阅读说明：本技术 一种小金胶囊及其制备方法 (Small gold capsule and preparation method thereof ) 是由 赵刚 任霞 余丽花 夏纯 丁全如 于 2019-12-04 设计创作，主要内容包括：本发明涉及中药制剂领域,具体涉及一种小金胶囊及其制备方法。该小金胶囊包括以下重量份的原料：人工麝香8-12g、木鳖子45-55g、制草乌35-42g、枫香脂40-45g、乳香20-30g、没药20-30g、五灵脂45-55g、当归20-30g、地龙45-55g、香墨3-5g。上述小金胶囊的制备方法如下：S1,将除去人工麝香后的其余成分分别粉碎成30-50目粗粉,得到粉碎物；S2,将步骤S1中的粉碎物加入微晶纤维素混合均匀,微晶纤维素的添加量为粉碎物总质量的16-18％；S3,将步骤S2中混合后的原料再次进行粉碎,粉碎成100-150目的细粉；S4,将研磨后的人工麝香加入到步骤S3中的细粉中,混合均匀后,装入胶囊即得。本发明是依据对小金胶囊的药效物质基础的研究,对小金胶囊中的重要组分进行调整优化,制得的小金胶囊的药效更佳。(The invention relates to the field of traditional Chinese medicine preparations, in particular to a small golden capsule and a preparation method thereof. The small gold capsules comprise the following raw materials in parts by weight: 8-12g of artificial musk, 45-55g of momordica cochinchinensis, 35-42g of prepared kusnezoff monkshood root, 40-45g of resina liquidambaris, 20-30g of frankincense, 20-30g of myrrh, 45-55g of trogopterus dung, 20-30g of angelica, 45-55g of earthworm and 3-5g of Chinese ink. The preparation method of the Xiaojin capsule comprises the following steps: s1, respectively pulverizing the rest materials except for artificial Moschus into 30-50 mesh coarse powder to obtain pulverized materials; s2, adding the crushed material in the step S1 into microcrystalline cellulose, and uniformly mixing, wherein the addition amount of the microcrystalline cellulose is 16-18% of the total mass of the crushed material; s3, crushing the raw materials mixed in the step S2 into fine powder of 100 meshes and 150 meshes again; s4, adding the ground artificial musk into the fine powder obtained in the step S3, uniformly mixing, and filling into capsules to obtain the musk capsule. According to the research on the drug effect material basis of the Xiaojin capsule, the invention adjusts and optimizes the important components in the Xiaojin capsule, and the prepared Xiaojin capsule has better drug effect.)

1. The Xiaojin capsule is characterized by comprising the following raw materials in parts by weight: 8-12g of artificial musk, 45-55g of momordica cochinchinensis, 35-42g of prepared kusnezoff monkshood root, 40-45g of resina liquidambaris, 20-30g of frankincense, 20-30g of myrrh, 45-55g of trogopterus dung, 20-30g of angelica, 45-55g of earthworm and 3-5g of Chinese ink.

2. The Xiaojin capsule of claim 1, comprising the following raw materials in parts by weight: 10g of artificial musk, 50g of semen momordicae, 38g of prepared kusnezoff monkshood root, 42g of resina liquidambaris, 25g of vinegar frankincense, 25g of vinegar myrrh, 50g of trogopterus dung, 25g of wine angelica, 50g of earthworm and 4g of fragrant ink.

3. The Xiaojin capsule of claim 1, wherein the processed kusnezoff monkshood root is processed kusnezoff monkshood root, and the processing of the processed kusnezoff monkshood root comprises the following steps: soaking clean radix Aconiti Kusnezoffii Preparata sample in water for 3-7 days, cleaning, adding water until radix Aconiti Kusnezoffii Preparata sample is immersed, decocting for 2-5 hr, taking out, air drying to six days, slicing, and drying.

4. The Xiaojin capsule of claim 3, wherein the processing of the radix aconiti kusnezoffii preparata comprises the following steps: soaking clean radix Aconiti Kusnezoffii Preparata sample in water for 4 days, cleaning, adding water until the radix Aconiti Kusnezoffii Preparata sample is immersed, decocting for 3 hr, taking out, air drying to six dry, slicing, and drying.

5. The Xiaojin capsule of claim 1, wherein the momordicae semen is a processed momordicae semen, and the processing of the momordicae semen comprises the steps of: weighing semen momordicae raw medicinal materials, mixing with fine sand according to the weight ratio of 1: 3, stir-frying in a frying pan at the sand frying temperature of 280 plus 320 ℃ until the green skin of the kernels falls off and changes color, the kernels are golden yellow and have crisp texture.

