CN111840370A

CN111840370A - Oil for treating hand-foot syndrome of tumor patients and preparation method thereof

Info

Publication number: CN111840370A
Application number: CN202010862887.0A
Authority: CN
Inventors: 张丽燕; 孙红; 沈琳; 查云萍
Original assignee: Beijing Cancer Hospital
Current assignee: Zhejiang Haihui Technology Co ltd
Priority date: 2020-08-25
Filing date: 2020-08-25
Publication date: 2020-10-30

Abstract

The invention discloses an oil for treating hand-foot syndrome of tumor patients and a preparation method thereof, wherein the oil comprises, by weight, 20-45 parts of lithospermum, 20-30 parts of sophora flavescens, 15-25 parts of safflower, 10-23 parts of rhizoma corydalis, 8-15 parts of liquorice, 5-12 parts of borneol and 850 parts of oily pharmaceutic adjuvant 700-containing materials. The oil agent provided by the invention overcomes the problems of inconvenient use method, inconvenient medicine preparation, poor moisturizing effect and the like in treatment means in the prior art, and has the advantages of convenience for patients to use, economy and easiness in preparation.

Description

Oil for treating hand-foot syndrome of tumor patients and preparation method thereof

Technical Field

The invention relates to the technical field of traditional Chinese medicines, in particular to a pure traditional Chinese medicine oil for treating hand-foot syndrome of tumor patients and a preparation method thereof.

Background

Chemotherapy and targeted therapy are the main treatment modes for patients with advanced tumors, however, the treatment mode also brings various adverse reactions while controlling tumor progression and prolonging the life of patients, and hand-foot syndrome is one of the common adverse reactions. The hand-foot syndrome is a general name of symptoms of acroanesthesia, dysesthesia, paresthesia, pain, fingerprint disappearance, skin swelling, erythema, desquamation, induration-like blisters and the like of tumor patients who receive chemotherapy or certain targeted therapies, and the symptoms of the patients are as follows: itching, red swelling, numbness, pain, chapping, thickened epidermis, even blister, desquamation, ulceration, secondary infection and other discomforts of hands and feet, serious patients influence the daily life of walking, eating and the like, and patients cannot take care of themselves, are damaged in image and suffer from extreme pain in body and mind. More important, the serious hand-foot syndrome can not be taken continuously, and the tumor treatment effect and prognosis are influenced.

Currently, the treatment means of the hand-foot syndrome are mainly the treatment of venous VitB6 and C0X-2 inhibitor, but the curative effect is limited and the safety risk exists. In addition, there are also external formulations which can be used for treatment, for example:

CN109223859A discloses a pharmaceutical composition for the topical treatment of hand-foot syndrome of tumor patients, which comprises notoginseng, spatholobus stem and dragon's blood.

CN109010775A discloses a traditional Chinese medicine decoction for hand-foot syndrome, which comprises the following raw materials: 10-30g of angelica sinensis, 5-15g of eucommia ulmoides, 5-15g of mangnolia officinalis, 10-30g of dried ginger, 5-20g of astragalus membranaceus, 5-20g of radix angelicae pubescentis, 10-30g of rhizoma notopterygii, 10-30g of garden balsam stem, 5-15g of cassia twig, 5-15g of lycopodium clavatum, 5-15g of rhizoma atractylodis, 5-15g of parasitic loranthus, 5-15g of honeycomb and 5-15g of radix clematidis.

CN108938759A discloses a medicine or daily chemical product composition for treating hand-foot syndrome, which is a preparation prepared from the following raw material medicines in parts by weight: 5-30 parts of ligusticum, 5-30 parts of epimedium, 10-40 parts of cassia twig, 5-30 parts of medicinal cyathula root, 5-30 parts of suberect spatholobus stem, 5-30 parts of red paeony root, 5-30 parts of pseudo-ginseng and 5-30 parts of lithospermum.

