CN101327302A - Chuanxiong tea tune soft capsule and its preparation method - Google Patents

Abstract

Chuanxiong Chatiao Soft Capsule and its preparation method. In modern medicine, "Chuanxiong Chatiao San" and its improved prescriptions are made into tablets, capsules, oral liquids, etc., which cannot achieve the efficacy of the original dosage form. The preparation method of Chuanxiong Chatiao Soft Capsules, put Chuanxiong, Chishao, Gastrodia elata, Notopterygium, Angelica dahurica, Asarum, chrysanthemum, mint, Fangfeng, tea leaves, licorice, Nepeta into a traditional Chinese medicine extraction tank by weight, add water to soak, and decoct three times; At the same time, the volatile oil is collected, combined with the water decoction extract and centrifugally filtered; the filtrate is concentrated under reduced pressure, spray-dried and crushed to less than 120 mesh; the extracted volatile oil is dissolved in a certain amount of edible oil, and the dry extract powder is mixed with the edible oil Mixing, the dry extract powder accounts for 20-50% of the mass of the oil base in the soft capsule, grinding the mixture with a colloid mill; adding pigmented gelatin as the capsule material to make the core extract oil base liquid, and pressing it into a soft capsule under stirring conditions; Soft capsules are obtained by drying, washing pills and drying. This product is used to replace Chuanxiong tea powder.

Description

Chuanxiong tea tune soft capsule and its preparation method

Technical field:

The invention relates to the preparation of a traditional Chinese medicine soft capsule, which is a Chuanxiong chatiao soft capsule and a preparation method thereof.

Background technique:

"Chuanxiong Tea Tiaosan" comes from the ancient medical book "Taiping Huimin Heji Bureau Prescription". Or headache pain. This prescription can disperse wind and cold, light clear and ascend, dredge collaterals and relieve pain. Treat Taiyang Meridian headache (back headache involving the nape), Baizhi cure Yangming Meridian headache (frontal pain); Asarum, Mint, Nepeta, and Fangfeng Xinsan ascend to evacuate upper wind pathogens, and strengthen the wind-relieving and pain-relieving ability of the three main herbs , and also relieve the exterior and become a ministerial drug; licorice and medicine slow the middle and become an adjuvant drug; clear tea can clear the upper part and lower it, so as to prevent the drugs from being too warm and dry, and rise and disperse, so that the rise and fall have a fall, and it is an envoy. The whole prescription can dispel wind and relieve pain, and it is mainly used to treat diseases such as attacking winds, dizziness, hemiplegia, nasal congestion, strong fever, and limb pain.

According to literature reports and ancient medical books, this formula has been clinically proven to be effective and widely used for many years. Most of the treatments are based on clinical syndrome differentiation, adding or subtracting formulas to expand the scope of its clinical application. Clinically, "Chuanxiong Cha Tiao San" has been prescribed Regulate bronchitis, sinusitis, urticaria, trigeminal neuralgia, rheumatoid arthritis and other intractable diseases. It is mainly based on the fact that Chuanxiong tea is used as an agent to evacuate wind-evil, and can cure diseases caused by wind-evil. The onset of wind pathogens has the characteristics of upper disease location, no fixed place, rapid onset, and fickleness. It is believed that sinusitis and trigeminal neuralgia are caused by wind carrying heat evil and clearing the orifices. products. For trigeminal neuralgia, gypsum, gentian, uncaria and other heat-clearing and fire-clearing agents can be added. Rheumatoid arthritis is caused by wind and cold-dampness, so add Chuanwu, Guizhi, Duhuo, Coix Seed, etc. to dispel wind, dispel cold and dehumidify. Urticaria is also caused by pathogenic wind, so silkworm, Kochia chinensis, Sophora flavescens, etc. are added to dispel wind and disperse pathogenic factors to relieve itching.

Due to the outstanding curative effect of "Chuanxiong tea blending powder", it has widely attracted the attention of clinical and scientific research units and enterprises. Aiming at the disadvantages of the original ancient prescription tea, such as inconvenient taking and bad taste, scientific research units and enterprises have successively developed improved traditional Chinese medicine. Dosage forms, such as tablets, capsules, granules, pills, etc. Among them, "Tongtian Oral Liquid" has been included in the "Chinese Pharmacopoeia" and "National Drug Standards" [WS3-014(Z-002)-2001(Z)], and the improved prescription of "Zhengtian Pill" based on this prescription The patented medicine has been widely used clinically, and the curative effect is reflected well.