6. The xiaojin capsule of claim 1, wherein the processing of frankincense comprises the following steps: removing impurities from the raw materials, crushing the large blocks, and sieving with a 4mm sieve; evenly stirring and moistening with 10% of vinegar, putting into an oven after the vinegar is completely absorbed, placing at a thickness of 1cm and a temperature of 100 ℃ and 120 ℃, and baking for 1 h.

7. The xiaojin capsule of claim 1, wherein the processing of myrrh comprises the following steps: putting clean Myrrha in a pan, parching with slow fire until the surface is slightly melted, spraying rice vinegar, parching until the surface is glossy, and cooling.

8. The method for preparing Xiaojin capsules as claimed in claim 1, wherein the processing of angelica sinensis comprises the following steps: cleaning radix Angelicae sinensis, sun drying, mixing with Chinese liquor, soaking, parching with slow fire, and air drying.

9. The method for preparing Xiaojin capsules according to claim 1, comprising the steps of:

s1, pulverizing semen Momordicae, radix Aconiti Kusnezoffii Preparata, resina Liquidambaris, Olibanum, Myrrha, Oletum Trogopterori, radix Angelicae sinensis, Lumbricus, and Chinese ink into 30-50 mesh coarse powder respectively to obtain pulverized material;

s2, adding the crushed material in the step S1 into microcrystalline cellulose, and uniformly mixing, wherein the addition amount of the microcrystalline cellulose is 16-18% of the total mass of the crushed material;

s3, crushing the raw materials mixed in the step S2 into fine powder of 100 meshes and 150 meshes again;

s4, adding the ground artificial musk into the fine powder obtained in the step S3, uniformly mixing, and filling into capsules to obtain the musk capsule.

Technical Field

The invention relates to the field of traditional Chinese medicine preparations, in particular to a small golden capsule and a preparation method thereof.

Background

The Xiaojin capsule is prepared from ten medicines of artificial musk, prepared kusnezoff monkshood root, cochinchina momordica seed, sweetgum resin, frankincense, myrrh, Chinese angelica, trogopterus dung, earthworm and fragrant ink by carrying out modern preparation process improvement on a prescription from the beginning of the famous medical Wanghou Shuichang, and has the effects of dissipating stagnation, reducing swelling, removing blood stasis, relieving pain and the like. The traditional Chinese medicine is used for treating initial carbuncle on yin, unchanged skin color, hard swelling and pain, multiple abscesses, goiter, scrofula, mammary rock and nodules of breast, has very wide modern clinical application, and has the most obvious curative effect on thyroid nodule, hyperplasia of mammary glands, breast cancer, hyperplasia of prostate and the like. The Chinese medicinal composition is popular in the market in clinic due to the advantages of low content of medicinal auxiliary materials, relatively high bioavailability, strong taste masking property, high safety and the like, and becomes a first-choice Chinese patent medicament for patients with breast diseases.