However, most of the treatment modes are soaking and washing modes, so that the operation is inconvenient, the clinical observation curative effect is poor, the symptom of the chapping is not relieved but aggravated, and some traditional Chinese medicine extracts in the formula are obtained and prepared in a complex way. Therefore, the search for an economic medicament for treating the hand-foot syndrome of the tumor patients, which has good curative effect and convenient use, has great significance for treating the tumor patients.

Disclosure of Invention

The invention aims to overcome the defects of the background technology and provides a pure traditional Chinese medicine oil for treating the hand-foot syndrome of a tumor patient and a preparation method thereof. The pure traditional Chinese medicine oil is obtained by treating the root cause of the hand-foot syndrome of a patient fundamentally by the observation and the inquiry of the traditional Chinese medicine experts in the oncology department, and the oil can overcome the problems of inconvenient use method, inconvenient medicine preparation, poor moisturizing effect and the like in the treatment means in the prior art. In addition, the invention is practiced in tumor patients, the formula is gradually adjusted according to practical results, and finally the obtained pure traditional Chinese medicine oil has good curative effect, is convenient for patients to use, is economic and is easy to prepare.

In order to achieve the aim of the invention, the pure traditional Chinese medicine oil for treating the hand-foot syndrome of the tumor patients comprises the following raw material medicines in parts by weight: 20-45 parts of lithospermum, 20-30 parts of radix sophorae flavescentis, 15-25 parts of safflower, 10-23 parts of rhizoma corydalis, 8-15 parts of liquorice and 5-12 parts of borneol.

Preferably, the pure traditional Chinese medicine oil for treating the hand-foot syndrome of the tumor patients further comprises 850 parts by weight of oily pharmaceutic adjuvant 700-850 parts.

Preferably, the pure traditional Chinese medicine oil for treating the hand-foot syndrome of the tumor patients consists of 20-45 parts of lithospermum, 20-30 parts of radix sophorae flavescentis, 15-25 parts of safflower, 10-23 parts of rhizoma corydalis, 8-15 parts of liquorice and 5-12 parts of borneol according to weight ratio.

Preferably, in some embodiments of the present invention, the pure traditional Chinese medicine oil for treating hand-foot syndrome of tumor patients comprises, by weight, 20-40 parts of lithospermum erythrorhizon, 20-30 parts of sophora flavescens, 15-25 parts of safflower, 10-20 parts of rhizoma corydalis, 8-15 parts of licorice, 5-10 parts of borneol, and 720-780 parts of oily pharmaceutic adjuvants.

Further preferably, in some embodiments of the present invention, the pure traditional Chinese medicine oil for treating hand-foot syndrome of tumor patients comprises, by weight, 40 parts of lithospermum erythrorhizon, 25 parts of sophora flavescens, 20 parts of safflower, 20 parts of rhizoma corydalis, 10 parts of liquorice, 10 parts of borneol, and 750 parts of oily pharmaceutic adjuvants.

Further preferably, in some embodiments of the present invention, the pure traditional Chinese medicine oil for treating hand-foot syndrome of tumor patients comprises, by weight, 30 parts of lithospermum erythrorhizon, 25 parts of sophora flavescens, 20 parts of safflower, 20 parts of rhizoma corydalis, 10 parts of liquorice, 8 parts of borneol, and 750 parts of oily pharmaceutic adjuvants.

Further preferably, in some embodiments of the present invention, the pure traditional Chinese medicine oil for treating hand-foot syndrome of tumor patients comprises, by weight, 30 parts of lithospermum erythrorhizon, 25 parts of sophora flavescens, 20 parts of safflower carthamus, 15 parts of rhizoma corydalis, 10 parts of liquorice, 10 parts of borneol, and 750 parts of oily pharmaceutic adjuvant.

Further preferably, in some embodiments of the present invention, the oily pharmaceutical excipient is mineral oil or vegetable oil, preferably, the vegetable oil is olive oil, and more preferably, the vegetable oil is edible olive oil.

