DE102021125043A1 - A composition of traditional Chinese medicine - Google Patents

Abstract

The invention belongs to the technical field of medicine and discloses a traditional Chinese medicine composition for treating allergic purpura. The traditional Chinese medicine composition is made up of the following components: flos farfarae, radix stemonae, aster tataricus, angelica sinensis, sophora flavescens, cortex moutan, panax notoginseng, and astragalus. The traditional Chinese medicine composition of the present invention has significant effects of clearing heat and detoxification, cooling blood and eliminating stains, eliminating blood stasis, and relieving pain, and is an effective drug for treating allergic purpura , especially wind-heat type allergic purpura.

Description

TECHNICAL FIELD

The invention relates to a technical field of traditional Chinese medicine, in particular to a traditional Chinese drug for the treatment of allergic purpura and to methods for producing the various dosage forms of the same.

BACKGROUND

Allergic purpura is a relatively common form of systemic vasculitis with minor vasculitis as the main pathology. The permeability of the patient's capillaries is increased, as a result of which lymph and blood penetrate into the interstices of the body, causing hematoma or exudative bleeding in internal organs and skin mucous membranes. The clinical symptoms of the disease mainly include skin purpura, abdominal pain, joint pain, gastrointestinal reactions, etc., and most patients experience kidney damage of varying degrees.

Western medicine mainly uses hormones and immunosuppressants in the clinical treatment of allergic purpura. While they play some role, they have limited control over the disease. They are prone to relapse and have many complications. The long-term medication has obvious side effects and the clinical effect is not very optimal.

According to the clinical symptoms, the disease belongs to the category of diseases such as "violet spot" and "blood syndrome" in traditional Chinese medicine. Traditional Chinese medicine believes that the cause is mainly divided into two areas: exogenous feelings and internal injuries. Exogenous feelings are mostly caused by yang strains such as wind heat and dry fire, and some are yin strains or damp-heat epidemics in which poison enters the interior and heat is reduced; internal injuries are due to inadequate equipment, food and drink, and chronic fever. The mechanism mostly consists of heat-stagnant blood points, internal injury points, heat-stagnant blood pressure, and stasis obstruction. Children are the body of immature yin and yang. They are weak in righteousness and prone to evil. When they sense evil, they often turn away from the heat. Wind-hot evil toxin fights camp blood, burns the blood network, blood does not flow through the meridians, overflows from the pulse, and exits as purpura.

TCM treatment of allergic purpura is mainly based on two types of symptoms: Wind-Heat type and Damp-Toxin type. It uses heat elimination and blood cooling, blood congestion elimination, stain elimination, dampness elimination and detoxification and other treatment methods. It improves local blood circulation and reduces capillary communication. Therefore, there is a need to develop a traditional Chinese medicine composition for the treatment of allergic purpura with more precise curative effects.

SUMMARY

The present invention provides a traditional Chinese medicinal composition for the treatment of allergic purpura, especially wind-heat type allergic purpura, the strict prescription, scientific compatibility, has significant curative effects, can maximize the curative effect of the drug, is convenient to prepare, has good patient compliance, and has no toxic and side effects.

In order to achieve the above objects, the technical solution of the present invention is the traditional Chinese medicinal composition for the treatment of allergic purpura, which is characterized in that the medicament is composed of the following medicines by weight: 12-14 parts of Flos farfarae, 13-15 parts of Radix Stemonae, 15-17 parts of Aster tataricus, 6-8 parts of Angelica sinensis, 4-6 parts Sophora flavescens, 10-12 parts Cortex Moutan, 16-18 parts Panax notoginseng, 13-15 Share Astragalus.

The most preferred technical solution of the present invention is that the drug of the present invention is prepared from the following raw materials in parts by weight: 13 parts flos far farae, 14 parts Radix Stemonae, 16 parts Aster tataricus, 7 parts Angelica sinensis, 5 parts Sophora flavescens, 11 parts Cortex Moutan, 17 parts Panax notoginseng, 14 parts Astragalus.

The dosage form of the above drug is an oral preparation.