The small golden capsule has complex formula, and various types of single medicine components including rare medicine, botanical medicine, resin medicine, animal excrement medicine and mineral medicine. The recipe is prepared and analyzed by numerous doctors in the later generations, wherein the artificial musk is a monarch drug which has the effects of activating blood and resolving masses, relieving swelling and pain, and inducing resuscitation and restoring consciousness; radix Aconiti Kusnezoffii Preparata has effects of dispelling pathogenic wind, removing dampness, warming channels and relieving pain; resina Liquidambaris has effects of dispelling pathogenic wind, promoting blood circulation, removing toxic substance, relieving pain, stopping bleeding, and promoting granulation; semen Momordicae has effects in dispersing pathogen accumulation, relieving swelling, removing toxic materials, and treating sore; oletum Trogopterori has effects of promoting blood circulation, relieving pain, removing blood stasis, and stopping bleeding; the earthworm clears away heat and calms the endogenous wind, dredges the collaterals, relieves asthma and promotes urination, and the five medicines are combined as ministerial medicines; radix Angelicae sinensis has effects in replenishing blood, promoting blood circulation, regulating menstruation, relieving pain, and moisturizing intestine; olibanum has effects in promoting blood circulation, promoting qi circulation, relieving pain, eliminating swelling, and promoting granulation; the myrrh activates blood circulation and promotes tissue regeneration, and the three medicines are combined as adjuvant medicines; xiang Mo is a guiding drug for astringing to stop bleeding, clearing away heat and toxic materials. Artificial musk, frankincense and sweetgum resin are used for attacking and fixing blood vessels, penetrating to channels and collaterals, and soothing liver-qi stagnation; the Chinese angelica, the Chinese ink, the myrrh and the cochinchina momordica seed have the effects of promoting the circulation of qi, relieving pain, reducing swelling and dissipating stagnation, the kusnezoff monkshood root has the effects of warming and dissipating cold-dampness, and the earthworm breaks blood and removes stasis, thereby achieving the effects of dissipating stagnation, reducing swelling, removing blood stasis and relieving pain. At present, the small gold capsules have obvious curative effect on treating various diseases such as hyperplasia of mammary glands, breast cancer, thyroid nodules and the like in clinic, but due to various medicinal materials and numerous components in the formula, the basic research on system pharmacodynamic substances is not carried out, and no research progress is made on the pharmacodynamic components which are mainly introduced into blood and the dynamic change rule in the main components. The blood serum of the Xiaojin capsule is preliminarily analyzed, so that the really effective medicinal components in the Xiaojin capsule are found, the components are selected for carrying out pharmacokinetic research, the dynamic change rule in vivo is researched, and a basis is provided for the clinical rational medication of the Xiaojin capsule; meanwhile, the action mechanism of the Xiaojin capsule is clarified at the level of a metabolome, and the preparation method has important significance for determining the action mechanism of the Xiaojin capsule and theoretically explaining the compatibility principle of the Xiaojin capsule, and is a necessary way for re-development of famous Chinese medicine.

Based on the above, the applicant (1) identified 50-100 kinds of chemical components from the drug effect substance basis of the Xiaojin capsule in vitro, and found 15-40 kinds of drug effect components in vivo; (2) the correlation between the Xiaojin capsule and the chemical components of the medicinal materials (artificial musk, cochinchina momordica seed, prepared kusnezoff monkshood root, resina Liquidambaris, frankincense, myrrh, Chinese angelica, trogopterus dung, earthworm and Chinese ink) is researched based on the fingerprint spectrum technology; (3) the in vivo metabolic processes of 5-10 key pharmacodynamic ingredients were studied.

The applicant conducted research on the non-volatile components in the Xiaojin capsules, and identified 158 chemical components in total from the Xiaojin capsules, wherein 29 components were confirmed by standard comparison. Meanwhile, the structural types of the microcapsule are analyzed and summarized, and the microcapsule comprises 28 alkaloids, 43 triterpenic acids, 7 flavonoids, 9 phthalides, 16 phenolic acids, 14 organic acids, 6 phosphorylcholine, 3 amino acids, 3 saccharides, 4 nucleosides, 4 steroids and 19 other types, and the alkaloids are important components of the small gold capsule for exerting the drug effect. Additional studies have shown that: the alkaloid component in the Xiaojin capsule is prepared from radix aconiti kusnezoffii, belongs to C19 type diterpenoid alkaloid, has various biological activities, and has good treatment effect on various diseases such as rheumatism, neuralgia, heart disease, paralysis, skin abscess and the like. Wherein, the aconitine alkaloid compound is the main component in radix Aconiti Kusnezoffii Preparata, the aconitine alkaloid has certain biotoxicity, and intoxication phenomena such as nausea, emesis, dyspnea, heart rate disorder, etc. can be caused by excessive oral administration, and the aconitine alkaloid can be divided into four types according to its structure, which are diester alkaloid (DDA), monoester alkaloid (MDA), and alcohol amine alkaloid (ADA). The biological toxicity is reduced in sequence, DDA has stronger toxicity, MDA and ADA have lower toxicity and good pharmacological activity, researches show that main blood-entering alkaloid components are Senbuxine A, aconitine, isosongorine, lyoxaline, 15-hydroxysinowurtzitine and Deoxyyaconine, and 6 alkaloid prototype components are mostly MDA and ADA type aconitine, which indicates that the processed radix aconiti kusnezoffii can be converted into MDA and ADA from DDA, so that the radix aconiti kusnezoffii has the effects of synergism and attenuation.