Further preferably, the licorice of the present invention is raw licorice.

The components in the oil agent can be adjusted in content according to the specific conditions and requirements of patients on the basis of the weight ratio. For example, if the patient has severe chap and wound, the weight part of the lithospermum in each dose is added to 40 parts; for patients with obvious pain (mostly seen in regorafenib patients), the weight portion of rhizoma corydalis in each dose is 20 portions; if the skin of a patient is thin and feels stabbing pain when the ointment is used, the weight part of borneol is increased to 10 parts per dose.

The pure traditional Chinese medicine oil for treating the hand-foot syndrome of the tumor patient can achieve the aim of penetrating pathogenic factors nearby by directly applying the pure traditional Chinese medicine oil on an affected part, and has the effects of clearing heat, cooling blood, detoxifying and relieving pain.

In the formula of the pure traditional Chinese medicine oil, the lithospermum is taken as a monarch drug to play the effects of cooling blood, activating blood and detoxifying. Wherein, the safflower and the lightyellow sophora root are ministerial drugs and respectively play roles in activating blood and dredging channels, dissipating blood stasis and relieving pain, clearing heat and drying dampness, and dispelling wind and relieving itching. Rhizoma corydalis is added to the medicine for promoting blood circulation and relieving pain, and borneol is added to relieve pain locally. The raw licorice root is a guiding drug and has the effects of relieving spasm and pain, harmonizing the drugs, and relieving the toxicity and the pungency of the drugs. The whole formula has the effects of clearing heat and cooling blood, dispelling wind and arresting itching, and activating blood and relieving pain, and has obvious drug effect on hand-foot syndrome caused by tumor chemotherapy drugs, particularly symptoms such as red and swollen hands and feet, pain, chapping, pruritus and the like.

The pure traditional Chinese medicine oil for treating the hand-foot syndrome of the tumor patients can also contain other pharmaceutically acceptable auxiliary materials, and the auxiliary materials can be carriers, diluents, adhesives, lubricants, surfactants or wetting agents and the like.

Furthermore, the pure traditional Chinese medicine oil for treating the hand-foot syndrome of the tumor patients can be further prepared into the following pharmaceutical preparations on the basis of the oil: powders, lozenges, creams, ointments, lotions, gels, emulsions and the like.

The pharmaceutical preparations of the present invention are preferably unit dosage forms which are subdivided into unit doses containing appropriate amounts of the active ingredient, which may be packaged preparations containing discrete amounts of the preparation. Other suitable therapeutic agents may also be included in the medicament, if desired.

On the other hand, the invention also provides a preparation method of the pure traditional Chinese medicine oil for treating the hand-foot syndrome of the tumor patients, and the method comprises the following steps:

(1) weighing lithospermum, radix sophorae flavescentis, safflower, rhizoma corydalis, liquorice, borneol and oily pharmaceutic adjuvants according to the required weight parts;

(2) wrapping radix Arnebiae, radix Sophorae Flavescentis, Carthami flos, rhizoma corydalis and Glycyrrhrizae radix with gauze respectively, placing into a container, adding oily medicinal adjuvants, decocting with strong fire until boiling, and decocting for 7-13 min;

(3) cooling to room temperature, sieving to another container, grinding Borneolum Syntheticum, adding, and mixing.

Further preferably, the container in the step (2) is a marmite.

Further preferably, the strong fire in the step (2) is 350-.

Preferably, the decoction in the step (2) is continued for 10 minutes after the pot is boiled.

Further preferably, the sieving in the step (3) is a 100-mesh sieving.

Further preferably, in the step (3), the container is a glass container.

On the other hand, the invention also provides application of the oil preparation in preparing a medicine for treating the hand-foot syndrome of a tumor patient.

Further preferably, the tumor patient is a tumor patient after radiotherapy, chemotherapy or targeted therapy.

Further preferably, the tumor patient is a patient with advanced tumor.