The oral preparations mentioned are granules, capsules or tablets.

The preparation method of the above oral preparations as granules is as follows: weigh the above components of traditional Chinese medicine according to the above proportions and pulverize them into coarse powder; Wrap with gauze and boil twice, add 8 times the amount of water for the first boil and soak for 4 hours; Boil for 2 hours, filter; Adding 4 times the amount of water for the second decoction, decoction for 2 hours, combining the decoction and filtering; Concentrating to a clear ointment with a specific gravity of 1.10-1.15 at 65°C, adding an appropriate amount of soft material of dextrin and sucrose, making a wet granule, passing through 80 mesh sieve, drying, sizing, sieving, bagging and packaging.

The preparation method of the above oral preparations as capsules is as follows: weigh the above components of traditional Chinese medicine according to the above proportions and pulverize them into coarse powder; Wrap with gauze and boil twice, add 8 times the amount of water for the first boil and soak for 4 hours; Boiling for 2 hours, filtering, adding 4 times the amount of water for the second boiling, boiling for 2 hours, combining the decoction and filtering; 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, pulverizing into medium powder, adding an appropriate amount of excipients, mixing evenly and filling into capsules.

The manufacturing process of the above oral preparations as tablets is as follows: weigh the above components of traditional Chinese medicine according to the above proportions and pulverize into coarse powder; Wrapping with gauze and boiling twice, adding 8 times the amount of water for the first boiling and soaking for 4 hours; Boil for 2 hours, filter; Adding 4 times the amount of water for the second decoction, decoction for 2 hours, combining the decoction and filtering; 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, pulverizing into medium powder, adding an appropriate amount of excipients, compressing and coating.

Traditional Chinese medicine believes that this disease is characterized by the body's yang and heat cloaked in moisture. It is caused by humidity and heat. It burns the veins and spills over onto the skin to form purpura; if it accumulates in the colon, it causes abdominal pain and blood in the stool; joint swelling and pain. The prescription of the present invention is strict, the medication is simplified, and the combination is reasonable. The whole recipe has the effect of eliminating heat and detoxifying, cooling the blood and eliminating stains, eliminating congestion and relieving pain. It has dialectical administration for allergic purpura, especially wind-heat type allergic purpura, and has strong targeted efficacy. After verification of clinical use, the curative effect is unequivocal, the drug property is mild, there are no toxic side effects and adverse reactions, and the safety factor is high.

The invention also relates to the use of the above 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 of 90 patients in the treatment group was significantly better than the control group, and by comparing the treatment group and the control group a, it can be seen that the traditional Chinese medicine composition of the present invention has a strict prescription. Changing the prescription has a major impact on the therapeutic effect. In addition, the vital parameters of the treatment group are stable and no serious adverse reactions such as allergies occur during treatment. After the treatment, the blood, urine and electrocardiogram of the patients in the treatment group were statistically evaluated and there were no obvious abnormalities. The results show that the clinical use of this recipe is safe and effective and worth 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. Modifications, combinations or substitutions of the present invention within the scope of the present invention or without departing from the spirit, spirit and scope of the present invention will be obvious to those skilled in the art and fall within the scope of the present invention.

Example 1. Granules

The raw materials of the present invention are weighed according to the following parts by weight: 13 parts Flos farfarae, 14 parts Radix Stemonae, 16 parts Aster tataricus, 7 parts Angelica sinensis, 5 parts Sophora flavescens, 11 parts Cortex Moutan, 17 parts Panax notoginseng, 14 parts Astragalus .

• Abwiegen der oben genannten Komponenten der traditionellen chinesischen Medizin entsprechend den oben genannten Proportionen und Pulverisieren zu einem groben Pulver; Einwickeln mit Gaze und zweimaliges Auskochen, Hinzufügen der 8-fachen Menge an Wasser für das erste Auskochen und 4 Stunden langes Einweichen; 2 Stunden langes Auskochen, Filtern; Hinzufügen der 4-fachen Menge an Wasser für das zweite Auskochen, Sie 2 Stunden langes Auskochen, Kombinieren der Dekokt und Filtern; Konzentrieren zu einer klaren Salbe mit einer relativen Dichte von 1.10-1,15 bei 65 °C, Hinzufügen einer angemessenen Menge an weichem Material aus Dextrin und Saccharose, Herstellen eines nassen Granulates, Passieren durch 80 Mesh-Sieb, Trocknen, Schlichten, Sieben, Beuteln und Verpacken.