The prescriptions in the traditional ancient books of "Chuanxiong Tea Blending" are: Chuanxiong, Nepeta, destemmed, four liang each (12g each), Angelica dahurica, notopterygium, licorice, two liang each (6g each), Asarum one liang (3g), Fangfeng removes reed one and two halves (4.5g), mint sees fire eight liang (12g). The usage is to grind the fine powder together, take two qian (6g) per serving, adjust it with green tea after eating, and take it regularly to clear the head. Modern usage: fine powder, each serving, twice a day, mixed with green tea. Most of the prescriptions contain aromatic and resuscitating medicinal materials and volatile active ingredients. The original process reasonably takes into account the complementary and beneficial effects of the medicinal properties of each component, which can basically guarantee the efficacy of the medicine. However, the improved dosage form of "Chuanxiong tea blending powder" developed at present, especially changed to oral liquid, capsule or granular granule, a large number of active ingredients in the original decoction, due to concentration and improved clarity, in the process The increase of alcohol precipitation and filtration process has caused the loss of active ingredients. In addition, it is difficult to retain the volatile oils that have the aroma and resuscitation effect of forsythia and peppermint in medicinal materials such as forsythia and peppermint, which directly affect the curative effect. The different active ingredients make the new dosage form of "Chuanxiong Cha Tiaosan" unable to fully achieve the efficacy of the original dosage form.

Invention content:

The object of the present invention is to provide a Chuanxiong Chatiao Soft Capsule, which is prepared by improving the ancient prescription "Chuanxiong Chatiao San" into a modern Chinese medicine new dosage form "soft capsule" and a preparation method thereof.

Above-mentioned purpose realizes by following technical scheme:

Chuanxiong Chatiao Soft Capsules, the composition includes: Chuanxiong, the ratio of parts by weight is: 5-200 parts of Chuanxiong, 1-100 parts of Chishao, 1-50 parts of Gastrodia elata, 5-100 parts of notopterygium, 5-100 parts of Angelica dahurica, 5-50 parts of pungent, 1-100 parts of chrysanthemum, 5-100 parts of mint, 5-30 parts of windproof, 5-100 parts of tea, 5-50 parts of licorice, 5-100 parts of Nepeta, made into soft capsules.

The preparation method of the Chuanxiong Chatiao Soft Capsules is to take the Chinese medicinal materials according to the above ratio of parts by weight, remove the mud and wash the Chinese medicinal materials, put them into a multifunctional Chinese medicine extraction tank, extract them, and centrifugally filter them; Concentrate under reduced pressure at 80°C to a relative density of 1.05-1.10, then spray dry it into a dry extract powder and pulverize it so that the fineness is less than 120 mesh; dissolve or emulsify the extracted volatile oil in edible oil, and The dry extract powder is mixed with edible oil dissolved with extracted volatile oil, the dry extract powder accounts for 20-50% of the oil base mass in the soft capsule, and then the mixture is homogeneously ground with a colloid mill; to add brown or red opaque pigment 0.5-5% gelatin is used as the capsule material to make capsule core extract oil matrix liquid, and the capsule core extract oil matrix is hydraulically made into soft capsules under the condition of stirring at 50-80°C; soft capsules are obtained by drying, washing pills, and drying .

The preparation method of the Chuanxiong Chatiao Soft Capsules, the extraction is as follows: soak the Chinese medicine in the above-mentioned Chinese medicine tank with water for 1-2 hours, decoct three times, the first time is 1-2 hours, the second time, the third time The times are 1-1.5 hours respectively; at the same time, the volatile oil is collected and the decoction extract is combined.

This technical solution has the following beneficial effects:

1. The invention mainly adopts the prescription of "Chuanxiong tea blending powder", re-determines the dosage of active ingredients according to the processing technology, follows the curative effect characteristics of the original prescription to the greatest extent, adopts the most advanced modern Chinese medicine soft capsule dosage form and technology, due to the production The process does not involve the issue of clarity, retains the functional ingredients of the original dosage form as much as possible, and dissolves all the extracted volatile oil in the oily base, collects the volatile oil during the extraction process, and adds it to the soft capsule scientifically and rationally. It is also homogeneously emulsified with the extracted extracts of other medicines, and contained in the opaque capsule material of soft capsules, so that the active ingredients are completely reasonable, cover the smell of traditional Chinese medicine, and make things convenient for patients.

2. Compared with the original decoction and improved oral liquid and hard capsules, the soft capsules prepared by this technology are not only convenient to take, but also isolated from the influence of external factors such as light, humidity and heat, so that the quality stability has been improved. Improve the curative effect, reduce the extraction process, reduce the cost, and improve the economic benefits. In addition, the soft capsule dosage form is a new dosage form of modern medicine. Through the external quality, it has changed the disadvantages of traditional Chinese medicine. The quality of Chinese medicine has been improved. The improvement has created the possibility for Chinese medicine to go to the world.