Preferably, the tumor patients are patients with the hand-foot syndrome, which comprises relieving itching, red swelling, numbness, pain, chapping, thickened epidermis, blister, desquamation, ulceration or secondary infection of the hand-foot.

The pure traditional Chinese medicine oil for treating the hand-foot syndrome of the tumor patients is a pure traditional Chinese medicine preparation, can be externally applied, is convenient for the patients to use, has good safety, has good moisturizing effect of the oil, is easy to obtain materials in the formula, has low cost and convenient decoction, and can be prepared and used by the majority of patients.

Drawings

FIG. 1 shows the appearance of a tumor patient before and after treating hand-foot syndrome with the pure Chinese medicinal oil of the embodiment 1 of the invention;

FIG. 2 is the appearance of a tumor patient before and after treating hand-foot syndrome with the pure Chinese medicinal oil of the embodiment 2 of the invention;

FIG. 3 shows the appearance of the affected parts before and after the treatment of hand-foot syndrome by the tumor patients with the pure Chinese medicinal oil of the embodiment 3 of the invention.

Detailed Description

In order to make the objects, technical solutions and advantages of the present invention more apparent, the present invention is described in further detail below with reference to the accompanying drawings and embodiments. Additional aspects and advantages of the invention will be set forth in part in the description which follows and, in part, will be obvious from the description, or may be learned by practice of the invention. It is to be understood that the following description is only illustrative of the present invention and is not to be construed as limiting the present invention.

The terms "comprises," "comprising," "includes," "including," "has," "having," "contains," "containing," or any other variation thereof, as used herein, are intended to cover a non-exclusive inclusion. For example, a composition, process, method, article, or apparatus that comprises a list of elements is not necessarily limited to only those elements but may include other elements not expressly listed or inherent to such composition, process, method, article, or apparatus.

When an amount, concentration, or other value or parameter is expressed as a range, preferred range, or as a range of upper preferable values and lower preferable values, this is to be understood as specifically disclosing all ranges formed from any pair of any upper range limit or preferred value and any lower range limit or preferred value, regardless of whether ranges are separately disclosed. For example, when a range of "1 to 5" is disclosed, the described range should be interpreted to include the ranges "1 to 4", "1 to 3", "1 to 2 and 4 to 5", "1 to 3 and 5", and the like. When a range of values is described herein, unless otherwise stated, the range is intended to include the endpoints thereof and all integers and fractions within the range.

Furthermore, the description below of the terms "one embodiment," "some embodiments," "an example," "a specific example," or "some examples" or the like means that in the present specification described in connection with the embodiment or example, schematic representations of the above terms do not necessarily refer to the same embodiment or example.

Further, the technical features of the embodiments of the present invention may be combined with each other as long as they do not conflict with each other. The components in the oil agent can be adjusted in content according to the specific conditions and requirements of patients on the basis of the weight ratio. For example, if the patient has severe chap and wound, the dosage of the lithospermum in each dose is increased to 40 g; for patients with obvious pain (mostly seen in regorafenib patients), the dosage of rhizoma corydalis in each dose is 20 g; if the skin of a patient is thin, the patient feels stabbing pain when using the ointment, and the dosage of borneol is increased to 10g in each dose.

Example 1

A pure traditional Chinese medicine oil for treating hand-foot syndrome of tumor patients comprises 40g of lithospermum, 25g of radix sophorae flavescentis, 20g of safflower, 20g of rhizoma corydalis, 10g of raw liquorice, 10g of borneol and 750g of edible olive oil.

The preparation method comprises the following steps:

(1) preparing lithospermum, radix sophorae flavescentis, safflower, rhizoma corydalis, raw liquorice, borneol and edible olive oil according to the material ratio, and respectively storing the lithospermum, the radix sophorae flavescentis, the safflower, the rhizoma corydalis, the raw liquorice, the borneol and the edible olive oil separately for later use;

(2) wrapping the lithospermum, the radix sophorae flavescentis, the safflower, the rhizoma corydalis and the raw liquorice prepared in the step (1) with gauze respectively to prevent the edible olive oil from being polluted, putting the edible olive oil into a marmite, adding the edible olive oil, decocting the mixture for 10 minutes after boiling the mixture with strong fire at the temperature of 380 ℃ in 350-;

(3) cooling to room temperature, sieving with 100 mesh sieve, pouring into glass container to obtain final product of 400-500ml, and grinding Borneolum Syntheticum and mixing.