The preparation method is as follows:

• Weighing the above components of traditional Chinese medicine according to the above proportions and pulverizing into a coarse powder; Wrapping with gauze and boiling twice, adding 8 times the amount of water for the first boiling and soaking for 4 hours; Boil for 2 hours, filter; Adding 4 times the amount of water for the second decoction, decoction for 2 hours, combining the decoction and filtering; Concentrating to a clear ointment with a specific gravity of 1.10-1.15 at 65°C, adding an appropriate amount of soft material of dextrin and sucrose, making a wet granule, passing through 80 mesh sieve, drying, sizing, sieving, bagging and packaging.

When the drug of the present invention is used for the treatment of allergic purpura, the prepared granules are taken as follows: each granule contains 0.5 g of raw drug, 2 times a day, 1 granule each time, and half an hour after meals.

Example 2. Capsules

The raw materials of the present invention are weighed according to the following parts by weight: 13 parts Flos farfarae, 14 parts Radix Stemonae, 16 parts Aster tataricus, 7 parts Angelica sinensis, 5 parts Sophora flavescens, 11 parts Cortex Moutan, 17 parts Panax notoginseng, 14 parts Astragalus .

• Abwiegen der oben genannten Komponenten der traditionellen chinesischen Medizin entsprechend den oben genannten Anteilen und Pulverisieren zu grobem Pulver; Einwickeln mit Gaze und zweimaliges Auskochen, Hinzufügen der 8-fachen Menge Wasser für die erste Abkochung und 4 Stunden langes Einweichen; 2 Stunden langes Auskochen, Filtern; Hinzufügen der 4-fachen Menge Wasser für die zweite Abkochung, 2 Stunden langes Auskochen, Kombinieren der Abkochung und Filtern; Konzentrieren zu einer klaren Salbe mit einer relativen Dichte von 1.10-1,15 bei 65 °C, Trocknen bei einer niedrigen Temperatur von 50°C, Pulverisieren zu mittlerem Pulver, Hinzufügen einer angemessenen Menge an Hilfsstoffen, gleichmäßiges Mischen und Abfüllen in Kapseln.

The preparation method is as follows:

• Weighing the above components of traditional Chinese medicine according to the above proportions and pulverizing into coarse powder; Wrapping with gauze and decoction twice, adding 8 times the amount of water for the first decoction and soaking for 4 hours; Boil for 2 hours, filter; Adding 4 times the amount of water for the second decoction, decoction for 2 hours, combining the decoction and filtering; Concentrating into a clear ointment with a relative density of 1.10-1.15 at 65°C, drying at a low temperature of 50°C, pulverizing into medium powder, adding an appropriate amount of excipients, mixing evenly and filling into capsules.

When the drug of the present invention is used for the treatment of allergic purpura, the prepared capsules, each containing 0.2 g of the raw drug, are taken three times a day, 2-3 capsules each, half an hour after meals.

Example 3. Tablets

The raw materials of the present invention are weighed according to the following parts by weight: 13 parts Flos farfarae, 14 parts Radix Stemonae, 16 parts Aster tataricus, 7 parts Angelica sinensis, 5 parts Sophora flavescens, 11 parts Cortex Moutan, 17 parts Panax notoginseng, 14 parts Astragalus .