3. The pharmacological and toxicological experiments of the "Chuanxiong Chatiao Soft Capsule" produced by this technology show that it is a medicine with low toxicity and no obvious side effects on the body. The experimental research is as follows:

(1) Acute toxicity test:

Determination of oral median lethal dose (LD ₅₀ ) in mice: 50 Kunming mice, weighing 18-22 g/mouse, were randomly divided into 5 groups, 10 in each group. After fasting for 10 hours before the test, take the medicinal liquid in the capsule of "Chuanxiong Chatiao Soft Capsule" once a day, orally orally. Observed for 1 week after administration, and recorded the symptoms of poisoning and death of the animals. _LD50 was calculated based on animal death.

Determination of the maximum tolerated dose (MTD) once a day: take 20 Kunming mice, each weighing 18-22g. The maximum concentration (crude drug 1g/mL) and the maximum volume tolerated by mice (0.05mL/g) of the drug solution in the "Chuanxiong Chatiao Soft Capsule" capsule can be intragastrically administered once. Thereafter, the observation continued for 7 days, during which the mice were allowed to eat and drink freely

(2) Subacute toxicity test test method:

60 female Wistar rats, weighing 120-150g/rat, were randomly divided into 4 groups after pre-feeding for 5 days, with 15 rats in each group. Group I was the control group, and groups II, III, and IV were medication groups. The medication group was fed with 1/10 MTD, 1/3 MTD and MTD doses respectively for 60 days; the control group was given the same dose of purified water.

Detection indicators: Observe and record the mental state, eating activities, and defecation of the animals every day, and weigh them once a week. Before administration and after the end of the experiment, blood was collected from the tail of the rats, and the whole blood was used for blood routine examination, and the serum was used for biochemical index detection. After the test was over, the animals were dissected, and the lesions of each tissue and organ were observed with the naked eye; the wet weight of the main organs (heart, liver, spleen, lung, kidney) was taken, and the organ coefficient of each organ was calculated (organ coefficient = Wet weight of organs/body weight×100).

test results

Acute toxicity test: Since the half-lethal dose of the mouse was not measured, the maximum tolerated dose of the mouse was measured once a day. The maximum tolerated dose of the mice was 50g/kg once a day orally, and no animal died within 7 days, and the mice had normal food intake, weight gain, shiny and soft coat, no loose stools or other abnormalities. The maximum tolerated dose in mice is equivalent to 139 times the clinical dose (0.36g/kg). It shows that "Chuanxiong Chatiao Soft Capsule" is a relatively safe medicine.

Subacute toxicity test: General situation: During the test period, no abnormalities were found in rat activity, appetite, coat color and feces and urine. The analysis of variance showed that the growth and development of the animals in each medication group had no significant difference compared with the control group (P>0.05). It shows that "Chuanxiong Chatiao Soft Capsule" has no adverse effect on the growth and development of rats. The weight gain of rats in each group is shown in Table 1.

Table 1 Effect of "Chuanxiong Chatiao Soft Capsule" on weight gain of rats (.X±S)

The effects of "Chuanxiong Chatiao Soft Capsule" on the blood routine and serum biochemical indexes of rats are shown in Table 2 and Table 3 respectively. There was no significant difference between the blood routine and serum biochemical indexes of rats in each group (P>0.05). It shows that "Chuanxiong Chatiao Soft Capsule" has no adverse effects on various blood cells, liver function and kidney function.

Table 2 Effect of "Chuanxiong Chatiao Soft Capsule" on blood routine indicators in rats (.X±S)

Table 3 Effect of "Chuanxiong Chatiao Soft Capsule" on serum biochemical indicators of rats (.X±S)

Table 4 The effect of "Chuanxiong Chatiao Soft Capsule" on the organ coefficient of rats (X±S)

The effect of "Chuanxiong Chatiao Soft Capsule" on the organ coefficient of rats is shown in Table 4. There is no significant difference between the organ coefficients of rats in each group (P>0.05). It shows that "Chuanxiong Chatiao Soft Capsule" has no damage to the main parenchymal organs of rats.