Example 2

A pure traditional Chinese medicine oil for treating hand-foot syndrome of tumor patients comprises 30g of lithospermum, 25g of radix sophorae flavescentis, 20g of safflower, 20g of rhizoma corydalis, 10g of raw liquorice, 8g of borneol and 750g of oily pharmaceutic adjuvant.

The preparation method comprises the following steps:

Example 3

A pure traditional Chinese medicine oil for treating hand-foot syndrome of tumor patients comprises 30g of lithospermum, 25g of radix sophorae flavescentis, 20g of safflower, 15g of rhizoma corydalis, 10g of raw liquorice, 10g of borneol and 750g of oily pharmaceutic adjuvant.

The preparation method comprises the following steps:

Example 4

A pure traditional Chinese medicine oil for treating hand-foot syndrome of tumor patients comprises 30g of lithospermum, 25g of radix sophorae flavescentis, 20g of safflower, 15g of rhizoma corydalis, 10g of raw liquorice, 7g of borneol and 750g of oily pharmaceutic adjuvant.

The preparation method comprises the following steps:

Effects of the embodiment

Study subjects: 2019.7-2020.6 were selected to be diagnosed with tumor patients at Beijing university tumor Hospital. The grouping standard is as follows: the age is more than or equal to 18 years old; histopathology confirmed malignant tumors; capecitabine or regorafenib drugs are applied; hand-foot syndrome occurs according to the NCI4.0 standard; willing to participate in the study; the patients with disturbance of consciousness are excluded, and the patients who use other medicines for treating the pedicure syndrome and the patients who stop using capecitabine or Ruigmanib medicines halfway are also excluded.

A total of 40 patients who were finally enrolled and completed the trial, 20 of them with capecitabine, 20 with regorafenib, aged average (56.15 ± 11.83) years, 19 with intestinal cancer, 15 with gastric cancer, 6 with interstitial tumors. The average disease duration (6.1 +/-2.9) months, and the treatment period is (5.6 +/-2.1) times. Mainly married (92.5%), Han nationality (97.5%), high school and college university calendar (67%), retirement (73%).

The research method comprises the following steps: the group consisted of 1 cancer department of traditional Chinese medicine, 1 digestive department of medical science and 2 nurses with experience of traditional Chinese medicine work for more than 15 years. After a nurse evaluates that a patient meets the condition of entering the group, the nurse provides a prescription after the patient is diagnosed by a main department of traditional Chinese medicine (the prescription is mainly the prescription in examples 1-4, the prescription can fluctuate within the proportion range of each component of the prescription, the main fluctuation is that people with severe chap and wound can add 40g of lithospermum in each dose, people with obvious pain can add 20g of rhizoma corydalis in each dose, if the skin of the patient is thin, the patient feels stabbing pain when using the prescription, the weight of borneol is added to 10g in each dose), the nurse takes the medicine, boils the traditional Chinese medicine according to requirements and sends the medicine to the patient, guides the patient to be soaked in warm water to wash hands and feet, evenly coats the oil twice a day, and packs 10-30ml each time according to the size of the wound for half an hour by using a preservative film to promote absorption.

The level of hand-foot syndrome and the relief of discomfort symptoms were assessed at the time of dispensing the oil and after 7-14 days. The evaluation tools are as follows.