• Abwiegen der oben genannten Komponenten der traditionellen chinesischen Medizin nach den oben genannten Proportionen und Pulverisieren zu grobem Pulver; Einwickeln mit Gaze und zweimaliges Auskochen, Hinzufügen der 8-fachen Menge an Wasser für das erste Auskochen, und 4 Stunden langes Ziehenlassen; Auskochen für 2h, Filtern; Hinzufügen der 4-fachen Menge an Wasser für das zweite Auskochen, Auskochen für 2 h, Kombinieren Sie des Dekokts und Filtern; Konzentrat in eine klare Salbe mit einer relativen Dichte von 1.10-1,15 bei 65 °C, Trocknen bei einer niedrigen Temperatur von 50°C, Pulverisieren zu mittlerem Pulver, Hinzufügen einer angemessenen Menge von Hilfsstoffen hinzu, Komprimieren und Beschichten.

The preparation method is as follows:

• Weighing the above components of traditional Chinese medicine according to the above proportions and pulverizing into coarse powder; Wrapping with gauze and boiling twice, adding 8 times the amount of water for the first boiling, and steeping for 4 hours; boil for 2h, filter; Adding 4 times the amount of water for the second off boil, decoction for 2 h, combine the decoction and filter; Concentrate into a clear ointment with a specific gravity of 1.10-1.15 at 65°C, drying at a low temperature of 50°C, pulverizing into medium powder, adding an appropriate amount of excipients, compressing and coating.

When the drug of the present invention is used for the treatment of allergic purpura, the prepared tablets, each containing 0.2 g of the raw drug, are taken three times a day, 2-3 tablets each, half an hour after meals.

Example 4. Granules

The raw materials of the present invention are weighed according to the following parts by weight: 12 parts Flos farfarae, 13 parts Radix Stemonae, 15 parts Aster tataricus, 6 parts Angelica sinensis, 4 parts Sophora flavescens, 10 parts Cortex Moutan, 16 parts Panax notoginseng, 13 parts Astragalus .

The preparation method is the same as in Example 1.

Example 5. Granules

The raw materials of the present invention are weighed according to the following parts by weight: 14 parts Flos farfarae, 15 parts Radix Stemonae, 17 parts Aster tataricus, 8 parts Angelica sinensis, 6 parts Sophora flavescens, 12 parts Cortex Moutan, 18 parts Panax notoginseng, 15 parts Astragalus .

The preparation method is the same as in Example 1.

Example 6. Granules

The raw materials of the present invention are weighed according to the following parts by weight: 13 parts Flos farfarae, 14 parts Radix Stemonae, 16 parts Aster tataricus, 7 parts Angelica sinensis, 5 parts Sophora flavescens, 11 parts Cortex Moutan, 14 parts Astragalus.

The preparation method is the same as in Example 1.