The applicant adopts high performance liquid chromatography to determine the fingerprint of 10 batches of small gold capsules, 16 common components are obtained through similarity analysis, the common components are identified and belong to each single medicine, then the common peaks are subjected to cluster analysis, and differences are evaluated, and the final result shows that the main medicinal material causing the differences of the 10 batches of small gold capsules is the liquidambar formosana, so that the aim of controlling the quality of the small gold capsules can be fulfilled by strengthening the quality control of the liquidambar formosana.

Disclosure of Invention

Aiming at the technical problems in the prior art, the invention provides a small gold capsule and a preparation method thereof.

The technical scheme for solving the technical problems is as follows:

the Xiaojin capsule is characterized by comprising the following raw materials in parts by weight: 8-12g of artificial musk, 45-55g of momordica cochinchinensis, 35-42g of prepared kusnezoff monkshood root, 40-45g of resina liquidambaris, 20-30g of frankincense, 20-30g of myrrh, 45-55g of trogopterus dung, 20-30g of angelica, 45-55g of earthworm and 3-5g of Chinese ink.

Preferably, the feed comprises the following raw materials in parts by weight: 10g of artificial musk, 50g of semen momordicae, 38g of prepared kusnezoff monkshood root, 42g of resina liquidambaris, 25g of vinegar frankincense, 25g of vinegar myrrh, 50g of trogopterus dung, 25g of wine angelica, 50g of earthworm and 4g of fragrant ink.

Wherein the processed radix aconiti kusnezoffii is processed radix aconiti kusnezoffii, and the processing of the processed radix aconiti kusnezoffii comprises the following steps: soaking clean radix Aconiti Kusnezoffii Preparata sample in water for 3-7 days, cleaning, adding water until radix Aconiti Kusnezoffii Preparata sample is immersed, decocting for 2-5 hr, taking out, air drying to six days, slicing, and drying.

Preferably, the processing of the radix aconiti kusnezoffii preparata comprises the following steps: soaking clean radix Aconiti Kusnezoffii Preparata sample in water for 4 days, cleaning, adding water until the radix Aconiti Kusnezoffii Preparata sample is immersed, decocting for 4 hr, taking out, air drying to six dry, slicing, and drying.

The momordica cochinchinensis seed is processed momordica cochinchinensis seed, and the processing of the momordica cochinchinensis seed comprises the following steps: weighing semen momordicae raw medicinal materials, mixing with fine sand according to the weight ratio of 1: 3, stir-frying in a frying pan at the sand frying temperature of 280 plus 320 ℃ until the green skin of the kernels falls off and changes color, the kernels are golden yellow and have crisp texture.

Wherein the processing of the frankincense comprises the following steps: removing impurities from the raw materials, crushing the large blocks, and sieving with a 4mm sieve; evenly stirring and moistening with 10% of vinegar, putting into an oven after the vinegar is completely absorbed, placing at a thickness of 1cm and a temperature of 100 ℃ and 120 ℃, and baking for 1 h.

Wherein the processing of the myrrh comprises the following steps: putting clean Myrrha in a pan, parching with slow fire until the surface is slightly melted, spraying rice vinegar, parching until the surface is glossy, and cooling.

Wherein the processing of the angelica comprises the following steps: cleaning radix Angelicae sinensis, sun drying, mixing with Chinese liquor, soaking, parching with slow fire, and air drying.

The invention also provides a preparation method of the Xiaojin capsule, which comprises the following steps:

s1, pulverizing semen Momordicae, radix Aconiti Kusnezoffii Preparata, resina Liquidambaris, Olibanum, Myrrha, Oletum Trogopterori, radix Angelicae sinensis, Lumbricus, and Chinese ink into 30-50 mesh coarse powder respectively to obtain pulverized material;

s2, adding the crushed material in the step S1 into microcrystalline cellulose, and uniformly mixing, wherein the addition amount of the microcrystalline cellulose is 16-18% of the total mass of the crushed material;

s3, crushing the raw materials mixed in the step S2 into fine powder of 100 meshes and 150 meshes again;

s4, adding the ground artificial musk into the fine powder obtained in the step S3, uniformly mixing, and filling into capsules to obtain the musk capsule.

According to the research on the drug effect substance basis of the Xiaojin capsule, the invention adjusts and optimizes the important components in the Xiaojin capsule and optimizes the processing technology, so that the prepared Xiaojin capsule has better drug effect.

Drawings

FIG. 1 is a pathological section of breast tissue of female SD rats: a normal group; b model group.

Detailed Description

The principles and features of this invention are described below in conjunction with specific embodiments, the examples given are intended to illustrate the invention and are not intended to limit the scope of the invention.