The maximum tolerated dose of "Chuanxiong Chatiao Soft Capsule" administered to mice is 50g/kg. Blood routine test shows that "Chuanxiong Chatiao Soft Capsule" has no adverse effect on various blood cells and bone marrow hematopoietic function of rats; tests on alkaline phosphatase, aspartate aminotransferase, total protein, albumin and creatinine in serum show that " Chuanxiong Tea Tiao Soft Capsules had no effect on the liver function of rats; the level of serum urea nitrogen is an important indicator reflecting renal function, and the test results showed that it changed within the normal range, and there was no abnormality in renal function, indicating that there was no adverse effect on renal function . Organ coefficient is a sensitive and effective indicator in toxicology to reflect the degree of damage to certain organs by the test substance. The results show that "Chuanxiong Chatiao Soft Capsule" has no harmful effect on heart, liver, spleen, lung and kidney and other substantial organs . The test results show that "Chuanxiong Chatiao Soft Capsule" has relatively low toxicity, which can ensure safe clinical use.

4. The "Chuanxiong Tea Tiao Soft Capsule" produced by this technology has a more significant curative effect than the "Chuanxiong Tea Tiao San" produced by the existing technology and the products of increasing and decreasing formulas. Animal pharmacology and pharmacodynamics tests show that: "Chuanxiong Tea Tiao Soft Capsule" can significantly improve the biochemical indicators of hemorheology in the pathological model of "blood stasis" in rats, and significantly reduce the number of writhing pain reactions in mice. Some pharmacological indicators It is significantly better than the new dosage form of "Chuanxiong Chatiao San" "Tongtian Oral Liquid", which shows that "Chuanxiong Chatiao Soft Capsules" can treat central headaches caused by vascular cavities and blood rheological lesions, which is what Chinese medicine says. Blood stasis headache has obvious therapeutic effect. The experimental results provide a strong theoretical basis for the clinical use of "Chuanxiong Chatiao Soft Capsule" for headache. The experimental research is as follows:

1. Test materials

1.1 Drugs and instruments

"Chuanxiong Tea Tiao Soft Capsule": Homemade (batch number: 20060202)

Taiji Tongtian Oral Liquid: Sichuan Taiji Pharmaceutical Co., Ltd. (batch number: 20060729)

Heparin sodium injection: Nanjing Xinbai Pharmaceutical Co., Ltd. (batch number: 20060518)

Epinephrine hydrochloride injection: Tianjin Jinyao Amino Acid Co., Ltd. (batch number: 0607211)

Nimodipine Tablets: Yunnan Dianbei Pharmaceutical Co., Ltd. (batch number: 0607211)

Automatic hemorheology detector: Chongqing Saihang Technology Development Co., Ltd. (Model: SH210A automatic hemorheology instrument)

1.2 Animals

Wistar rats, half male and half female, weighing 250-350 g: Kunming mice, half male and half male, weighing 18-22 g, provided by the animal room of Harbin Pharmaceutical Group General Pharmaceutical Factory.

2. Methods and conclusions:

2.1 Effect of "Chuanxiong Chatiao Soft Capsule" on the hemorheology of rats

2.1.1 Test group administration method and dosage

Normal animal blank control group: 15 rats, intragastrically administered with purified water 5ml/rat, tid, 7d.

"Chuanxiong Chatiao Soft Capsule" high-dose group: 15 rats, 100mg.kg-1 calculated according to crude drug amount, tid, 7d.

"Chuanxiong Chatiao Soft Capsule" medium-dose group: 15 rats, 55 mg.kg-1 calculated according to crude drug amount, tid, 7d.

"Chuanxiong Chatiao Soft Capsule" low-dose group: 15 rats, 10 mg.kg-1 calculated according to crude drug amount, tid, 7d.

Pathological model group: 15 rats, intragastrically administered with purified water 5ml/rat, tid, 7d.

Positive control drug (nimodipine) group: 20mg.kg-1, tid, 7d.

Tongtian oral liquid group: 1ml.kg-1, tid, 7d.

2.1.2 Test methods and results.

All groups in the test stopped feeding and feeding on the seventh day.

"Chuanxiong Chatiao Soft Capsule" high, medium and low dose groups, pathological model group, Tongtian Oral Liquid group, and positive control group received subcutaneous injection of epinephrine hydrochloride injection 0.08ml/100g on the seventh day, once every 4 hours, for two days in total. The second time, during which the rats were immersed in ice water for 5 minutes, and the feeding was stopped until the second day. The rats in each group and the control group were cut off each stem to take blood, and the rats were shaken evenly in a beaker with a small amount of heparin sodium. Determination of hemorheological parameters. The results are shown in Table 5.

