für das zweite Abkochen Zugeben der 4-fachen Menge an Wasser, 2 Stunden Abkochen, Mischen der Sude und Filtrieren; Aufkonzentrieren zu einer klaren Salbe mit einer relativen Dichte von 1,10 bis 1,15 bei 65 °C, Zugeben einer geeigneten Menge an weichem Material aus Dextrin und Saccharose, Herstellen von feuchten Granulatkörnern, Passieren durch ein Sieb mit Maschenzahl 80, Trocknen, Dimensionieren, erneutes Sieben, Einsacken und Verpacken.

The manufacturing process consists of the following:

• weighing the above traditional Chinese medicine ingredients according to the above proportions and crushing into a coarse powder; Wrap with gauze and boil twice, for the first boil add 8 times the amount of water and steep for 4 hours; 2 h boil, filter; for the second boil, add 4 times the amount of water, boil for 2 hours, mix the brew and filter; Concentrate to a clear ointment with a specific gravity of 1.10 to 1.15 at 65°C, add an appropriate amount of soft material of dextrin and sucrose, prepare wet granules, pass through an 80 mesh sieve, dry, size , re-sifting, bagging and packaging.

When using the medicament according to the present invention for the treatment of allergic purpura, 1 granule grain is taken twice a day half an hour after meals, each granule grain containing an active ingredient content of 0.5 g.

EXAMPLE 2: Capsules

The raw materials according to the present invention are weighed according to the following proportions by weight: 13 parts red peony root, 14 parts morning glory (Codonopsis pilosula), 16 parts woad leaves (Isatidis folium), 7 parts indigo naturalis, 5 parts cord tree (Sophora flavescens), 11 parts shrub peony Root bark (Moutan cortex), 17 parts pseudoginseng (Panax notoginseng), 14 parts tragacanth (Astragalus),

• Abwiegen der vorstehend genannten Bestandteile der traditionellen chinesischen Medizin gemäß den oben genannten Anteilen und Zerkleinern zu einem grobem Pulver; Umwickeln mit Gaze und zweimaliges Abkochen, für das erste Abkochen Zugeben der 8-fachen Menge an Wasser und Weichen lassen für 4 Stunden; 2 h Abkochen, Filtrieren; für das zweite Abkochen Zugeben der 4-fachen Menge an Wasser, 2 Stunden Abkochen, Mischen der Sude und Filtrieren; Aufkonzentrieren zu einer klaren Salbe mit einer relativen Dichte von 1,10 bis 1,15 bei 65 °C, Trocknen bei niedriger Temperatur von 50°C, Zerkleinern zu einem mittelfeinen Pulver, Zugeben einer geeigneten Menge an Hilfsstoffen, gleichmäßiges Vermischen und Einfüllen in Kapseln.

The manufacturing process consists of the following:

• weighing the above traditional Chinese medicine ingredients according to the above proportions and crushing into a coarse powder; Wrap with gauze and boil twice, for the first boil add 8 times the amount of water and steep for 4 hours; 2 h boil, filter; for the second boil, add 4 times the amount of water, boil for 2 hours, mix the brew and filter; Concentrating into a clear ointment with a specific gravity of 1.10-1.15 at 65°C, drying at a low temperature of 50°C, crushing into a medium-fine powder, adding an appropriate amount of excipients, mixing uniformly, and filling into capsules .

When using the drug according to the present invention for the treatment of allergic purpura, 2-3 capsules are taken 3 times a day half an hour after meals, each capsule containing 0.2 g of raw drug.

EXAMPLE 3: Tablets

The raw materials according to the present invention are weighed according to the following proportions by weight: 13 parts red peony root, 14 parts morning glory (Codonopsis pilosula), 16 parts woad leaves (Isatidis folium), 7 parts indigo naturalis, 5 parts cord tree (Sophora flavescens), 11 parts shrub peony Root bark (Moutan cortex), 17 parts pseudoginseng (Panax notoginseng), 14 parts tragacanth (Astragalus).