1. 1. Allgemeine Informationen über den Fall:
   • Es wurden 90 Patienten ausgewählt, bei denen im Krankenhaus eine allergische Purpura vom Wind-Hitze-Typ diagnostiziert wurde, darunter 51 Männer und 39 Frauen im Alter von 4 bis 55 Jahren, mit einem Durchschnittsalter von 38,2 Jahren, einem Krankheitsverlauf von 6 bis 50 Tagen und einem durchschnittlichen Krankheitsverlauf von 14,5 Tagen. Die Patienten hatten einen purpurnen Hautausschlag, der häufiger an beiden unteren Gliedmaßen und am Gesäß auftrag. Der Ausschlag war höher als die Haut und verblasste nicht unter Druck. Es gab 22 Fälle mit unterschiedlich starken gastrointestinalen Symptomen, meist paroxysmale Schmerzen oder Koliken, und 24 Fälle mit unterschiedlich starken Gelenkschwellungen und -schmerzen. Die Patienten wurden nach dem Zufallsprinzip in eine Behandlungsgruppe, eine Kontrollgruppe a und eine Kontrollgruppe b mit jeweils 30 Fällen eingeteilt. Die drei Gruppen wiesen keine statistisch signifikanten Unterschiede in Bezug auf Alter, Zustand und Krankheitsverlauf auf (P>0,05) und waren vergleichbar.
2. 2. Behandlungsmethoden:
   • Behandlungsgruppe 1: Einnahme des in Beispiel 1 der vorliegenden Erfindung hergestellten Granulates, wobei jedes Granulat 0,5 g Rohdroge enthält, zweimal täglich oral, jeweils 1 Granulat, und Einnahme desselben eine halbe Stunde nach den Mahlzeiten.
   • Kontrollgruppe a: Gemäß der konventionellen Behandlung der westlichen Medizin wurden Loratadin 5 mg oral, einmal täglich, Cimetidin 20 mg/kg/d intravenös in zwei geteilten Dosen verabreicht und gleichzeitig Vitamin C Calcium gegeben. In schweren Fällen wurde ein Hormon der Nebennierenrinde verabreicht, und wer mit Bakterien oder Viren infiziert war, erhielt eine antiinfektiöse Behandlung.
   • Alle oben genannten Behandlungen waren zweiwöchige Therapien. Die heilende Wirkung wurde nach zwei Behandlungstherapien beobachtet.
3. 3. Der Bewertungsmaßstab für die Heilwirkung bezieht sich auf die einschlägigen Standards der „Standards für die Diagnose und Heilwirkung von Krankheiten und Syndromen der traditionellen chinesischen Medizin“:
   • Geheilt: Nach einer 4-wöchigen Behandlung sind die klinischen Symptome vollständig verschwunden, und es treten keine neuen purpurnen Hautveränderungen auf.
   • Signifikant wirksam: Nach vierwöchiger Behandlung waren die klinischen Symptome des Kindes deutlich reduziert, und die Hautläsionen bildeten sich um ≥70 % zurück.
   • Wirksam: Nach einer 4-wöchigen Behandlung sind die klinischen Symptome gelindert, und die Hautläsionen sind um ≥70 % zurückgegangen.
   • Unwirksam: Die klinischen Symptome der Kinder haben sich nach 4 Wochen Behandlung nicht gebessert oder verschlechtert.
   • Die Gesamtzahl der geheilten, signifikant wirksamen und wirksamen Fälle ist die Gesamtwirkungsrate.
4. 4. Nachbereitung:
   • Alle Patienten in dieser Studie wurden 1-6 Monate lang nachbeobachtet.
5. 5. Statistische Verarbeitung: Verwendung der Software SPSS13.0 für die statistische Verarbeitung, P<0,05 bedeutet, dass der Unterschied statistisch signifikant ist. Verwendet wurde der t-Test für die Zählung der Daten. Die Varianzanalyse wurde für den Vergleich von Mengen zwischen mehreren Gruppen verwendet, und der x2-Test wurde für den Vergleich von Raten verwendet.
6. 6. Therapeutische Wirkung:
   • Während des klinischen Beobachtungsprozesses schlossen alle 90 Patienten ohne Shedding die klinische Beobachtung ab. Der Vergleich der heilenden Wirkung zwischen den beiden Gruppen ist in der nachstehenden Tabelle dargestellt.

Gruppe n geheilt deutlich wirksam wirksam unwirksam Gesamtwirkungsgrad Behandlungsgruppe 30 11 10 7 2 93,3% Kontrollgruppe 30 4 8 10 8 73,3% Clinical observation on the treatment of wind-heat type allergic purpura with the pharmaceutical composition of the present invention