2.1.3 Discussion

a. There are significant differences between the biochemical indicators of each test group and the control group. The results of the positive control group and the pathological model group are true and accurate, and the whole experiment is scientific and reasonable.

b. From the experimental results, it can be seen that the "Chuanxiong Chatiao Soft Capsules" high, medium and low dose groups, positive control group, control group, and Tongtian Oral Liquid group are all different from the pathological model group in plasma viscosity, whole blood viscosity, medium, and There were significant differences in low shear value, whole blood reduced viscosity, hematocrit and other biochemical indicators.

c. The Tongtian oral liquid group and the "Chuanxiong Chatiao Soft Capsules" high, medium and low dose groups can significantly improve the blood biochemical indicators of rats, and there is no significant difference with the "Chuanxiong Chatiao Soft Capsules" low-dose group (P> 0.05)

Table 5 Comparison of the effects of "Chuanxiong Chatiao Soft Capsule" and Tongtian Oral Liquid on the hemorheology of rats

Note: Compared with the control group, ▲P<0.01, ▲▲P<0.05, compared with the pathological model group *P<0.01, **P<0.05

2.2 Comparison of the analgesic effect of "Chuanxiong Chatiao Soft Capsule" and Tongtian Oral Liquid by writhing method

2.2.1 Test group administration method and dosage

Normal animal blank control group: 15 rats, intragastrically administered with purified water 5ml/rat, tid, 7d.

"Chuanxiong Chatiao Soft Capsules" high-dose group: 15 rats, 0.96mg.kg-1 based on crude drug amount, tid, 7d.

"Chuanxiong Chatiao Soft Capsules" medium-dose group: 15 rats, 0.48mg.kg-1 based on the crude drug amount, tid, 7d.

"Chuanxiong Chatiao Soft Capsules" low-dose group: 15 rats, 0.24mg.kg-1 based on crude drug amount, tid, 7d.

Pathological model group: 15 rats, intragastrically administered with purified water 5ml/rat, tid, 7d.

Positive control drug (morphine) group: intragastric administration of purified water 5ml/rat, tid, 7d later. Inject 0.018mg.kg-1 intraperitoneally.

Tongtian oral liquid group: 0.9ml.kg-1, tid, 7d.

2.2.2 Test methods and results.

The control group was intraperitoneally injected with 0.2ml/normal saline

In addition, 0.2ml/mouse of 0.5% acetic acid was injected intraperitoneally in each group of other experiments, and the times of writhing reactions of mice in each group were observed immediately within 15 minutes, and statistically compared. The results are shown in Table 6.

2.2.3 Discussion:

a. There are significant differences in the number of writhing reactions of the mice in each test group and the control group. The results of the positive control group and the pathological model group are true and accurate, and the whole experiment is scientific and reasonable.

b. From the experimental results, it can be seen that the high, medium and low dose groups of "Chuanxiong Chatiao Soft Capsule", positive control group, control group, Tongtian Oral Liquid group and pathological model group have significant differences in the number of writhing reactions in mice .

c. Tongtian oral liquid group and "Chuanxiong Chatiao Soft Capsule" high, medium and low dose groups can significantly improve the number of writhing mice, and there is no significant difference with the "Chuanxiong Chatiao Soft Capsule" low-dose group (P> 0.05)

Table 6 Comparison of the analgesic effect of "Chuanxiong Chatiao Soft Capsule" and Tongtian Oral Liquid on mice (x±s, n=15)

Note: Compared with the control group, ▲P＜0.01

5. The traditional Chinese medicine soft capsule dosage form produced by this process technology uses the original traditional water decoction process in the extraction process, which reduces the process of alcohol precipitation, extraction and concentration of existing oral liquids, tablets, and granules, and reduces the cost. The extraction process alone reduces the cost by nearly 10%.

6. Compared with the improved dosage form of "Chuanxiong Tea Tiaosan" "Tongtian Oral Liquid" which is widely used in clinical practice, the soft capsule produced by this technology is not only convenient to take and carry, but also reduces the packaging cost, only the oral liquid bottle is one item , the daily dose reduces the direct cost by nearly 0.3 yuan. Moreover, the appearance quality has been improved, the quality of traditional Chinese medicine products has been improved, and it has reached the international level.