• Abwiegen der vorstehend genannten Bestandteile der traditionellen chinesischen Medizin gemäß den oben genannten Anteilen und Zerkleinern zu einem grobem Pulver; Umwickeln mit Gaze und zweimaliges Abkochen, für das erste Abkochen Zugeben der 8-fachen Menge an Wasser und Weichen lassen für 4 Stunden; 2 h Abkochen, Filtrieren; für das zweite Abkochen Zugeben der 4-fachen Menge an Wasser, 2 Stunden Abkochen, Mischen der Sude und Filtrieren; Aufkonzentrieren zu einer klaren Salbe mit einer relativen Dichte von 1,10 bis 1,15 bei 65 °C, Trocknen bei niedriger Temperatur von 50°C, Zerkleinern zu einem mittelfeinen Pulver, Zugeben einer geeigneten Menge an Hilfsstoffen, Pressen und Beschichten.

The manufacturing process consists of the following:

• weighing the above traditional Chinese medicine ingredients according to the above proportions and crushing into a coarse powder; Wrap with gauze and boil twice, for the first boil add 8 times the amount of water and steep for 4 hours; 2 h boil, filter; for the second boil, add 4 times the amount of water, boil for 2 hours, mix the brew and filter; Concentrating into a clear ointment with a specific gravity of 1.10-1.15 at 65°C, drying at a low temperature of 50°C, crushing into a medium-fine powder, adding an appropriate amount of excipients, pressing and coating.

When using the drug according to the present invention for the treatment of allergic purpura, 2-3 tablets are taken 3 times a day half an hour after meals, each tablet containing 0.2 g of raw drug.

EXAMPLE 4 Granules

The raw materials according to the present invention are weighed according to the following proportions by weight: 12 parts of red peony root, 13 parts of morning glory (Codonopsis pilosula), 15 parts of woad leaves (Isatidis folium), 6 parts of indigo naturalis, 4 parts of cord tree (Sophora flavescens), 10 parts of shrub peony Root bark (Moutan cortex), 16 parts pseudoginseng (Panax notoginseng), 13 parts tragacanth (Astragalus).

The manufacturing process corresponds to that of example 1.

EXAMPLE 5: Granules

The raw materials according to the present invention are weighed according to the following proportions by weight: 14 parts red peony root, 15 parts morning glory (Codonopsis pilosula), 17 parts woad leaves (Isatidis folium), 8 parts indigo naturalis, 6 parts cord tree (Sophora flavescens), 12 parts shrub peony Root bark (Moutan cortex), 18 parts pseudoginseng (Panax notoginseng), 15 parts tragacanth (Astragalus).

The manufacturing process corresponds to that of example 1.

EXAMPLE 6: Granules

The raw materials according to the present invention are weighed according to the following proportions by weight: 13 parts red peony root, 14 parts morning glory (Codonopsis pilosula), 16 parts woad leaves (Isatidis folium), 7 parts indigo naturalis, 5 parts cord tree (Sophora flavescens), 11 parts shrub peony Root bark (Moutan cortex), 14 parts Astragalus (Astragalus).

The manufacturing process corresponds to that of example 1.

Clinical Observation of the Treatment of Wind-Heat Type Allergic Purpura with the Medicament According to the Present Invention

1. General information about the case:

90 patients diagnosed with wind-heat allergic purpura in our hospital were selected, including 51 males and 39 females, aged 4 to 55 years, with an average age of 38.2 years, the course of the disease 6 to 50 days and the average disease course was 14.5 days. The patients presented with purpura Skin that is more common on the lower limbs and buttocks. The rash is raised above the skin's surface and does not fade under pressure. Gastrointestinal symptoms of varying degrees were present in 22 cases, mostly paroxysmal pain or colic, and 24 cases had varying degrees of joint swelling and joint pain. The patients were randomly divided into the treatment group, a control group a and a control group b with 30 cases each. There were no statistically significant differences in age, condition and course of disease between the three groups (p > 0.05) and they were comparable.

2. Treatment method:

Treatment Group 1: The granules prepared in Example 1 of the present invention, each containing 0.5 g of the raw drug per granule, were taken orally, 1 granule each twice a day, half an hour after meals.

Control group a: According to the conventional treatment of Western medicine, loratadine 5 mg was orally administered once a day, cimetidine 20 mg/kg/day was intravenously administered in two divided doses, and vitamin C/calcium was administered simultaneously. Adrenocortical hormone has been used for severe cases, and anti-infective treatment has been given to people infected with bacteria or viruses.