1. 1. General information about the case:
   • 90 patients were selected who were diagnosed with wind-heat allergic purpura in the hospital, including 51 men and 39 women, aged 4 to 55 years, with an average age of 38.2 years, a course of the disease from 6 to 50 days and an average course of the disease of 14.5 days. Patients had a purplish rash that was more common on both lower limbs and buttocks. The rash was higher than the skin and did not fade under pressure. There were 22 cases with varying degrees of gastrointestinal symptoms, mostly paroxysmal pain or colic, and 24 cases with varying degrees of joint swelling and pain. The patients were randomly divided into a treatment group, a control group a and a control group b, each with 30 cases. The three groups had no statistically significant differences in age, condition, and disease progression (P>0.05) and were comparable.
2. 2. Treatment methods:
   • Treatment Group 1: Taking the granules prepared in Example 1 of the present invention, each granule containing 0.5 g of the raw drug, orally twice a day, 1 granule each, and taking it half an hour after meals.
   • Control group a: According to the conventional treatment of Western medicine, loratadine 5 mg orally once a day, cimetidine 20 mg/kg/d intravenously in two divided doses were administered, and vitamin C calcium was given at the same time. In severe cases, an adrenal cortex hormone was given, and those infected with bacteria or viruses received anti-infective treatment.
   • All of the above treatments were two-week regimens. The healing effect was observed after two treatment therapies.
3. 3. The evaluation standard for the curative effect refers to the relevant standards of the “Standards for the diagnosis and curative effect of diseases and syndromes of traditional Chinese medicine”:
   • Healed: After 4 weeks of treatment, the clinical symptoms have completely disappeared and no new purplish lesions appear.
   • Significantly effective: After 4 weeks of treatment, the child's clinical symptoms were significantly reduced and the skin lesions regressed by ≥70%.
   • Effective: After 4 weeks of treatment, clinical signs are reduced and skin lesions are reduced by ≥70%.
   • Ineffective: The children's clinical symptoms have not improved or worsened after 4 weeks of treatment.
   • The total number of cured, significantly effective and effective cases is the overall effectiveness rate.
4. 4. Follow-up:
   • All patients in this study were followed up for 1-6 months.
5. 5. Statistical processing: Using SPSS13.0 software for statistical processing, P<0.05 means the difference is statistically significant. The t-test was used to count the data. Analysis of variance was used for comparing amounts between multiple groups, and the x2 test was used for comparing rates.
6. 6. Therapeutic Effect:
   • During the clinical observation process, all 90 patients completed clinical observation without shedding. The comparison of the curative effect between the two groups is shown in the table below.

group n healed clearly effective effective ineffective overall efficiency 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 over 90%.

From the above table, it can be seen that the treatment effect of the treatment group is significantly better than that of the control group, P<0.05, there is a significant difference. Also, by comparing the treatment group and the control group, it can be known that the traditional Chinese medicinal composition of the present invention has a strict prescription, and the treatment group is significantly better than the control group, and there is a significant difference. At the same time, the laboratory indicators of the treatment group, such as blood and urine tests and the electrocardiogram, were statistically evaluated, and no obvious abnormalities were found. The results show that the clinical use of this recipe is safe and effective and worth further research and dissemination.

Claims (6)

Traditional Chinese medicine composition, characterized in that the traditional Chinese medicine composition is made of the following raw materials in parts by weight: 12-14 parts Flos farfarae, 13-15 parts Radix Stemonae, 15-17 parts Aster tataricus, 6-8 parts Angelica sinensis, 4-6 parts Sophora flavescens, 10-12 parts Cortex Moutan, 16-18 parts Panax notoginseng, 13-15 parts Astragalus. Composition according to traditional Chinese medicine claim 1 , characterized in that the composition of traditional Chinese medicine is prepared from the following raw materials in parts by weight: 13 parts Caulis Ionicerae, 14 parts Radix Stemonae, 16 parts Aster tataricus, 7 parts Angelica sinensis, 5 parts Sophora flavescens, 11 parts Cortex Moutan, 17 parts Panax notoginseng, 14 parts 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. The composition according to traditional Chinese medicine claim 3 characterized in that the manufacturing process of the granules is as follows: weighing the above components of traditional Chinese medicine according to the above proportions and pulverizing into coarse powder; Wrapping with gauze and boiling twice, adding 8 times the amount of water for the first boiling and soaking for 4 hours; Boil for 2 hours, filter; Adding 4 times the amount of water for the second decoction, decoction for 2 hours, combining decoction and filtering; Concentrating to a clear ointment with a specific gravity of 1.10-1.15 at 65°C, adding an appropriate amount of soft material of dextrin and sucrose, making a wet granule, sieving through 80 mesh sieve, drying, sizing, sieving , bagging and packaging. Using the composition of traditional Chinese medicine according to claim 1 or 2 in the manufacture of medicines for the treatment of allergic purpura of the wind-heat type.