The specific embodiment of the present invention:

Example 1:

A preparation method of "Chuanxiong Chatiao Soft Capsule", which comprises: firstly weighing various traditional Chinese medicines according to weight ratio, including 200 parts of Chuanxiong, 100 parts of Radix Paeoniae Rubra, 50 parts of Gastrodia elata, 100 parts of notopterygium, 100 parts of Angelica dahurica, 50 parts of pepper, 100 parts of chrysanthemum, 100 parts of mint, 30 parts of windproof, 100 parts of tea, 50 parts of licorice, remove the mud and wash them, put them into a multi-functional Chinese medicine extraction tank, add water and decoct three times, the first time 1- 2 hours, 1-1.5 hours for the second time and the third time respectively; at the same time, collect the volatile oil, combine the decoction liquid extract, and centrifugal filter; concentrate the filtrate under reduced pressure at 60°C to a relative density of 1.05, and then Spray drying to become dry extract powder and pulverize to make it finer than 120 mesh; dissolve the extracted volatile oil in a certain amount of edible oil, mix the dry extract powder with the edible oil in which the extracted volatile oil is dissolved, and dry soak The cream powder accounts for 20-50% of the mass of the oil base in the soft capsule, and then the mixture is homogeneously ground with a colloid mill; the gelatin with added pigment is used as the capsule material to make the oil base liquid of the capsule core extract, and it is mixed under the condition of stirring at 70°C. 100-500 soft capsules are made by hydraulic pressure of the capsule core extract oil matrix; the soft capsules are made by drying, washing pills and drying.

Example 2:

A preparation method of "Chuanxiong Chatiao Soft Capsule", which comprises: firstly weighing various traditional Chinese medicines according to the weight ratio, including 127 parts of Chuanxiong, 53 parts of Radix Paeoniae Rubra, 21 parts of Gastrodia elata, 42 parts of notopterygium, 42 parts of Angelica dahurica, 10 parts of pungent, 53 parts of chrysanthemum, 84 parts of mint, 15 parts of windproof, 63 parts of tea, 21 parts of licorice, etc., remove the mud and wash them, put them in a multi-functional Chinese medicine extraction tank, add water and decoct three times, the first time 1 -2 hours, 1-1.5 hours for the second time and the third time respectively; at the same time, collect the volatile oil, combine the water decoction extract, and centrifugal filter; concentrate the filtrate under reduced pressure at 60°C to a relative density of 1.05, and then It is spray-dried to become dry extract powder and pulverized so that the fineness is less than 120 meshes; the extracted volatile oil is dissolved in a certain amount of edible oil, and the dry extract powder is mixed with the edible oil dissolved with the extracted volatile oil, and dried The extract powder accounts for 20-50% of the mass of the oil base in the soft capsule, and then the mixture is homogeneously ground with a colloid mill; the gelatin with added pigment is used as the capsule material to make the capsule core extract oil base liquid, and it is stirred at 70°C The capsule core extract oil base is hydraulically made into 100-500 soft capsules; the soft capsules are obtained through drying, pill washing and drying.

Example 3:

The preparation method of "Chuanxiong Chatiao Soft Capsule" described in Example 1: First, weigh each herb by weight, including 127 parts of Chuanxiong, 53 parts of Radix Paeoniae Rubra, 21 parts of Tianma, 42 parts of Notopterygium, 42 parts of Angelica dahurica, 10 parts of asarum, 53 parts of chrysanthemum, 5 parts of mint, 15 parts of windproof, 63 parts of tea, 21 parts of licorice and other Chinese medicinal materials, remove the mud and wash them, put them into a multi-functional traditional Chinese medicine extraction tank, add water and decoct three times, 1-2 hours for one time, 1-1.5 hours for the second time and 1.5 hours for the third time; at the same time, collect the volatile oil, combine the decoction liquid extract, and centrifugal filter; concentrate the filtrate under reduced pressure at 60°C to a relative density of 1.05 , and then spray-dry it into dry extract powder and pulverize it so that the fineness is less than 120 mesh; crush aromatic Chinese medicinal materials such as mint leaves into 120 mesh for sealed storage; dissolve the extracted volatile oil in a certain amount of edible oil , mix other aromatic traditional Chinese medicines such as dry extract powder and mint 84 parts with edible oil dissolved in extracted volatile oil, dry extract powder and other dry matter account for 20-50% of the oil-based mass in the soft capsule, and then mix the mixture with colloid Grinding for homogeneous grinding; use gelatin added with pigment as the capsule material to make capsule core extract oil matrix liquid, and hydraulically make capsule core extract oil matrix into 100-500 soft capsules under the condition of stirring at 70 ° C; after drying, Wash the pills and dry to make soft capsules.