All of the above treatments are two-week treatment cycles. The healing effect was noted after two treatment cycles.

• Geheilt: nach 4 Wochen Behandlung waren die klinischen Symptome vollständig verschwunden und es lagen keine neue Purpura-Hautläsionen vor.

3. The evaluation scale of the curative effect refers to the relevant standards of the “Diagnosis and Curative Effects Standards of Diseases and Syndromes According to Traditional Chinese Medicine”:

• Healed: after 4 weeks of treatment, the clinical signs had completely disappeared and there were no new purpuric skin lesions.

Significantly effective: After 4 weeks of treatment, the child's clinical symptoms were significantly reduced and the skin lesions had cleared by at least 70%.

Effective: after 4 weeks of treatment, clinical signs had been alleviated and skin lesions had cleared by at least 70%.

Ineffective: after 4 weeks of treatment, the children's clinical symptoms had not improved or had worsened.

The overall efficacy rate is composed of the total number of cured, significantly effective and effective cases.

4. Progress control:

All patients in this study were followed up for 1 to 6 months.

5. Statistical processing:

SPSS13.0 software was used for statistical processing, a p<0.05 indicates the difference is statistically significant. The t-test was used to count data. Analysis of variance was used to compare amounts between multiple groups and the x2 test was used to compare rates.

6. Therapeutic Effect:

During the clinical observation process, all 90 patients completed clinical observation. The table below shows a comparison of the curative effect between the two groups. group n healed significantly effective effective ineffective overall effectiveness rate treatment group 30 11 10 7 2 93.3% control group 30 4 8th 10 8th 73.3% According to the clinical observation of other examples, the overall effectiveness rate is more than 90%.

From the table above it can be seen that the treatment effect in the treatment group is significantly better than in the control group, p<0.05, there is a significant difference. Also, comparing the treatment group with the control group, the composition of traditional Chinese medicine according to the present invention is strictly indicated, and the treatment group is significantly better than the control group and there is a significant difference. At the same time, the laboratory values of the treatment group such as blood values, urine values and electrocardiograms were statistically processed, and no obvious abnormalities were found. The results show that the clinical use of this formula is safe and effective and deserves further research and dissemination.

Claims (6)

Composition of traditional Chinese medicine, characterized in that the composition of traditional Chinese medicine is made of the following raw materials, in parts by weight: 12-14 parts of red peony root, 13-15 parts of morning glory (Codonopsis pilosula), 15-17 parts of woad leaves ( Isatidis folium), 6 - 8 parts indigo naturalis, 4 - 6 parts cord tree (Sophora flavescens), 10 - 12 parts tree peony root bark (Moutan cortex), 16 - 18 parts pseudoginseng (Panax notoginseng), 13 - 15 parts astragalus (Astragalus ). Composition according to traditional Chinese medicine claim 1 , characterized in that the composition of traditional Chinese medicine is made of the following raw materials, in parts by weight: 13 parts of red peony root, 14 parts of morning glory (Codonopsis pilosula), 16 woad leaves (Isatidis folium), 7 parts of indigo naturalis, 5 parts of cord tree (Sophora flavescens), 11 parts tree peony root bark (Moutan cortex), 17 parts pseudoginseng (Panax notoginseng), 14 parts tragacanth (Astragalus). Composition according to traditional Chinese medicine claim 1 or 2 , characterized in that the composition of traditional Chinese medicine is an oral preparation. Composition according to traditional Chinese medicine claim 3 , characterized in that the oral preparation is a capsule, a granule or a tablet. Composition according to traditional Chinese medicine claim 3 characterized in that the granules are prepared by: weighing the above components of traditional Chinese medicine according to the above proportions and crushing into a coarse powder; Wrap with gauze and boil twice, for the first boil add 8 times the amount of water and steep for 4 hours; 2 h boil, filter; for the second boiling add 4 times the amount of water, boil for 2 hours, mix the brew and filter; Concentrate to a clear ointment with a specific gravity of 1.10 to 1.15 at 65°C, add an appropriate amount of soft material of dextrin and sucrose, prepare wet granules, pass through an 80 mesh sieve, dry, size , re-sifting, bagging and packaging. Using the composition of traditional Chinese medicine according to claim 1 or 2 for the manufacture of medicaments for the treatment of allergic purpura of the wind-heat type.