Criteria for the NCI classification of hand-foot syndrome: level 0, completely normal; first, minor skin changes or dermatitis (e.g., erythema, desquamation) with paresthesia (e.g., numbing, stinging, burning) without affecting daily activities; secondly, the skin changes are accompanied by pain, daily activities are slightly affected, and the skin surface is complete; third, ulcerative dermatitis or skin changes, with severe pain, severely affects daily life, with significant tissue damage (e.g., desquamation, blisters, bleeding, edema).

The research results are as follows: all patients have different degrees of hand-foot syndrome when the patients are put into the group, and the symptoms of the patients such as dry crack, pain, swelling, ulceration and the like are obviously relieved after the intervention. Referring to NCI4.0 standard, 28 (70%) of 40 patients with hand-foot syndrome healed, with the capecitabine group accounting for 75% and the regorafenib group accounting for 65%. Patients of other grades are also reduced in different degrees, the traditional Chinese medicine formula has a remarkable improvement effect on the hand-foot syndrome of the patients, P is less than 0.01, and the details are shown in Table 1.

TABLE 1 symptoms before and after administration of the pure Chinese medicinal oil of the present invention to patients with hand-foot syndrome (calculated by SPSS20.0 software)

It will be understood by those skilled in the art that the foregoing is only a preferred embodiment of the present invention, and is not intended to limit the invention, and that any modification, equivalent replacement, or improvement made within the spirit and principle of the present invention should be included in the scope of the present invention.

Claims

1. The oil agent is characterized by comprising the following raw material medicines in percentage by weight: 20-45 parts of lithospermum, 20-30 parts of radix sophorae flavescentis, 15-25 parts of safflower, 10-23 parts of rhizoma corydalis, 8-15 parts of liquorice and 5-12 parts of borneol.

2. The oil agent as claimed in claim 1, wherein the oil agent further comprises 850 parts by weight of oily pharmaceutic adjuvants 700.

3. The oil agent as claimed in claim 2, wherein the oil agent comprises, by weight, 20-40 parts of lithospermum erythrorhizon, 20-30 parts of sophora flavescens, 15-25 parts of safflower, 10-20 parts of rhizoma corydalis, 8-15 parts of liquorice, 5-10 parts of borneol, and 720-780 parts of oily pharmaceutical excipients.

4. An oil agent according to claim 3, wherein the oil agent comprises, by weight, 30 parts of lithospermum erythrorhizon, 25 parts of sophora flavescens, 20 parts of safflower carthamus, 20 parts of rhizoma corydalis, 10 parts of liquorice, 8 parts of borneol and 750 parts of oily pharmaceutic adjuvants.

5. The oil agent according to claim 3, which comprises 30 parts by weight of lithospermum erythrorhizon, 25 parts by weight of sophora flavescens, 20 parts by weight of safflower carthamus, 15 parts by weight of rhizoma corydalis, 10 parts by weight of raw licorice, 10 parts by weight of borneol and 750 parts by weight of oily pharmaceutic adjuvant.

6. An oil as claimed in any one of claims 1 to 5, wherein the oily pharmaceutical excipient is a vegetable oil, preferably olive oil.

7. A process for the preparation of an oil as claimed in any one of claims 1 to 6, characterized in that it comprises the following steps:

(2) wrapping radix Arnebiae, radix Sophorae Flavescentis, Carthami flos, rhizoma corydalis and Glycyrrhrizae radix with gauze respectively, placing into a container, adding oily medicinal adjuvants, decocting at 380 deg.C at 350-;

8. The method for preparing the oil agent according to claim 7, wherein the decocting in the step (2) is continued for 10 minutes after the boiling.

9. Use of an oil according to any one of claims 1-6 in the preparation of a medicament for the treatment of extremity syndrome in a patient with a tumor.

10. The use of the oil of claim 9 in the preparation of a medicament for the treatment of a tumor-associated hand and foot syndrome, wherein said treatment of a tumor-associated hand and foot syndrome comprises the relief of itching, redness, numbness, pain, chapping, thickening of the epidermis, blisters, desquamation, ulceration or secondary infection of the hand and foot.