Example 4:

The preparation method of "Chuanxiong Chatiao Soft Capsule" described in Example 1: First, weigh each Chinese medicine according to the weight ratio, including 24 parts of Chuanxiong, 24 parts of Schizonepeta, 12 parts of Notopterygium, 12 parts of Angelica dahurica, and 6 parts of Asarum , 9 parts of Fangfeng, 12 parts of licorice, 24 parts of mint, 10-50 parts of tea leaves and other Chinese medicinal materials, remove the mud and wash them, put them into a multi-functional Chinese medicine extraction tank, add water and decoct three times, the first time for 1-2 hours , the second time and the third time are 1-1.5 hours respectively; at the same time, collect the volatile oil, combine the water decoction extract, and centrifugal filter; concentrate the filtrate under reduced pressure at 60°C to a relative density of 1.05, and then spray dry it Become dry extract powder and pulverize to make it finer than 120 mesh; crush mint leaves and other aromatic Chinese herbal medicines into 120 mesh for sealed storage; dissolve the extracted volatile oil in a certain amount of edible oil, and dry extract powder and other aromatic traditional Chinese medicines such as mint 84 are mixed with the edible oil dissolved in the extracted volatile oil, the dry extract powder and other dry matter account for 20-50% of the oil base mass in the soft capsule, and then the mixture is homogeneously ground with a colloid mill; The gelatin with added pigment is used as the capsule material to make the capsule core extract oil matrix liquid, and the capsule core extract oil matrix is hydraulically made into 100-500 soft capsules under the condition of stirring at 70°C; it is obtained by drying, washing pills, and drying Softgels.

Example 5:

A preparation method of "Chuanxiong Chatiao Soft Capsule", which comprises: firstly weighing various traditional Chinese medicines according to the weight ratio, including 127 parts of Chuanxiong, 53 parts of Radix Paeoniae Rubra, 21 parts of Gastrodia elata, 42 parts of notopterygium, 42 parts of Angelica dahurica, 10 parts of pungent, 84 parts of mint, 15 parts of Fangfeng, 63 parts of tea, 21 parts of licorice, etc., remove the mud and wash, put them into a multi-functional Chinese medicine extraction tank, add water and decoct three times, the first time 1-2 hours, The second time and the third time are 1-1.5 hours respectively; at the same time, the volatile oil is collected, the water decoction extract is combined, and centrifugally filtered; the filtrate is concentrated under reduced pressure at 60°C to a relative density of 1.05, and then spray-dried to become The dry extract powder is crushed so that the fineness is less than 120 meshes; the extracted volatile oil is dissolved in a certain amount of edible oil, and the dry extract powder is mixed with the edible oil in which the extracted volatile oil is dissolved. 20-50% of the mass of the oil base in the soft capsule, and then the mixture is homogeneously ground with a colloid mill; the gelatin with added pigment is used as the capsule material to make the capsule core extract oil matrix liquid, and the capsule core is soaked under stirring at 70 ° C. The ointment base is hydraulically made into 100-500 soft capsules; the soft capsules are made by drying, washing pills and drying.

Embodiment 6:

A preparation method of "Chuanxiong Chatiao Soft Capsule", which comprises: first weighing various traditional Chinese medicines in proportion by weight, including 127 parts of Chuanxiong, 53 parts of Radix Paeoniae Rubra, 50 parts of Gastrodia elata, 42 parts of notopterygium, 42 parts of Angelica dahurica, 10 parts of pungent, 53 parts of chrysanthemum, 84 parts of mint, 15 parts of windproof, 63 parts of tea, 21 parts of licorice, etc., remove the mud and wash them, put them in a multi-functional Chinese medicine extraction tank, add water and decoct three times, the first time 1 -2 hours, 1-1.5 hours for the second time and the third time respectively; at the same time, collect the volatile oil, combine the water decoction extract, and centrifugal filter; concentrate the filtrate under reduced pressure at 60°C to a relative density of 1.05, and then It is spray-dried to become dry extract powder and pulverized so that the fineness is less than 120 meshes; the extracted volatile oil is dissolved in a certain amount of edible oil, and the dry extract powder is mixed with the edible oil dissolved with the extracted volatile oil, and dried The extract powder accounts for 20-50% of the mass of the oil base in the soft capsule, and then the mixture is homogeneously ground with a colloid mill; the gelatin with added pigment is used as the capsule material to make the capsule core extract oil base liquid, and it is stirred at 70°C The capsule core extract oil base is hydraulically made into 100-500 soft capsules; the soft capsules are obtained through drying, pill washing and drying.

Embodiment 7:

A preparation method of "Chuanxiong Chatiao Soft Capsule", which comprises: firstly weighing various traditional Chinese medicines according to the weight ratio, including 127 parts of Chuanxiong, 53 parts of Radix Paeoniae Rubra, 21 parts of Gastrodia elata, 42 parts of notopterygium, 42 parts of Angelica dahurica, 10 parts of peppermint, 84 parts of mint, 10 parts of chrysanthemum, 15 parts of Fangfeng, 63 parts of tea, 21 parts of licorice, etc., remove the mud and wash, put them in a multi-functional Chinese medicine extraction tank, add water and decoct three times, the first time 1 -2 hours, 1-1.5 hours for the second time and the third time respectively; at the same time, collect the volatile oil, combine the water decoction extract, and centrifugal filter; concentrate the filtrate under reduced pressure at 60°C to a relative density of 1.05, and then It is spray-dried to become dry extract powder and pulverized so that the fineness is less than 120 meshes; the extracted volatile oil is dissolved in a certain amount of edible oil, and the dry extract powder is mixed with the edible oil dissolved with the extracted volatile oil, and dried The extract powder accounts for 20-50% of the mass of the oil base in the soft capsule, and then the mixture is homogeneously ground with a colloid mill; the gelatin with added pigment is used as the capsule material to make the capsule core extract oil base liquid, and it is stirred at 70°C The capsule core extract oil base is hydraulically made into 100-500 soft capsules; the soft capsules are obtained through drying, pill washing and drying.

Embodiment 8:

A preparation method of "Chuanxiong Chatiao Soft Capsule", which comprises: first weighing various traditional Chinese medicines in proportion by weight, including 127 parts of Chuanxiong, 53 parts of Radix Paeoniae Rubra, 2 parts of Gastrodia elata, 42 parts of Notopterygium, 42 parts of Angelica dahurica, 10 parts of peppermint, 84 parts of mint, 10 parts of chrysanthemum, 15 parts of Fangfeng, 63 parts of tea, 21 parts of licorice, etc., remove the mud and wash, put them in a multi-functional Chinese medicine extraction tank, add water and decoct three times, the first time 1 -2 hours, 1-1.5 hours for the second time and the third time respectively; at the same time, collect the volatile oil, combine the water decoction extract, and centrifugal filter; concentrate the filtrate under reduced pressure at 60°C to a relative density of 1.05, and then It is spray-dried to become dry extract powder and pulverized so that the fineness is less than 120 meshes; the extracted volatile oil is dissolved in a certain amount of edible oil, and the dry extract powder is mixed with the edible oil dissolved with the extracted volatile oil, and dried The extract powder accounts for 20-50% of the mass of the oil base in the soft capsule, and then the mixture is homogeneously ground with a colloid mill; the gelatin with added pigment is used as the capsule material to make the capsule core extract oil base liquid, and it is stirred at 70°C The capsule core extract oil base is hydraulically made into 100-500 soft capsules; the soft capsules are obtained through drying, pill washing and drying.

Claims (3)

1. A Chuanxiong Chatiao Soft Capsule, which consists of: Rhizoma Chuanxiong, characterized in that the ratio of parts by weight is: 5-200 parts of Rhizoma Chuanxiong, 1-100 parts of Radix Paeoniae Rubra, 1-50 parts of Gastrodia elata, and 5-100 parts of Qianghuo , 5-100 parts of Angelica dahurica, 5-50 parts of Asarum, 1-100 parts of chrysanthemum, 5-100 parts of mint, 5-30 parts of Fangfeng, 5-100 parts of tea, 5-50 parts of licorice, 5-100 parts of nepeta , made into soft capsules. 2. a preparation method of Chuanxiong Chatiao Soft Capsules as claimed in claim 1, according to the above ratio of parts by weight, Chinese medicinal materials are taken, and it is characterized in that: Chinese medicinal materials are deslimed and cleaned, put into a multifunctional Chinese medicine extraction tank, Carry out extraction and centrifugal filtration; concentrate the filtrate under reduced pressure at 60-80°C to a relative density of 1.05-1.10, then spray-dry it to dry extract powder and pulverize it so that the fineness is less than 120 mesh; extract the The volatile oil is dissolved or emulsified in edible oil, and the dry extract powder is mixed with the edible oil dissolved with the extracted volatile oil. The dry extract powder accounts for 20-50% of the mass of the oil base in the soft capsule, and then the mixture is homogenized with a colloid mill. Grinding; use 0.5-5% gelatin with brown or red opaque pigment as the capsule material to make capsule core extract oil matrix liquid, and hydraulically make capsule core extract oil matrix into soft capsules under stirring condition at 50-80°C; Soft capsules are obtained by drying, washing pills and drying. 3. the preparation method of Chuanxiong Chatiao Soft Capsules according to claim 2 is characterized in that: the extraction is: soak the Chinese medicine in the above-mentioned Chinese medicine tank with water for 1-2 hours, decoct three times, the first time 1 -2 hours, 1-1.5 hours for the second and third times respectively; at the same time, collect the volatile oil and combine the water decoction extract.